About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of hepatobiliary surgery as choledochoduodenal anastomosis
A Previous upper abdominal surgery as total or partial gastric resection.
Morbid obesity.
Uncorrectable coagulopathy.
Trial design
Single group
Treatments tested in this trial
Laparoendoscopic rendezvous
Procedure/SurgeryThe 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
Treatment groups
Trial outcomes
Primary outcomes
Assess the success rate of LERV for difficult cannulation
Assess the success rate of LERV for difficult cannulation
Secondary outcomes
assess the success rate of LERV in clearing the common bile duct in patients with choledocholithiasis
CBD clearance success,Complete extraction of all stones during LERV judged by ERCP imaging
incidence of postsphincterotomy bleeding
obvious bleeding during ERCP Or delayed as melena
incidence of Acute pancreatitis
increase serum amylase and lipase
Recurrence of common bile duct stones
The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound.
Sponsors and contacts
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