Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange

Обзор

This prospective, unicenter, randomized controlled trial evaluates whether a positive bile culture at index ERCP with plastic stenting identifies patients who benefit from earlier stent exchange. Patients with no previous history of sphincterotomy and positive bile cultures after an ERCP will be randomized to stent exchange at 1 month versus 3 months to assess whether personalized scheduling reduces early stent occlusion and secondary acute cholangitis.

Подробное описание

A positive bile culture obtained at the index ERCP in patients with no previous history of sphincterotomy undergoing plastic biliary stenting may represent a key, yet currently largely ignored, predictor of early stent occlusion and subsequent acute cholangitis. Based on the findings of the TEMPEST Study, conducted in the Gastroenterology Department of Colentina Clinical Hospital (currently submitted for publication), which suggested a clinical benefit of earlier scheduled ERCP for stent exchange in this high-risk subgroup, we hypothesize that bile culture-guided scheduling of stent exchange can improve clinical outcomes.

To test this hypothesis, we propose a prospective, unicentric, randomized controlled trial comparing patients with positive bile cultures at index ERCP randomized to early stent exchange at 1 month versus standard exchange at 3 months. The primary objective is to determine whether personalized scheduling based on initial bile culture results reduces the incidence of early acute cholangitis, thereby offering a simple, low-cost strategy to optimize post-ERCP management and prevent further complications.

Вмешательства

• Другое stent exchange
  standard stent exchange at three months according to the institutional norms
• Другое Scheduled biliary stent exchange at one month
  Patients within the active arm will have scheduled stent exchange at one month, in comparison to those in the control arm, which will have scheduled stent exchange at three months, according to the institutional norms in place

Первичные конечные точки

• Comparative analysis of the incidence rates of acute cholangitis in the scheduled stent exchange group, at one month, vs. standard stent exchange at three months [Срок оценки: from enrollment to the end of treatment at three months]

Критерии участия

Критерии включения

• All patients between 18 and 90 years old with native papilla and obstructive jaundice of any etiology requiring plastic biliary stent placement, with a positive bile culture at index ERCP who can provide written informed consent (obtained from the patient or legal caregiver).

Критерии исключения

• prior ERCP attempts
• patients with bilio-digestive surgical or endoscopic anastomoses
• inability to provide informed consent due to cognitive, legal, or medical reasons
• scheduled surgical resection within one month after 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

Открытое

Основная цель

Профилактика

Центры проведения

Румыния · 1 центр

• Colentina Clinical Hospital — Bucharest

Идентификаторы

NCT: NCT07379749 · 42/12.12.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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