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Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

Sponsor: Riga East Clinical University Hospital • ClinicalTrials.gov ID: NCT07814976

Registry updated: 2026-09-11

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Description

The purpose of the PAPRELAX study is to evaluate the intraoperative effect of intravenous hyoscine butylbromide during laparoscopic transcystic balloon dilation of the papilla of Vater in adult patients undergoing surgical treatment for choledocholithiasis. The study will evaluate whether administration of hyoscine butylbromide influences the duration of transcystic papillary balloon dilation and the balloon inflation pressure required for papillary dilation. Eligible participants enrolled prospectively will receive 20 mg of intravenous hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation. Procedural characteristics and postoperative outcomes will be compared with those of a historical control cohort of patients who previously underwent the same procedure without hyoscine butylbromide.

Interventions

Hyoscine Butylbromide (Drug)
Hyoscine butylbromide 20 mg will be administered intravenously during laparoscopic transcystic balloon dilation of the papilla of Vater. The intervention is intended to reduce smooth muscle tone during transcystic papillary manipulation and balloon dilation. Frequency: Single intraoperative administration

Eligibility criteria

Inclusion Criteria: 1. Age 18 years or older. 2. Written informed consent for participation in the study. 3. Confirmed choledocholithiasis. 4. Common bile duct stone diameter of 15 mm or less. 5. General medical condition permitting laparoscopic cholecystectomy. Exclusion Criteria: 1. Age younger than 18 years. 2. Refusal to provide written informed consent. 3. Spontaneous antegrade evacuation of common bile duct stones during conservative treatment. 4. Previous cholecystectomy. 5. Common bile duct stone diameter greater than 15 mm. 6. General medical condition not permitting laparoscopic cholecystectomy.

Conditions

Choledocholithiasis Common Bile Duct Stones

Locations

Riga East University Hospital — Riga, Latvia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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