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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823780
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Study Description
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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.

Condition or disease Intervention/treatment
Liver Cirrhosis Esophageal and Gastric Varices Dietary Supplement: nutrient solution

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 Design
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Study Type : Observational
Actual Enrollment : 397 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis:An Observational Study
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : October 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
early enteral nutrition support group
Nutrient solution is provided through oral nutrient solution within 4-48 hours after endoscopic treatment
 Dietary Supplement: nutrient solution
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


Outcome Measures
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Primary Outcome Measures :
  1. rebleeding [ Time Frame: 2 to 30days ]
    the rate of rebleeding after endoscopic therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis of gastroesophageal varices undergoing endoscopic
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823780


Locations
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China, Shandong
Qilu Hospital , Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Principal Investigator: Gao Yanjing, PhD.MD Qilu Hospital , Shandong University
  Study Documents (Full-Text)

Documents provided by Qilu Hospital of Shandong University:
Study Protocol and Statistical Analysis Plan  [PDF] September 1, 2020

More Information
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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04823780    
Other Study ID Numbers: 20200901-Qilu
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qilu Hospital of Shandong University:
Early enteral nutrition
Esophageal and Gastric Varices
Rebleeding
Additional relevant MeSH terms:
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Liver Cirrhosis
Esophageal and Gastric Varices
Varicose Veins
Fibrosis
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal