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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Sumit Rungta, DM- Medical Gastroenterology
- Número de teléfono: +919935537944
- Correo electrónico: drsumitrungta79@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dr Sayan Malakar, DM- Medical Gastroenterology
- Número de teléfono: +919007057890
- Correo electrónico: oneandonludrsayan@gmail.com
Ubicaciones de estudio
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- King George Medical University
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Contacto:
- Dr Sumit Rungta, DM-Medical Gastroenterology
- Número de teléfono: +919935537944
- Correo electrónico: drsumitrungta79@gmail.com
-
Contacto:
- Dr Sayan Malakar, DM-Medical Gastroenterology
- Número de teléfono: +919007057890
- Correo electrónico: oneandonlydrsayan@gmail.com
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Investigador principal:
- Dr Mayank Agarwal, MD Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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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Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: Two weeks
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Two weeks
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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
Periodo de tiempo: Two weeks
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Two weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To compare the incidence of adverse effects in Vonoprazan and Rabeprazole groups
Periodo de tiempo: Two weeks
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Two weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr Sumit Rungta, DM- Medical Gastroenterology, King George Medical University, Lucknow, UP, India
Publicaciones y enlaces útiles
Publicaciones Generales
- Oshima T, Miwa H. Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases. J Neurogastroenterol Motil. 2018 Jul 30;24(3):334-344. doi: 10.5056/jnm18029.
- Lin L, Cui B, Deng Y, Jiang X, Liu W, Sun C. The Efficacy of Proton Pump Inhibitor in Cirrhotics with Variceal Bleeding: A Systemic Review and Meta-Analysis. Digestion. 2021;102(2):117-127. doi: 10.1159/000505059. Epub 2020 Feb 21.
- de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
- Jamwal KD, Maiwall R, Sharma MK, Kumar G, Sarin SK. Case Control Study of Post-endoscopic Variceal Ligation Bleeding Ulcers in Severe Liver Disease: Outcomes and Management. J Clin Transl Hepatol. 2019 Mar 28;7(1):32-39. doi: 10.14218/JCTH.2018.00059. Epub 2019 Mar 10.
- Lashen SA, Shamseya MM, Shamseya AM, Hablass FH. Efficacy of Vonoprazan vs. Pantoprazole or Non-acid Suppression in Prevention of Post-variceal Ligation Ulcer Bleeding in Portal Hypertension: A Multi-arm Randomized Controlled Trial. J Clin Exp Hepatol. 2023 Nov-Dec;13(6):962-971. doi: 10.1016/j.jceh.2023.05.008. Epub 2023 May 19.
- Lo EA, Wilby KJ, Ensom MH. Use of proton pump inhibitors in the management of gastroesophageal varices: a systematic review. Ann Pharmacother. 2015 Feb;49(2):207-19. doi: 10.1177/1060028014559244.
- Garcia-Saenz-de-Sicilia M, Sanchez-Avila F, Chavez-Tapia NC, Lopez-Arce G, Garcia-Osogobio S, Ruiz-Cordero R, Tellez-Avila FI. PPIs are not associated with a lower incidence of portal-hypertension-related bleeding in cirrhosis. World J Gastroenterol. 2010 Dec 14;16(46):5869-73. doi: 10.3748/wjg.v16.i46.5869.
- Cho E, Jun CH, Cho SB, Park CH, Kim HS, Choi SK, Rew JS. Endoscopic variceal ligation-induced ulcer bleeding: What are the risk factors and treatment strategies? Medicine (Baltimore). 2017 Jun;96(24):e7157. doi: 10.1097/MD.0000000000007157.
- Hidaka H, Nakazawa T, Wang G, Kokubu S, Minamino T, Takada J, Tanaka Y, Okuwaki Y, Watanabe M, Tanabe S, Shibuya A, Koizumi W. Long-term administration of PPI reduces treatment failures after esophageal variceal band ligation: a randomized, controlled trial. J Gastroenterol. 2012 Feb;47(2):118-26. doi: 10.1007/s00535-011-0472-0. Epub 2011 Sep 28.
- Polski JM, Brunt EM, Saeed ZA. Chronology of histological changes after band ligation of esophageal varices in humans. Endoscopy. 2001 May;33(5):443-7. doi: 10.1055/s-2001-14259.
- Sinclair M, Vaughan R, Angus PW, Gow PJ, Parker F, Hey P, Efthymiou M. Risk factors for band-induced ulcer bleeding after prophylactic and therapeutic endoscopic variceal band ligation. Eur J Gastroenterol Hepatol. 2015 Aug;27(8):928-32. doi: 10.1097/MEG.0000000000000387.
- Petrasch F, Grothaus J, Mossner J, Schiefke I, Hoffmeister A. Differences in bleeding behavior after endoscopic band ligation: a retrospective analysis. BMC Gastroenterol. 2010 Jan 15;10:5. doi: 10.1186/1471-230X-10-5.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2355/Ethics/2026
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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