One-stage laparoendoscopic approach for gallbladder and common bile duct stones
Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis.
This trial tests whether a single-operation laparoendoscopic 'rendezvous' approach—combining laparoscopic gallbladder removal with endoscopic bile duct clearance—works safely and effectively for patients with both gallbladder and common bile duct stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Trial ID | NCT07008170 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study compares a one-stage laparoendoscopic rendezvous technique (intraoperative endoscopic sphincterotomy with laparoscopic cholecystectomy) against the conventional two-stage approach (preoperative ERCP followed by laparoscopic cholecystectomy) for cholecystocholedocholithiasis. Patients are enrolled based on imaging or laboratory evidence of concurrent or highly suspected common bile duct stones and must be fit for general anesthesia and endoscopic procedures. The main outcomes are stone clearance, technical success including difficult cannulation rates, procedure-related complications, and postoperative recovery. Procedures and follow-up are conducted at a single center to document efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are patients with confirmed or highly suspected concomitant gallbladder and common bile duct stones who are fit for general anesthesia and endoscopic procedures and have not had complex prior hepatobiliary surgery.
Not a fit: Patients with prior major hepatobiliary or upper abdominal resections, morbid obesity, uncorrectable coagulopathy, pregnancy, or who decline consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the one-stage approach could clear both gallbladder and bile duct stones in a single operation, reducing total procedures, hospital time, and anesthesia exposure.
How similar studies have performed: Laparoendoscopic rendezvous has been reported in adult case series to improve cannulation success and reduce the need for two separate procedures, though randomized and pediatric data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients having stone(s) in the gallbladder and concurrent common bile duct , as determined by MRCP(magnetic resonance cholangiopancreatography) or US. * Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for common bile duct stones, such as dilated CBD( common bile duct ) on US examination \> 7 mm in diameter without obvious common bile duct stones, high serum bilirubin level, and/or high serum alkaline phosphatase level, were also included in this study. (high risk for cholecystocholedocholithiasis) * Previous failed ERCP attempt * Patients fit for general anesthesia and tolerant of pneumoperitoneum and endoscopic procedures. Exclusion Criteria: * History of hepatobiliary surgery as choledochoduodenal anastomosis * A Previous upper abdominal surgery as total or partial gastric resection. * Morbid obesity. * Uncorrectable coagulopathy. * Patients who refused to give consent. * Pregnancy. * Suspected malignant biliary stricture or cholangiocarcinoma * Severe acute cholangitis with hemodynamic instability or septic shock requiring immediate biliary drainage (may necessitate emergent ERCP or percutaneous drainage first) * Impacted CBD stones or stones deemed too large for endoscopic extraction (e.g., \> 1.5 cm) * Severe cardiopulmonary disease significantly increasing operative risk. * Intrahepatic bile duct stones with indications for surgery. * Patients with choledocholithiasis \>2 cm or a large number of stones were difficult to remove.
Where this trial is running
Minya
- Liver and GIT hospital , Minia University — Minya, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.