Original Paper Received: April 30, 2014 Accepted after revision: September 7, 2014 Published online: January 22, 2015

Dig Surg 2015;32:1–8 DOI: 10.1159/000368326

Primary Closure and Rate of Bile Leak following Laparoscopic Common Bile Duct Exploration via Choledochotomy Jie Hua Shengping Lin Daohai Qian Zhigang He Ti Zhang Zhenshun Song Department of Hepatobiliary and Pancreatic Surgery, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, China

Abstract Background: Choledocholithiasis is traditionally managed by endoscopic retrograde cholangiopancreatography or T-tube insertion following common bile duct exploration. This study examined the efficacy and safety of primary duct closure following laparoscopic common bile duct exploration (LCBDE) via choledochotomy. Methods: Between September 2011 and September 2013, 157 consecutive patients underwent LCBDE via choledochotomy. Results: Of 157 LCBDE procedures, 138 (87.9%) were successfully completed with primary closure of the choledochotomy. Eight patients (5.1%) underwent closure with T-tube drainage after choledochotomy and 11 patients (7.0%) were converted to open surgery. The biliary tree was free of stones at the end of surgery in 154 patients (98.1%). Postoperative bile leak occurred in 6 patients (3.8%). The median follow-up period was 18 (2–33) months, with no evidence of further bile duct stones or bile duct stricture in any patients. Univariable analysis revealed that successful duct clearance (p = 0.010) and diameter of the common bile duct (p < 0.001) were two significant risk factors for bile leak. Conclusions: Primary duct closure following LCBDE is effective and safe for the management of choledocholithiasis. The postoperative bile leak rate may be low in skilled laparoscopic surgeons with a careful selection of patients. © 2015 S. Karger AG, Basel

© 2015 S. Karger AG, Basel 0253–4886/15/0321–0001$39.50/0 E-Mail [email protected] www.karger.com/dsu

Introduction

Choledocholithiasis, which is the second most common complication of cholecystolithiasis, occurs in 10– 20% of the patients with symptomatic gallstones [1, 2]. Some stones may pass spontaneously into the duodenum, but others will cause full or partial obstruction of the bile and/or pancreatic duct. The consequences can include biliary colic, obstructive jaundice, cholangitis, acute pancreatitis, and, if left untreated, liver cirrhosis [3]. In the prelaparoscopic era, routine endoscopic retrograde cholangiopancreatography (ERCP)/endoscopic stone extraction prior to open cholecystectomy was widely used and was found to be broadly comparable to a single-stage approach of open cholecystectomy and bile duct exploration. However, as laparoscopic cholecystectomy (LC) has replaced open cholecystectomy as the reference standard for treatment of gallbladder stones, patients with concomitant gallbladder stones and common bile duct stones (CBDS) may be managed by laparoscopic common bile duct exploration (LCBDE) at the time of LC or undergo LC in conjunction with perioperative ERCP [4–6]. Although there is no evidence of a difference in efficacy, morbidity, or mortality when these approaches are compared, LCBDE is associated with a shorter hospital stay and requires fewer procedures [7]. In addition, LCBDE

Jie Hua and Shengping Lin contributed equally to this work.

Zhenshun Song, MD, PhD Department of Hepatobiliary and Pancreatic Surgery Shanghai Tenth People’s Hospital, Tongji University School of Medicine 301 Yanchang Middle Road, Shanghai 200072 (China) E-Mail zs_song @ hotmail.com

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Key Words Primary closure · Laparoscopic choledochotomy · Choledocholithiasis

Patients From September 1, 2011, to September 30, 2013, a total of 176 consecutive patients underwent LCBDE at the Department of Hepatobiliary and Pancreatic Surgery, Shanghai Tenth People’s Hospital, Shanghai. Of these patients, 19 underwent laparoscopic transcystic bile duct exploration and 157 required laparoscopic choledochotomy. Patients were selected for LCBDE after they had the diagnosis of choledocholithiasis confirmed by a preoperative

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Dig Surg 2015;32:1–8 DOI: 10.1159/000368326

Fig. 1. Schematic diagram showing the port sites of LCBDE.

abdominal ultrasonography and/or magnetic resonance cholangiopancreatography (MRCP). Patients’ clinical records were reviewed for age, sex, presentations, American Society of Anesthesiologists classification, number of stones identified intraoperatively, operative time, estimated blood loss, number of transfusions, time to drain removal, postoperative hospital stay, postoperative bile leak, in-hospital morbidity and mortality, retained CBDS, readmissions, and reoperation. Common bile duct (CBD) diameters were measured preoperatively on MRCP images and estimated intraoperatively under direct vision. Operative Technique All the operations were performed by three experienced laparoscopic surgeons. The operation was performed under general anesthesia and the patient was given prophylactic antibiotics intravenously on induction (Cefmetazole 2.0 g). The patient was placed in the American position with head up and table tilt to the left. The surgeon stood to the left of the patient with the camera holder by his side and the first assistant to the right side of the patient. A 30° video laparoscope was employed and the surgery was carried out with a standard four-port approach for cholecystectomy: a 10-mm port at the umbilicus for the laparoscope, a 5-mm port at the midclavicular line close to the right costal margin for the choledochoscope, and two 5-mm ports at the epigastrium and the right anterior axillary line for operating (fig. 1).

Hua/Lin/Qian/He/Zhang/Song

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Materials and Methods

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avoids disturbing the anatomy of the sphincter of Oddi and, therefore, avoids long-term sequelae of sphincterotomy, which include recurrent ampullary stenosis, chronic bacterial colonization of the biliary tree, recurrent cholangitis, primary CBDS, and increased risk for future pancreaticobiliary malignancy [8]. LCBDE was first employed in the 1990s and can be either transcystic or performed through a choledochotomy. Some surgeons have reported high success rates and low morbidity rates with the transcystic approach [9, 10]. However, the transcystic approach is limited in terms of applicability because it only allows the retrieval of small stones and the access to the common hepatic duct is poor [11]. Choledochotomy, providing the ability to see both proximal and distal biliary tree and to remove large impacted stones, is now preferred by the majority of surgeons. T-tubes were traditionally inserted in open bile duct exploration because of the risk of bile leak from the choledochotomy, which arose as a result of an uncertainty regarding duct clearance or because of the presence of edema and inflammation as a result of blind instrumentation of the duct. However, its usage causes inconvenience to the patients and is associated with a high morbidity rate of 16.4%, including T-tube displacement, bile leak with either the T-tube in situ or after its removal, and wound infection around the T-tube [12]. LCBDE with optical magnification, direct visualization, and more delicate instrumentation allows reduced trauma to the bile duct and has resulted in an increasing tendency to close the duct primarily. This avoids the morbidity associated with Ttubes and the necessity for T-tube cholangiograms, though only a relatively small number of surgeons perform primary duct closure laparoscopically due to its technical difficulties and concern about postoperative bile leak. The aim of this study was to retrospectively evaluate the effectiveness and safety of primary duct closure following LCBDE via choledochotomy and to identify the potential risk factors for postoperative bile leak.

Color version available online

a

b

Fig. 2. Laparoscopic primary closure of the CBD. The duct was closed with absorbable 4-0 PDS II sutures in a continuous over-and-overlocking fashion from one side to the other (a) and then continuous sutures back to the side where the suture started with increased stitch length (b).

Primary Closure of Laparoscopic Choledochotomy

At the end of the procedure, the gallbladder and the CBDS were retrieved with a plastic bag through the umbilical port site. A silicone Jackson-Pratt drain was then placed in the subhepatic space and was removed on the second or third postoperative day if there was no evidence of bile leak. Outcome Definitions and Follow-Up Operative time was defined as the interval between the initial skin incision and skin closure. Postoperative hospital stay was defined as the number of days spent in the hospital postoperatively. In-hospital mortality and morbidity were defined as the number of deaths or complications that occurred in hospital. Complications were graded according to the Clavien-Dindo classification of surgical complications [13]. Follow-up assessment using liver function tests and ultrasound was carried out at 2 weeks and 3 months after surgery. Statistical Analysis Data were analyzed using the software package SPSS 13.0 (SPSS, Inc., Chicago, Ill., USA). Continuous variables were expressed as median (range). Univariable analysis of bile leak was performed by logistic regression. p < 0.05 was considered statistically significant.

Results

From September 1, 2011, to September 30, 2013, a total of 157 patients underwent LCBDE via choledochotomy for choledocholithiasis. The demographic characteristics, clinical presentation, and history of previous surgery of the patients are summarized in table 1. The intraoperative and postoperative outcomes are summarized in table 2. We found CBDS (n = 131) or inDig Surg 2015;32:1–8 DOI: 10.1159/000368326

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The operation was started with the dissection of Calot’s triangle, and the cystic artery was clipped with an absorbable clip (Lapro-Clip; Tyco Healthcare, Covidien, Norwalk, Conn., USA) and cut off. Similarly, the distal cystic duct was clipped 1 cm away from the CBD to avoid further passage of stones from the gallbladder into the CBD. The gallbladder was then dissected free off the liver bed with hook cautery and was left behind to facilitate the retraction and exposure of the bile duct during exploration. When the CBD was identified, a 1.0-cm longitudinal supraduodenal choledochotomy was made using hook scissors, which may be extended to facilitate extraction of larger stones. In cases where the anatomy of the extrahepatic bile ducts was not obvious, we used needle aspiration of bile to confirm the CBD. The stones were extracted from the bile duct by direct access with Randall stone forceps and/or by using a 5-mm choledochoscope (CHF-V; Olympus, Tokyo, Japan) and a Dormia basket (FG-24X-1; Olympus). When using the Dormia basket under the choledochoscope, the basket should pass through the distal CBD into the duodenum to prevent the retained stones from being incarcerated in the sphincter of Oddi. Holmium laser lithotripsy was also used if necessary to clear large solitary or impacted stones. After all stones were retrieved, clearance of the proximal and distal bile duct was confirmed by choledochoscopy. The choledochotomy was then closed primarily with absorbable 4-0 PDS II sutures (Ethicon Inc., Somerville, N.J., USA) in a continuous over-and-overlocking fashion from one side to the other (fig. 2a). To reduce the risk of bile leak from the choledochotomy, we used continuous sutures back to the side where the suture started with increased stitch length (fig. 2b). For some patients with severe inflammatory edema of the CBD, inflammatory stricture of the sphincter of Oddi, or unremovable small mural stones, a latex rubber T-tube of appropriate size was inserted into the CBD incision to decrease the bile duct pressure and allow bile to drain out of the body. After the tube had been positioned in place, the CBD incision was closed using interrupted sutures (4-0 PDS II). Saline was flushed through the T-tube to rule out leakage.

Table 1. Clinical characteristics of patients with choledocholithiasis (n = 157)

Age, years Gender Male Female Biliary colic Obstructive jaundice Acute cholecystitis Acute cholangitis Acute pancreatitis ASA scores Previous cholecystectomy Previous upper abdominal surgery Previous ERCP/EST CBD diameter on preoperative MRCP, mm

62 (22–88) 79 (50.3) 78 (49.7) 116 (73.9) 76 (48.4) 34 (21.6) 17 (10.8) 6 (3.8) 2 (1–3) 3 (1.9) 14 (8.9) 6 (3.8) 12 (4–24)

Values are median (range) or n (%). ASA = American Society of Anesthesiologists; EST = endoscopic sphincterotomy.

Table 2. Intraoperative data and postoperative outcomes (n = 157)

Choledocholithiasis at exploration Bile sludge at exploration Primary closure T-tube drainage Conversion to open surgery Stones Diameter of stones, mm Edema of the CBD wall CBD diameter at exploration, mm Operative time, min Estimated blood loss, ml Blood transfusion Successful duct clearance Time to removal of drain, days Postoperative hospital stay, days Postoperative bile leak Mortality Morbidity Retained CBD stones Readmission within 30 days Reoperation

131 (83.4) 20 (12.7) 138 (87.9) 8 (5.1) 11 (7.0) 2 (0–11) 8 (2–25) 14 (8.9) 12 (4–25) 135 (85–430) 20 (5–200) 0 154 (98.1) 4 (1–27) 5 (2–32) 6 (3.8) 0 9 (5.7) 3 (1.9) 0 0

Values are median (range) or n (%).

chotomy because of severe inflammatory edema of the CBD (n = 4), inflammatory stricture of the sphincter of Oddi (n = 2), or unremovable small mural stones (n = 2). Eleven patients (7.0%) were converted to open surgery and the reasons for conversion were large impacted stones (n = 6), Mirizzi syndrome (n = 2), dense adhesions and unclear anatomy (n = 1), cholecystoduodenal fistula (n = 1), and hypercapnia (n = 1). The median operative time was 125 (range 85–430) min. At the end of the LCBDE, the biliary tree was free of stones in 154 patients (98.1%). Two patients had unremovable small mural stones during the operation; therefore, a T-tube was placed through the CBD incision. The retained stones were successfully removed through the sinus tract of the T-tube using the choledochoscope after 6 weeks. One patient with primary closure of the CBD had a retained stone diagnosed by postoperative MRCP, which was successfully removed by ERCP. The overall rate of retained stones was, therefore, 1.9% (3 of 157 patients). There was no postoperative death of any patient. Postoperative complications occurred in 9 patients and are listed in table 3. Two patients experienced minor bile leak, which stopped spontaneously with extended peritoneal drainage. Another two patients had bile leak in the surgical drain without peritonitis and were treated with intravenous antibiotics with stoppage of leakage after 5 days. One patient with primary closure had subhepatic bile accumulation on day 4 and was successfully managed by ultrasound-guided drainage. One patient experienced major bile leak because of accidental slippage of the T-tube. He was then treated by ERCP and endoscopic nasobiliary drainage, and the slipped T-tube served as a peritoneal drainage. The patient recovered uneventfully and was discharged after 2 weeks with no further evidence of bile leak. The median follow-up was 18 (range 2–33) months, with no evidence of further bile duct stones or bile duct stricture in any patient. Univariable analysis revealed two significant risk factors for bile leak: successful duct clearance (p = 0.010) and diameter of the CBD (p < 0.001; table 4).

Discussion

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Dig Surg 2015;32:1–8 DOI: 10.1159/000368326

In this retrospective study of 157 patients undergoing LCBDE via choledochotomy, primary duct closure was successfully completed laparoscopically in 138 cases (87.9%). The remaining patients were managed with insertion of T-tubes (5.1%) or converted to open exploration (7.0%). The rate of duct clearance was 98.1% and the Hua/Lin/Qian/He/Zhang/Song

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traluminal bile sludge (n = 20) in 151 patients (96.2%) on exploration, leaving 6 patients (3.8%) with only a dilated CBD without stones. Primary closure of the choledochotomy was successfully performed under the laparoscope in 138 patients (87.9%). Eight patients (5.1%) underwent closure with T-tube drainage after laparoscopic choledo-

Table 3. Complications and their management

Gradea

Patients

Complications

Management

I II

IIIa

2 2 1 1 1 2

bile leak bile leak respiratory tract infection hemolytic anemia postoperative hypertension bile leak

IIIb IVa IVb V

0 0 0 0

– – – –

conservative intravenous antibiotics intravenous antibiotics intravenous methylprednisolone intravenous nitroglycerin ultrasound-guided drainage; ERCP/ENBD and the slipped T-tube served as a peritoneal drainage – – – –

ENBD = Endoscopic nasobiliary drainage. a Clavien-Dindo classification of surgical complications.

Table 4. Univariable logistic regression analysis of risk factors for bile leak

Risk factors Successful duct clearance Yes No Diameter of the CBD ≥8 mm 30 patients with primary duct closure are presented.

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Dig Surg 2015;32:1–8 DOI: 10.1159/000368326

of the patients which were selected for laparoscopic choledochotomy to have a wide CBD (≥8 mm in diameter). Bile leak may occur regardless of whether the choledochotomy has primarily been closed or whether T-tubes have been inserted. In our series, 5 patients (3.6%) in the primary closure group experienced postoperative bile leak, which is comparable with the bile leak rates of 1.6– 7% observed by others (table 5). Successful duct clearance was an important factor to prevent bile leak after primary duct closure. Consideration should always be given to urgent MRCP or ERCP to detect and remove retained stones when postoperative bile leak is encountered. In our study, the diameter of the CBD was found to be another risk factor for postoperative bile leak by univariable analysis. Although criteria concerning the diameter of the CBD for laparoscopic choledochotomy are lacking, several reports have found that a diameter of the CBD 

Primary closure and rate of bile leak following laparoscopic common bile duct exploration via choledochotomy.

Choledocholithiasis is traditionally managed by endoscopic retrograde cholangiopancreatography or T-tube insertion following common bile duct explorat...
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