An interventional study of Laparoendoscopic rendezvous in Gall Stone, Common Bile Duct Calculi and Cholecystitis, Chronic, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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.
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 :
Exclusion Criteria:
Step 1: Laparoscopic Phase Step 2: Endoscopic Phase Step 3: Completion
Procedure: 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
Assess the success rate of LERV for difficult cannulation
Assess the success rate of LERV for difficult cannulation
Time frame: Intraoperative
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
Time frame: intraoperative
incidence of postsphincterotomy bleeding
obvious bleeding during ERCP Or delayed as melena
Time frame: 30 days after LERV
incidence of Acute pancreatitis
increase serum amylase and lipase
Time frame: 30 days after ERCP
Recurrence of common bile duct stones
The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound.
Time frame: 60 days after LERV
Incidence of bile leak
bile aspirated from the abdominal cavity
Time frame: 30 days after LERV
incidence of Perforation
by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Time frame: 30 days after LERV
incidence of Acute cholangitis
intermittent chills, fever, increased proinflammatory blood markers after ERCP
Time frame: 60 days after LERV
incidence of bile duct stricture
after LERV
Time frame: 1 year after LERV
Plan to share: No
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