Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones
Launched by MINIA UNIVERSITY · Jun 4, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a procedure called laparoendoscopic rendezvous, which is used to treat patients, especially children, who have both gallstones and stones in the common bile duct. These stones can cause serious issues, like infections or jaundice. The trial aims to see how effective and safe this method is for removing these stones in patients who may have complex cases.
To participate in this study, patients must have stones in both the gallbladder and the common bile duct, as confirmed by special imaging tests. It also includes those with certain symptoms indicating possible complications, such as abdominal pain or elevated liver enzymes. However, some patients may not be eligible, like those with a history of certain surgeries or severe health conditions. If someone qualifies and chooses to participate, they can expect to undergo a minimally invasive procedure to remove the stones, with careful monitoring for safety throughout the trial.
Gender
ALL
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.
About Minia University
Minia University is a prestigious educational institution located in Egypt, dedicated to advancing medical research and clinical trials. With a commitment to fostering innovation and improving healthcare outcomes, the university collaborates with a diverse range of stakeholders, including healthcare professionals and researchers. Minia University aims to enhance clinical practices through rigorous research methodologies and ethical standards, contributing to the body of knowledge in the medical field while addressing local and global health challenges. The university's clinical trial initiatives are designed to evaluate new treatments and interventions, ensuring a positive impact on patient care and community health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minya, , Egypt
Patients applied
Trial Officials
Saleh K Saleh, MD
Principal Investigator
Minia University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported