Xingshun Qi, Yiling Li, Bimin Li, Xuefeng Luo, Xiaofeng Liu, Chunqing Zhang, Mingkai Chen, Derun Kong, Yunhai Wu, Fernando Gomes Romeiro, Metin Basaranoglu, Jianzhong Zhang, Qianqian Li, Ran Wang, Xiaodong Shao, Lin Guan, Ningning Wang, Yu You, Mingyan He, Xiaoze Wang, Ju Huang, Wenming Wu, Qun Li, Mingyan Zhang, Guangchuan Wang, Chi Zhang, Du Cheng, Qianqian Zhang, Xuechan Mei, Na Sun, Yuan Ban, Mariana Barros Marcondes, Fabio da Silva Yamashiro, Emine Mutlu, Zheng Zheng, Mengyuan Peng, Wentao Xu, Zhe Li, Lu Chai, Enqiang Linghu
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT06031402.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241295452"},"PeriodicalIF":3.9000,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558738/pdf/","citationCount":"0","resultStr":"{\"title\":\"Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial.\",\"authors\":\"Xingshun Qi, Yiling Li, Bimin Li, Xuefeng Luo, Xiaofeng Liu, Chunqing Zhang, Mingkai Chen, Derun Kong, Yunhai Wu, Fernando Gomes Romeiro, Metin Basaranoglu, Jianzhong Zhang, Qianqian Li, Ran Wang, Xiaodong Shao, Lin Guan, Ningning Wang, Yu You, Mingyan He, Xiaoze Wang, Ju Huang, Wenming Wu, Qun Li, Mingyan Zhang, Guangchuan Wang, Chi Zhang, Du Cheng, Qianqian Zhang, Xuechan Mei, Na Sun, Yuan Ban, Mariana Barros Marcondes, Fabio da Silva Yamashiro, Emine Mutlu, Zheng Zheng, Mengyuan Peng, Wentao Xu, Zhe Li, Lu Chai, Enqiang Linghu\",\"doi\":\"10.1177/17562848241295452\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in liver cirrhosis. 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Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial.
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.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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