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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dmitrijs Aleksandrovs, Dr.
- Telefonnummer: +37127013234
- E-post: dmitrijs.aleksandrovs@gmail.com
Studera Kontakt Backup
- Namn: Anastasija Klodčika, Dr.
- Telefonnummer: +371 26705309
Studieorter
-
-
-
Riga, Lettland
- Rekrytering
- Riga East University Hospital
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Kontakt:
- Igors Ivanovs, Asoc.Prof.
- Telefonnummer: +371 29184455
- E-post: dr.igors.ivanovs@gmail.com
-
Huvudutredare:
- Dmitrijs Aleksandrovs, Dr.
-
Underutredare:
- Anastasija Klodčika, Dr.
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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.
- General medical condition permitting laparoscopic cholecystectomy.
Exclusion Criteria:
- Age younger than 18 years.
- Refusal to provide written informed consent.
- Spontaneous antegrade evacuation of common bile duct stones during conservative treatment.
- Previous cholecystectomy.
- Common bile duct stone diameter greater than 15 mm.
- General medical condition not permitting laparoscopic cholecystectomy.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Balloon Inflation Pressure Required for Papillary Dilation
Tidsram: Intraoperative
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Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.
|
Intraoperative
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Complications
Tidsram: 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.
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Within 30 days after the index surgical procedure.
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: Igors Ivanovs, Asoc.Prof., University of Latvia
- Huvudutredare: Dmitrijs Aleksandrovs, Dr., University of Latvia
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Gallvägssjukdomar
- Gallgångssjukdomar
- Kolelithiasis
- Vanliga gallvägssjukdomar
- Choledocholithiasis
- Organiska kemikalier
- Heterocykliska föreningar
- Alkaloider
- Aminer
- AZA -föreningar
- Kvartära ammoniumföreningar
- Heterocykliska föreningar, överbryggad ring
- Tropaner
- Azabicyclo -föreningar
- Överbryggade cykloföreningar, heterocykliska
- Scopolaminederivat
- Butylskopolammoniumbromid
Andra studie-ID-nummer
- PAPRELAX-2026-01
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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