EUS guided coil treatment for preventing bleeding in gastric varices
Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
This study is testing if a new procedure using ultrasound to place coils can help prevent bleeding in people with high-risk stomach varices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Months to 80 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06370169 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of endoscopic ultrasound (EUS) guided coil embolization as a primary prophylactic treatment for patients with high-risk gastric varices. Patients with dilated submucosal veins in the stomach will undergo the procedure under deep sedation or general anesthesia, supervised by an anesthesiologist. The study includes a baseline evaluation with clinical examinations and imaging tests, and aims to assess the effectiveness of this intervention over a duration of six months. Participants will be monitored for any complications post-procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with gastric fundal varices larger than 2.0 cm and classified as high risk for bleeding.
Not a fit: Patients with a history of portosystemic shunt procedures or those requiring secondary prophylaxis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of bleeding in patients with high-risk gastric varices.
How similar studies have performed: While similar approaches have been explored, this specific method of EUS guided coil embolization for primary prophylaxis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: - Each patient must meet all the following criteria to be enrolled in this study: 1. Gastric fundal varices larger than 2.0 cm in total diameter 2. High risk GV (GOV 2/IGV 1) 3. Primary prophylaxis 4. Patients with known fundal varices 5. Ability to give a signed informed consent Exclusion criteria: - The exclusion criteria for these volunteers will be: 1. Patients with a history of TIPS or any other portosystemic shunt procedure 2. Oesophageal stricture 3. Patient not fit for general anaesthesia 4. Secondary prophylaxis 5. Pediatric Patients (\<18 years) 6. Pregnant or lactating mother 7. Not willing to participate
Where this trial is running
Hyderabad, Telangana
- Asian institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Jahangeer Dr Basha, MD DM
- Email: drjahangeer09@gmail.com
- Phone: 04023378888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.