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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Laparoendoscopic rendezvous

    Procedure/Surgery

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Laparoendoscopic rendezvous(LERV)Other 1 intervention

Trial outcomes

Primary outcomes

1

Assess the success rate of LERV for difficult cannulation

Assess the success rate of LERV for difficult cannulation

Time frame
Intraoperative

Secondary outcomes

1

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
2

incidence of postsphincterotomy bleeding

obvious bleeding during ERCP Or delayed as melena

Time frame
30 days after LERV
3

incidence of Acute pancreatitis

increase serum amylase and lipase

Time frame
30 days after ERCP
4

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

Other outcomes

Sponsors and contacts

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