Clinical trial NCT07008170: Laparoendoscopic Rendezvous for Concomitant Gall Bladder Stones and Common Bile Duct Stones
Official title: Laparoendoscopic Rendezvous for Difficult Cholecystocholedocholithiasis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gall Stone
Common Bile Duct Calculi
Cholecystitis, Chronic
Choledocholithiasis
Periampullary Diverticula
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 stay.

• Risk Factors for Difficult Cannulation Patient Factors (Anatomy)

A. Risk factors of difficult cannulation during ERCP based on preprocedural abdominal CT findings:

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

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.

Primary outcomes:
measure: Assess the success rate of LERV for difficult cannulation
timeFrame: Intraoperative
Secondary outcomes:
measure: assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis
timeFrame: intraoperative
measure: incidence of postsphincterotomy bleeding
timeFrame: 30 days after LERV
measure: incidence of Acute pancreatitis
timeFrame: 30 days after ERCP
measure: Recurrence of common bile duct stones
timeFrame: 60 days after LERV
measure: Incidence of bile leak
timeFrame: 30 days after LERV
measure: incidence of Perforation
timeFrame: 30 days after LERV
measure: incidence of Acute cholangitis
timeFrame: 60 days after LERV
measure: incidence of bile duct stricture
timeFrame: 1 year after LERV
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Liver and GIT hospital , Minia University
Study officials:
affiliation: Minia University
name: Saleh K Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References: