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Comparison of Rabeprazole and Vonoprazan in the Prevention of Post-endoscopic Variceal Ligation Ulcer in Patients With Cirrhosis

26. maj 2026 opdateret af: Sumit Rungta, King George's Medical University

The study aims to to evaluate Vonoprazan effectiveness in prevention of post endoscopic variceal ligation (EVL) ulcer and its related bleed in comparison to Rabeprazole.

All patients who are eligible for the study will be screened from outpatient department and endoscopy lab. Patients who are diagnosed to have oesophageal varices and requiring EVL will be enrolled after fulfilling inclusion and exclusion criteria.

Patient clinical and demographic data will be collected in proforma. Patients who are willing to participate in the study will be randomized into two arms in 1:1 ratio. One arm is Vonoprazan 20 mg once a day group and second arm will be rabeprazole 20 mg once a day. Duration of therapy will be 2 weeks. Patients will also be advised to take nonselective beta blockers (NSBB) as per standard of care.

Patients will undergo upper GI endoscopy after 2 weeks to evaluate varices and ulcers, ulcer will be classified according to Jamwal & Sarin classification system.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Bleeding from esophageal varices is a serious consequence of portal hypertension, and endoscopic variceal ligation (band ligation) is a mainstay of treatment. After the bands are applied, shallow mucosal ulcers predictably develop at the band sites and usually heal over roughly three weeks; occasionally, however, these healing ulcers bleed and contribute to illness and death. One proposed driver of delayed healing and bleeding is the exposure of these ulcers to stomach acid, which has led clinicians to use acid-lowering medicines-most often proton pump inhibitors-after the procedure, though the evidence that this helps remains inconsistent.

Vonoprazan belongs to a newer class of acid-suppressing agents (potassium-competitive acid blockers) that act on the gastric proton pump quickly, reversibly, and durably, overcoming several shortcomings of conventional proton pump inhibitors. Its value in lowering the burden of ulcers that form after band ligation has barely been examined.

This investigator-initiated trial will compare vonoprazan with rabeprazole, a standard proton pump inhibitor, in adults with cirrhosis and portal hypertension who are undergoing band ligation of esophageal varices. Three hundred eligible, consenting participants will be allocated in equal numbers to either vonoprazan 20 mg once daily or rabeprazole 20 mg once daily, each given for two weeks alongside standard beta-blocker therapy. The follow-up endoscopy at two weeks will be recorded, and the ulcers will be measured and graded by an endoscopist. The chief measure of interest is the size of the largest band-site ulcer (in millimetres) seen on the two-week surveillance endoscopy. Additional measures include the number of ulcers per patient, the grade of any bleeding ulcers, episodes of post-procedure bleeding through four weeks, swallowing-related symptoms such as pain and difficulty swallowing, and the occurrence of side effects including spontaneous bacterial peritonitis. The work will be carried out over eight months at a single tertiary-care gastroenterology unit in Lucknow, India.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Indien
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Indien, 226003
        • King George Medical University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Dr Mayank Agarwal, MD Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 18 years and above
  • Diagnosis of portal hypertension and esophageal varix should be established by endoscopy.
  • Who are willing to participate in the study

Exclusion Criteria:

  • Negative consent
  • Diagnosed with HCC
  • Already taking PPI/Vonoprazan for other indications
  • Using anticoagulants and antiplatelets

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Role of Vonoprazan in prevention of post EVL ulcer

Patients who are diagnosed to have esophageal varices and requiring EVL will be enrolled Patients who are willing to participate in the study will be randomized into two arms in 1:1 ratio. The experimental arm will receive Vonoprazan 20 mg once a day for 2 weeks. Patients will also be advised to take nonselective beta blockers (NSBB) as per standard of care.

Patients will undergo upper GI endoscopy after 2 weeks to evaluate varices and ulcers, ulcer will be classified according to Jamwal & Sarin classification system.
Medicin: Vonoprazan

Patients who are willing to participate in the study will be randomized into two arms in 1:1 ratio. One arm is Vonoprazan 20 mg once a day group and second arm will be rabeprazole 20 mg once a day. Duration of therapy will be 2 weeks. Patients will also be advised to take nonselective beta blockers (NSBB) as per standard of care.

Patients will undergo upper GI endoscopy after 2 weeks to evaluate varices and ulcers, ulcer will be classified according to Jamwal & Sarin classification system.
Aktiv komparator: Role of Rabeprazole in prevention of post EVL ulcer

Patients who are diagnosed to have esophageal varices and requiring EVL will be enrolled Patients who are willing to participate in the study will be randomized into two arms in 1:1 ratio. The comparator arm will receive Rabeprazole 20 mg once a day for 2 weeks. Patients will also be advised to take nonselective beta blockers (NSBB) as per standard of care.

Patients will undergo upper GI endoscopy after 2 weeks to evaluate varices and ulcers, ulcer will be classified according to Jamwal & Sarin classification system.
Medicin: Rabeprazol

Patients who are willing to participate in the study will be randomized into two arms in 1:1 ratio. One arm is Vonoprazan 20 mg once a day group and second arm will be rabeprazole 20 mg once a day. Duration of therapy will be 2 weeks. Patients will also be advised to take nonselective beta blockers (NSBB) as per standard of care.

Patients will undergo upper GI endoscopy after 2 weeks to evaluate varices and ulcers, ulcer will be classified according to Jamwal & Sarin classification system.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To compare the maximum post-EVL esophageal ulcer diameter (mm) at 2 weeks (Day 14), measured on surveillance upper GI endoscopy, between the Vonoprazan and Rabeprazole groups.
Tidsramme: Two weeks
Two weeks
To compare the number of post-EVL ulcers per participant at Day 14, and the severity of any bleeding ulcers (graded by the Jamwal & Sarin classification), between the Vonoprazan and Rabeprazole groups
Tidsramme: Two weeks
Two weeks

Sekundære resultatmål

Resultatmål
Tidsramme
To compare the incidence of adverse effects in Vonoprazan and Rabeprazole groups
Tidsramme: Two weeks
Two weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

King George's Medical University

Efterforskere

  • Ledende efterforsker: Dr Sumit Rungta, DM- Medical Gastroenterology, King George Medical University, Lucknow, UP, India

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. juli 2026

Studieafslutning (Anslået)

31. juli 2026

Datoer for studieregistrering

Først indsendt

8. april 2026

Først indsendt, der opfyldte QC-kriterier

26. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2355/Ethics/2026

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Endoskopisk varicebåndsligering

Kliniske forsøg med Vonoprazan

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