Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Sucralfate + High dose Pantoprazole: Syp. Sucralfate 1g thrice daily + Tab. Pantoprazole 40mg twice daily x 21 days post EVL
Control Intervention1: High Dose Pantoprazole alone: Tab. Pa
Sponsors
Internal Fluid Research Grant CMC Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive subjects presenting for elective / emergency variceal band ligation will be considered eligible for inclusion in the study. Inclusion criteria are subjects with portal hypertension and varices between the ages of 18 and 80 years who has had a history of prior variceal hemorrhage. Patients undergoing secondary EVL will only be recruited.
Exclusion criteria
Exclusion criteria: The exclusion criteria for the study include patients with hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT), acute PVT, or intolerance to non-selective beta-blockers; those using anticoagulation or antiplatelet drugs; pregnant individuals or patients under 18 years of age; and those undergoing ongoing therapy with anti-acid agents or with a history of allergy or adverse reactions to proton pump inhibitors and/or sucralfate. Additionally, patients with pre-existing esophageal ulcers, a history of surgical anti-reflux procedures (e.g., Nissen, Belsey, or Toupet), or Barrett s esophagus are excluded, as are those undergoing primary endoscopic variceal ligation (EVL) or with a history of liver transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective 1. The number of esophageal ulcers identified at follow-up endoscopy 2. The size of esophageal ulcers identified at follow-up endoscopy after EVL Timepoint: Primary Objective 1. The number of esophageal ulcers identified at follow-up endoscopy 2. The size of esophageal ulcers identified at follow-up endoscopy after EVL Secondary Objective: 1. Incidence of post-EVL ulcer bleed 2. Delta hemoglobin after 21 days from the last scopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Incidence of post-EVL ulcer bleed 2. Delta hemoglobin after 21 days from the last scopy Timepoint: 14 - 21 days post EVL | — |
Countries
India
Contacts
Public ContactVijay Alexander
Christian Medical College Hospital
Outcome results
None listed