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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05302661
Other study ID # 20211013-Li
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 19, 2022
Est. completion date February 19, 2024

Study information

Verified date February 2022
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 508
Est. completion date February 19, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Behavioral:
re-education
Contact patients by phone or wechat and guide them

Locations

Country Name City State
China Qilu Hospital Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary rebleeding rebleeding from any channel can be followed up through medical institutions or telephone 2 yeas
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