NCT06785701

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

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B\&C Cirrhosis. 2. Hypothesis - Early use of endoscopy along with adequate resuscitation and medical optimization in patients with Child B/C cirrhosis would lead to higher rates of endoscopic hemostasis thereby associated with better clinical outcomes, in terms of in hospital mortality rate and Liver failure related mortality in post bleed, recurrent bleeding rates. 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.

Conditions

• Acute Variceal Bleed

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-01-21
• Last updated: 2025-01-21

Locations

1 site across 1 country: India