Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07814976

Acronym

PAPRELAX

Enrollment

Registered

2026-09-11

Start date

2026-01-04

Completion date

2027-02-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis, Common Bile Duct Stones

Keywords

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

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.

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.

Interventions

DRUGHyoscine 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Balloon Inflation Pressure Required for Papillary Dilation	Intraoperative	Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.

Secondary

Measure	Time frame	Description
Postoperative Complications	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.

Countries

Latvia

Contacts

CONTACTDmitrijs Aleksandrovs, Dr.

dmitrijs.aleksandrovs@gmail.com+37127013234

CONTACTAnastasija Klodčika, Dr.

+371 26705309

STUDY_DIRECTORIgors Ivanovs, Asoc.Prof.

University of Latvia

PRINCIPAL_INVESTIGATORDmitrijs Aleksandrovs, Dr.