Endoscopic ultra sonography guided thrombin with glue injection in gastric varices
Phase 4
- Conditions
- Health Condition 1: K318- Other specified diseases of stomach and duodenum
- Registration Number
- CTRI/2024/01/061478
- Lead Sponsor
- MMCSBY Scheme Govt of Rajasthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age group- =18
2. Patients diagnosed with gastric varices type GOV2 or IGV1 according to the Sarin classification
3. Treated for active bleed or secondary prophylaxis
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Technical success- defined as completion of the intended procedure <br/ ><br>2. Clinical success- defined as complete and immediate obliteration of the varix, <br/ ><br>evaluated via esophagogastroduodenoscopy (EGD) and the absence of flow during <br/ ><br>EUS Doppler evaluationTimepoint: Follow-up EGD and an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month and 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival and adverse events will be evaluated. <br/ ><br>Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital and review of medical, EGD, and EUS records.
- Secondary Outcome Measures
Name Time Method 1. Reappearance of gastric varices during follow-up <br/ ><br>2. Rebleeding, the need for reintervention <br/ ><br>3. The complication & survival ratesTimepoint: Follow-up EGD & an EUS Doppler evaluation will be performed at 1st month 3rd month, 6th month & 12th month after the initial procedure. The reappearance of gastric varices, need for reintervention, survival & adverse events will be evaluated. <br/ ><br>Patients will be followed upto 12th months after enrollment or until the date of death via visits to the SMS hospital & review of medical, EGD, & EUS records.