ORIGINAL ARTICLE
Long-term Outcome of Primary Closure After Laparoscopic Common Bile Duct Exploration Combined With Choledochoscopy Hee Jung Yi, MD, Geun Hong, MD, Seog Ki Min, MD, and Hyeon Kook Lee, MD, PhD
Background: Primary closure after laparoscopic common bile duct exploration (LCBDE) is considered to be a safe alternative to Ttube drainage on the basis of the short-term outcome. However, little published data exist regarding the biliary complications at the long-term follow-up of primary closure versus T-tube drainage following LCBDE. Hence, the aim of this study is to assess the long-term outcome of primary closure after LCBDE. Materials and Methods: This is a retrospective study of 142 consecutive patients who underwent LCBDE combined with choledochoscopy for CBD stones. After LCBDE, the choledochotomy was closed by primary closure (group P) in 91 patients (64.1%) and with T-tube drainage (group T) in 51 patients (35.9%). The data on operative outcome and long-term biliary complications were compared between the 2 groups. Results: The mean operation time was significantly shorter in group P than group T (168.9 ± 50.1 min for group P vs. 198.0 ± 59.6 min for group T, P = 0.002). The hospital stay was significantly shorter in group P than in group T (8.59 ± 6.0 d for group P vs. 14.96 ± 5.4 d for group T, P = 0.001). Postoperative bile leak occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T. With a mean follow-up of 48.8 months, the stone recurrence rate in group P and group T were 4.4% and 5.9%, respectively (P = 0.722). During the follow-up period, there was no sign of biliary stricture or other biliary complications in both groups. Conclusions: The long-term follow-up data on primary closure after LCBDE indicated a low incidence of recurrent stones, and no biliary strictures. Thus, primary closure after LCBDE with choledochoscopy is considered to be a safe and effective alternative to T-tube drainage in terms of long-term outcome. Key Words: laparoscopic common bile duct exploration, primary closure, choledochoscopy
(Surg Laparosc Endosc Percutan Tech 2015;25:250–253)
C
ommon bile duct (CBD) stones are detected in 10% to 18% of patients undergoing laparoscopic cholecystectomy for gallbladder stones.1 Endoscopic and laparoscopic treatment of CBD stones are the well-known minimally invasive treatment options. Endoscopic retrograde cholangiopancreatography (ERCP) remains the preferred approach for managing suspected CBD stones.
Received for publication July 26, 2014; accepted March 2, 2015. From the Department of Surgery, Ewha Womans University School of Medicine, Seoul, Korea. The authors declare no conflicts of interest. Reprints: Hyeon Kook Lee, MD, PhD, Ewha Womans University Mokdong Hospital, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 158-710, Korea (e-mail: [email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
250 | www.surgical-laparoscopy.com
However, ERCP is associated with serious complications such as pancreatitis, hemorrhage, cholangitis, duodenal perforation (5% to 11%), and mortality of up to 1%.2,3 Laparoscopic common bile duct exploration (LCBDE) has the advantage of managing CBD stones associated with gallbladder stone by single-stage procedure and avoidance of ERCP.4–6 LCBDE can be performed either by transcystic or by choledochotomy approach, depending upon the size and location of the stones.7–9 LCBDE by choledochotomy has the advantage that it can provide unrestricted access to both the CBD and the common hepatic duct, enabling access to more difficult stones.10 As laparoscopic choledochotomy may increase the risk of postoperative bile leak, T-tube drainage of CBD has been widely used based on the experience of open CBD exploration. However, there are numerous reports on the complications associated with T-tube drainage.11–13 Recent systemic reviews showed that primary closure of the CBD alone is superior to T-tube drainage on the basis of the short-term outcome.14,15 However, little published data exist regarding the biliary complications at long-term follow-up of primary closure versus T-tube drainage after LCBDE by choledochotomy. Therefore, the aim of this study is to assess the long-term outcomes of primary closure after LCBDE with the use of choledochoscope.
MATERIALS AND METHODS This is a retrospective study of 142 consecutive patients who underwent LCBDE by choledochotomy for CBD stones from January 2000 to December 2011. The diagnosis of CBD stones was based on image studies such as ultrasonography, computed tomography (CT), ERCP, and magnetic resonance cholangiopancreatography (MRCP) with supporting laboratory test results. The diameter of CBD was measured based on the images of CT, ERCP, and MRCP. Laparoscopic choledochotomy approach was indicated only when the CBD diameter based on image studies was Z8 mm. In the early part of this series, the CBD is routinely closed with T-tube after laparoscopic choledochotomy to minimize the risk of bile leak and provide percutaneous access for cholangiography and extraction of residual stones. However, T-tube drainage showed no benefit in our previous study.16 Currently, most choledochotomy incisions are done with primary closure. A T-tube is inserted at the surgeon’s discretion in the setting of residual stones. After LCBDE, the choledochotomy was closed by primary closure without drainage (group P) in 91 patients (64.1%) and with T-tube drainage (group T) in 51 patients (35.9%). The data on demographics, operative outcomes, postoperative complications, recurrence rate of CBD
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stones, and long-term biliary complications were collected and analyzed for comparison between the 2 groups. Mean follow-up period was 48.8 months (range, 6 to 153 mo).
Primary Closure After Laparoscopic Choledochotomy
TABLE 1. Characteristics of Patients Who Underwent LCBDE by Choledochotomy for CBD Stones
P Group
Operative Techniques After a patient was placed in the supine position 3 trocars were inserted in umbilical, medial epigastric, and right anterior axillary line, respectively, as usual. The fourth 10 mm trocar was inserted in right midclavicular area for the choledochoscope. After the dissection of the gallbladder-cystic duct junction, the cystic duct was clipped. The dissection continued to expose the cystic duct-CBD junction and the anterior surface of the CBD. The longitudinal choledochotomy is made in the anterior aspect of the CBD. After the choledochotomy, stones were pushed out through the opening by manipulating the CBD using blunt forceps and applying saline irrigation. Then, a flexible choledochoscope was routinely used to examine distal and proximal bile duct. The extraction of stones was done using a stone basket, a balloon catheter, and electrohydraulic lithotripsy through the working channel of the choledochoscope. After all stones were removed, the clearance of the intrahepatic/extrahepatic bile duct was confirmed with the flexible choledochoscope. Intraoperative cholangiography (IOC) was not performed. The choledochotomy incision was primarily closed with continuous suture using Vicryl 3-0 suture material. For patients who underwent T-tube drainage, a T-tube of 16 Fr was inserted into the choledochotomy incision site, which was then secured with same suture. A closed suction drain was placed on Morison’s pouch. The T-tube was removed 2 weeks postoperatively, after the absence of stones with T-tube cholangiography was confirmed. At 3 or 6 months follow-up, physical examination and laboratory tests were performed on the patients. Imaging studies such as ultrasonography and CT were performed if there were abnormal findings on the physical examination and laboratory tests.
Statistical Analysis Statistical analysis was performed using SPSS 20.0 software (IBM Co., Armonk, NY). The w2 test was used for comparing categorical variables. Continuous variables were expressed as mean ± SD and comparisons of data were performed with the Student t test or the Fisher exact test, where appropriate. Variables were considered significant with P < 0.05.
T Group
No. patients 91 51 Age (mean ± SD) (y) 67.25 ± 15.78 65.51 ± 15.25 Sex [n (%)] Male 45 (49.5) 29 (56.9) Female 46 (50.5) 22 (43.1) Comorbidity 47 (51.7) 18 (35.3) Cardiovascular disease 40 16 Diabetes mellitus 14 8 Liver disease 6 0 Pulmonary disease 8 2 Others 2 3 Obstructive jaundice [n (%)] 45 (49.5) 34 (66.7) ASA score [n (%)] 1 6 (6.6) 6 (11.8) 2 74 (81.3) 27 (52.9) 3 9 (9.9) 8 (15.7) Abdominal operation history 13 (14.3) 7 (13.7) [n (%)]
P 0.524 0.484 0.216
0.053 0.869
1.000
ASA indicates American Society of Anesthesiologist; CBD, common bile duct; LCBDE, laparoscopic common bile duct exploration.
shorter in group P than in group T (8.59 ± 6.0 d for group P vs. 14.96 ± 5.4 d for group T, P = 0.001). There was no difference in postoperative complications between group P and group T. Postoperative bile leak occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T (Table 2). All patients with bile leakage in both groups recovered through conservative management with drainage.
Long-term Results With a mean follow-up period of 48.8 months, recurrent CBD stones developed in 7 patients (5.3%) of 142 patients who had no residual stones. The recurrent stone rate in group P and group T were 4.4% and 5.9%, respectively, which were not significantly different (P = 0.722). The late recurrence, 24 months postoperatively, occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T (Table 3). ERCP was used to remove recurrent CBD stones in 4 patients and hepaticojejunostomy was performed in 3 patients. During the follow-up period, there was no sign of biliary stricture or other biliary complications in both groups.
DISCUSSION RESULTS Short-term Results There were no significant differences regarding demographic and clinical characteristics between the 2 groups (Table 1). The mean size of CBD was 14.2 ± 5.7 mm in group P and 15.2 ± 6.9 mm in group T, which was not significantly different between 2 groups. Conversions to open surgery were done in 3 patients (3.3%) in group P and 2 patients (3.9%) in group T (P = 1.000). The reasons for conversion were severe adhesion, CBD injury, and CBD stricture. Stone clearance rates were not significantly different between 2 groups (100% for group P vs. 98.0% for group T, P = 0.359). The mean operation time was significantly shorter in group P than group T (168.9 ± 50.1 min for group P vs. 198.0 ± 59.6 min for group T, P = 0.002). The hospital stay was significantly Copyright
r
This study showed the long-term outcome on primary closure after LCBDE with a low incidence of recurrent stones, and no biliary strictures. This result suggests that primary closure after LCBDE is a safe alternative to T-tube drainage in terms of the long-term outcome and hence the routine use of a T-tube may no longer be justified. LCBDE has the advantage of managing CBD stones associated with gallbladder stone by single-stage procedure and, therefore, ERCP can be avoided.17–19 LCBDE can be performed either through the transcystic approach or the choledochotomy approach. A prospective study showed the stone clearance rate higher in choledochotomy group (91.9%) than in transcystic group (66.6%) with no significant difference in the complication rate.20 In addition, some studies reported that a transcystic approach was not very satisfactory in achieving complete clearance of the CBD.4,7,14 Considering these results, the transcystic
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Yi et al
TABLE 2. Comparison of the Operative Outcome Following LCBDE
Open conversion [n (%)] Stone clearance [n (%)] Mean operation time (min) Postoperative hospital stay (day) Complications [n (%)] Bile leakage Bleeding Pneumonia
P Group (N = 91)
T Group (N = 51)
P
3 (3.3) 91 (100) 168.9 ± 50.1
2 (3.9) 50 (98.0) 198.0 ± 59.6
1.000 0.359 0.002
8.59 ± 6.0
14.96 ± 5.4
0.001
3 (3.3) 2 0 1
1 (2.0) 1 0 0
0.654
LCBDE indicates laparoscopic common bile duct exploration.
approach has limitations related to size and location of stone. In this study, LCBDE by choledochotomy had the stone clearance rate of 99.3% and low operative complication rate of 2.8%, and these results also support the advantage of laparoscopic choledochotomy approach. However, laparoscopic choledochotomy can be associated with the risk of bile leak. On the basis of the experience of open CBD exploration, T-tube drainage of CBD has been used to decompress the biliary tree, to reduce the risk of bile leak and to extract any residual stones through the T-tube tract. Despite these potential advantages, T-tube drainage was associated with morbidities including fluid and electrolyte disturbances, sepsis, localized pain, persistent biliary fistulas, late biliary stricture, and prolonged hospital stay.21–24 Previous studies comparing postoperative bile leak after primary closure versus T-tube drainage showed that the differences between the 2 groups were not significant, which were similar to our finding.25,26 These results indicate that T-tube drainage does not prevent bile leaks after LCBDE. A recent systematic review comparing short-term outcome of primary closure with that of T-tube drainage after LCBDE showed that T-tube drainage may increase the operating time and hospital stay and other complication rates were comparable between 2 groups.14 These findings are consistent with experience of this study. Most of T-tube drainage after LCBDE was adopted in the early part of this series and laparoscopic choledochotomies currently are performed with primary closure. A choledochoscopy enables complete stones clearance and makes sure no residual stone before primary closure. This study has shown that the stone clearance rate is almost 100% by the use of flexible choledochoscopy without IOC. IOC has been widely used to find unexpected stone with negative TABLE 3. Comparison of the Long-term Follow-up Result Between Primary Closure and T-tube Drainage Groups After LCBDE
P Group
T Group
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results in CBD by preoperative ultrasonography. However, in this study, IOC was not used because CBD stones were confirmed with ERCP or MRCP before operation. A study by Topal et al27 comparing flexible choledochoscopy with IOC showed that the duration of LCBDE with flexible choledochoscope was significantly shorter with no difference regarding stone clearance, morbidity, and length of hospital stay. These results suggest that the use of a flexible choledochoscope is preferable to fluoroscopic guidance and the routine use of IOC may not be necessary for LCBDE. As mentioned, many studies that compared primary closure with T-tube drainage after LCBDE focused on the short-term outcome. However, to fully assess the effect of T-tube drainage versus primary closure after LCBDE, longterm follow-up data regarding recurrence of CBD stones and bile duct stricture are necessary. The rate of recurrent stones following LCBDE has been reported in up to 6%.4,28,29 A study by Zhang et al30 showed that with a median follow-up of 40 months, stone recurrence rate was 2% in primary closure and 3.26% in T-tube drainage (P = 0.672). In this study, the rates of recurrent stone in primary closure and T-tube drainage group were 4.4% and 5.9%, respectively, and not significantly different between 2 groups, although mean follow-up time was longer in T-tube drainage group (Table 3). These data show that T-tube drainage does not prevent the recurrence of CBD stones. Long-term biliary complications such as bile duct stricture can become a major concern for patients who undergo LCBDE by choledochotomy. Cai et al showed no biliary stricture in both primary closure and T-tube drainage after LCBDE by longitudinal choledochotomy at median followup of 26 months.21 Khaled et al10 reported CBD stricture in 1 (0.8%) of 120 patients with primary closure following LCBDE through a transverse choledochotomy at median follow-up of 39.2 months. In this study, long-term biliary complications such as biliary stricture did not occur in either primary closure or T-tube drainage group after LCBDE by longitudinal choledochotomy. Biliary stricture following LCBDE seems to rarely occur regardless of a transverse or longitudinal choledochotomy. These results reveal that primary closure after LCBDE can be performed without increased risk of long-term complications such as bile duct stricture. In conclusion, LCBDE with use of flexible choledochoscope was satisfactory in achieving complete stone clearance. Primary closure after LCBDE showed shorter operative time and hospital stay compared with T-tube drainage. Long-term follow-up data on primary closure after LCBDE indicated a low incidence of recurrent stones, and no biliary strictures. Thus, primary closure after LCBDE with flexible choledochoscope is considered to be a safe and effective alternative to T-tube drainage with acceptable long-term outcome, as well as short-term outcome.
P
Mean follow-up period (mo) 41.3 ± 23.6 59.7 ± 52.62 0.022 Recurrence [n (%)] 4 (4.4) 3 (5.9) 0.722 Early recurrence (< 24 mo) 2 (2.2) 1 (2.0) Late recurrence (Z24 mo) 2 (2.2) 2 (3.9) Long-term biliary complication 0 0 Biliary stricture 0 0 LCBDE indicates laparoscopic common bile duct exploration.
REFERENCES 1. Dasari BV, Tan CJ, Gurusamy KS, et al. Surgical versus endoscopic treatment of bile stones. Cochrane Database Syst Rev. 2013;12:CD003327. 2. Coelho-Prabhu N, Shah ND, Van Houten H, et al. Endoscopic retrograde cholangiopancreatography: utilization and outcomes in a 10-year population-based cohort. BMJ Open. 2013;3:e002689.
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3. Schreurs WH, Juttmann JR, Stuifbergen WN, et al. Management of common bile duct stones. Surg Endosc. 2002;16: 1068–1072. 4. Paganini AM, Guerrieri M, Sarnari J, et al. Long-term results after laparoscopic transverse choledochotomy for common bile duct stones. Surg Endosc. 2005;19:705–709. 5. Nathason LK, O’Rourke NA, Martin IJ, et al. Post operative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: a randomized trial. Ann Surg. 2005;242:188–192. 6. Ricardi R, Islam S, Canete JJ, et al. Effectiveness and longterm results of laparoscopic common bile duct exploration. Surg Endosc. 2003;17:19–22. 7. Paganini AM, Guerrieri M, Sarnari J, et al. Thirteen year’s experience with laparoscopic transcystic common bile duct exploration for stones. Surg Endosc. 2007;21:34–40. 8. Thompson MH, Tranter SE. All-comers policy for laparoscopic exploration of the common bile duct. Br J Surg. 2002;89:1608–1612. 9. Waage A, Stro¨mberg C, Leijonmarck CE, et al. Long-term results from laparoscopic common bile duct exploration. Surg Endosc. 2003;17:1181–1185. 10. Khaled YS, Malde DJ, de Souza C, et al. Laparoscopic bile duct exploration via choledochotomy followed by primary duct closure is feasible and safe for the treatment for choledocholithiasis. Surg Endosc. 2013;27:4164–4170. 11. Ahmed I, Pradhan C, Beckingham IJ, et al. Is a T-tube necessary after common bile duct exploration? World J Surg. 2008;32:1485–1488. 12. Abella´n Morcillo I, Qurashi K, Abrisqueta Carrio´n J, et al. Laparoscopic common bile duct exploration. Lessons learned after 200 cases. Cir Esp. 2014;92:341–347. 13. Ahmed M, Diggory RT. Case-based review: bile peritonitis after T-tube removal. Ann R Coll Surg Engl. 2013;95:383–385. 14. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after laparoscopic common bile duct exploration (review). Cochrane Database Syst Rev. 2013;6:CD005641. 15. Yin Z, Xu K, Sun J, et al. Is the end of the T-tube drainage era in laparoscopic choledochotomy for common bile duct stones is coming? Ann Surg. 2013;257:54–66. 16. Noh KT, Min SK, Lee HK. Comparison of primary closure and T-tube drainage following laparoscopic CBD exploration. J Korean Surg Soc. 2009;77:399–403. 17. Koc B, Karahan S, Adas G, et al. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013;206:457–463.
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Primary Closure After Laparoscopic Choledochotomy
18. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC + LCBDE vs. ERCP/S + LC for common bile duct stone disease. Arch Surg. 2010;134:28–33. 19. Noble H, Tranter S, Chesworth T, et al. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. Laparoendosc Adv Surg Tech A. 2009;19:713–720. 20. Jameel M, Darmas M, Baker AL, et al. Trend towards primary closure following laparoscopic exploration of the common bile duct. Ann R Coll Surg Engl. 2008;90:29–35. 21. Cai H, Sun Y, Bai J, et al. Primary closure following laparoscopic common bile duct exploration combined with intraoperative cholangiography and choledochoscopy. World J Surg. 2013;36:164–170. 22. Leida Z, Ping B, Shuguang W, et al. A randomized comparison of primary closure and T-tube drainage of common bile duct after laparoscopic choledochotomy. Surg Endosc. 2008;22: 1595–1600. 23. Wills VL, Gibson K, Karihaloot C, et al. Complications of biliary T-tube after choledochotomy. ANZ J Surg. 2002; 72:177–180. 24. Martin IJ, Bailey IS, Rhodes M, et al. Towards T-tube free laparoscopic bile duct exploration: a methodologic evolution during 300 consecutive procedures. Ann Surg. 1998;228:29–34. 25. Wu X, Yang Y, Dong P, et al. Primary closure versus T tube drainage in laparoscopic common bile duct exploration: a meta- analysis of randomized clinical trial. Langenbecks Arch Surg. 2012;397:909–916. 26. Zhu QD, Tao CL, Zhou MT, et al. Primary closure versus Ttube drainage after common bile duct exploration for choledocholithiasis. Langenbecks Arch Surg. 2011;396:53–62. 27. Topal B, Aerts R, Penninckx F. Laparoscopic common bile duct stone clearance with flexible choledochoscopy. Surg Endosc. 2007;21:2317–2321. 28. Dong ZT, Wu GZ, Luo KL, et al. Primary closure after laparoscopic common bile duct exploration versus T-tube. J Surg Res. 2014;189:249–254. 29. Lee HM, Min SK, Lee HK. Long-term results of laparoscopic common bile duct exploration by choledochotomy for choledocholithiasis: 15-year experience from a single center. Ann Surg Treat Res. 2014;86:1–6. 30. Zhang HW, Chen YJ, Wu CH, et al. Laparoscopic common bile duct exploration with primary closure for management of choledocholithiasis: a retrospective analysis and comparison with conventional T-tube drainage. Am Surg. 2014;80: 178–181.
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Long-term Outcome of Primary Closure After Laparoscopic Common Bile Duct Exploration Combined With Choledochoscopy Hee Jung Yi, MD, Geun Hong, MD, Seog Ki Min, MD, and Hyeon Kook Lee, MD, PhD
Background: Primary closure after laparoscopic common bile duct exploration (LCBDE) is considered to be a safe alternative to Ttube drainage on the basis of the short-term outcome. However, little published data exist regarding the biliary complications at the long-term follow-up of primary closure versus T-tube drainage following LCBDE. Hence, the aim of this study is to assess the long-term outcome of primary closure after LCBDE. Materials and Methods: This is a retrospective study of 142 consecutive patients who underwent LCBDE combined with choledochoscopy for CBD stones. After LCBDE, the choledochotomy was closed by primary closure (group P) in 91 patients (64.1%) and with T-tube drainage (group T) in 51 patients (35.9%). The data on operative outcome and long-term biliary complications were compared between the 2 groups. Results: The mean operation time was significantly shorter in group P than group T (168.9 ± 50.1 min for group P vs. 198.0 ± 59.6 min for group T, P = 0.002). The hospital stay was significantly shorter in group P than in group T (8.59 ± 6.0 d for group P vs. 14.96 ± 5.4 d for group T, P = 0.001). Postoperative bile leak occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T. With a mean follow-up of 48.8 months, the stone recurrence rate in group P and group T were 4.4% and 5.9%, respectively (P = 0.722). During the follow-up period, there was no sign of biliary stricture or other biliary complications in both groups. Conclusions: The long-term follow-up data on primary closure after LCBDE indicated a low incidence of recurrent stones, and no biliary strictures. Thus, primary closure after LCBDE with choledochoscopy is considered to be a safe and effective alternative to T-tube drainage in terms of long-term outcome. Key Words: laparoscopic common bile duct exploration, primary closure, choledochoscopy
(Surg Laparosc Endosc Percutan Tech 2015;25:250–253)
C
ommon bile duct (CBD) stones are detected in 10% to 18% of patients undergoing laparoscopic cholecystectomy for gallbladder stones.1 Endoscopic and laparoscopic treatment of CBD stones are the well-known minimally invasive treatment options. Endoscopic retrograde cholangiopancreatography (ERCP) remains the preferred approach for managing suspected CBD stones.
Received for publication July 26, 2014; accepted March 2, 2015. From the Department of Surgery, Ewha Womans University School of Medicine, Seoul, Korea. The authors declare no conflicts of interest. Reprints: Hyeon Kook Lee, MD, PhD, Ewha Womans University Mokdong Hospital, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul 158-710, Korea (e-mail: [email protected]). Copyright r 2015 Wolters Kluwer Health, Inc. All rights reserved.
250 | www.surgical-laparoscopy.com
However, ERCP is associated with serious complications such as pancreatitis, hemorrhage, cholangitis, duodenal perforation (5% to 11%), and mortality of up to 1%.2,3 Laparoscopic common bile duct exploration (LCBDE) has the advantage of managing CBD stones associated with gallbladder stone by single-stage procedure and avoidance of ERCP.4–6 LCBDE can be performed either by transcystic or by choledochotomy approach, depending upon the size and location of the stones.7–9 LCBDE by choledochotomy has the advantage that it can provide unrestricted access to both the CBD and the common hepatic duct, enabling access to more difficult stones.10 As laparoscopic choledochotomy may increase the risk of postoperative bile leak, T-tube drainage of CBD has been widely used based on the experience of open CBD exploration. However, there are numerous reports on the complications associated with T-tube drainage.11–13 Recent systemic reviews showed that primary closure of the CBD alone is superior to T-tube drainage on the basis of the short-term outcome.14,15 However, little published data exist regarding the biliary complications at long-term follow-up of primary closure versus T-tube drainage after LCBDE by choledochotomy. Therefore, the aim of this study is to assess the long-term outcomes of primary closure after LCBDE with the use of choledochoscope.
MATERIALS AND METHODS This is a retrospective study of 142 consecutive patients who underwent LCBDE by choledochotomy for CBD stones from January 2000 to December 2011. The diagnosis of CBD stones was based on image studies such as ultrasonography, computed tomography (CT), ERCP, and magnetic resonance cholangiopancreatography (MRCP) with supporting laboratory test results. The diameter of CBD was measured based on the images of CT, ERCP, and MRCP. Laparoscopic choledochotomy approach was indicated only when the CBD diameter based on image studies was Z8 mm. In the early part of this series, the CBD is routinely closed with T-tube after laparoscopic choledochotomy to minimize the risk of bile leak and provide percutaneous access for cholangiography and extraction of residual stones. However, T-tube drainage showed no benefit in our previous study.16 Currently, most choledochotomy incisions are done with primary closure. A T-tube is inserted at the surgeon’s discretion in the setting of residual stones. After LCBDE, the choledochotomy was closed by primary closure without drainage (group P) in 91 patients (64.1%) and with T-tube drainage (group T) in 51 patients (35.9%). The data on demographics, operative outcomes, postoperative complications, recurrence rate of CBD
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stones, and long-term biliary complications were collected and analyzed for comparison between the 2 groups. Mean follow-up period was 48.8 months (range, 6 to 153 mo).
Primary Closure After Laparoscopic Choledochotomy
TABLE 1. Characteristics of Patients Who Underwent LCBDE by Choledochotomy for CBD Stones
P Group
Operative Techniques After a patient was placed in the supine position 3 trocars were inserted in umbilical, medial epigastric, and right anterior axillary line, respectively, as usual. The fourth 10 mm trocar was inserted in right midclavicular area for the choledochoscope. After the dissection of the gallbladder-cystic duct junction, the cystic duct was clipped. The dissection continued to expose the cystic duct-CBD junction and the anterior surface of the CBD. The longitudinal choledochotomy is made in the anterior aspect of the CBD. After the choledochotomy, stones were pushed out through the opening by manipulating the CBD using blunt forceps and applying saline irrigation. Then, a flexible choledochoscope was routinely used to examine distal and proximal bile duct. The extraction of stones was done using a stone basket, a balloon catheter, and electrohydraulic lithotripsy through the working channel of the choledochoscope. After all stones were removed, the clearance of the intrahepatic/extrahepatic bile duct was confirmed with the flexible choledochoscope. Intraoperative cholangiography (IOC) was not performed. The choledochotomy incision was primarily closed with continuous suture using Vicryl 3-0 suture material. For patients who underwent T-tube drainage, a T-tube of 16 Fr was inserted into the choledochotomy incision site, which was then secured with same suture. A closed suction drain was placed on Morison’s pouch. The T-tube was removed 2 weeks postoperatively, after the absence of stones with T-tube cholangiography was confirmed. At 3 or 6 months follow-up, physical examination and laboratory tests were performed on the patients. Imaging studies such as ultrasonography and CT were performed if there were abnormal findings on the physical examination and laboratory tests.
Statistical Analysis Statistical analysis was performed using SPSS 20.0 software (IBM Co., Armonk, NY). The w2 test was used for comparing categorical variables. Continuous variables were expressed as mean ± SD and comparisons of data were performed with the Student t test or the Fisher exact test, where appropriate. Variables were considered significant with P < 0.05.
T Group
No. patients 91 51 Age (mean ± SD) (y) 67.25 ± 15.78 65.51 ± 15.25 Sex [n (%)] Male 45 (49.5) 29 (56.9) Female 46 (50.5) 22 (43.1) Comorbidity 47 (51.7) 18 (35.3) Cardiovascular disease 40 16 Diabetes mellitus 14 8 Liver disease 6 0 Pulmonary disease 8 2 Others 2 3 Obstructive jaundice [n (%)] 45 (49.5) 34 (66.7) ASA score [n (%)] 1 6 (6.6) 6 (11.8) 2 74 (81.3) 27 (52.9) 3 9 (9.9) 8 (15.7) Abdominal operation history 13 (14.3) 7 (13.7) [n (%)]
P 0.524 0.484 0.216
0.053 0.869
1.000
ASA indicates American Society of Anesthesiologist; CBD, common bile duct; LCBDE, laparoscopic common bile duct exploration.
shorter in group P than in group T (8.59 ± 6.0 d for group P vs. 14.96 ± 5.4 d for group T, P = 0.001). There was no difference in postoperative complications between group P and group T. Postoperative bile leak occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T (Table 2). All patients with bile leakage in both groups recovered through conservative management with drainage.
Long-term Results With a mean follow-up period of 48.8 months, recurrent CBD stones developed in 7 patients (5.3%) of 142 patients who had no residual stones. The recurrent stone rate in group P and group T were 4.4% and 5.9%, respectively, which were not significantly different (P = 0.722). The late recurrence, 24 months postoperatively, occurred in 2 patients (2.2%) in group P and 1 patient (2.0%) in group T (Table 3). ERCP was used to remove recurrent CBD stones in 4 patients and hepaticojejunostomy was performed in 3 patients. During the follow-up period, there was no sign of biliary stricture or other biliary complications in both groups.
DISCUSSION RESULTS Short-term Results There were no significant differences regarding demographic and clinical characteristics between the 2 groups (Table 1). The mean size of CBD was 14.2 ± 5.7 mm in group P and 15.2 ± 6.9 mm in group T, which was not significantly different between 2 groups. Conversions to open surgery were done in 3 patients (3.3%) in group P and 2 patients (3.9%) in group T (P = 1.000). The reasons for conversion were severe adhesion, CBD injury, and CBD stricture. Stone clearance rates were not significantly different between 2 groups (100% for group P vs. 98.0% for group T, P = 0.359). The mean operation time was significantly shorter in group P than group T (168.9 ± 50.1 min for group P vs. 198.0 ± 59.6 min for group T, P = 0.002). The hospital stay was significantly Copyright
r
This study showed the long-term outcome on primary closure after LCBDE with a low incidence of recurrent stones, and no biliary strictures. This result suggests that primary closure after LCBDE is a safe alternative to T-tube drainage in terms of the long-term outcome and hence the routine use of a T-tube may no longer be justified. LCBDE has the advantage of managing CBD stones associated with gallbladder stone by single-stage procedure and, therefore, ERCP can be avoided.17–19 LCBDE can be performed either through the transcystic approach or the choledochotomy approach. A prospective study showed the stone clearance rate higher in choledochotomy group (91.9%) than in transcystic group (66.6%) with no significant difference in the complication rate.20 In addition, some studies reported that a transcystic approach was not very satisfactory in achieving complete clearance of the CBD.4,7,14 Considering these results, the transcystic
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TABLE 2. Comparison of the Operative Outcome Following LCBDE
Open conversion [n (%)] Stone clearance [n (%)] Mean operation time (min) Postoperative hospital stay (day) Complications [n (%)] Bile leakage Bleeding Pneumonia
P Group (N = 91)
T Group (N = 51)
P
3 (3.3) 91 (100) 168.9 ± 50.1
2 (3.9) 50 (98.0) 198.0 ± 59.6
1.000 0.359 0.002
8.59 ± 6.0
14.96 ± 5.4
0.001
3 (3.3) 2 0 1
1 (2.0) 1 0 0
0.654
LCBDE indicates laparoscopic common bile duct exploration.
approach has limitations related to size and location of stone. In this study, LCBDE by choledochotomy had the stone clearance rate of 99.3% and low operative complication rate of 2.8%, and these results also support the advantage of laparoscopic choledochotomy approach. However, laparoscopic choledochotomy can be associated with the risk of bile leak. On the basis of the experience of open CBD exploration, T-tube drainage of CBD has been used to decompress the biliary tree, to reduce the risk of bile leak and to extract any residual stones through the T-tube tract. Despite these potential advantages, T-tube drainage was associated with morbidities including fluid and electrolyte disturbances, sepsis, localized pain, persistent biliary fistulas, late biliary stricture, and prolonged hospital stay.21–24 Previous studies comparing postoperative bile leak after primary closure versus T-tube drainage showed that the differences between the 2 groups were not significant, which were similar to our finding.25,26 These results indicate that T-tube drainage does not prevent bile leaks after LCBDE. A recent systematic review comparing short-term outcome of primary closure with that of T-tube drainage after LCBDE showed that T-tube drainage may increase the operating time and hospital stay and other complication rates were comparable between 2 groups.14 These findings are consistent with experience of this study. Most of T-tube drainage after LCBDE was adopted in the early part of this series and laparoscopic choledochotomies currently are performed with primary closure. A choledochoscopy enables complete stones clearance and makes sure no residual stone before primary closure. This study has shown that the stone clearance rate is almost 100% by the use of flexible choledochoscopy without IOC. IOC has been widely used to find unexpected stone with negative TABLE 3. Comparison of the Long-term Follow-up Result Between Primary Closure and T-tube Drainage Groups After LCBDE
P Group
T Group
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results in CBD by preoperative ultrasonography. However, in this study, IOC was not used because CBD stones were confirmed with ERCP or MRCP before operation. A study by Topal et al27 comparing flexible choledochoscopy with IOC showed that the duration of LCBDE with flexible choledochoscope was significantly shorter with no difference regarding stone clearance, morbidity, and length of hospital stay. These results suggest that the use of a flexible choledochoscope is preferable to fluoroscopic guidance and the routine use of IOC may not be necessary for LCBDE. As mentioned, many studies that compared primary closure with T-tube drainage after LCBDE focused on the short-term outcome. However, to fully assess the effect of T-tube drainage versus primary closure after LCBDE, longterm follow-up data regarding recurrence of CBD stones and bile duct stricture are necessary. The rate of recurrent stones following LCBDE has been reported in up to 6%.4,28,29 A study by Zhang et al30 showed that with a median follow-up of 40 months, stone recurrence rate was 2% in primary closure and 3.26% in T-tube drainage (P = 0.672). In this study, the rates of recurrent stone in primary closure and T-tube drainage group were 4.4% and 5.9%, respectively, and not significantly different between 2 groups, although mean follow-up time was longer in T-tube drainage group (Table 3). These data show that T-tube drainage does not prevent the recurrence of CBD stones. Long-term biliary complications such as bile duct stricture can become a major concern for patients who undergo LCBDE by choledochotomy. Cai et al showed no biliary stricture in both primary closure and T-tube drainage after LCBDE by longitudinal choledochotomy at median followup of 26 months.21 Khaled et al10 reported CBD stricture in 1 (0.8%) of 120 patients with primary closure following LCBDE through a transverse choledochotomy at median follow-up of 39.2 months. In this study, long-term biliary complications such as biliary stricture did not occur in either primary closure or T-tube drainage group after LCBDE by longitudinal choledochotomy. Biliary stricture following LCBDE seems to rarely occur regardless of a transverse or longitudinal choledochotomy. These results reveal that primary closure after LCBDE can be performed without increased risk of long-term complications such as bile duct stricture. In conclusion, LCBDE with use of flexible choledochoscope was satisfactory in achieving complete stone clearance. Primary closure after LCBDE showed shorter operative time and hospital stay compared with T-tube drainage. Long-term follow-up data on primary closure after LCBDE indicated a low incidence of recurrent stones, and no biliary strictures. Thus, primary closure after LCBDE with flexible choledochoscope is considered to be a safe and effective alternative to T-tube drainage with acceptable long-term outcome, as well as short-term outcome.
P
Mean follow-up period (mo) 41.3 ± 23.6 59.7 ± 52.62 0.022 Recurrence [n (%)] 4 (4.4) 3 (5.9) 0.722 Early recurrence (< 24 mo) 2 (2.2) 1 (2.0) Late recurrence (Z24 mo) 2 (2.2) 2 (3.9) Long-term biliary complication 0 0 Biliary stricture 0 0 LCBDE indicates laparoscopic common bile duct exploration.
REFERENCES 1. Dasari BV, Tan CJ, Gurusamy KS, et al. Surgical versus endoscopic treatment of bile stones. Cochrane Database Syst Rev. 2013;12:CD003327. 2. Coelho-Prabhu N, Shah ND, Van Houten H, et al. Endoscopic retrograde cholangiopancreatography: utilization and outcomes in a 10-year population-based cohort. BMJ Open. 2013;3:e002689.
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3. Schreurs WH, Juttmann JR, Stuifbergen WN, et al. Management of common bile duct stones. Surg Endosc. 2002;16: 1068–1072. 4. Paganini AM, Guerrieri M, Sarnari J, et al. Long-term results after laparoscopic transverse choledochotomy for common bile duct stones. Surg Endosc. 2005;19:705–709. 5. Nathason LK, O’Rourke NA, Martin IJ, et al. Post operative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: a randomized trial. Ann Surg. 2005;242:188–192. 6. Ricardi R, Islam S, Canete JJ, et al. Effectiveness and longterm results of laparoscopic common bile duct exploration. Surg Endosc. 2003;17:19–22. 7. Paganini AM, Guerrieri M, Sarnari J, et al. Thirteen year’s experience with laparoscopic transcystic common bile duct exploration for stones. Surg Endosc. 2007;21:34–40. 8. Thompson MH, Tranter SE. All-comers policy for laparoscopic exploration of the common bile duct. Br J Surg. 2002;89:1608–1612. 9. Waage A, Stro¨mberg C, Leijonmarck CE, et al. Long-term results from laparoscopic common bile duct exploration. Surg Endosc. 2003;17:1181–1185. 10. Khaled YS, Malde DJ, de Souza C, et al. Laparoscopic bile duct exploration via choledochotomy followed by primary duct closure is feasible and safe for the treatment for choledocholithiasis. Surg Endosc. 2013;27:4164–4170. 11. Ahmed I, Pradhan C, Beckingham IJ, et al. Is a T-tube necessary after common bile duct exploration? World J Surg. 2008;32:1485–1488. 12. Abella´n Morcillo I, Qurashi K, Abrisqueta Carrio´n J, et al. Laparoscopic common bile duct exploration. Lessons learned after 200 cases. Cir Esp. 2014;92:341–347. 13. Ahmed M, Diggory RT. Case-based review: bile peritonitis after T-tube removal. Ann R Coll Surg Engl. 2013;95:383–385. 14. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after laparoscopic common bile duct exploration (review). Cochrane Database Syst Rev. 2013;6:CD005641. 15. Yin Z, Xu K, Sun J, et al. Is the end of the T-tube drainage era in laparoscopic choledochotomy for common bile duct stones is coming? Ann Surg. 2013;257:54–66. 16. Noh KT, Min SK, Lee HK. Comparison of primary closure and T-tube drainage following laparoscopic CBD exploration. J Korean Surg Soc. 2009;77:399–403. 17. Koc B, Karahan S, Adas G, et al. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013;206:457–463.
Copyright
r
Primary Closure After Laparoscopic Choledochotomy
18. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC + LCBDE vs. ERCP/S + LC for common bile duct stone disease. Arch Surg. 2010;134:28–33. 19. Noble H, Tranter S, Chesworth T, et al. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. Laparoendosc Adv Surg Tech A. 2009;19:713–720. 20. Jameel M, Darmas M, Baker AL, et al. Trend towards primary closure following laparoscopic exploration of the common bile duct. Ann R Coll Surg Engl. 2008;90:29–35. 21. Cai H, Sun Y, Bai J, et al. Primary closure following laparoscopic common bile duct exploration combined with intraoperative cholangiography and choledochoscopy. World J Surg. 2013;36:164–170. 22. Leida Z, Ping B, Shuguang W, et al. A randomized comparison of primary closure and T-tube drainage of common bile duct after laparoscopic choledochotomy. Surg Endosc. 2008;22: 1595–1600. 23. Wills VL, Gibson K, Karihaloot C, et al. Complications of biliary T-tube after choledochotomy. ANZ J Surg. 2002; 72:177–180. 24. Martin IJ, Bailey IS, Rhodes M, et al. Towards T-tube free laparoscopic bile duct exploration: a methodologic evolution during 300 consecutive procedures. Ann Surg. 1998;228:29–34. 25. Wu X, Yang Y, Dong P, et al. Primary closure versus T tube drainage in laparoscopic common bile duct exploration: a meta- analysis of randomized clinical trial. Langenbecks Arch Surg. 2012;397:909–916. 26. Zhu QD, Tao CL, Zhou MT, et al. Primary closure versus Ttube drainage after common bile duct exploration for choledocholithiasis. Langenbecks Arch Surg. 2011;396:53–62. 27. Topal B, Aerts R, Penninckx F. Laparoscopic common bile duct stone clearance with flexible choledochoscopy. Surg Endosc. 2007;21:2317–2321. 28. Dong ZT, Wu GZ, Luo KL, et al. Primary closure after laparoscopic common bile duct exploration versus T-tube. J Surg Res. 2014;189:249–254. 29. Lee HM, Min SK, Lee HK. Long-term results of laparoscopic common bile duct exploration by choledochotomy for choledocholithiasis: 15-year experience from a single center. Ann Surg Treat Res. 2014;86:1–6. 30. Zhang HW, Chen YJ, Wu CH, et al. Laparoscopic common bile duct exploration with primary closure for management of choledocholithiasis: a retrospective analysis and comparison with conventional T-tube drainage. Am Surg. 2014;80: 178–181.
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