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

NCT ID: NCT04823780

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

397 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-20

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis Esophageal and Gastric Varices

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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early enteral nutrition support group

Nutrient solution is provided through oral nutrient solution within 4-48 hours after endoscopic treatment

nutrient solution

Intervention Type DIETARY_SUPPLEMENT

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

parenteral Nutrition Group

Intravenous nutrition is provided within 48 hours after endoscopic treatment

No interventions assigned to this group

Interventions

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nutrient solution

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gao Yanjing, PhD.MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Qilu Hospital , Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20200901-Qilu

Identifier Type: -

Identifier Source: org_study_id

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