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

Primary Purpose

Liver Cirrhosis, Esophageal Varices Bleeding, Gastric Variceal Bleeding

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
re-education
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qilu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

case group will receive re-education after leave hospital

control case group will receive no re-education after leave hospital

Arm Description

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

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

Outcomes

Primary Outcome Measures

rebleeding
rebleeding from any channel can be followed up through medical institutions or telephone

Secondary Outcome Measures

Full Information

First Posted
October 21, 2021
Last Updated
March 27, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05302661
Brief Title
Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis
Official Title
Effect of Re-education on Rebleeding Rate After Endoscopic Treatment of Esophageal and/or Gastric Varices in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 19, 2022 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
February 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Esophageal Varices Bleeding, Gastric Variceal Bleeding, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
508 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case group will receive re-education after leave hospital
Arm Type
Experimental
Arm Description
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
Arm Title
control case group will receive no re-education after leave hospital
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
re-education
Intervention Description
Contact patients by phone or wechat and guide them
Primary Outcome Measure Information:
Title
rebleeding
Description
rebleeding from any channel can be followed up through medical institutions or telephone
Time Frame
2 yeas

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanjing Gao, MD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

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

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