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

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for treating difficult cases of choledocholithiasis, which is when gallstones block the common bile duct. The trial will compare a new robotic surgery approach to the traditional method that involves a two-step process. In the robotic approach, the surgeon uses advanced robotic tools to perform the surgery in one go, while the traditional method first uses an endoscopic technique to remove the stones and then follows up with surgery later. Researchers want to see if the robotic method is more effective in clearing the stones and has fewer complications.

To participate in this trial, patients must have challenging gallstone cases, such as large stones or multiple stones, and they should not have had previous gallbladder surgery. Participants will be randomly assigned to either the robotic surgery group or the traditional method. They can expect to be monitored for how well the stones are cleared, any complications that arise, and how long they need to stay in the hospital after the procedure. This study is important because it could help establish a new standard for treating difficult gallstone cases if the robotic approach proves to be safer and more effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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