The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

June 12, 2021 updated by: ChenMingkai, Renmin Hospital of Wuhan University

A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

This study is a prospective, multi-center and observational clinical study. Investigators would like to explore the optimal emergency endoscopy timing in cirrhosis patients with esophagogastric variceal bleeding (EGVB) by evaluating and comparing the efficacy and safety of emergency endoscopy performed at different times ( within 6 hours or between 6 and 24 hours after gastroenterologic consultation ) and its impact on the short-term prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Between July 2021 and April 2022, patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled consecutively according to the following criteria: (1) age≥18 years; (2) A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination); (3) The cause of bleeding was identified as esophageal and/or gastric vein rupture. Exclusion criteria are as follows: (1) End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma); (2) The subject (or legal representative/guardian) refused to sign the informed consent.

Patients were divided into urgent-endoscopy group (< 6h) and early-endoscopy group (6h-24h) according to the time interval from gastroenterologic consultation to the start of emergency endoscopy.

Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until death or the end of the study.

Study Type

Observational

Enrollment (Anticipated)

608

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled this study.

Description

Inclusion Criteria:

  • age≥18 years
  • A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination)
  • The cause of bleeding was identified as esophageal and/or gastric vein rupture

Exclusion Criteria:

  • End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma)
  • The subject (or legal representative/guardian) refused to sign the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
urgent-endoscopy group
the time interval from gastroenterologic consultation to the start of emergency endoscopy < 6 hours
early-endoscopy group
the time interval from gastroenterologic consultation to the start of emergency endoscopy between 6 and 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
six-week mortality rate
Time Frame: 6 weeks after treatment
Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.
6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate success hemostasis rate
Time Frame: within 24 hours after traetment
Successful immediate hemostasis refers to successful hemostasis under endoscopy, and no active bleeding manifestations such as hematemesis, hemorrhagic shock and progressive decline of hemoglobin within 24 hours.
within 24 hours after traetment
five-day rebleeding rate
Time Frame: 5 days after treatment
Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment.
5 days after treatment
detection rate of bleeding site
Time Frame: during endoscopy
Identify the site of bleeding during endoscopy.
during endoscopy
mean operating time
Time Frame: during endoscopy
The time interval between the beginning and end of endoscopy.
during endoscopy
the needs of salvage treatment
Time Frame: 6 weeks
Salvage treatment refers to the additional three-chamber and two-capsule compression hemostasis, re-endoscopic therapy, interventional therapy or surgical treatment due to failure of hemostasis by emergency endoscopy or re-bleeding after successful hemostasis.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Collaborators

The First Affiliated Hospital of Nanchang University
Fudan University
Beijing Friendship Hospital
Southwest Hospital, China
Beijing Shijitan Hospital, Capital Medical University
Hubei Hospital of Traditional Chinese Medicine
Yichang Central People's Hospital
Shiyan Renmin Hospital
Wuhan No.1 Hospital
The Third People's Hospital of Hubei Province
Fuyang NO.2 Renmin Hospital
Wuhan Puren Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Wuhan Hanyang Hospital
Chibi Renmin Hospital

Investigators

  • Principal Investigator: Mingkai Chen, PHD, Renmin Hospital of Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 12, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 12, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDRY2021-K061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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