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Starting soon Not applicable

A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB

NCT06785701 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2025-01-20
Last updated
2025-01-21

Condition(s) studied

Acute Variceal Bleed

Investigational drug(s) / intervention(s)

Upper Gastrointestinal Endoscopy

Upper Gastrointestinal Endoscopy: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Child B and C cirrhotic patients with history of AVB 2. \>18YRS and \<75 yrs. 3. Fluid responsive within 1 hour after resuscitation Exclusion Criteria: 1. EHPVO / NCPH 2. Lack of consent Pregnancy 3. Child A cirrhotics 4. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours). 5. Need of Dual vasopressors at presentation In Hospital patients with Bleed 6. HCC patients with AVB 7. Patients presented with AVB on going antiplatelets/anticoagulants.

Primary outcome measure(s)

  • Proportion of mortality within 6 weeks in Child B&C — 6 weeks

Trial sites (1)

FacilityCityRegionStatus
Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785701 on ClinicalTrials.gov ↗ ← All trials in India