NCT04823780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

February 4, 2021

Last Update Submit

February 23, 2022

Conditions

Liver CirrhosisEsophageal and Gastric Varices

Keywords

Early enteral nutritionEsophageal and Gastric VaricesRebleeding

Outcome Measures

Primary Outcomes (1)

  • rebleeding

    the rate of rebleeding after endoscopic therapy

    2 to 30days

Study Arms (2)

early enteral nutrition support group

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

Dietary Supplement: nutrient solution

parenteral Nutrition Group

Intravenous nutrition is provided within 48 hours after endoscopic treatment

Interventions

nutrient solutionDIETARY_SUPPLEMENT

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

early enteral nutrition support group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cirrhosis of gastroesophageal varices undergoing endoscopic

You may qualify if:

  • Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital , Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Liver CirrhosisEsophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesHypertension, Portal

Study Officials

  • Gao Yanjing, PhD.MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

April 1, 2021

Study Start

September 1, 2020

Primary Completion

August 30, 2021

Study Completion

October 20, 2021

Last Updated

March 2, 2022

Record last verified: 2021-03

Locations

CN(1)