Gallbladder Stenting in FC-SEMS

Официальное название

Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study

Обзор

The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis. The main question it aims to answer is: Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis. Participants will: 1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement 2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis

Вмешательства

• Устройство Double plastic pigtail stent plus fully covered self-expandable metal stent
  After contrast injection, the cystic duct orifice will be detected. Using a sphincterotome, a 0.035-inch hydrophilic angled guidewire will be negotiated into the gallbladder. Dilation of the cystic duct will be performed using standard devices designed for biliary intervention, including pneumatic dilators or dilation progressive catheters. After dilation, a 7Fr plastic, double pigtail stent, length of 12 or 15 cm, will be deployed across the papilla. Finally, a fully-covered self-expandable met
• Устройство Fully covered self-expandable metal stent
  After biliary cannulation, a fully covered self-expandable metal stent will be placed for biliary drainage

Первичные конечные точки

• Acute cholecystitis [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Overall adverse events [Срок оценки: 6 months]
• Hospitalization [Срок оценки: 6 months]
• Disease-free survival [Срок оценки: 6 months]
• Technical success [Срок оценки: 1 mont]
• Procedure time [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Adult patients
• Signed informed consent
• Patients requiring covered metal stent placement for managing MBO
• High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
• tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
• presence of at least 2 of the following:

• gallbladder stones;
• CBD diameter ≤ 10 mm;
• intraprocedural gallbladder opacification;
• cystic duct orifice at risk of being covered by the fully-covered stent

Критерии исключения

• History of cholecystectomy
• Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
• Patients with previous gallbladder drainage
• Acute cholecystitis is already present based on the Tokyo guidelines

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• AOUI Verona — Verona

Идентификаторы

NCT: NCT06820541 · GB-COVER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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