Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

NCT07814976 | Recruiting

• 1 other identifier: PAPRELAX-2026-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Bile Duct Stones; Choledocholithiasis

Keywords

Choledocholithiasis; Common Bile Duct Stones; Hyoscine Butylbromide; Papilla of Vater; Papillary Balloon Dilation; Transcystic Approach; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Balloon Inflation Pressure Required for Papillary Dilation

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

  Intraoperative

Secondary Outcomes (1)

• Postoperative Complications

  Within 30 days after the index surgical procedure.

Study Arms (1)

Hyoscine Butylbromide

EXPERIMENTAL

Participants with confirmed choledocholithiasis undergoing laparoscopic transcystic balloon dilation of the papilla of Vater will receive hyoscine butylbromide 20 mg intravenously during the procedure. Procedural characteristics and postoperative outcomes will be prospectively recorded. Outcomes will subsequently be compared with those of a retrospective historical control cohort that underwent the same procedure without administration of hyoscine butylbromide.

Drug: 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

Also known as: Buscopan

Hyoscine Butylbromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Latvia: collaborator
• Riga East Clinical University Hospital: lead

Study Sites (1)

Riga East University Hospital

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Igors Ivanovs, Asoc.Prof.

  University of Latvia

  STUDY DIRECTOR

• Dmitrijs Aleksandrovs, Dr.

  University of Latvia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitrijs Aleksandrovs, Dr.

CONTACT

+37127013234; dmitrijs.aleksandrovs@gmail.com

Anastasija Klodčika, Dr.

CONTACT

+371 26705309

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asoc.Prof.

Model Details: Prospective single-arm interventional study with comparison of procedural and postoperative outcomes with a retrospective historical control cohort of patients who underwent the same surgical procedure without hyoscine butylbromide.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 11, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

LA (1)