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NCT Number: NCT07608536

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King George Medical University

Lucknow, Uttar Pradesh, 226003, India

Location contact

Dr Mayank Agarwal, MD Medicine

PRINCIPAL_INVESTIGATOR

Dr Sayan Malakar, DM-Medical Gastroenterology

CONTACT

[email protected]

+919007057890

Dr Sumit Rungta, DM-Medical Gastroenterology

CONTACT

[email protected]

+919935537944

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vonoprazan

Drug

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.

Rabeprazol

Drug

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.

Primary outcomes

  1. 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.

    Time frame: Two weeks

  2. 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

    Time frame: Two weeks

Secondary outcomes

  1. To compare the incidence of adverse effects in Vonoprazan and Rabeprazole groups

    Time frame: Two weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Sayan Malakar, DM- Medical Gastroenterology

CONTACT

[email protected]

+919007057890

Dr Sumit Rungta, DM- Medical Gastroenterology

CONTACT

[email protected]

+919935537944

Sponsors and collaborators

Lead sponsor

King George's Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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