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

NCT ID: NCT05302661

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-19
• Study Completion Date: 2024-02-19

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

Conditions

Liver Cirrhosis; Esophageal Varices Bleeding; Gastric Variceal Bleeding; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

re-education

Intervention Type: BEHAVIORAL

Contact patients by phone or wechat and guide them

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

re-education

Contact patients by phone or wechat and guide them

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanjing Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

20211013-Li

Identifier Type: -

Identifier Source: org_study_id