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

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.

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.

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.