Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis (PAPRELAX)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Choledocholithiasis; Common Bile Duct Stones
• Intervention / Treatment: Drug: Hyoscine Butylbromide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitrijs Aleksandrovs, Dr.; Phone Number: +37127013234; Email: dmitrijs.aleksandrovs@gmail.com
• Study Contact Backup: Name: Anastasija Klodčika, Dr.; Phone Number: +371 26705309

Study Locations

• Latvia
  • Riga, Latvia
    • Recruiting
    • Riga East University Hospital
    • Contact: Igors Ivanovs, Asoc.Prof.; Phone Number: +371 29184455; Email: dr.igors.ivanovs@gmail.com
    • Principal Investigator: Dmitrijs Aleksandrovs, Dr.
    • Sub-Investigator: Anastasija Klodčika, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hyoscine Butylbromide; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications	Number and proportion of participants experiencing postoperative complications following laparoscopic transcystic papillary balloon dilation with intraoperative administration of hyoscine butylbromide.	Within 30 days after the index surgical procedure.

Collaborators and Investigators

• Sponsor: Riga East Clinical University Hospital
• Collaborators: University of Latvia
• Investigators: Study Director: Igors Ivanovs, Asoc.Prof., University of Latvia; Principal Investigator: Dmitrijs Aleksandrovs, Dr., University of Latvia

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic Cholecystectomy; Choledocholithiasis; Common Bile Duct Stones; Hyoscine Butylbromide; Papilla of Vater; Papillary Balloon Dilation; Transcystic Approach
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Choledocholithiasis; Organic Chemicals; Heterocyclic Compounds; Alkaloids; Amines; Aza Compounds; Quaternary Ammonium Compounds; Heterocyclic Compounds, Bridged-Ring; Tropanes; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Scopolamine Derivatives; Butylscopolammonium Bromide
• Other Study ID Numbers: PAPRELAX-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant data underlying the results reported in the publication may be made available upon reasonable scientific request and following approval by the study investigators and applicable institutional and data-protection authorities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No