An interventional study of Hyoscine Butylbromide in Choledocholithiasis and Common Bile Duct Stones, sponsored by Riga East Clinical University Hospital. Recruiting at 1 site in Latvia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Riga East Clinical University Hospital · Not applicable, Interventional, and Treatment
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.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Riga East Clinical University Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Buscopan
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.
Time frame: Intraoperative
Postoperative Complications
Number and proportion of participants experiencing postoperative complications following laparoscopic transcystic papillary balloon dilation with intraoperative administration of hyoscine butylbromide.
Time frame: Within 30 days after the index surgical procedure.
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.
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Studies of the drug tested here: Butylscopolammonium Bromide
Riga East Clinical University Hospital