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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Upper Gastrointestinal Endoscopy.
- Who it may be relevant to
- Registry conditions: Acute Variceal Bleed. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Proportion of mortality within 6 weeks in Child B&C [Time frame: 6 weeks]
Secondary outcome measures (8)
- Proportion of rebleed within 6 weeks in Chid B &C [Time frame: 6 weeks]
- Proportion of patients rebleed at D5 [Time frame: Day 5]
- Proportion of patients required repeated hospital admissions and number days pf hospitalisation [Time frame: 6 weeks]
- Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy [Time frame: 6 weeks]
- Proportion of patients developing Ischemic hepatitis [Time frame: 6 weeks]
- Patients need of TIPS/BRTO/EUS in AVB [Time frame: 6 weeks]
- Percentage of endoscopic hemostasis is achieved at 24 hours [Time frame: 24 hours]
- Percentage requiring ICU saty and duration of saty post AVB [Time frame: 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT06785701 · ILBS-AVB-01