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
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Proportion of mortality within 6 weeks in Child B&C
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Child B and C cirrhotic patients with history of AVB.
- •Fluid responsive within 1 hour after resuscitation.
Exclusion Criteria
- •EHPVO / NCPH 2.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.
Outcomes
Primary Outcomes
Proportion of mortality within 6 weeks in Child B&C
Time Frame: 6 weeks
Secondary Outcomes
- 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)
- Patients need of TIPS/BRTO/EUS in AVB.(6 weeks)
- Percentage of endoscopic hemostasis is achieved at 24 hours.(24 hours)
- Percentage requiring ICU saty and duration of saty post AVB(6 weeks)
Investigators
Dr Sanda Kavitha
Institute of Liver and Biliary Sciences