Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding
• Intervention / Treatment: Procedure: Endoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingshun Qi, MD; Phone Number: 18909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: Xingshun Qi, MD; Email: xingshunqi@126.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
      • Contact: Xingshun Qi, MD; Phone Number: 18909881019; Email: xingshunqi@126.com
      • Contact: Qianqian Li; Phone Number: 13940307473; Email: 1208594776@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early endoscopy group; Intervention of endoscopy is within 12 hours after admission	Procedure: Endoscopy; Endoscopy
Active Comparator: Delayed endoscopy group; Intervention of endoscopy is within 12-24 hours after admission	Procedure: Endoscopy; Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The failure to control bleeding after admissions	Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.	within 5 days admission
6-week rebleeding	Rebleeding is defined as new onset of hematemesis or melena after successful treatment.	6-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-week all-cause mortality	Death.	6-week
Adverse events	Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.	up to 6 weeks

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: Xingshun Qi, MD, General Hospital of Shenyang Military Area; Principal Investigator: Yiling Li, MD, First Hospital of China Medical University; Principal Investigator: Bimin Li, MD, The First Affiliated Hospital of Nanchang University; Principal Investigator: Xuefeng Luo, MD, West China Hospital; Principal Investigator: Xiaofeng Liu, MD, The 960th Hospital of the Chinese People's Liberation Army; Principal Investigator: Chunqing Zhang, MD, Affiliated Provincial Hospital of Shandong First Medical University; Principal Investigator: Mingkai Chen, MD, People's Hospital of Wuhan University; Principal Investigator: Derun Kong, MD, The First Affiliated Hospital of Anhui Medical University; Principal Investigator: Fernando G Romeiro, MD, Botucatu Medical School; Principal Investigator: Andrea Mancuso, MD, Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli; Principal Investigator: Nahum Méndez-Sánchez, MD, Medica Sur Clinic and Foundation; Principal Investigator: Enqiang Linghu, MD, The First Medical Center of Chinese PLA General Hospital; Principal Investigator: Metin Basaranoglu, MD, Bezmialem Vakif University; Principal Investigator: Yunhai Wu, MD, The Sixth People's Hospital of Shenyang

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; survival; endoscopy; liver cirrhosis; variceal bleeding; gastrointestinal bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: XHNKKY-ENDO-AVB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No