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

NCT ID: NCT07008170

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-07-15

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.

Detailed Description

The incidence of concomitant choledocholithiasis in patients with gallstone disease has been reported to range between 10% and 20% depending on geographic distribution.The ideal management of cholecysto-choledocholithiasis is still a matter of debate; different modalities, including the open and the laparoscopic approach, and sequential or simultaneous techniques, have been applied with success.

The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD( common bile duct) stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).

The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification.

Aim of the study is to evaluate use of laparoendoscopic rendezvous for difficult cholecystocholedocholithiasis using preprocedural abdominal CT findings. Primary outcome is to performs difficult biliary cannulation by rendezvous technique while secondary outcomes is to to detect morbidity (especially post-ERCP pancreatitis) , success of CBD clearance and to detect overall hospital

Risk factors of difficult cannulation during ERCP based on preprocedural abdominal CT findings in the study :

1. periampullary diverticulum

2. Location of the major papilla other than the descending duodenum

3. Presence of papilla bulging

4. Choledochoduodenal (CD) angle: the angle between the distal common bile duct and adjacent duodenum,

5. CBD( common bile duct) diameter

6. Far distal CBD (common bile duct) stone B. Laboratory investigation: normal bilirubin C. Previous upper gastrointestinal tract surgery/ Surgically altered anatomy

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoendoscopic rendezvous(LERV)

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

Group Type: OTHER

Laparoendoscopic rendezvous

Intervention Type: 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

Interventions

Laparoendoscopic rendezvous

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

01201765401 ext. +2

Ayman M Hassanen, MD

Role: CONTACT

Ayman.hassan@mu.edu.eg

0 109 275 8555 ext. +2

Facility Contacts

Saleh K Saleh, MD

Role: primary

salehkhairy@mu.edu.eg

01201765401 ext. +2

Other Identifiers

1379/12/2024

Identifier Type: -

Identifier Source: org_study_id