JMIR Publications

ABSTRACT

Background:

The optimal approach for patients with gallbladder stones and intermediate risk for choledocholithiasis still remains undetermined. Usage of endoscopic retrograde cholangiopancreatography for diagnostic purpose should be minimized as it carries considerable risk of post-procedural complications and nowadays less invasive and safer techniques are available.

Objective:

This study compares two different management strategies: endoscopic ultrasound before laparoscopic cholecystectomy versus intraoperative cholangiography for patients with symptomatic cholecystolithiasis and intermediate risk for choledocholithiasis.

Methods:

It is a clinical randomized active-controlled single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy due to symptomatic gallbladder stones with intermediate risk for choledocholithiasis. The risk for choledocholithiasis is calculated using an original prognostic score – Vilnius University Hospital Index. This index in a retrospective evaluation showed better prognostic performance than the score proposed by American Society for Gastrointestinal Endoscopy in 2010. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“Endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be administered in another arm (“Cholecystectomy first”). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. Secondary endpoints will include accuracy of the different management strategies, adverse events of interventions, duct clearance and technical success of interventions (intraoperative cholangiography, endoscopic ultrasound, endoscopic retrograde cholangiography), costs of treatment.

Results:

The trial protocol approved by the Vilnius Regional Biomedical Research Ethics Committee in December 2017. Enrollment of patients was started in January 2018. As of to June 2020, 66 patients are enrolled.

Conclusions:

This trial is planned to determine superior strategy for patients with intermediate common bile duct stones risk and to define a simple and safe algorithm on managing choledocholithiasis. Clinical Trial: The trial is registered at ClinicalTrials.gov, identification number NCT03658863.