Liver CirrhosisNCT04823780
The Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices
- What is being tested?
- nutrient solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 397 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis of gastroesophageal varices undergoing endoscopic
Who may be able to join
- Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis:An Observational Study
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.
Read the 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.
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Being tested
- nutrient solution
- Keywords
- Early enteral nutrition, Esophageal and Gastric Varices, Rebleeding
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrient solutionDietary supplement
For the patients with esophageal and gastric varices after endoscopic treatment，start taking the nutrient solution at the fourth hour.
| Study group | Role | What they receive |
|---|---|---|
| early enteral nutrition support group | Nutrient solution is provided through oral nutrient solution within 4-48 hours after endoscopic treatment Receives: Dietary Supplement: nutrient solution | |
| parenteral Nutrition Group | Intravenous nutrition is provided within 48 hours after endoscopic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding
the rate of rebleeding after endoscopic therapy
Measured: 2 to 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2020
- Primary completion30 Aug 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gao Yanjing, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823780
- Sponsor's protocol ID
- 20200901-Qilu
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Early Enteral Nutrition on Endoscopic Therapy of Esophagogastric Varices in Liver Cirrhosis:An Observational Study
- ClinicalTrials.gov ID
- NCT04823780
- Acronym / sponsor ID
- 20200901-Qilu
- Conditions
- Liver Cirrhosis, Esophageal and Gastric Varices
- Keywords
- Early enteral nutrition, Esophageal and Gastric Varices, Rebleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early enteral nutrition support group | – | Dietary Supplement: nutrient solutionNutrient solution is provided through oral nutrient solution within 4-48 hours after endoscopic treatment |
| parenteral Nutrition Group | – | –Intravenous nutrition is provided within 48 hours after endoscopic treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis of gastroesophageal varices undergoing endoscopic
Key inclusion criteria (1 listed)
- Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrient solutionFor the patients with esophageal and gastric varices after endoscopic treatment，start taking the nutrient solution at the fourth hour. | Dietary supplement | early enteral nutrition support group |
Primary outcome
rebleeding
Time frame: 2 to 30days
the rate of rebleeding after endoscopic therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gao Yanjing, PhD.MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rebleeding (time frame: 2 to 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.