Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PAPRELAX study is a single-center prospective interventional trial with a historical control group. It examines the intraoperative effect of 20 mg intravenous hyoscine butylbromide administered during laparoscopic transcystic papillary balloon dilation in adults with choledocholithiasis. Key outcomes include the duration of the dilation and the balloon inflation pressure required for papillary dilation, as well as postoperative complications. Prospective participants will be compared to a retrospective cohort who underwent the same procedure without hyoscine butylbromide. The trial takes place at Riga East Clinical University Hospital in Riga, Latvia, with collaboration from the University of Latvia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Riga East University Hospital
  Riga, Latvia Recruiting

Study contacts

• Principal investigator: Dmitrijs Aleksandrovs, Dr. — University of Latvia
• Study coordinator: Dmitrijs Aleksandrovs, Dr.
• Email: dmitrijs.aleksandrovs@gmail.com
• Phone: +37127013234

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.