Clinical Trial

The Significance of Laparoscopic Transcystic Papilla Vateri Balloon Dilatation in Patients With Choledocholithiasis.

Study acronym: DILAILA
Active, Not Recruiting
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Summary
A prospective randomized trial. It is planned to analyze groups of patients with cholecystitis and choledocholithiasis. As part of the study, after signing the consent, the patients will be divided into two groups that have indications for surgical therapy. A two-stage therapy will be applied to one group, where initially endoscopic retrograde cholangiopancreatography with evacuation of gallstone from the common bile duct will be prescribed, and as the second stage, patients will undergo surgery - laparoscopic cholecystectomy. For the second group, a one-stage therapy tactic will be applied, where during the operation (laparoscopic cholecystectomy), transcystic papilla Vateri balloon dilation with antegrade gallstone evacuation from the common bile duct will be applied. For patients who will be proven to have a stone in the common bile duct and patients who meet the study inclusion criteria, a sealed envelope will be placed in the medical history with a specific therapeutic tactic that will be applied to the patient's treatment. Each envelope will be assigned a number. Using a computer and a randomizer, an envelope with a number will be selected, which will be assigned to each patient. The postoperative course, duration of surgery, length of hospitalization, types of complications and their frequency after surgery, the creator of successful outcomes, the cost of the treatment method in the specific medical institution will be analyzed. The data will be processed with the IBM SPSS program and analyzed according to the parametric/non-parametric distribution of the data.
Trial Details
NCT Number NCT07503964
Lead Sponsor Riga East Clinical University Hospital
Collaborators: University of Latvia
Conditions Choledocholithiasis, Choledocholithiasis With Cholecystitis
Enrollment 100 participants
Start Date 2025-05-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-31