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NCT Number: 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

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.

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Key information

Conditions

Acute Variceal Bleed

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences (ILBS)

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

Location contact

Dr Sanda Kavitha, MD

CONTACT

[email protected]

01146300000

About this study

  • Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B&C Cirrhosis.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Upper gastrointestinal endoscopy

Procedure

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.

Primary outcomes

  1. Proportion of mortality within 6 weeks in Child B&C

    Time frame: 6 weeks

Secondary outcomes

  1. Proportion of rebleed within 6 weeks in Chid B &C

    Time frame: 6 weeks

  2. Proportion of patients rebleed at D5

    Time frame: Day 5

  3. Proportion of patients required repeated hospital admissions and number days pf hospitalisation

    Time frame: 6 weeks

  4. Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy

    Time frame: 6 weeks

  5. Proportion of patients developing Ischemic hepatitis

    Time frame: 6 weeks

  6. Patients need of TIPS/BRTO/EUS in AVB

    Time frame: 6 weeks

  7. Percentage of endoscopic hemostasis is achieved at 24 hours

    Time frame: 24 hours

  8. Percentage requiring ICU saty and duration of saty post AVB

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Harsh Vardhan Tevethia, DM

CONTACT

[email protected]

01146300000

Dr Sanda Kavitha, MD

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.