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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dmitrijs Aleksandrovs, Dr.
- 電話番号：+37127013234
- メール：dmitrijs.aleksandrovs@gmail.com
研究連絡先のバックアップ
- 名前：Anastasija Klodčika, Dr.
- 電話番号：+371 26705309
研究場所
-
-
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Riga、ラトビア
- 募集
- Riga East University Hospital
-
コンタクト：
- Igors Ivanovs, Asoc.Prof.
- 電話番号：+371 29184455
- メール：dr.igors.ivanovs@gmail.com
-
主任研究者：
- Dmitrijs Aleksandrovs, Dr.
-
副調査官：
- Anastasija Klodčika, Dr.
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Balloon Inflation Pressure Required for Papillary Dilation
時間枠：Intraoperative
|
Balloon inflation pressure required to perform transcystic balloon dilation of the papilla of Vater during the index surgical procedure.
|
Intraoperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Complications
時間枠：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.
|
Within 30 days after the index surgical procedure.
|
協力者と研究者
捜査官
- スタディディレクター：Igors Ivanovs, Asoc.Prof.、University of Latvia
- 主任研究者：Dmitrijs Aleksandrovs, Dr.、University of Latvia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PAPRELAX-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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