Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Официальное название

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial

Обзор

Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?

Подробное описание

Acute cholangitis is a serious infection of the biliary system caused by biliary obstruction and infected bile, which may rapidly progress to sepsis if not promptly treated. Standard management includes systemic antibiotics and urgent biliary drainage, most commonly by endoscopic retrograde cholangiopancreatography (ERCP). However, biliary obstruction may impair biliary excretion of systemically administered antibiotics, resulting in subtherapeutic antibiotic concentrations within infected bile. Intraductal administration of antibiotics during ERCP may achieve higher local antimicrobial concentrations at the site of infection. This study evaluates the efficacy and safety of intraductal antibiotic administration during ERCP as an adjunct to standard systemic antibiotic therapy in patients with acute cholangitis.

Вмешательства

• Препарат Gentamicin - single dose
  Administration described in arm/group description
• Препарат Distilled water
  Administration described in arm/group description

Первичные конечные точки

• To evaluate the efficacy of local intraductal antibiotic administration during ERCP in patients with acute cholangitis, as assessed by resolution of clinical symptoms and improvement in inflammatory markers and liver function tests. [Срок оценки: Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP.]

Вторичные конечные точки (3)

• To compare the length of hospital stay [Срок оценки: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).]
• To compare the duration of intravenous antibiotic therapy. [Срок оценки: From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days).]
• To compare the number of participants that developed a peri-procedural complication. [Срок оценки: Evaluated at specific timepoints during the procedure until day 3 following ERCP.]

Критерии участия

Критерии включения

• The patients diagnosed with mild and moderate acute cholangitis based on TG 18
• Planned for ERCP within 48 hours
• 18 years old and above

Критерии исключения

• Severe acute cholangitis
• History of antibiotic hypersensitivity
• Receiving cancer chemotherapy, steroids, or immunosuppressive agents
• Concomitant infections
• Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months
• Known or suspected perforated tympanic membrane, myasthenia gravis

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Canselor Tuanku Muhriz UKM — Cheras

Публикации

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• Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe PMID 28941329
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Идентификаторы

NCT: NCT07407491 · JEP-2024-337

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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