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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Dr Sumit Rungta, DM- Medical Gastroenterology
- Telefonnummer: +919935537944
- E-post: drsumitrungta79@gmail.com
Studer Kontakt Backup
- Navn: Dr Sayan Malakar, DM- Medical Gastroenterology
- Telefonnummer: +919007057890
- E-post: oneandonludrsayan@gmail.com
Studiesteder
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- King George Medical University
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Ta kontakt med:
- Dr Sumit Rungta, DM-Medical Gastroenterology
- Telefonnummer: +919935537944
- E-post: drsumitrungta79@gmail.com
-
Ta kontakt med:
- Dr Sayan Malakar, DM-Medical Gastroenterology
- Telefonnummer: +919007057890
- E-post: oneandonlydrsayan@gmail.com
-
Hovedetterforsker:
- Dr Mayank Agarwal, MD Medicine
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
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. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: Two weeks
|
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
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dr Sumit Rungta, DM- Medical Gastroenterology, King George Medical University, Lucknow, UP, India
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
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- 2355/Ethics/2026
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