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NCT Number: NCT07814976

Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

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.

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Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholelithiasis Common Bile Duct Diseases Common Bile Duct Stones Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riga East University Hospital

Riga, Latvia

Location status: Recruiting

About this study

Choledocholithiasis is commonly treated using endoscopic or surgical bile duct clearance techniques. Laparoscopic transcystic papillary balloon dilation enables antegrade clearance of common bile duct stones during laparoscopic surgery.

Smooth muscle contraction and papillary spasm may complicate transcystic manipulation, balloon passage, and dilation of the papilla of Vater. Hyoscine butylbromide is a peripheral antimuscarinic agent that reduces gastrointestinal smooth muscle tone and is routinely used in several gastrointestinal endoscopic and radiological procedures.

The PAPRELAX study is a single-center prospective interventional study with a retrospective historical control cohort.

In the prospective cohort, eligible adult patients with confirmed choledocholithiasis undergoing laparoscopic transcystic papillary balloon dilation will receive hyoscine butylbromide 20 mg intravenously during the procedure.

Procedural data will include the duration of transcystic papillary balloon dilation and the balloon inflation pressure required to perform dilation of the papilla of Vater. Postoperative complications will also be recorded.

The outcomes of prospectively enrolled patients receiving hyoscine butylbromide will be compared with a historical cohort of patients who previously underwent laparoscopic transcystic papillary balloon dilation without administration of hyoscine butylbromide.

The study is conducted at Riga East Clinical University Hospital "Gaiļezers", Riga, Latvia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Written informed consent for participation in the study.
  • Confirmed choledocholithiasis.
  • Common bile duct stone diameter of 15 mm or less.
  • General medical condition permitting laparoscopic cholecystectomy.

Exclusion criteria

  • Age younger than 18 years.
  • Refusal to provide written informed consent.
  • Spontaneous antegrade evacuation of common bile duct stones during conservative treatment.
  • Previous cholecystectomy.
  • Common bile duct stone diameter greater than 15 mm.
  • General medical condition not permitting laparoscopic cholecystectomy.

Treatment and study plan

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

Other names: Buscopan

Primary outcomes

  1. Balloon Inflation Pressure Required for Papillary Dilation

    Time frame: Intraoperative

    Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.

Secondary outcomes

  1. Postoperative Complications

    Time frame: Within 30 days after the index surgical procedure.

    Number and proportion of participants experiencing postoperative complications following laparoscopic transcystic papillary balloon dilation with intraoperative administration of hyoscine butylbromide.

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Sponsors and collaborators

Lead sponsor

Riga East Clinical University Hospital

Other Gov

Collaborators

  • University of Latvia

Registry information

Official study title

Intraoperative Hyoscine Butylbromide During Laparoscopic Transcystic Papillary Balloon Dilation for Choledocholithiasis: A Prospective Interventional Study With Historical Controls

Acronym: PAPRELAX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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