Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial.

Autor:	Qi X; Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenyang, Liaoning Province 110840, China., Li Y; Department of Gastroenterology, The First Affiliated Hospital of China Medical University, Shenyang, China., Li B; Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China., Luo X; Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, China., Liu X; Department of Gastroenterology, The 960th Hospital of the Chinese People's Liberation Army, Jinan, Shandong, China., Zhang C; Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China., Chen M; Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China., Kong D; Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, China., Wu Y; Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang, Shenyang, China., Romeiro FG; Internal Medicine Department, Botucatu Medical School, São Paulo, Brazil., Basaranoglu M; Division of Gastroenterology, Department of Internal Medicine, Bezmialem Vakif University, Istanbul, Turkey., Zhang J; Division of Medical Research, Unimed Scientific Inc., Wuxi, China., Li Q; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Wang R; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Shao X; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Guan L; Department of Gastroenterology, The First Affiliated Hospital of China Medical University, Shenyang, China., Wang N; Department of Gastroenterology, The First Affiliated Hospital of China Medical University, Shenyang, China., You Y; Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China., He M; Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China., Wang X; Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, China., Huang J; Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, China., Wu W; Department of Gastroenterology, The 960th Hospital of the Chinese People's Liberation Army, Jinan, Shandong, China., Li Q; Department of Gastroenterology, The 960th Hospital of the Chinese People's Liberation Army, Jinan, Shandong, China., Zhang M; Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China., Wang G; Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China., Zhang C; Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China., Cheng D; Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China., Zhang Q; Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, China., Mei X; Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, China., Sun N; Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang, Shenyang, China., Ban Y; Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang, Shenyang, China., Marcondes MB; Internal Medicine Department, Botucatu Medical School, São Paulo, Brazil., Yamashiro FDS; Internal Medicine Department, Botucatu Medical School, São Paulo, Brazil., Mutlu E; Division of Gastroenterology, Department of Internal Medicine, Bezmialem Vakif University, Istanbul, Turkey., Zheng Z; Division of Medical Research, Unimed Scientific Inc., Wuxi, China., Peng M; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Xu W; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Li Z; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Chai L; Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China., Linghu E; Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, No. 28 Fuxing Road, Beijing 100853, China.
Jazyk:	angličtina
Zdroj:	Therapeutic advances in gastroenterology [Therap Adv Gastroenterol] 2024 Nov 13; Vol. 17, pp. 17562848241295452. Date of Electronic Publication: 2024 Nov 13 (Print Publication: 2024).
DOI:	10.1177/17562848241295452
Abstrakt:	Background: Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in 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 the timing of endoscopy on the outcomes of cirrhotic patients with AVB. Methods: A total of 368 cirrhotic patients presenting with AUGIB who are highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and clinical presentation at admission and then randomly assigned at a 1:1 ratio into early (within 12 h after admission) and delayed (within 12-24 h 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. Conclusion: Considering existing evidence originates from non-randomized studies, this RCT will provide high-quality evidence to uncover whether cirrhotic patients with AVB should undergo early endoscopy to control bleeding and improve survival. Trial Registration: ClinicalTrials.gov identifier: NCT06031402. Competing Interests: The authors declare that there is no conflict of interest. (© The Author(s), 2024.)
Databáze:	MEDLINE
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