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

Institute of Liver and Biliary Sciences, India

Status: Not yet enrolling

Conditions: Acute Variceal Bleed

Treatments: Procedure: Upper Gastrointestinal Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06785701

ILBS-AVB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Emergent Endoscopy

Experimental group

Description:

UGIE T1-T4 hrs

Treatment:

Procedure: Upper Gastrointestinal Endoscopy

Early endoscopy

Active Comparator group

Description:

UGIE T4-T12 hrs

Treatment:

Procedure: Upper Gastrointestinal Endoscopy