NCT07008170 Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones
| NCT ID | NCT07008170 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Gall Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-06-15 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC( laparoscopic cholecystectomy) after ERCP( endoscopic retrograde cholangiopancreatography). The aim of this prospective study is to evaluate the efficacy and safety Laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis.
Eligibility 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.
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07008170 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gall Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07008170 currently recruiting?
Yes, NCT07008170 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07008170 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07008170 clinical trial?
NCT07008170 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 80 participants.