Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi

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Abstract

<div class="section"> <a class="named-anchor" id="ab-soi180024-1">  </a> <h5 class="section-title" id="d3631509e296">Question</h5> <p id="d3631509e298">What technique is best for surgical management of gallstone disease with biliary duct calculi? </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-2">  </a> <h5 class="section-title" id="d3631509e301">Findings</h5> <p id="d3631509e303">In this systematic review and network meta-analysis of 20 randomized clinical trials that included 2489 unique patients and 4 surgical techniques combining laparoscopic cholecystectomy with a second technique, the rendezvous approach (laparoscopic cholecystectomy plus intraoperative cholangiopancreatography) was associated with the highest rates of safety and success compared with the other approaches. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-3">  </a> <h5 class="section-title" id="d3631509e306">Meaning</h5> <p id="d3631509e308">The rendezvous approach should be the first choice for patients with gallstone disease and biliary duct calculi. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-4">  </a> <h5 class="section-title" id="d3631509e312">Importance</h5> <p id="d3631509e314">Several techniques are used for surgical treatment of gallstone disease with biliary duct calculi, but the safety and efficacy of these approaches have not been compared. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-5">  </a> <h5 class="section-title" id="d3631509e317">Objectives</h5> <p id="d3631509e319">To compare the efficacy and safety of 4 surgical approaches to gallstone disease with biliary duct calculi. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-6">  </a> <h5 class="section-title" id="d3631509e322">Data Sources</h5> <p id="d3631509e324">MEDLINE, Scopus, and ISI-Web of Science databases, articles published between 1950 and 2017 and searched from August 12, 2017, to September 14, 2017. Search terms used were <i>LCBDE</i>, <i>LC</i>, <i>preoperative</i>, <i>ERCP</i>, <i>postoperative</i>, <i>period</i>, <i>cholangiopancreatography</i>, <i>endoscopic</i>, <i>retrograde</i>, <i>rendezvous</i>, <i>intraoperative</i>, <i>one-stage</i>, <i>two-stage</i>, <i>single-stage</i>, <i>gallstone</i>, <i>gallstones</i>, <i>calculi</i>, <i>stone</i>, <i>therapy</i>, <i>treatment</i>, <i>therapeutics</i>, <i>surgery</i>, <i>surgical</i>, <i>procedures</i>, <i>clinical trials</i> as topic, <i>random</i>, and <i>allocation</i> in several logical combinations. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-7">  </a> <h5 class="section-title" id="d3631509e412">Study Selection</h5> <p id="d3631509e414">Randomized clinical trials comparing at least 2 of the following strategies: preoperative endoscopic retrograde cholangiopancreatography (PreERCP) plus laparoscopic cholecystectomy (LC); LC with laparoscopic common bile duct exploration (LCDBE); LC plus intraoperative endoscopic retrograde cholangiopancreatography (IntraERCP); and LC plus postoperative ERCP (PostERCP). </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-8">  </a> <h5 class="section-title" id="d3631509e417">Data Extraction and Synthesis</h5> <p id="d3631509e419">A frequentist random-effects network meta-analysis was performed. The surface under the cumulative ranking curve (SUCRA) was used to show the probability that each approach would be the best for each outcome. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-9">  </a> <h5 class="section-title" id="d3631509e422">Main Outcomes and Measures</h5> <p id="d3631509e424">Primary outcomes were the safety to efficacy ratio using overall mortality and morbidity rates as the main indicators of safety and the success rate as an indicator of efficacy. Secondary outcomes were acute pancreatitis, biliary leak, overall bleeding, operative time, length of hospital stay, total cost, and readmission rate. </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-10">  </a> <h5 class="section-title" id="d3631509e427">Results</h5> <p id="d3631509e429">The 20 trials comprised 2489 patients (and 2489 procedures). Laparoscopic cholecystectomy plus IntraERCP had the highest probability of being the most successful (SUCRA, 87.2%) and safest (SUCRA, 69.7%) with respect to morbidity. All approaches had similar results regarding overall mortality. Laparoscopic cholecystectomy plus LCBDE was the most successful for avoiding overall bleeding (SUCRA, 83.3%) and for the shortest operative time (SUCRA, 90.2%) and least total cost (SUCRA, 98.9%). Laparoscopic cholecystectomy plus IntraERCP was the best approach for length of hospital stay (SUCRA, 92.7%). Inconsistency was found in operative time (indirect estimate, 19.05; 95% CI, 2.44-35.66; <i>P</i> = .02) and total cost (indirect estimate, 17.06; 95% CI, 3.56-107.21; <i>P</i> = .04). Heterogeneity was observed for success rate (τ, 0.8), operative time (τ, >1), length of stay (τ, >1), and total cost (τ, >1). </p> </div><div class="section"> <a class="named-anchor" id="ab-soi180024-11">  </a> <h5 class="section-title" id="d3631509e438">Conclusions and Relevance</h5> <p id="d3631509e440">The combined LC and IntraERCP approach had the greatest odds to be the safest and appears to be the most successful. Laparoscopic cholecystectomy plus LBCDE appears to reduce the risk of acute pancreatitis but may be associated with a higher risk of biliary leak. </p> </div><p class="first" id="d3631509e444">This systematic review and meta-analysis compares 4 surgical strategies that combine laparoscopic cholecystectomy and a second technique to assess which strategy is most successful in patients with gallstone disease with common bile duct stones. </p>

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Most cited references 16

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A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited.

A Ireland, Chris Collins, Edward Fitzgerald … (2003)

To define the incidence of problematic common bile duct calculi in patients undergoing laparoscopic cholecystectomy. In patients selected for laparoscopic cholecystectomy, the true incidence of potentially problematic common bile duct calculi and their natural history has not been determined. We evaluated the incidence and early natural history of common bile duct calculi in all patients undergoing laparoscopic cholecystectomy with intraoperative and delayed postoperative cholangiography. Operative cholangiography was attempted in all patients. In those patients in whom a filling defect was noted in the bile duct, the fine bore cholangiogram catheter was left securely clipped in the cystic duct for repeated cholangiography at 48 hours and at approximately 6 weeks postoperatively. Operative cholangiography was attempted in 997 consecutive patients and was accomplished in 962 patients (96%). Forty-six patients (4.6%) had at least one filling defect. Twelve of these had a normal cholangiogram at 48 hours (26% possible false-positive operative cholangiogram) and a further 12 at 6 weeks (26% spontaneous passage of calculi). Spontaneous passage was not determined by either the number or size of calculi or by the diameter of the bile duct. Only 22 patients (2.2% of total population) had persistent common bile duct calculi at 6 weeks after laparoscopic cholecystectomy and retrieved by endoscopic retrograde cholangiopancreatography. Choledocholithiasis occurs in 3.4% of patients undergoing laparoscopic cholecystectomy but more than one third of these pass the calculi spontaneously within 6 weeks of operation and may be spared endoscopic retrograde cholangiopancreatography. Treatment decisions based on assessment by operative cholangiography alone would result in unnecessary interventions in 50% of patients who had either false positive studies or subsequently passed the calculi. These data support a short-term expectant approach in the management of clinically silent choledocholithiasis in patients selected for LC.

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Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones.

M. Rhodes, L. Sussman, L. Cohen … (1998)

The management of stones in the common bile duct in the laparoscopic era is controversial. The three major options are preoperative endoscopic retrograde cholangiography (ERCP), laparoscopic exploration of the common bile duct (LECBD), or postoperative ERCP. Between August, 1995, and August, 1997, 471 laparoscopic cholecystectomies were done in our department. In 427 (91%), satisfactory peroperative cholangiography was obtained. In 80 (17%) of these cases there were stones in the common bile duct, 40 patients were randomised to LECBD and 40 to postoperative ERCP. If LECBD failed, patients had either open exploration of the common bile duct or postoperative ERCP. If one postoperative ERCP failed, the procedure was repeated until the common bile duct was cleared of stones or an endoprosthesis was placed to prevent stone impaction. The primary endpoints were duct-clearance rates, morbidity, operating time, and hospital stay. Analyses were by intention to treat. Age and sex distribution of patients was similar in the randomised groups. Duct clearance after the first intervention was 75% in both groups. By the end of treatment, duct clearance was 100% in the laparoscopic group compared with 93% in the ERCP group. Duration of treatment was a median of 90 min (range 25-310) in the laparoscopic group (including ERCPs for failed LECBD) compared with 105 min (range 60-255) in the postoperative ERCP group (p = 0.1, 95% CI for difference -5 to 40). Hospital stay was a median of 1 day (range 1-26) in the laparoscopic group compared with 3.5 days (range 1-11) in the ERCP group (p = 0.0001, 95% CI 1-2). LECBD is as effective as ERCP in clearing the common bile duct of stones. There is a non-significant trend to shorter time in the operating theatre and a significantly shorter hospital stay in patients treated by LECBD.

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Laparoscopic common bile duct exploration.

Joseph Petelin (2003)

Herein I describe my >12-year experience with laparoscopic common bile duct exploration (LCBDE). From 21 September 1989 through 31 December 2001, 3,580 patients presented with symptomatic biliary tract disease. Laparoscopic cholecystecomy (LC) was attempted in 3,544 of them (99.1%) and completed in 3,527 (99.5%). Laparoscopic cholangiograms (IOC) were performed in 3,417 patients (96.4%); in 344 cases (9.7%), the IOC was abnormal. Forty-nine patients (1.4%) underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP), and 33 patients (0.9%) underwent postoperative ERCP. LCBDE was attempted in 326 cases and completed in 321 (98.5%). It was successful in clearing the duct in 317 of the 344 patients with abnormal cholangiograms (92.2%). The mean operating time for all patients undergoing LC with or without cholangiograms or LCBDE or other additional surgery was 56.9 min. Mean length of stay was 22.1 h. The mean operating time for LC only patients ( n = 2530)--that is, those not undergoing LCBDE or any other additional procedure--was 47.6 min; their mean postoperative length of stay was 17.2 h. Ductal exploration was performed via the cystic duct in 269 patients, (82.5%) and through a choledochotomy in 57 patients (17.5%). T-tubes were used in patients in whom there was concern for possible retained debris or stones, distal spasm, pancreatitis, or general poor tissue quality secondary to malnutrition or infection. In cases where choledochotomy was used, a T-tube was placed in 38 patients (67%), and primary closure without a T-tube was done in 19 (33%). There were no complications in the group of patients who underwent choledochotomy and primary ductal closure without T-tube placement or in the group in whom T-tubes were placed. Common bile duct (CBD) stones still occur in 10% of patients. These stones are identified by IOC. IOC can be performed in >96.4% of cases of LC. LCBDE was successful in clearing these stones in 97.2% of patients in whom it was attempted and in 92.2% of all patients with normal IOCs. Most LCBDEs in this series were performed via the cystic duct because of the stone characteristics and ductal anatomy. Selective laparoscopic placement of T-tubes in patients requiring choledochotomy (67%) appears to be a safe and effective alternative to routine T-tube drainage of the ductal system. ERCP, which was required for 5.8% of patients with abnormal cholangiograms, and open CBDE, which was used in 2.0%, still play an important role in the management of common bile duct pathology. The role of ERCP, with or without sphincterotomy, has returned to its status in the prelaparoscopic era. LCBDE may be employed successfully in the vast majority of patients harboring CBD stones.

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Title: JAMA Surgery

Abbreviated Title: JAMA Surg

Publisher: American Medical Association (AMA)

ISSN (Print): 2168-6254

Publication date Created: July 01 2018

Publication date (Print): July 18 2018

Volume: 153

Issue: 7

Page: e181167

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[1 ]Department of Internal Medicine and Surgery (DIMEC), Alma Mater Studiorum, University of Bologna, Sant’Orsola-Malpighi Hospital, Bologna, Italy

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DOI: 10.1001/jamasurg.2018.1167

PMC ID: 6137518

PubMed ID: 29847616

SO-VID: 0a2261e1-36cf-4602-bbef-e55f28e743ad

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Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi : A Systematic Review and Network Meta-analysis

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Most cited references 16

A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited.

Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones.

Laparoscopic common bile duct exploration.

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