Liver CirrhosisNCT05302661
Effect of Re-education on Rebleeding Rate After Endoscopic Treatment in Liver Cirrhosis
A study testing re-education in people with Liver Cirrhosis and Esophageal Varices Bleeding, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Esophageal Varices Bleeding, Gastric Variceal Bleeding
- What is being tested?
- re-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2022to 19 Feb 2024
- Phase
- Interventional
- 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
Who may be able to join
- Esophageal and / or gastric varices ；
- liver cirrhosis ；
- patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
- All subjects or their guardians must sign the subject consent form before entering the test
Who cannot join
- Patients with mental illness, severe hearing loss and unable to take care of themselves ;
- ASA score ≥ grade IV at discharge ;
- Hepatic encephalopathy ≥ stage II;
- Patients with liver cancer;
- Pregnant and lactating women;
- Patients who cannot sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Re-education on Rebleeding Rate After Endoscopic Treatment of Esophageal and/or Gastric Varices in Patients With Liver Cirrhosis
A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis
Read the detailed description
After receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. The patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past
- Being tested
- re-education
- Medical subject headings
- Liver Cirrhosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
re-educationBehavioural
Contact patients by phone or wechat and guide them
| Study group | Role | What they receive |
|---|---|---|
| case group will receive re-education after leave hospital | Experimental | The participants were randomly divided into re-education group and non re-education group according to the random number table. The re-education group will receive regular re-education not noly when they leave hospital but also after leave hospital in our preset time by telephone or wechat. The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on Receives: Behavioral: re-education |
| control case group will receive no re-education after leave hospital | No intervention | The participants were randomly divided into re-education group and non re-education group according to the random number table. without re-education group will receive regular re-education when they leave hospital.The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding
rebleeding from any channel can be followed up through medical institutions or telephone
Measured: 2 yeas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Feb 2022
- Primary completion19 Feb 2024 (estimated)
- Study completion19 Feb 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanjing Gao, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302661
- Sponsor's protocol ID
- 20211013-Li
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2021
- Last updated
- 31 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Re-education on Rebleeding Rate After Endoscopic Treatment of Esophageal and/or Gastric Varices in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05302661
- Acronym / sponsor ID
- 20211013-Li
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 19 Feb 2024 (estimated)
- Study completion
- 19 Feb 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
A prospective, randomized controlled study on whether re-education after discharge can reduce the rebleeding rate after endoscopic treatment of esophageal and gastric varices in patients with liver cirrhosis
Detailed description
After receiving esophageal variceal ligation and （or） gastric fundus variceal sclerotherapy, patients with outside hospitalthe rate of bleeding due to liver cirrhosis shall be re-educated outside the hospital, including diet, drugs, anticoagulation of portal vein thrombosis,regular endoscopic treatment, reexamination , nutrition, etc. The patients were divided into the first treatment group and the more thanonce treatment group according to whether they had received endoscopic treatment in the past
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group will receive re-education after leave hospital | Experimental | Behavioral: re-educationThe participants were randomly divided into re-education group and non re-education group according to the random number table. The re-education group will receive regular re-education not noly when they leave hospital but also after leave hospital in our preset time by telephone or wechat. The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on |
| control case group will receive no re-education after leave hospital | No intervention | –The participants were randomly divided into re-education group and non re-education group according to the random number table. without re-education group will receive regular re-education when they leave hospital.The content of re-education includes diet form and diet structure,medication compliance and regularity, and recheck compliance, moderate exercise and so on |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Esophageal and / or gastric varices ；
- liver cirrhosis ；
- patients receiving endoscopic treatment (esophagogastric variceal sclerosis and/or ligation) ；
- All subjects or their guardians must sign the subject consent form before entering the test
Key exclusion criteria (6 listed)
- Patients with mental illness, severe hearing loss and unable to take care of themselves ;
- ASA score ≥ grade IV at discharge ;
- Hepatic encephalopathy ≥ stage II;
- Patients with liver cancer;
- Pregnant and lactating women;
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 |
|---|---|---|
| re-educationContact patients by phone or wechat and guide them | Behavioural | case group will receive re-education after leave hospital |
Primary outcome
rebleeding
Time frame: 2 yeas
rebleeding from any channel can be followed up through medical institutions or telephone
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Yanjing Gao, 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?
A study testing re-education in people with Liver Cirrhosis and Esophageal Varices Bleeding, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 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?
Results are not available in the source record.
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 yeas). 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 31 Mar 2022.