Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion.
Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS.
Study period: 1.0 years
Sample size: 42
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Occluded/plug assisted Retrograde Transvenous Obliteration. | Experimental | Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. |
|
| Endoscopic Variceal Obturation | Active Comparator | endoscopic variceal glue therapy will be done till obturation every 3 weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon occluded/plug assisted retrograde transvenous obliteration. | Procedure | Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient having bleeding from GV at 12 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving complete or partial obturation of GV | 6 months | |
| Proportion of patients having change in grade of EV and bleeding from EV | 6 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Endoscopic Variceal Obturation | Procedure | Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly. |
|
| Proportion of patients having appearance or worsening of PHG |
| 6 months |
| Change in HVPG in those patients who bleed after BRTO/PRTO | 6 months |
| Change in HVPG in those patients who bleed after EVO | 6 months |
| Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography | 6 months |
| Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography | 6 months |
| Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy | 6 months |
| Proportion of patient developing post procedure liver failure | 6 months |
| Proportion of patient developing post acute kidney injury or sepsis | 6 months |
| Duration of hospital stay poof procedure | 12 months |
| Evaluation of expertise of endoscopists | 12 months |
| Any variceal bleed | 12 months |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided