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

NCT05611840 · Chinese University of Hong Kong · Updated 31 Aug 2023

What is being tested
Robotic surgery; Endo-laparoscopic surgery
For
Choledocholithiasis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 90 people. The full rules are on the registry page.
Where
Hong Kong
When
Starts or started 1 May 2023, ends 31 Dec 2025. Registered 10 Nov 2022.
Results
None posted yet.

In the researchers' words

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,…
ClinicalTrials.gov, NCT05611840

Sites

  • Chinese University of Hong KongHong Kong, Hong Kong