NCT06785701

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 15, 2025

Last Update Submit

January 15, 2025

Conditions

Acute Variceal Bleed

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Emergent Endoscopy

EXPERIMENTAL

UGIE T1-T4 hrs

Procedure: Upper Gastrointestinal Endoscopy

Early endoscopy

ACTIVE COMPARATOR

UGIE T4-T12 hrs

Procedure: Upper Gastrointestinal Endoscopy

Interventions

Upper Gastrointestinal EndoscopyPROCEDURE

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.

Early endoscopyEmergent Endoscopy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Child B and C cirrhotic patients with history of AVB
  • \>18YRS and \<75 yrs.
  • Fluid responsive within 1 hour after resuscitation

You may not qualify if:

  • EHPVO / NCPH
  • Lack of consent Pregnancy
  • Child A cirrhotics
  • Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
  • Need of Dual vasopressors at presentation In Hospital patients with Bleed
  • HCC patients with AVB
  • Patients presented with AVB on going antiplatelets/anticoagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Dr Sanda Kavitha, MD

CONTACT

01146300000sandakavitha1001@gmail.com

Dr Harsh Vardhan Tevethia, DM

CONTACT

01146300000harshvardhantevethia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 21, 2025

Study Start

January 20, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 21, 2025

Record last verified: 2025-01

Locations

IN(1)