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.

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 Overview

• Status: Not yet recruiting
• Conditions: Acute Variceal Bleed
• Intervention / Treatment: Procedure: Upper Gastrointestinal Endoscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Sanda Kavitha, MD; Phone Number: 01146300000; Email: sandakavitha1001@gmail.com
• Study Contact Backup: Name: Dr Harsh Vardhan Tevethia, DM; Phone Number: 01146300000; Email: harshvardhantevethia@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences (ILBS)
      • Contact: Dr Sanda Kavitha, MD; Phone Number: 01146300000; Email: sandakavitha1001@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emergent Endoscopy; UGIE T1-T4 hrs	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.
Active Comparator: Early endoscopy; UGIE T4-T12 hrs	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of mortality within 6 weeks in Child B&C	6 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: ILBS-AVB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No