Acute Esophageal Variceal HemorrhageNCT06011980
Life-2023-02 Esophagogastric Variceal Bleeding
A study testing Growth Inhibitor in people with Acute Esophageal Variceal Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Esophageal Variceal Hemorrhage
- What is being tested?
- Growth Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to 10 Aug 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute esophagogastric bleeding with hepatic cirhosis;
- stable status (no active bleeding)
Who cannot join
- endoscopic test limitation;
- previous acute esophagogastric bleeding treatment history;
- ICU;
- pregnant;
- Immunity disabled;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, 310000
WEI WEI
About this study
Official title: Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding
Read the detailed description
Participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. All the patients will take CTP test to confirm the blood flow status of the portal vein before endoscopic treatment. After that they will be randomly divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5 days; B. no growth inhibitor will be applied after the treatment.
- Conditions
- Acute Esophageal Variceal Hemorrhage
- Being tested
- Growth Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth InhibitorDrug
growth inhibitors for 250-500μg/h, ivgtt. for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in this group will take growth inhibitors for 5 days after endoscopic treatment. Receives: Drug: Growth Inhibitor |
| Group B | No intervention | Participants in this group will not take growth inhibitor treatment after endoscopic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding rate after the endoscopic treatment in Group A at 1 month
record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)
Measured: 1 month after the endoscopic treatment
rebleeding rate after the endoscopic treatment in Group A at 3 months
record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)
Measured: 3 months after the endoscopic treatment
rebleeding rate after the endoscopic treatment in Group A at 6 months
record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)
Measured: 6 months after the endoscopic treatment
rebleeding rate after the endoscopic treatment in Group B at 1 month
record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)
Measured: 1 month after the endoscopic treatment
rebleeding rate after the endoscopic treatment in Group B at 3 months
record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)
Measured: 3 months after the endoscopic treatment
rebleeding rate after the endoscopic treatment in Group B at 6 months
record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
Measured: 6 months after the endoscopic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study startAug 2023 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Esophageal Variceal HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011980
- Sponsor's protocol ID
- 2023-0407
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: on request
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
- ClinicalTrials.gov ID
- NCT06011980
- Acronym / sponsor ID
- 2023-0407
- Conditions
- Acute Esophageal Variceal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 25 Aug 2023 (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.
Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding
Detailed description
Participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. All the patients will take CTP test to confirm the blood flow status of the portal vein before endoscopic treatment. After that they will be randomly divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5 days; B. no growth inhibitor will be applied after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Growth InhibitorParticipants in this group will take growth inhibitors for 5 days after endoscopic treatment. |
| Group B | No intervention | –Participants in this group will not take growth inhibitor treatment after endoscopic treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute esophagogastric bleeding with hepatic cirhosis;
- stable status (no active bleeding)
Key exclusion criteria (5 listed)
- endoscopic test limitation;
- previous acute esophagogastric bleeding treatment history;
- ICU;
- pregnant;
- Immunity disabled;
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 |
|---|---|---|
| Growth Inhibitorgrowth inhibitors for 250-500μg/h, ivgtt. for 5 days | Drug | Group A |
Primary outcome
rebleeding rate after the endoscopic treatment in Group A at 1 month
Time frame: 1 month after the endoscopic treatment
record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)
rebleeding rate after the endoscopic treatment in Group A at 3 months
Time frame: 3 months after the endoscopic treatment
record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)
rebleeding rate after the endoscopic treatment in Group A at 6 months
Time frame: 6 months after the endoscopic treatment
record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)
rebleeding rate after the endoscopic treatment in Group B at 1 month
Time frame: 1 month after the endoscopic treatment
record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)
rebleeding rate after the endoscopic treatment in Group B at 3 months
Time frame: 3 months after the endoscopic treatment
record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)
rebleeding rate after the endoscopic treatment in Group B at 6 months
Time frame: 6 months after the endoscopic treatment
record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided. on request
Related trials for Acute Esophageal Variceal Hemorrhage
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Inhibitor in people with Acute Esophageal Variceal Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 5 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 25 Aug 2023. 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?
Contact WEI WEI (15267175186, wwze@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rebleeding rate after the endoscopic treatment in Group A at 1 month (time frame: 1 month after the endoscopic treatment). The study lists 6 primary outcomes in all. 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 25 Aug 2023.