One vs. Two Stents for Gallbladder Disease

Официальное название

A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates

Обзор

This randomized trial will look at whether placing two cystic duct stents is more effective than one cystic duct stent in preventing recurrent gallbladder disease (cholecystitis, gallstone pancreatitis, or biliary colic) among patients who are not immediate surgical candidates for removal of their gallbladder. The study will evaluate the safety profile, including rates of recurrent cholecystitis, biliary colic, and procedure-related complications, and technical success, defined as successful placement of stents into the gallbladder. The main questions it aims to answer are: 1. Does placement of two transpapillary cystic duct stents reduce the risk of recurrent symptomatic gallbladder disease compared to one stent? 2. Is there a difference in procedure-related adverse events (post-ERCP pancreatitis, cholangitis, stent migration) between the two strategies? Researchers will compare outcomes between patients randomized to one stent versus two stents to determine which approach provides better long-term gallbladder drainage and fewer recurrent events. Participants will: Be evaluated for eligibility and provide informed consent prior to undergoing an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopy where a guidewire is placed into the bile duct from the small intestine. They will then undergo ERCP with transpapillary cystic duct stent placement, randomized to one or two stents. All participants will receive standard post-procedure care and follow-up assessments for recurrence, adverse events, and need for reintervention.

Вмешательства

• Процедура ERCP with one stent placement
  One transpapillary cystic duct stent will be placed into the gallbladder via ERCP
• Процедура ERCP with two stent placement
  Two transpapillary cystic duct stents will be placed into the gallbladder via ERCP

Первичные конечные точки

• Clinical Success [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Technical Success [Срок оценки: 1 day]
• Time to Recurrence [Срок оценки: 6 months]
• Reintervention [Срок оценки: 6 months]
• Adverse Events [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Males or non-pregnant females presenting with cholecystitis, biliary colic or gallstone pancreatitis.
• Age 18-95.
• Participants must be willing and able to provide informed consent
• Referred for ERCP for management of 1) suspected choledocholithiasis 2) acute biliary pancreatitis and/or 3) acute cholangitis in whom cholecystectomy is expected to be delayed > 30 days or are deemed to not be surgical candidates for cholecystectomy.

Критерии исключения

• Inability to provide informed consent
• History of surgically altered upper gastrointestinal anatomy (e.g. Roux-en-Y gastric bypass, Billroth I/II) precluding standard ERCP
• History of primary sclerosing cholangitis
• History of gallbladder cancer
• History of cholecystectomy
• Unsuccessful biliary cannulation during ERCP -

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

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Публикации

• Storm AC, Vargas EJ, Chin JY, Chandrasekhara V, Abu Dayyeh BK, Levy MJ, Martin JA, Topazian MD, Andrews JC, Schiller HJ, Kamath PS, Petersen BT. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-748.e1. doi: 10.1016/j.gie.2021.03.025. Epub 2021 Mar 30. PMID 33798540

Идентификаторы

NCT: NCT07222527 · 24-011410 · 95352001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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