Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT

NCT04786743 | Recruiting DMC

• 1 other identifier: JinlingH-2021Gastro-ClinicalT
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

Acute variceal upper gastrointestinal hemorrhage remains a hot potato in cirrhotic patients. The purpose of this study is to figure out whether urgent endoscopy (within 6h after gastroenterological consultation) is superior to non-urgent endoscopy (between 6h and 24h after gastroenterological consultation) in reducing rebleeding for these patients. This is a multi-centered, prospective, randomized, and controlled trial. 400 patients with suspected variceal bleeding will be randomized in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of acute variceal hemorrhage. This trial will provide valuable insights into the efficacy between the urgent endoscopy group and the non-urgent endoscopy group.

Conditions

Acute Upper Gastrointestinal Hemorrhage; Cirrhosis; Varice Bleed; Gastroesophageal Varices

Keywords

Endoscopic intervention; Acute variceal hemorrhage; RCT

Outcome Measures

Primary Outcomes (1)

• Rebleeding

  Rebleeding refers to recurrent bleeding after the control of AVH, which is defined as the occurrence of at least one of the following items: (I) hematemesis, melena or hematochezia; (II) decrease in SBP of more than 20 mmHg from the original level or an increase in heart rate of 20 beats/min; and (III) decrease in hemoglobin level of 30 g/L in the absence of a blood transfusion.

  42 days

Secondary Outcomes (8)

• All-cause mortality

  42 days

• Persistent bleeding

  1 day

• length of hospitalization

  42 days

• Transfers to the ICU

  42 days

• Secondary endoscopic intervention

  42 days

Study Arms (2)

non-urgent endoscopy group

EXPERIMENTAL

undergo endoscopy between 6 and 24 hours after gastroenterological consultation

Other: endoscopic intervention

urgent endoscopy group

OTHER

undergo endoscopy within 6 hours after gastroenterological consultation

Other: endoscopic intervention

Interventions

endoscopic intervention OTHER

performing endoscopy

Also known as: drugs, transjugular intrahepatic portosystemic stent shunt (TIPSS), surgery

non-urgent endoscopy group; urgent endoscopy group

Eligibility Criteria

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

You may qualify if:

• (I) patients who have pathological or clinical and imaging evidence indicating a diagnosis of cirrhosis; (II) patients with clinical symptoms associated with AVH (hematemesis, melena or hematochezia) before admission or during hospitalization; (III) patients who are hemodynamically stable before or after initial fluid resuscitation.

You may not qualify if:

• (I) pregnancy; (II) lactation; (III) less than 18 years; (IV) patients with a history of taking anticoagulant or antiplatelet drugs within 2 weeks prior to admission.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Jinling Hospital, China: lead
• The first affiliated Hospital of Nanjing Medical University, Jiangsu Province: collaborator
• The Affiliated Wuxi People's Hospital of Nanjing Medical University: collaborator

Study Sites (4)

Affiliated Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

RECRUITING

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

The Affiliated Wuxi People's Hospital of Nanjing Medical University

Wuxi, Jiangsu, 214043, China

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Fibrosis

Interventions

Pharmaceutical Preparations; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fangyu Wang, M.D.

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuoxin Yang, M.D.

CONTACT

+8618761679906; yzxbeyond@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded to the randomization allocation and will not participate in the practical treatment and intervention. Professional academic statisticians blinded to the group allocation will conduct all the analyses. However, the endoscopists will not participate in the outcome assessment. Furthermore, they will not need to disclose details of their interventional procedures to the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology and Hepatology

Model Details: Eligible patients are randomly assigned in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The block size is pre-specified, but physicians and investigators are not notified of this during the study. Allocation concealment is implemented by the mobile client randomization tool "Randomization Allocation Tool (RAT)".

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 8, 2021
• Study Start: April 20, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)