RCT on Robotic vs. Endo-laparoscopic Approach for Difficult Choledocholithiasis

NCT05611840 | Unknown DMC

• 1 other identifier: 003kkcng/surg/cuhk
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Gallstone disease is a very common disease identity in the world. Migration of stones from gallbladder to common bile duct (CBD), causing CBD stones (choledocholithiasis), occurs in up to 22% of cases. Traditionally, choledocholithiasis can be managed by therapeutic endoscopic retrograde cholangiopancreatography (ERCP) with interval cholecystectomy in 85% of patients. In around 15% of the patients, the clearance of choledocholithiasis cannot be effectively achieved with standard ERCP (difficult choledocholithiasis). As recommended by European Society of Gastrointestinal Endoscopy guideline, difficult choledocholithiasis can be managed by either endoscopic or surgical approaches. Clinical evidences by meta-analyses comparing endoscopic with surgical approaches are conflicting. Considering the timing of cholecystectomy to eliminate the pathological source of CBD stone, one-stage laparoscopic CBD exploration LCBDE plus laparoscopic cholecystectomy LC is an attractive approach. Although one-stage laparoscopic approach is associated with higher stone clearance rate (up to 96%) than traditional two-stage endo-laparoscopic approach (preoperative ERCP and LC), postoperative complication rate is substantial (up to 17%). Among those complications, postoperative bile leak is likely related to laparoscopic instrumental limitations in LCBDE. With advancement of da Vinci robotic system, there are 3-dimensional dual cameras providing high-quality intraoperative view and 7-degree of freedom of robotic instruments. The system is able to cope with complex hepatobiliary surgical procedure, including robotic CBD exploration (RCBDE). Theoretically, postoperative bile leak following RCBDE is lower than that of LCBDE. Hence, one-stage RCBDE plus robotic cholecystectomy RC could become a new standard of treatment for difficult choledocholithiasis. Up till now, only case series have reported the safety and efficacy of RCBDE. There is, however, no prospective randomized trial comparing one-stage RCBDE and RC with traditional two-stage endo-laparoscopic approach (preoperative ERCP and interval LC) for difficult choledocholithiasis, in terms of stone clearance rate and procedure-related complications. The investigators thus propose a single-center randomized trial on this issue. 90 patients (45 patients in each arm) with difficult choledocholithiasis will be randomized to definitive treatment by either one-stage robotic approach or two-stage endo-laparoscopic approach. The primary outcome is the stone clearance rate. The secondary outcomes include treatment related morbidity, hospital mortality, and hospital stay. This will be the first randomized trial in the world evaluating the efficacy of the novel one-stage robotic approach for difficult choledocholithiasis, and it will certainly add level 1 evidence to change the management algorithm for choledochothiliasis.

Conditions

Choledocholithiasis

Keywords

Difficult; Choledocholithiasis; Robotic; Endo-laparoscopic; Randomized; Trial

Outcome Measures

Primary Outcomes (1)

• Common bile duct stone clearance rate

  The rate of retained common bile duct stone after intervention as assessed by ERCP at 6 weeks

  up to 6 weeks

Secondary Outcomes (5)

• Hospital mortality

  Up to 4 weeks

• Hospital stay

  Up to 4 weeks

• Bile leakage rate after surgery

  Up to 4 weeks

• Complication rate as assessed by Clavien-Dindo classification

  Up to 4 weeks

• Hospital cost

  Up to 4 weeks

Study Arms (2)

Robotic group

EXPERIMENTAL

One-stage robotic common bile duct exploration and cholecystectomy

Procedure: Robotic surgery

Endo-laparoscopic group

ACTIVE COMPARATOR

Two stage therapeutic endoscopic retrograde cholangiopancreatography (ERCP) with interval laparoscopic cholecystectomy

Procedure: Endo-laparoscopic surgery

Interventions

Robotic surgery PROCEDURE

one-stage robotic common bile duct exploration and cholecystectomy

Robotic group

Endo-laparoscopic surgery PROCEDURE

Two-stage therapeutic ERCP plus interval laparoscopic cholecystectomy

Endo-laparoscopic group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitions of difficult CBD stone: stone size \> 1.5cm, and/or multiple stones \> 3, and/or narrow and angled distal common bile duct (CBD) (\< 1350)
• Diagnostic ERCP with successful CBD deep cannulation and temporarily CBD stenting
• No history of cholecystectomy
• General condition fit for GA

You may not qualify if:

• History of recurrent pyogenic cholangitis
• Failed endoscopic biliary stenting by initial ERCP
• Complications of ERCP (severe necrotizing pancreatitis, papillotomy bleeding or bowel perforation)
• Previous upper abdominal surgery, including gastrectomy
• General condition unfit for GA

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (11)

• Abou-Saif A, Al-Kawas FH. Complications of gallstone disease: Mirizzi syndrome, cholecystocholedochal fistula, and gallstone ileus. Am J Gastroenterol. 2002 Feb;97(2):249-54. doi: 10.1111/j.1572-0241.2002.05451.x.

  PMID: 11866258 BACKGROUND

• Williams E, Beckingham I, El Sayed G, Gurusamy K, Sturgess R, Webster G, Young T. Updated guideline on the management of common bile duct stones (CBDS). Gut. 2017 May;66(5):765-782. doi: 10.1136/gutjnl-2016-312317. Epub 2017 Jan 25.

  PMID: 28122906 BACKGROUND

• Odemis B, Kuzu UB, Oztas E, Saygili F, Suna N, Coskun O, Aksoy A, Sirtas Z, Ari D, Akpinar Y. Endoscopic Management of the Difficult Bile Duct Stones: A Single Tertiary Center Experience. Gastroenterol Res Pract. 2016;2016:8749583. doi: 10.1155/2016/8749583. Epub 2016 Nov 24.

  PMID: 27999591 BACKGROUND

• Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.

  PMID: 30943551 BACKGROUND

• Dasari BV, Tan CJ, Gurusamy KS, Martin DJ, Kirk G, McKie L, Diamond T, Taylor MA. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev. 2013 Dec 12;2013(12):CD003327. doi: 10.1002/14651858.CD003327.pub4.

  PMID: 24338858 BACKGROUND

• Ji WB, Zhao ZM, Dong JH, Wang HG, Lu F, Lu HW. One-stage robotic-assisted laparoscopic cholecystectomy and common bile duct exploration with primary closure in 5 patients. Surg Laparosc Endosc Percutan Tech. 2011 Apr;21(2):123-6. doi: 10.1097/SLE.0b013e31820ad553.

  PMID: 21471807 BACKGROUND

• Alkhamesi NA, Davies WT, Pinto RF, Schlachta CM. Robot-assisted common bile duct exploration as an option for complex choledocholithiasis. Surg Endosc. 2013 Jan;27(1):263-6. doi: 10.1007/s00464-012-2431-0. Epub 2012 Jul 7.

  PMID: 22773235 BACKGROUND

• Szold A, Bergamaschi R, Broeders I, Dankelman J, Forgione A, Lango T, Melzer A, Mintz Y, Morales-Conde S, Rhodes M, Satava R, Tang CN, Vilallonga R; European Association of Endoscopic Surgeons. European Association of Endoscopic Surgeons (EAES) consensus statement on the use of robotics in general surgery. Surg Endosc. 2015 Feb;29(2):253-88. doi: 10.1007/s00464-014-3916-9. Epub 2014 Nov 8.

  PMID: 25380708 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Cuschieri A, Lezoche E, Morino M, Croce E, Lacy A, Toouli J, Faggioni A, Ribeiro VM, Jakimowicz J, Visa J, Hanna GB. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999 Oct;13(10):952-7. doi: 10.1007/s004649901145.

  PMID: 10526025 BACKGROUND

• Donner A. Approaches to sample size estimation in the design of clinical trials--a review. Stat Med. 1984 Jul-Sep;3(3):199-214. doi: 10.1002/sim.4780030302.

  PMID: 6385187 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Kelvin Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelvin Ng, PhD

CONTACT

(852)35051496; kelvinng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 10, 2022
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)