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Summary-Variceal bleeding - 70% of all upper gastro-intestinal bleeding episodes in patients with portal hypertension, and they result from esophageal varices (EVs), gastric varices (GVs), or ectopic varices.
Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates and liver related adverse events. From time of presentation to emergent endoscopy that is 4 hours can reduce the mortality when compared early endoscopy within 4-12 hours so that mortality rate related to bleed can reduced and early hemostasis can be achieved.
Study population- Patient presenting with AVB as per definition in Child B &C cirrhotics.
Study design- Randomized Control Trial Non Inferior Trial. Study area- ILBS , Delhi Intervention: Patient after screening for all exclusion criteria will be randomized into either Emergent endoscopy or Early endoscopy
Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the Endoscopy procedure.Post procedure patient will be followed and evaluated for rebleed, mortality, liver related events if any like Hepatic encephalopathy, Ascites, Ischemic hepatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergent Endoscopy | Experimental | UGIE T1-T4 hrs |
|
| Early endoscopy | Active Comparator | UGIE T4-T12 hrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper Gastrointestinal Endoscopy | Procedure | After Entering to emergency based on time of hemetemsis and based on presentation to ER , patient will be assessed and based on hemodyamic stability patient can be taken Early/Emergent endoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mortality within 6 weeks in Child B&C | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of rebleed within 6 weeks in Chid B &C | 6 weeks | |
| Proportion of patients rebleed at D5 | Day 5 | |
| Proportion of patients required repeated hospital admissions and number days pf hospitalisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Sanda Kavitha, MD | Contact | 01146300000 | sandakavitha1001@gmail.com | |
| Dr Harsh Vardhan Tevethia, DM | Contact | 01146300000 | harshvardhantevethia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| 6 weeks |
| Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy | 6 weeks |
| Proportion of patients developing Ischemic hepatitis | 6 weeks |
| Patients need of TIPS/BRTO/EUS in AVB | 6 weeks |
| Percentage of endoscopic hemostasis is achieved at 24 hours | 24 hours |
| Percentage requiring ICU saty and duration of saty post AVB | 6 weeks |
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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