Role of Emergent vs Early Endoscopy (type of endoscopy procedure) in Cirrhotic Patients With Acute Variceal Bleed (Disease).

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 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079297

Enrollment

220

Registered

2025-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: Emergent Endoscopy UGIE T1-T4 hrs: After Entering to emergency based on time of hemetemsis and based on presentation to ER , patient will be assessed and based on hemodyamic stability p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Child B and C cirrhotic patients with history of AVB. 2. Fluid responsive within 1 hour after resuscitation

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Proportion of mortality within 6 weeks in Child B&CTimepoint: 6 weeks	—

Secondary

Measure	Time frame
Proportion of rebleed within 6 weeks in Chid B &C.Timepoint: 6 weeks;Proportion of patients rebleed at D5.Timepoint: Day 5;Proportion of patients required repeated hospital admissions and number days pf hospitalisationTimepoint: 6 weeks;Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy.Timepoint: 6 weeks;Proportion of patients developing Ischemic hepatitis.Timepoint: 6 weeks;Patients need of TIPS/BRTO/EUS in AVB.Timepoint: 6 weeks;Percentage of endoscopic hemostasis is achieved at 24 hours.Timepoint: 24 hours;Percentage requiring ICU saty and duration of saty post AVBTimepoint: 6 weeks	—

Measure

Time frame

Proportion of rebleed within 6 weeks in Chid B &C.Timepoint: 6 weeks;Proportion of patients rebleed at D5.Timepoint: Day 5;Proportion of patients required repeated hospital admissions and number days pf hospitalisationTimepoint: 6 weeks;Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy.Timepoint: 6 weeks;Proportion of patients developing Ischemic hepatitis.Timepoint: 6 weeks;Patients need of TIPS/BRTO/EUS in AVB.Timepoint: 6 weeks;Percentage of endoscopic hemostasis is achieved at 24 hours.Timepoint: 24 hours;Percentage requiring ICU saty and duration of saty post AVBTimepoint: 6 weeks

—

Countries

India

Contacts

Public ContactDr Harsh Vardhan Tevethia

Institute of Liver and Biliary Sciences

harshvardhantevethia@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026