Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis

March 27, 2022 updated by: Qilu Hospital of Shandong University

Effect of Re-education on Rebleeding Rate After Endoscopic Treatment of Esophageal and/or Gastric Varices in Patients With Liver Cirrhosis

A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

After receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. The patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past

Study Type

Interventional

Enrollment (Anticipated)

508

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Esophageal and / or gastric varices ；
  • liver cirrhosis ；
  • patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
  • All subjects or their guardians must sign the subject consent form before entering the test

Exclusion Criteria:

  • Patients with mental illness, severe hearing loss and unable to take care of themselves ;
  • ASA score ≥ grade IV at discharge ;
  • Hepatic encephalopathy ≥ stage II;
  • Patients with liver cancer;
  • Pregnant and lactating women;
  • Patients who cannot sign 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: case group will receive re-education after leave hospital
The participants were randomly divided into re-education group and non re-education group according to the random number table. The re-education group will receive regular re-education not noly when they leave hospital but also after leave hospital in our preset time by telephone or wechat. The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on
Behavioral: re-education
Contact patients by phone or wechat and guide them
No Intervention: control case group will receive no re-education after leave hospital
The participants were randomly divided into re-education group and non re-education group according to the random number table. without re-education group will receive regular re-education when they leave hospital.The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rebleeding
Time Frame: 2 yeas
rebleeding from any channel can be followed up through medical institutions or telephone
2 yeas

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Yanjing Gao, MD, Qilu Hospital, Shandong University

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 (Actual)

February 19, 2022

Primary Completion (Anticipated)

February 19, 2024

Study Completion (Anticipated)

February 19, 2024

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211013-Li

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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