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Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer

NCT05227833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2024-08-30

No results posted yet for this study

Summary

Endoscopic variceal ligation (EVL) is used to control and prevent variceal bleeding in patients with liver cirrhosis, but it can be complicated by bleeding from post-EVL ulcers. the current study aims at evaluating the potential benefit of different acid-suppressive therapies in prevention of post band ligation ulcer/bleeding. We will include 234 patients with cirrhotic portal hypertension undergoing endoscopic band ligation. Patients will be randomly allocated into one group of acid suppressive therapy (Vonoprazan or pantoprazole) versus placebo for 14 days. Re-endoscopy will be done after 2 weeks of treatment to assess the healing of post ligation ulcers. Any form of upper gastrointestinal bleeding will be documented.

Conditions

  • Portal Hypertension
  • Variceal Hemorrhage
  • Ulcer Hemorrhage

Interventions

DRUG

Vonoprazan fumarate (Vonaspire)

Patients assigned to Vonoprazan (vonaspire) tablets will receive a daily dose of 20 mg before breakfast starting from the first day of band ligation.

DRUG

Pantoprazole 40mg

Patients assigned to Pantoprazole tablets (Controloc OR Antopral OR Perloc) will receive a daily dose of 40 mg before breakfast starting from the first day of band ligation.

OTHER

Placebo

No Intervention

Sponsors & Collaborators

  • Alexandria University Hospital, Alexandria, Alexandria Governorate, Egypt

    collaborator UNKNOWN

  • Alexandria University

    lead OTHER

Principal Investigators

  • Sameh Lashen, MD · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-11-15
Completion
2022-11-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227833 on ClinicalTrials.gov