Endoscopic Ultrasound (EUS) guided management of gastric varices: coil embolisation withabsorbable gelatin sponge versus coil embolisation with cyanoacrylate glue injectio
Phase 4
- Conditions
- Health Condition 1: K318- Other specified diseases of stomach and duodenum
- Registration Number
- CTRI/2023/12/060491
- Lead Sponsor
- MMCSBY Scheme Govt of Rajasthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patient with age = 18 years
2. Diagnosed with gastric varices type GOV2 or IGV1 on upper GI endoscopy according to the sarin classification.
3. All patients will be included irrespective of bleeding status (past bleeder/ non bleeder / active bleeder).
Exclusion Criteria
1. Age < 18 years and > 75 year of age
2. Platelet count < 50 000 /dl or an international normalized ratio (INR) = 2
3. Patient with concurrent hepatorenal syndrome and/or multiorgan failure
4. Pregnant or nursing female
5. Patient with prior surgery of upper gastrointestinal tract
6. Hemodyanimically unstable/ Shock (bp < 90 mm Hg)
7. EUS specific procedural contraindication
8. Patients who did not give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of cases with obliteration of varices evaluated via EUS doppler <br/ ><br>2.Proportion of cases with reappearance of varices <br/ ><br>3.Proportion of cases with rebleeding <br/ ><br>4.Proportion of cases with need for reintervention <br/ ><br>5.Proportion of cases needs blood transfusion <br/ ><br>6.Proportion of cases with pre and post treatment hemoglobin values. <br/ ><br>7.Proportion of cases with adverse events <br/ ><br>8.Proportion of cases with technical success <br/ ><br>Timepoint: 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. <br/ ><br>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. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Proportion of cases needs blood transfusion <br/ ><br>2.Proportion of cases with pre and post treatment hemoglobin values. <br/ ><br>3.Proportion of cases with adverse events <br/ ><br>4.Proportion of cases with technical success <br/ ><br>Timepoint: 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. <br/ ><br>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. <br/ ><br>