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NCT Number: NCT06031402

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shenyang, Liaoning, China

Location status: Recruiting

Location contact

Qianqian Li

CONTACT

[email protected]

13940307473

Xingshun Qi, MD

CONTACT

[email protected]

18909881019

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

endoscopy

Procedure

Endoscopy

Primary outcomes

  1. The failure to control bleeding after admissions

    Time frame: within 5 days admission

    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.

  2. 6-week rebleeding

    Time frame: 6-week

    Rebleeding is defined as new onset of hematemesis or melena after successful treatment.

Secondary outcomes

  1. 6-week all-cause mortality

    Time frame: 6-week

    Death.

  2. Adverse events

    Time frame: up to 6 weeks

    Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingshun Qi, MD

CONTACT

[email protected]

18909881019

Xingshun Qi, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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