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

Not Applicable

• Conditions: Liver Cirrhosis; Gastric Variceal Bleeding; Bleeding; Esophageal Varices Bleeding
• Interventions: Behavioral: re-education

• Registration Number: NCT05302661
• Lead Sponsor: Qilu Hospital of Shandong University

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

Study Timeline

• Study First Submitted: 2021-10-21
• Status Verified: 2022-02
• Study Start: 2022-02-19
• Study First Submitted QC: 2022-03-27
• Last Update Submitted: 2022-03-27
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2024-02-19
• Study Completion: 2024-02-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 508

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case group will receive re-education after leave hospital	re-education	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

Primary Outcome Measures

Name	Time	Method
rebleeding	2 yeas	rebleeding from any channel can be followed up through medical institutions or telephone

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China