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治験 NCT07495111（対象：Cholelithiasis Associated With Common Bile Duct Stones）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis 88 無作為化
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07495111 は 介入研究 臨床試験 で、Cholelithiasis Associated With Common Bile Duct Stones に関するものです。現在は 募集中 で、2025年12月1日 から開始しています。88 名の参加者 の募集が計画されています。この試験は Qilu Hospital of Shandong University によって主導され、2028年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly colle...もっと見る
公式タイトル
Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis
疾患名
Cholelithiasis Associated With Common Bile Duct Stonesその他の研究識別子
- 2025SDU-QILU-2
NCT番号
開始日
2025-12-01
最終更新日
2026-03-27
終了予定日
2028-06
目標参加者数
88
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Cholelithiasis with Concomitant Choledocholithiasis
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
post-ERCP pancreatitis
Randomized Controlled Trial (RCT)
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
post-ERCP pancreatitis
Randomized Controlled Trial (RCT)
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Receive rectal indomethacin alone | rectal indomethacin alone rectal indomethacin was used alone in the control group |
実験的Combination of indomethacin plus a prophylactic pancreatic stent | Prophylactic pancreatic stent All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The Proportion of Patients with Post-ERCP Pancreatitis | If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis. | 24 hours to 72 hours after ERCP |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis | The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. | Within 1 months after ERCP |
Clinical Success Rate | Complete removal of gallbladder stones. | Within 1 months after ERCP |
The Proportion of Patients with Other Complications | Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc. | Within 6 months after ERCP |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Patients aged 18 years or older;
- Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
- Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
- Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
- The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
- Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age <35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ;
- Patients who voluntarily provide signed informed consent.
- Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
- Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
- Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
- Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
- Pregnant women;
- Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
- Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
- Patients with congenital or acquired absence of the rectum;
- Patients with severe acute pancreatitis
Qilu Hospital of Shandong University試験中央連絡先
連絡先: Zhen Li, MD, 18560086106, [email protected]
1 1カ国の場所
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China
募集中