1. Patients with cirrhosis undergoing endoscopic variceal ligation (EVL) due to acute variceal bleeding and receive IV PPI and octreotide before EGD (EGD within 12 hours) 2. Patients with cirrhosis undergoing endoscopic variceal ligation (EVL) due to prophylaxis variceal bleeding Variceal bleeding Endoscopic variceal ligation (EVL) PCAB Post-EVL ulcer
Conditions
Interventions
Group A: Vonoprazan 20 mg, 1 tablet orally once daily after breakfast for 14 days.,Group B: Omeprazole 20 mg, 1 tablet orally once daily 1 hour before breakfast for 14 days.,Group C: No acid suppressi
Vonoprazan ,Omeprazole,No acid suppression
Sponsors
The gastroenterological association of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged between 18 and 75 years. 2. Diagnosed with cirrhosis with no prior history of variceal ligation, or if previously treated with band ligation, the current banding site must not involve a post-EVL scar from a prior procedure; and currently presenting with esophageal varices indicated for endoscopic variceal ligation (EVL). 3. In cases of acute gastrointestinal bleeding from esophageal varices, patients must receive an immediate intravenous bolus of pantoprazole 80 mg followed by a continuous intravenous infusion of 8 mg/hour, combined with an immediate intravenous bolus of octreotide 50 mcg followed by a continuous intravenous infusion of 50 mcg/hour, undergo EVL within 12 hours of diagnosis, and discontinue pantoprazole after endoscopy for subsequent randomization into the study arms. 4. Able to undergo repeat endoscopy at 2 weeks. 5. Able to complete a follow-up period of at least 4 weeks post-EVL. 6. Willing to participate in the study and provide signed informed consent. Note: If rebleeding occurs within 14 days prior to the scheduled repeat endoscopy, the patient will undergo repeat endoscopy to determine the etiology of the bleeding and receive standard of care management. For example, if bleeding is secondary to a post-EVL ulcer, it will be treated with proton pump inhibitors in combination with octreotide. Such patients will not be excluded from the study, as the incidence of post-EVL bleeding leading to 30-day readmission after EVL is also evaluated as a secondary outcome in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. History of hypersensitivity or severe adverse reactions to proton pump inhibitors (PPIs) or vonoprazan. 2. Concurrent use of medications that interact with vonoprazan or omeprazole, such as rilpivirine, or strong CYP3A4 inducers (rifampicin, carbamazepine). 3. Presence of acute liver failure or grade lll-lV hepatic encephalopathy. 4. Pregnant or breastfeeding women. 5. Inability to cooperate or presence of psychiatric disorders that impair decision making capacity. 6. Inability to undergo repeat endoscopy (development of complications, death). Discontinuation Criteria (or Study Termination Criteria) 1. Development of an allergic reaction to the study medication. 2. Intolerance to adverse effects of the medication. 3. Poor medication adherence or failure to complete the prescribed medication regimen. 4. Loss to follow-up or failure to attend scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-EVL ulcer 2 weeks Endoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication 4 weeks Chest pain, dysphagia, fever,Re-hospitalization 4 weeks Cause of re-admission | — |
Countries
Thailand
Contacts
Public ContactKiattikul Samniangsoong
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Outcome results
None listed