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NCT04823780 Clinical Trial

The Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Investigation of the Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis:An Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04823780
Other study ID # 20200901-Qilu
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date October 20, 2021

Study information
Verified date March 2021
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate the safety of early enteral nutrition on endoscopic therapy of esophagogastric varices in Liver Cirrhosis ,and to assess the impact of different eating times on patients, so as to determine the best time for patients to obtain nutrition after surgery.

Description:

For patients with gastroesophageal varices in Liver Cirrhosis,, there is no clear guideline and consensus on when to start eating after endoscopic treatment. In 2015, a randomized controlled study in Taiwan of China confirmed that compared with liquid diet given 48 h after endoscopic treatment, liquid diet given 4 h and started enteral nutrition would not increase the risk of rebleeding, and could improve the nutritional status of patients. However, some patients after endoscopic treatment would suffer from post-sternal pain, abdominal pain, nausea, vomiting and other discomforts, affecting appetite and delay the diet time. Based on the above research background, we observed and evaluated the safety and effectiveness of early enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, and analyzed the influencing factors of enteral nutrition in patients with cirrhotic esophageal and gastric varices after endoscopic treatment, so as to further clarify the optimal time for patients to eat after endoscopic treatment.

Recruitment information / eligibility
Status Completed
Enrollment 397
Est. completion date October 20, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy Exclusion Criteria: - Endoscopic treatment of uncontrollable bleeding - Accompanied with other endoscopic treatments that need to be fasting - With obvious hepatic encephalopathy and liver failure - Did not sign the informed consent form and refused to participate

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• nutrient solution
For the patients with esophageal and gastric varices after endoscopic treatment,start taking the nutrient solution at the fourth hour.

Locations
Country Name City State
China Qilu Hospital , Shandong University 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 the rate of rebleeding after endoscopic therapy 2 to 30days
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