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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dmitrijs Aleksandrovs, Dr.
- 전화번호: +37127013234
- 이메일: dmitrijs.aleksandrovs@gmail.com
연구 연락처 백업
- 이름: Anastasija Klodčika, Dr.
- 전화번호: +371 26705309
연구 장소
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Riga, 라트비아
- 모병
- Riga East University Hospital
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연락하다:
- Igors Ivanovs, Asoc.Prof.
- 전화번호: +371 29184455
- 이메일: dr.igors.ivanovs@gmail.com
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수석 연구원:
- Dmitrijs Aleksandrovs, Dr.
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부수사관:
- Anastasija Klodčika, Dr.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Balloon Inflation Pressure Required for Papillary Dilation
기간: Intraoperative
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Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.
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Intraoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Complications
기간: Within 30 days after the index surgical procedure.
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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.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Igors Ivanovs, Asoc.Prof., University of Latvia
- 수석 연구원: Dmitrijs Aleksandrovs, Dr., University of Latvia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PAPRELAX-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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