Health Condition 1: K74- Fibrosis and cirrhosis of liver
Conditions
Interventions
Intervention1: Vonoprazan: In participants randomized to the intervention arm, vonoprazan at the dose of 20mg once daily will be started within 24 hours of EVL. The vonoprazan tablets will be administ
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients undergoing EVL 2) Willing to provide written informed consent for participation and follow-up
Exclusion criteria
Exclusion criteria: 1) Acute on chronic liver failure/ Sepsis necessitating admission 2) Pregnancy and lactation 3) Patients already included in this trial 4) Non-cirrhotic portal hypertension 5) Presence of gastroduodenal ulcers meriting PPI therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Longitudinal ordinal outcome scale Grade 0: Uncomplicated course; taking carvedilol and undergoing repeat EVL as scheduled Grade 1: Post EVL ulcer delaying EVL/ repeat endoscopy; chest pain requiring analgesics; non-bloody vomiting requiring antiemetics; fever requiring antipyretics; if admitted then less than 24 hours Grade 2: Requirement for blood transfusions/ IV iron/ albumin/ diuretics/ anti HE measures; admitted for more than 24 hours Grade 3: Post EVL bleed requiring repeat endoscopy/ TIPS Grade 4: Acute-on-chronic liver failure/ requirement for organ support (e.g. dialysis/ mechanical ventilation/ inotropes)/ liver transplantation Grade 5: Death Timepoint: 0-, 3-, 6-, 9- and 12-week followup | — |
Secondary
| Measure | Time frame |
|---|---|
| Rebleeding with mortality as competing eventTimepoint: 12-week;Mortality (all-cause and liver-related)Timepoint: 12-week;Duration of hospital stayTimepoint: 12-week;Need for TIPSS over follow-upTimepoint: 12-week;Self reported quality of life (CLDQ -chronic liver disease related quality of life)Timepoint: 12-week;Patients global impression of change (PGIC questionnaire)Timepoint: 12-week | — |
Countries
India
Contacts
Public ContactDr Shalimar
AIIMS, New Delhi
Outcome results
None listed