Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07008170

Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis

Led by Minia University · Updated on 2025-06-19

80

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gallbladder stones combined with common bile duct stones, known as cholecystocholedocholithiasis, affect a notable number of patients and present challenges in treatment. This study focuses on patients experiencing difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP), a key procedure for stone removal. Researchers aim to evaluate the safety and effectiveness of the laparoendoscopic rendezvous (LERV) technique, which combines laparoscopic and endoscopic methods in a single operation to manage this condition. The study involves a single-stage procedure called laparoendoscopic rendezvous, which integrates laparoscopic cholecystectomy with intra-operative endoscopic sphincterotomy and stone removal. The technique includes an antegrade trans-cystic cannulation of the bile duct to aid endoscopic access, followed by stone clearance and the completion of gallbladder removal. The process has three main steps: the laparoscopic phase, the endoscopic phase, and completion. The study compares this approach against the traditional two-stage method involving pre-operative endoscopic sphincterotomy followed by laparoscopic cholecystectomy. Participants will undergo assessments during and after the procedure, including monitoring for successful bile duct cannulation, stone clearance, and complications such as pancreatitis, bleeding, bile leaks, perforation, cholangitis, and bile duct strictures. Follow-ups will assess short-term and long-term outcomes up to one year after the procedure. The study aims to provide detailed information on the effectiveness and safety of the laparoendoscopic rendezvous technique for treating difficult cholecystocholedocholithiasis.

CONDITIONS

Brief Title

Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with stones in both the gallbladder and common bile duct confirmed by MRCP or ultrasound
  • Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, or high suspicion of common bile duct stones
  • Patients with previous failed ERCP attempt
  • Patients fit for general anesthesia and able to tolerate laparoscopic and endoscopic procedures
Not Eligible

You will not qualify if you...

  • History of hepatobiliary surgery such as choledochoduodenal anastomosis
  • Previous upper abdominal surgery like total or partial gastric resection
  • Morbid obesity
  • Uncorrectable coagulopathy
  • Refusal to give consent
  • Pregnancy
  • Suspected malignant biliary stricture or cholangiocarcinoma
  • Severe acute cholangitis with instability or septic shock needing urgent drainage
  • Impacted or very large common bile duct stones (over 1.5 cm)
  • Severe cardiopulmonary disease raising operative risk
  • Intrahepatic bile duct stones needing surgery
  • Choledocholithiasis larger than 2 cm or too many stones difficult to remove

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - One day (single procedure)

Participants undergo a single-stage procedure combining laparoscopic cholecystectomy with intra-operative endoscopic sphincterotomy to remove gallbladder and common bile duct stones.

1 in-person surgical procedure visit

Follow-up

Duration - Up to 1 year after treatment

Participants are monitored after the procedure to assess recovery and detect any complications such as bleeding, pancreatitis, bile leak, perforation, cholangitis, or bile duct stricture.

Several follow-up visits up to 1 year

Trial Site Locations

Total: 1 location

1

Liver and GIT hospital , Minia University

Minya, Egypt, 61519

Actively Recruiting

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Research Team

S

Saleh K Saleh, MD

A

Ayman M Hassanen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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