One-stage laparoendoscopic approach for gallbladder and common bile duct stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.