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

Completed

• Conditions: Liver Cirrhosis; Esophageal and Gastric Varices
• Interventions: Dietary Supplement: nutrient solution

• Registration Number: NCT04823780
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-02-04
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-04-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-10-20
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early enteral nutrition support group	nutrient solution	Nutrient solution is provided through oral nutrient solution within 4-48 hours after endoscopic treatment

Primary Outcome Measures

Name	Time	Method
rebleeding	2 to 30days	the rate of rebleeding after endoscopic therapy

Trial Locations

Locations (1)

Qilu Hospital , Shandong University; 🇨🇳 Jinan, Shandong, China