A Phase 3 interventional study of Vonoprazan and Rabeprazol in Endoscopic Variceal Band Ligation, sponsored by King George's Medical University. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by King George's Medical University · Phase 3, Interventional, and Prevention
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.
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.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's planned enrollment of 300 is above the median of 65 across 291 interventional studies indexed under Ulcer.
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Exclusion Criteria:
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.
Drug: Vonoprazan
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.
Drug: 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.
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.
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
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
To compare the incidence of adverse effects in Vonoprazan and Rabeprazole groups
Time frame: Two weeks
Plan to share: No
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vonoprazan
King George's Medical University