Gastric Varices BleedingEUSNCT06370169
EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
A study testing Endoscopic ultrasound placement of Coil and glue in people with Gastric Varices Bleeding, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Gastric Varices Bleeding
- What is being tested?
- Endoscopic ultrasound placement of Coil and glue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2022to 10 Aug 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 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Each patient must meet all the following criteria to be enrolled in this study:
- Gastric fundal varices larger than 2.0 cm in total diameter
- High risk GV (GOV 2/IGV 1)
- Primary prophylaxis
- Patients with known fundal varices
- Ability to give a signed informed consent
Who cannot join
- The exclusion criteria for these volunteers will be:
- Patients with a history of TIPS or any other portosystemic shunt procedure
- Oesophageal stricture
- Patient not fit for general anaesthesia
- Secondary prophylaxis
- Pediatric Patients (<18 years)
- Pregnant or lactating mother
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian institute of Gastroenterology
Hyderabad, Telangana, 500082
Jahangeer Dr Basha, MD DM, 04023378888, drjahangeer09@gmail.com
Sandeep Dr Nath, MD, 04023378888, sandip.nath@ymail.com
About this study
Official title: Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.
Read the detailed description
In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the stomach, found in patients with portal hypertension or elevated pressure in the portal venous system. The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. After the procedure patients will be discharged to home unless there is any indication for admission, such as significant abdominal pain, bleeding or chest pain. For enrolment into the study, patient has to sign an informed consent form which is provided at the end. First, we will do baseline evaluation of the patient which includes detailed clinical examination, routine laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6 months. Only the routine tests necessary for the management of disease will be charged.
- Conditions
- Gastric Varices Bleeding
- Being tested
- Endoscopic ultrasound placement of Coil and glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound placement of Coil and glueDevice
Also called Ultrasound
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ultrasound Placement of coil and glue | Other | Single arm study The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue
Duration 1,3,06 months for observation of gastric varices bleeding... Receives: Device: Endoscopic ultrasound placement of Coil and glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome will measure number of patient had achieved complete obliteration of varices
Repeat Endoscopic ultrasound findings of residual flow
Measured: 6 months for observation
Secondary outcomes (2)
Number of patient needed re intervention
Repeat coil application on follow-up
Measured: 6 months for observation
Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)
These are the definite data which will be statistically analyzed
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Aug 2022
- Primary completion30 Mar 2024
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Varices BleedingStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Dr Ramchandani, MD DM, Study director, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370169
- Sponsor's protocol ID
- ROSC 1
- Acronym
- EUS
- Status last verified
- Mar 2024
- First submitted
- 21 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
- ClinicalTrials.gov ID
- NCT06370169
- Acronym / sponsor ID
- EUS / ROSC 1
- Conditions
- Gastric Varices Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 17 Apr 2024 (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 standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.
Detailed description
In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the stomach, found in patients with portal hypertension or elevated pressure in the portal venous system. The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. After the procedure patients will be discharged to home unless there is any indication for admission, such as significant abdominal pain, bleeding or chest pain. For enrolment into the study, patient has to sign an informed consent form which is provided at the end. First, we will do baseline evaluation of the patient which includes detailed clinical examination, routine laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6 months. Only the routine tests necessary for the management of disease will be charged.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ultrasound Placement of coil and glue | Other | Device: Endoscopic ultrasound placement of Coil and glueSingle arm study The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue Duration 1,3,06 months for observation of gastric varices bleeding... |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Gastric fundal varices larger than 2.0 cm in total diameter
- High risk GV (GOV 2/IGV 1)
- Primary prophylaxis
- Patients with known fundal varices
- Ability to give a signed informed consent
Key exclusion criteria (8 listed)
- Patients with a history of TIPS or any other portosystemic shunt procedure
- Oesophageal stricture
- Patient not fit for general anaesthesia
- Secondary prophylaxis
- Pediatric Patients (<18 years)
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 ultrasound placement of Coil and glueAlso: UltrasoundThe standard treatment of bleeding gastric varices is obliteration with placement of coil and glue | Device | Endoscopic ultrasound Placement of coil and glue |
Primary outcome
The outcome will measure number of patient had achieved complete obliteration of varices
Time frame: 6 months for observation
Repeat Endoscopic ultrasound findings of residual flow
2 secondary outcomes
Number of patient needed re intervention
Time frame: 6 months for observation
Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
Mohan Dr Ramchandani, MD DM study director
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound placement of Coil and glue in people with Gastric Varices Bleeding, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 6 inclusion and 8 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 17 Apr 2024. 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 India. 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 Jahangeer Dr Basha, MD DM (04023378888 ext. 231, drjahangeer09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The outcome will measure number of patient had achieved complete obliteration of varices (time frame: 6 months for observation). 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 17 Apr 2024.