Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

Обзор

Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.

Подробное описание

A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.

Вмешательства

• Процедура Endoscopy
  Endoscopy

Первичные конечные точки

• The failure to control bleeding after admissions [Срок оценки: within 5 days admission]
• 6-week rebleeding [Срок оценки: 6-week]

Вторичные конечные точки (2)

• 6-week all-cause mortality [Срок оценки: 6-week]
• Adverse events [Срок оценки: up to 6 weeks]

Критерии участия

Критерии включения

• patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture;
• patients with a diagnosis of liver cirrhosis based on imaging and pathology;
• patients and/or their relatives who sign informed consents;
• patients' age ≥18 years.

Критерии исключения

• patients who have undergone endoscopy at other hospitals before admissions;
• patients' hemodynamics are unstable after resuscitation;
• patients with severe cardiovascular or cerebrovascular diseases or renal injury;
• patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases;
• patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;
• patients with mental illness;
• pregnancy.

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

Лечение

Центры проведения

Китай · 1 центр

• Department of Gastroenterology, General Hospital of Northern Theater Command (formerly cal — Шэньян

Публикации

• Bai Z, Wang R, Cheng G, Ma D, Ibrahim M, Chawla S, Qi X. Outcomes of early versus delayed endoscopy in cirrhotic patients with acute variceal bleeding: a systematic review with meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e868-e876. doi: 10.1097/MEG.0000000000002282. PMID 35048654
• Peng Y, Qi X, Dai J, Li H, Guo X. Child-Pugh versus MELD score for predicting the in-hospital mortality of acute upper gastrointestinal bleeding in liver cirrhosis. Int J Clin Exp Med. 2015 Jan 15;8(1):751-7. eCollection 2015. PMID 25785053
• Peng Y, Qi X, Guo X. Child-Pugh Versus MELD Score for the Assessment of Prognosis in Liver Cirrhosis: A Systematic Review and Meta-Analysis of Observational Studies. Medicine (Baltimore). 2016 Feb;95(8):e2877. doi: 10.1097/MD.0000000000002877. PMID 26937922
• Li Y, Li H, Zhu Q, Tsochatzis E, Wang R, Guo X, Qi X. Effect of acute upper gastrointestinal bleeding manifestations at admission on the in-hospital outcomes of liver cirrhosis: hematemesis versus melena without hematemesis. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1334-1341. doi: 10.1097/MEG.0000000000001524. PMID 31524777
• Qi X, Li Y, Li B, Luo X, Liu X, Zhang C, Chen M, Kong D, Wu Y, Romeiro FG, Basaranoglu M, Zhang J, Li Q, Wang R, Shao X, Guan L, Wang N, You Y, He M, Wang X, Huang J, Wu W, Li Q, Zhang M, Wang G, Zhang C, Cheng D, Zhang Q, Mei X, Sun N, Ban Y, Marcondes MB, Yamashiro FDS, Mutlu E, Zheng Z, Peng M, Xu W, Li Z, Chai L, Linghu E. Timing of endoscopy in cirrhotic patients with acute variceal bleeding: PMID 39539489

Идентификаторы

NCT: NCT06031402 · XHNKKY-ENDO-AVB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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