Gastric Varices Bleeding
Conditions
Brief 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. 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.
Interventions
DEVICEEndoscopic ultrasound placement of Coil and glue
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The outcome will measure number of patient had achieved complete obliteration of varices | 6 months for observation | Repeat Endoscopic ultrasound findings of residual flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient needed re intervention | 6 months for observation | Repeat coil application on follow-up |
| Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days) | 90 days | These are the definite data which will be statistically analyzed |
Countries
India
Contacts
Primary ContactJahangeer Dr Basha, MD DM
Backup ContactSandeep Dr Nath, MD
Outcome results
None listed