Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiga East Clinical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age younger than 18 years.
Refusal to provide written informed consent.
Spontaneous antegrade evacuation of common bile duct stones during conservative treatment.
Previous cholecystectomy.
Trial design
Design model
Single group
Treatments tested in this trial
Hyoscine Butylbromide
DrugHyoscine 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
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Hyoscine ButylbromideExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
IntraoperativeSecondary outcomes
1
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.Sponsors and contacts
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Riga East Clinical University Hospital
Lead sponsor
University of Latvia
Collaborator
Source ClinicalTrials.gov