ArticleJMIR research protocols2021
Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial.
Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03658863 (Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis), which is not on this map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Clinical observation of laparoscopic cholecystectomy combined with endoscopic retrograde cholangiopancreatography or common bile duct lithotripsy.World journal of clinical cases · 2022Article
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe optimal approach for patients with gallbladder stones and intermediate risk of choledocholithiasis remains undetermined. The use of endoscopic retrograde cholangiopancreatography for diagnosis should be minimized as it carries considerable risk of postprocedural complications, and nowadays, less invasive and safer techniques are available.
objectiveThis study compares the two management strategies of endoscopic ultrasound before laparoscopic cholecystectomy and intraoperative cholangiography for patients with symptomatic cholecystolithiasis and intermediate risk of choledocholithiasis.
methodsThis is a randomized, active-controlled, single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy for symptomatic gallbladder stones with intermediate risk of choledocholithiasis. The risk of choledocholithiasis is calculated using an original prognostic score (the Vilnius University Hospital Index). This index in a retrospective evaluation showed better prognostic performance than the score proposed by the 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 performed in another arm ("cholecystectomy first"). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. The secondary endpoints are accuracy of the different management strategies, adverse events of the interventions, duct clearance and technical success of the interventions (intraoperative cholangiography, endoscopic ultrasound, and endoscopic retrograde cholangiography), and cost of treatment.
resultsThe trial protocol was approved by the Vilnius Regional Biomedical Research Ethics Committee in December 2017. Enrollment of patients was started in January 2018. As of June 2020, 66 patients have been enrolled.
conclusionsThis trial is planned to determine the superior strategy for patients with intermediate risk of common bile duct stones and to define a simple and safe algorithm for managing choledocholithiasis.
trial registrationClinicalTrials.gov NCT03658863; https://clinicaltrials.gov/ct2/show/NCT03658863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18837.
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