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

NCT07008170 | Recruiting DMC

• 1 other identifier: 1379/12/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gall Stone; Common Bile Duct Calculi; Cholecystitis, Chronic; Choledocholithiasis; Periampullary Diverticula

Outcome Measures

Primary Outcomes (1)

• Assess the success rate of LERV for difficult cannulation

  Assess the success rate of LERV for difficult cannulation

  Intraoperative

Secondary Outcomes (8)

• assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis

  intraoperative

• incidence of postsphincterotomy bleeding

  30 days after LERV

• incidence of Acute pancreatitis

  30 days after ERCP

• Recurrence of common bile duct stones

  60 days after LERV

• Incidence of bile leak

  30 days after LERV

Study Arms (1)

Laparoendoscopic rendezvous(LERV)

OTHER

Step 1: Laparoscopic Phase Step 2: Endoscopic Phase Step 3: Completion

Procedure: Laparoendoscopic rendezvous

Interventions

Laparoendoscopic rendezvous PROCEDURE

The main principles of LERV technique consists of 1. An antegrade trans cystic cannulation of the bile duct during laparoscopic cholecystectomy, with a guidewire that can be retrieved with a duodenoscope, thus facilitating retrograde bile duct cannulation. 2. An over-the-wire sphincterotome is then inserted and standard maneuvers of endoscopic common bile duct stones clearance are performed. 3. The procedure is then completed by cholecystectomy in one procedure

Laparoendoscopic rendezvous(LERV)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Gallstones; Cholecystitis; Bronchiolitis Obliterans Syndrome; Choledocholithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Common Bile Duct Diseases; Bile Duct Diseases

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Ayman M Hassanen, MD

CONTACT

0 109 275 8555; Ayman.hassan@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: June 15, 2025
• Primary Completion: June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)