Esophageal and Gastric VaricesNCT05978752
Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices
A study testing Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices, Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices and Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated) in people with Esophageal and Gastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and Gastric Varices
- What is being tested?
- Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices, Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices and Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOV1 esophageal and gastric varices identified by CT; more than 18 years old;
Who cannot join
- Complicated with liver cancer, severe cardiopulmonary insufficiency, stage III and above hepatic encephalopathy, severe natural portal shunt formation, and previous treatment of portal hypertensive bleeding (including endoscopic, interventional, and surgical procedures).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics
The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.
Read the detailed description
Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the gold standard for detecting portal pressure in clinical practice is hepatic venous pressure gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single origin, the left gastric vein. If the fundus varicose veins receive complete embolization treatment, the esophageal variceal blood flow should be completely blocked, and such patients do not need to perform esophageal surgery. However, this has not been reported in the literature.
Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all of whom will receive HVPG detects. The patients were randomly divided into three groups. The patients in group A will receive endoscopic gel embolization for gastric varices and esophageal varices ligation treatment, group B patients will receive endoscopic gastric variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the patients in group C will receive endoscopic gelatinization of gastric fundus varices (esophageal varices were not treated). Patients in the three groups were followed up with CTP and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional endoscopic treatment will be provided if necessary. If bleeding occurs again during this period, timely treatment (medication, endoscopy, intervention or surgery) is required according to the condition.
A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.
- Conditions
- Esophageal and Gastric Varices
- Being tested
- Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices, Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices, Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)
- Keywords
- GOV1 esophagogastric varices, HVPG, endoscopic treatment
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varicesProcedure or surgery
For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.
Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varicesProcedure or surgery
For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.
Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)Procedure or surgery
For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | The patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation. Receives: Procedure: Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices |
| B | Active comparator | The patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices. Receives: Procedure: Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices |
| C | Experimental | The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated). Receives: Procedure: Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis rate
the percentage of hemostasis
Measured: 6 month
Secondary outcomes (1)
Postoperative bleeding recurrence rate
Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and Gastric VaricesStudies 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
- Model description
- The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Hospital Affiliated to Zhejiang University, Lanxi People's Hospital, Lishui Country People's Hospital, Shandong Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Li, Master, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaLiangjing Wang, Doctor, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978752
- Sponsor's protocol ID
- 2023-0437
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics
- ClinicalTrials.gov ID
- NCT05978752
- Acronym / sponsor ID
- 2023-0437
- Conditions
- Esophageal and Gastric Varices
- Keywords
- GOV1 esophagogastric varices, HVPG, endoscopic treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Hospital Affiliated to Zhejiang University, Lanxi People's Hospital, Lishui Country People's Hospital, Shandong Provincial Hospital
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 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.
The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.
Detailed description
Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the gold standard for detecting portal pressure in clinical practice is hepatic venous pressure gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single origin, the left gastric vein. If the fundus varicose veins receive complete embolization treatment, the esophageal variceal blood flow should be completely blocked, and such patients do not need to perform esophageal surgery. However, this has not been reported in the literature.
Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all of whom will receive HVPG detects. The patients were randomly divided into three groups. The patients in group A will receive endoscopic gel embolization for gastric varices and esophageal varices ligation treatment, group B patients will receive endoscopic gastric variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the patients in group C will receive endoscopic gelatinization of gastric fundus varices (esophageal varices were not treated). Patients in the three groups were followed up with CTP and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional endoscopic treatment will be provided if necessary. If bleeding occurs again during this period, timely treatment (medication, endoscopy, intervention or surgery) is required according to the condition.
A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varicesThe patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation. |
| B | Active comparator | Procedure: Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varicesThe patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices. |
| C | Experimental | Procedure: Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GOV1 esophageal and gastric varices identified by CT; more than 18 years old;
Key exclusion criteria (1 listed)
- Complicated with liver cancer, severe cardiopulmonary insufficiency, stage III and above hepatic encephalopathy, severe natural portal shunt formation, and previous treatment of portal hypertensive bleeding (including endoscopic, interventional, and surgical procedures).
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 |
|---|---|---|
| Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varicesFor patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation. | Procedure or surgery | A |
| Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varicesFor patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy. | Procedure or surgery | B |
| Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated. | Procedure or surgery | C |
Primary outcome
hemostasis rate
Time frame: 6 month
the percentage of hemostasis
1 secondary outcome
Postoperative bleeding recurrence rate
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
Wei Li, Master study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Liangjing Wang, Doctor study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices, Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices and Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated) in people with Esophageal and Gastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Hongxia Li, Doctor (+8618252006898, lhx100918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemostasis rate (time frame: 6 month). 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 24 Aug 2023.