Clinical trial NCT06031402: Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding
Official title: Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Upper Gastrointestinal Bleeding
Acute Variceal Bleeding
Keywords: liver cirrhosis
variceal bleeding
gastrointestinal bleeding
endoscopy
survival
randomized controlled trial
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The failure to control bleeding after admissions
timeFrame: within 5 days admission
measure: 6-week rebleeding
timeFrame: 6-week
Secondary outcomes:
measure: 6-week all-cause mortality
timeFrame: 6-week
measure: Adverse events
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
state: Liaoning
Study officials:
affiliation: General Hospital of Shenyang Military Area
name: Xingshun Qi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Yiling Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Bimin Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Xuefeng Luo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The 960th Hospital of the Chinese People's Liberation Army
name: Xiaofeng Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Provincial Hospital of Shandong First Medical University
name: Chunqing Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Wuhan University
name: Mingkai Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Derun Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Botucatu Medical School
name: Fernando G Romeiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli
name: Andrea Mancuso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medica Sur Clinic and Foundation
name: Nahum Méndez-Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Medical Center of Chinese PLA General Hospital
name: Enqiang Linghu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sixth People&amp;amp;amp;amp;#39;s Hospital of Shenyang
name: Yunhai Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Metin Basaranoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.