j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 2 4 9 e2 5 4
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Primary closure after laparoscopic common bile duct exploration versus T-tube Zhi-Tao Dong, MD, Guo-Zhong Wu, MD,* Kun-lun Luo, MD, and Jie-Ming Li, MD Department of General Surgery, The 101st Hospital of Chinese People’s Liberation Army, Wuxi, Jiangsu, China
article info
abstract
Article history:
Background: Laparoscopic common bile duct exploration (LCBDE) is now one of the main
Received 25 December 2013
methods for treating choledocholithiasis accompanied with cholelithiasis. The objective of
Received in revised form
our study was to assess the safety and effectiveness of laparoscopic primary closure for the
5 March 2014
treatment of common bile duct (CBD) stones compared with T-tube drainage.
Accepted 18 March 2014
Methods: Patients who underwent CBD stones were studied prospectively from 2002e2012
Available online 24 March 2014
in a single center. A total of 194 patients were randomly assigned to group A (LCBDE with primary closure) with 101 cases and group B (LCBDE with T-tube drainage) with 93 cases.
Keywords:
Intraoperative cholangiography and choledochoscopy were performed in all patients. Pa-
Common bile duct exploration
tient demographics, intraoperative findings, postoperative stay, complications, and hos-
Choledochotomy
pital expenses were recorded and analyzed.
Laparoscopic
Results: There was no mortality in the two groups. Four patients (3.96%) of group A were
Primary closure
converted to open surgery, and three patients (3.23%) in group B. The mean operating time was much shorter in group A than in group B (102.6 15.2 min versus 128.6 20.4 min, P < 0.05). The length of postoperative hospital stay was longer in group B (4.9 3.2 d) than in group A (3.2 2.1 d). The hospital expenses were significantly lower in group A. Three patients experienced postoperative complications, which were related to the usage of the T-tube in group B. The incidences of overall postoperative complications were insignificantly lower in group A. Conclusions: Laparoscopic primary closure of CBD is safe and effective for the management of CBD stones, and can be performed routinely as an alternative to T-tube drainage. ª 2014 Elsevier Inc. All rights reserved.
1.
Introduction
Choledocholithiasis is the second most common complication of cholecystolithiasis, it is found in 10% of patients who underwent cholecystectomy. The common interventional options for treatment of common bile ducts (CBDs) were pre-, intra-, or post-operative endoscopic retrograde cholangiopancreatography (ERCP) and open common bile duct exploration [1]. Although, these techniques are certainly
useful in managing choledocholithiasis, they are not without morbidity, mortality, and significant lifestyle disruption. With the development of laparoscopic equipment and technique, laparoscopic common bile duct exploration (LCBDE) had become a popular method for the treatment of choledocholithiasis. A European Association of Endoscopic Surgery study concluded that a single-stage approach for the management of choledocholithiasis is a better option for patients of American
* Corresponding author. Department of General Surgery, 101st Hospital of Chinese People’s Liberation Army, North Xingyuan Road, Wuxi, Jiangsu 21044, China. Tel.: þ86 0 51085142114; fax: þ86 0 51085142059. E-mail address: [email protected] (G.-Z. Wu). 0022-4804/$ e see front matter ª 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2014.03.055
250
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 2 4 9 e2 5 4
Society of Anesthesiologists grade 1 or 2 compared with the twostage approach of endoscopic stone extraction followed by laparoscopic cholecystectomy [2]. There is also good evidence to favor LCBDE over routine preoperative or postoperative therapeutic ERCP. Now, single-stage LCBDE is regarded as a primary and cost effective treatment method with less morbidity. Traditionally, the CBD is closed with T-tube drainage. However, T-tube usage is associated with recognized morbidity of 10.5%e20%, including bile leak, pain, and a long time to take along before removal and inconvenience to the patient. These disadvantages led several surgeons to perform CBD exploration with primary duct closure. The aim of the study was to analyze the safety and effectiveness of laparoscopic primary closure for the treatment of CBD stones compared with T-tube drainage.
2.
Methods
2.1.
Ethics statement
The study protocol was approved and the study was performed under the supervision of the ethics committee of The 101st Hospital of Chinese People’s Liberation Army (Wuxi 214044, China). The protocol was implemented in accordance with provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. Freely given written informed consent had to be obtained from every patient. No individually identifying patient characteristics are collected nor reported.
2.2.
Patients
This is a prospective study of 194 consecutive patients who underwent LCBDE operations from 2002e2012 in a single center. The patients were diagnosed choledocholithiasis by history, physical examination, biochemical data, preoperative abdominal ultrasonography, magnetic resonance cholangiopancreatography, or ERCP. The indications for LCBDE were as follows:
Presence of large (>6 mm) calculi. Cystic duct 5). Dilated CBD >6 mm. Stones in the common hepatic duct. Very low and spiral cystic ductecommon hepatic duct junction.
Informed consent for randomization to primary closure or Ttube drainage was requested of all patients; none refused. Patients were randomly assigned to group A (LCBDE with primary closure) or group B (LCBDE with T-tube drainage) by means of the Research Randomizer (http://www.randomizer.org). All procedures were performed by the same consultant surgeon.
2.3.
Surgical procedure
LC was performed by the standard four-port technique. We used the 30 video-laparoscope (Stryker, Kalamazoo, MI) placed through the 10-mm umbilical port, a 10-mm port was placed at the epigastrium and two 5-mm ports on the right abdomen. The operation was started with the dissection of Calot triangle; then, the cystic artery was clipped and cut off. Then, the distal cystic duct was clipped and cut off 1 cm away from CBD. Transcystic intraoperative cholangiography was performed through an additional stab incision on the right hypochondrium; so, the biliary anatomy and the number, size, and location of bile duct stones were confirmed. The anterior aspect wall of CBD was cleared for approximately 1e2 cm. Choledochotomy was performed transversely in the supraduodenal part on the anterior aspect of the CBD, a 5-mm flexible choledochoscope (Olympus, Tokyo, Japan) was inserted through epigastrium port into the CBD. A Dormia basket (Cook, Bloomington, IN) was used to retrieve the stones. The impacted stones were often difficult to manage because they were hard to extract by Dormia basket, so electrohydraulic lithotripsy was used. After all the stones were retrieved, clearance of the bile duct was confirmed repeatedly by choledochoscopy rather than potentially time-consuming cholangiography. After complete clearance of the CBD, the choledochotomy was closed primarily with interrupted Vicryl 4-0 sutures (Ethicon, NJ) in group A. For patients in group B, a latex rubber T-tube of appropriate size (14e20 Fr) was inserted into the CBD incision. After the tube had been positioned in place, the CBD incision was closed using interrupted Vicryl 4-0 sutures (Ethicon). Saline was flushed through the T-tube to rule out leakage. A single infrahepatic suction drain was placed near the CBD incision in all patients. It was removed after 48e96 h if there was no bile leak. In case of biliary drainage, a cholangiography was performed on the third to fifth postoperative day. If there was no residual stone, the patients were discharged with Ttube in situ and the T-tube was removed 3e4 wk later.
2.4.
Follow-up
The exclusion criteria were as follows: Thin CBD ( 0.05). Four patients (3.96%) of group A were converted to open surgery, and three patients (3.23%) in group B, the reasons for conversion were serious adhesions, unclear anatomy, impacted stone, cholecystoduodenal fistula, and Mirizzi type 2 syndrome. The mean operating time was much shorter in group A than in group B (102.6 15.2 min versus 128.6 20.4 min, P < 0.05). The length of postoperative hospital stay was longer in group B (4.9 3.2 d) than in group A (3.2 2.1 d). There was no statistically significant difference in diameter of CBD, conversion to open surgery, intraoperative blood loss, interval between surgery and getting out of bed, interval between surgery and recovery of gastrointestinal function, and postoperative complications between the two groups, but the operating time, postoperative hospital stay, and hospital expenses in primary closure group were statistically lower than that of the T-tube drainage group (Table 2). We succeeded in removing stones from choledochus in 93 patients (95.88%) in group A and 87 patients (96.67%) in group B. The four patients with retain stones in group A were cleared successfully at postoperative ERCP. In group A, the retaining stones in two patients were removed through the sinus tract of the T-tube using the choledochoscope. The other patient underwent ERCP and endoscopic sphincterotomy with extraction of retain stones because of a narrow sinus tract. There was no mortality in both groups. In group A, 13 patients experienced postoperative complications (13.4%), including four patients experienced minor bile leakage, which stopped spontaneously with extended peritoneal drainage. One patient with major bile leak, ERCP, and biliary stenting
251
was performed with good results. One patient experienced postoperative acute biliary pancreatitis and was treated by endoscopic sphincterotomy and endoscopic nasobiliary drainage. Relaparoscopy was performed because of intraabdominal bleeding in one patient. Other complications included one wound infection and one case of pneumonia. In the T-tube drainage group, 15 patients (16.67%) experienced postoperative complications, intra-abdominal bleeding occurred in two patients and were cured with conservative therapy. Accidental slippage of tube occurred in one patient and was treated with T-tube replacement by relaparoscopy. Four patients experienced bile leakage around the T-tube, of whom three patients stopped spontaneously with extended peritoneal and T-tube drainage, the other patient was cured by ERCP and biliary stenting. Bile peritonitis was seen in two patients (2.22%) after Ttube removal, another tube was then placed into the sinus tract, and the two patients recovered with expectant treatment. Other complications included one wound infection and two cases of pneumonia. The incidence of overall postoperative complications was insignificantly lower in group A (Table 3). The median follow-up was 12 mo, with no recurrence or bile duct stricture occurring during that time.
4.
Discussion
LC is considered as the “gold standard” for managing symptomatic cholecystolithiasis, LCBDE was considered as a natural step forward with the goal of having less morbidity and mortality for choledocholithiasis. In 2008, the UK guidelines recommended LCBDE as the treatment of choice for patients with CBD stones undergoing laparoscopic cholecystectomy [3]. Now, LCBDE has been proved to be a safe, cost-effective, and efficient method of returning the patients to their former lifestyles with less financial or social disruption [4]. A meta-analysis of 1762 patients who underwent LCBDE from 19 studies worldwide showed a mean duct clearance of 80% with average morbidity of
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Primary closure after laparoscopic common bile duct exploration versus T-tube Zhi-Tao Dong, MD, Guo-Zhong Wu, MD,* Kun-lun Luo, MD, and Jie-Ming Li, MD Department of General Surgery, The 101st Hospital of Chinese People’s Liberation Army, Wuxi, Jiangsu, China
article info
abstract
Article history:
Background: Laparoscopic common bile duct exploration (LCBDE) is now one of the main
Received 25 December 2013
methods for treating choledocholithiasis accompanied with cholelithiasis. The objective of
Received in revised form
our study was to assess the safety and effectiveness of laparoscopic primary closure for the
5 March 2014
treatment of common bile duct (CBD) stones compared with T-tube drainage.
Accepted 18 March 2014
Methods: Patients who underwent CBD stones were studied prospectively from 2002e2012
Available online 24 March 2014
in a single center. A total of 194 patients were randomly assigned to group A (LCBDE with primary closure) with 101 cases and group B (LCBDE with T-tube drainage) with 93 cases.
Keywords:
Intraoperative cholangiography and choledochoscopy were performed in all patients. Pa-
Common bile duct exploration
tient demographics, intraoperative findings, postoperative stay, complications, and hos-
Choledochotomy
pital expenses were recorded and analyzed.
Laparoscopic
Results: There was no mortality in the two groups. Four patients (3.96%) of group A were
Primary closure
converted to open surgery, and three patients (3.23%) in group B. The mean operating time was much shorter in group A than in group B (102.6 15.2 min versus 128.6 20.4 min, P < 0.05). The length of postoperative hospital stay was longer in group B (4.9 3.2 d) than in group A (3.2 2.1 d). The hospital expenses were significantly lower in group A. Three patients experienced postoperative complications, which were related to the usage of the T-tube in group B. The incidences of overall postoperative complications were insignificantly lower in group A. Conclusions: Laparoscopic primary closure of CBD is safe and effective for the management of CBD stones, and can be performed routinely as an alternative to T-tube drainage. ª 2014 Elsevier Inc. All rights reserved.
1.
Introduction
Choledocholithiasis is the second most common complication of cholecystolithiasis, it is found in 10% of patients who underwent cholecystectomy. The common interventional options for treatment of common bile ducts (CBDs) were pre-, intra-, or post-operative endoscopic retrograde cholangiopancreatography (ERCP) and open common bile duct exploration [1]. Although, these techniques are certainly
useful in managing choledocholithiasis, they are not without morbidity, mortality, and significant lifestyle disruption. With the development of laparoscopic equipment and technique, laparoscopic common bile duct exploration (LCBDE) had become a popular method for the treatment of choledocholithiasis. A European Association of Endoscopic Surgery study concluded that a single-stage approach for the management of choledocholithiasis is a better option for patients of American
* Corresponding author. Department of General Surgery, 101st Hospital of Chinese People’s Liberation Army, North Xingyuan Road, Wuxi, Jiangsu 21044, China. Tel.: þ86 0 51085142114; fax: þ86 0 51085142059. E-mail address: [email protected] (G.-Z. Wu). 0022-4804/$ e see front matter ª 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2014.03.055
250
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 2 4 9 e2 5 4
Society of Anesthesiologists grade 1 or 2 compared with the twostage approach of endoscopic stone extraction followed by laparoscopic cholecystectomy [2]. There is also good evidence to favor LCBDE over routine preoperative or postoperative therapeutic ERCP. Now, single-stage LCBDE is regarded as a primary and cost effective treatment method with less morbidity. Traditionally, the CBD is closed with T-tube drainage. However, T-tube usage is associated with recognized morbidity of 10.5%e20%, including bile leak, pain, and a long time to take along before removal and inconvenience to the patient. These disadvantages led several surgeons to perform CBD exploration with primary duct closure. The aim of the study was to analyze the safety and effectiveness of laparoscopic primary closure for the treatment of CBD stones compared with T-tube drainage.
2.
Methods
2.1.
Ethics statement
The study protocol was approved and the study was performed under the supervision of the ethics committee of The 101st Hospital of Chinese People’s Liberation Army (Wuxi 214044, China). The protocol was implemented in accordance with provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. Freely given written informed consent had to be obtained from every patient. No individually identifying patient characteristics are collected nor reported.
2.2.
Patients
This is a prospective study of 194 consecutive patients who underwent LCBDE operations from 2002e2012 in a single center. The patients were diagnosed choledocholithiasis by history, physical examination, biochemical data, preoperative abdominal ultrasonography, magnetic resonance cholangiopancreatography, or ERCP. The indications for LCBDE were as follows:
Presence of large (>6 mm) calculi. Cystic duct 5). Dilated CBD >6 mm. Stones in the common hepatic duct. Very low and spiral cystic ductecommon hepatic duct junction.
Informed consent for randomization to primary closure or Ttube drainage was requested of all patients; none refused. Patients were randomly assigned to group A (LCBDE with primary closure) or group B (LCBDE with T-tube drainage) by means of the Research Randomizer (http://www.randomizer.org). All procedures were performed by the same consultant surgeon.
2.3.
Surgical procedure
LC was performed by the standard four-port technique. We used the 30 video-laparoscope (Stryker, Kalamazoo, MI) placed through the 10-mm umbilical port, a 10-mm port was placed at the epigastrium and two 5-mm ports on the right abdomen. The operation was started with the dissection of Calot triangle; then, the cystic artery was clipped and cut off. Then, the distal cystic duct was clipped and cut off 1 cm away from CBD. Transcystic intraoperative cholangiography was performed through an additional stab incision on the right hypochondrium; so, the biliary anatomy and the number, size, and location of bile duct stones were confirmed. The anterior aspect wall of CBD was cleared for approximately 1e2 cm. Choledochotomy was performed transversely in the supraduodenal part on the anterior aspect of the CBD, a 5-mm flexible choledochoscope (Olympus, Tokyo, Japan) was inserted through epigastrium port into the CBD. A Dormia basket (Cook, Bloomington, IN) was used to retrieve the stones. The impacted stones were often difficult to manage because they were hard to extract by Dormia basket, so electrohydraulic lithotripsy was used. After all the stones were retrieved, clearance of the bile duct was confirmed repeatedly by choledochoscopy rather than potentially time-consuming cholangiography. After complete clearance of the CBD, the choledochotomy was closed primarily with interrupted Vicryl 4-0 sutures (Ethicon, NJ) in group A. For patients in group B, a latex rubber T-tube of appropriate size (14e20 Fr) was inserted into the CBD incision. After the tube had been positioned in place, the CBD incision was closed using interrupted Vicryl 4-0 sutures (Ethicon). Saline was flushed through the T-tube to rule out leakage. A single infrahepatic suction drain was placed near the CBD incision in all patients. It was removed after 48e96 h if there was no bile leak. In case of biliary drainage, a cholangiography was performed on the third to fifth postoperative day. If there was no residual stone, the patients were discharged with Ttube in situ and the T-tube was removed 3e4 wk later.
2.4.
Follow-up
The exclusion criteria were as follows: Thin CBD ( 0.05). Four patients (3.96%) of group A were converted to open surgery, and three patients (3.23%) in group B, the reasons for conversion were serious adhesions, unclear anatomy, impacted stone, cholecystoduodenal fistula, and Mirizzi type 2 syndrome. The mean operating time was much shorter in group A than in group B (102.6 15.2 min versus 128.6 20.4 min, P < 0.05). The length of postoperative hospital stay was longer in group B (4.9 3.2 d) than in group A (3.2 2.1 d). There was no statistically significant difference in diameter of CBD, conversion to open surgery, intraoperative blood loss, interval between surgery and getting out of bed, interval between surgery and recovery of gastrointestinal function, and postoperative complications between the two groups, but the operating time, postoperative hospital stay, and hospital expenses in primary closure group were statistically lower than that of the T-tube drainage group (Table 2). We succeeded in removing stones from choledochus in 93 patients (95.88%) in group A and 87 patients (96.67%) in group B. The four patients with retain stones in group A were cleared successfully at postoperative ERCP. In group A, the retaining stones in two patients were removed through the sinus tract of the T-tube using the choledochoscope. The other patient underwent ERCP and endoscopic sphincterotomy with extraction of retain stones because of a narrow sinus tract. There was no mortality in both groups. In group A, 13 patients experienced postoperative complications (13.4%), including four patients experienced minor bile leakage, which stopped spontaneously with extended peritoneal drainage. One patient with major bile leak, ERCP, and biliary stenting
251
was performed with good results. One patient experienced postoperative acute biliary pancreatitis and was treated by endoscopic sphincterotomy and endoscopic nasobiliary drainage. Relaparoscopy was performed because of intraabdominal bleeding in one patient. Other complications included one wound infection and one case of pneumonia. In the T-tube drainage group, 15 patients (16.67%) experienced postoperative complications, intra-abdominal bleeding occurred in two patients and were cured with conservative therapy. Accidental slippage of tube occurred in one patient and was treated with T-tube replacement by relaparoscopy. Four patients experienced bile leakage around the T-tube, of whom three patients stopped spontaneously with extended peritoneal and T-tube drainage, the other patient was cured by ERCP and biliary stenting. Bile peritonitis was seen in two patients (2.22%) after Ttube removal, another tube was then placed into the sinus tract, and the two patients recovered with expectant treatment. Other complications included one wound infection and two cases of pneumonia. The incidence of overall postoperative complications was insignificantly lower in group A (Table 3). The median follow-up was 12 mo, with no recurrence or bile duct stricture occurring during that time.
4.
Discussion
LC is considered as the “gold standard” for managing symptomatic cholecystolithiasis, LCBDE was considered as a natural step forward with the goal of having less morbidity and mortality for choledocholithiasis. In 2008, the UK guidelines recommended LCBDE as the treatment of choice for patients with CBD stones undergoing laparoscopic cholecystectomy [3]. Now, LCBDE has been proved to be a safe, cost-effective, and efficient method of returning the patients to their former lifestyles with less financial or social disruption [4]. A meta-analysis of 1762 patients who underwent LCBDE from 19 studies worldwide showed a mean duct clearance of 80% with average morbidity of
