Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

NCT06031402 | Recruiting

• 1 other identifier: XHNKKY-ENDO-AVB
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding

Keywords

liver cirrhosis; variceal bleeding; gastrointestinal bleeding; endoscopy; survival; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 6-week all-cause mortality

  6-week

• Adverse events

  up to 6 weeks

Study Arms (2)

Early endoscopy group

EXPERIMENTAL

Intervention of endoscopy is within 12 hours after admission

Procedure: Endoscopy

Delayed endoscopy group

ACTIVE COMPARATOR

Intervention of endoscopy is within 12-24 hours after admission

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

Endoscopy

Delayed endoscopy group; Early endoscopy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

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

Shenyang, Liaoning, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 35048654 BACKGROUND

• 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.

  PMID: 25785053 BACKGROUND

• 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.

  PMID: 26937922 BACKGROUND

• 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.

  PMID: 31524777 BACKGROUND

• 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.

  PMID: 39539489 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

• Yunhai Wu, MD

  The Sixth People's Hospital of Shenyang

  PRINCIPAL INVESTIGATOR

• Metin Basaranoglu, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi, MD

CONTACT

18909881019; xingshunqi@126.com

Xingshun Qi, MD

CONTACT

xingshunqi@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Model Details: 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)

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 11, 2023
• Study Start: September 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)