Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

NCT ID: NCT06031402

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2026-12-31

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.

Conditions

Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early endoscopy group

Intervention of endoscopy is within 12 hours after admission

Group Type: EXPERIMENTAL

Endoscopy

Intervention Type: PROCEDURE

Endoscopy

Delayed endoscopy group

Intervention of endoscopy is within 12-24 hours after admission

Group Type: ACTIVE_COMPARATOR

Endoscopy

Intervention Type: PROCEDURE

Endoscopy

Interventions

Endoscopy

Endoscopy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Xingshun Qi

Director of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingshun Qi, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Shenyang Military Area

Yiling Li, MD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Bimin Li, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Xuefeng Luo, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Xiaofeng Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The 960th Hospital of the Chinese People's Liberation Army

Chunqing Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Provincial Hospital of Shandong First Medical University

Mingkai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Wuhan University

Derun Kong, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Fernando G Romeiro, MD

Role: PRINCIPAL_INVESTIGATOR

Botucatu Medical School

Andrea Mancuso, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda di Rilievo Nazionale ad Alta Specializzazione Civico-Di Cristina-Benfratelli

Nahum Méndez-Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Medica Sur Clinic and Foundation

Enqiang Linghu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Medical Center of Chinese PLA General Hospital

Yunhai Wu, MD

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital of Shenyang

Metin Basaranoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingshun Qi, MD

Role: CONTACT

xingshunqi@126.com

18909881019

Xingshun Qi, MD

Role: CONTACT

xingshunqi@126.com

Facility Contacts

Xingshun Qi, MD

Role: primary

xingshunqi@126.com

18909881019

Qianqian Li

Role: backup

1208594776@qq.com

13940307473

References

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.

Reference Type: BACKGROUND

PMID: 35048654 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25785053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26937922 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31524777 (View on PubMed)

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: protocol of a multicenter randomized controlled trial. Therap Adv Gastroenterol. 2024 Nov 13;17:17562848241295452. doi: 10.1177/17562848241295452. eCollection 2024.

Reference Type: DERIVED

PMID: 39539489 (View on PubMed)

Other Identifiers

XHNKKY-ENDO-AVB

Identifier Type: -

Identifier Source: org_study_id