MedTrace Logo

Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT

NCT04786743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-05-18

No results posted yet for this study

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

Interventions

OTHER

endoscopic intervention

performing endoscopy

Sponsors & Collaborators

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

    collaborator OTHER

  • The first affiliated Hospital of Nanjing Medical University, Jiangsu Province

    collaborator UNKNOWN

  • The Affiliated Wuxi People's Hospital of Nanjing Medical University

    collaborator UNKNOWN

  • Jinling Hospital, China

    lead OTHER

Principal Investigators

  • Fangyu Wang, M.D. · Jinling Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2026-02-11
Completion
2026-02-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786743 on ClinicalTrials.gov