Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial

Summary

A number of treatment modalities are currently in use for gastric variceal bleeding (GVB). Balloon-occluded, plug-assisted, and coil-assisted retrograde transvenous obliteration (RTO) procedures are described in the literature as treatments for GVB after a bleeding episode occurs. Preliminary data suggests that prophylactic treatment of gastric varices may improve patient outcomes compared to conservative management. This study aims to compare pre-emptive treatment of gastric varices with current recommended medical management in a randomized prospective study design. Eligible patients will be randomized to receive RTO or to continue conservative management. Patients will be followed for up to 2 years for comparison of clinical outcomes, including episodes of gastric variceal bleeding, overall survival and transplant-free survival, complications, and secondary interventions.

Timeline

Start

2026-10

Primary completion

2027-11

Completion

2028-11

Publications

• Background Terada K, Ogi T, Yoneda N, Yokka A, Sugiura T, Koda W, Kobayashi S, Gabata T. Coil-assisted retrograde transvenous obliteration (CARTO) for the treatment of gastric varices via a single access route using steerable microcatheter: a case report. CVIR Endovasc. 2020 Jun 14;3(1):30. doi: 10.1186/s42155-020-00124-3.
• Background Gwon DI, Ko GY, Yoon HK, Sung KB, Kim JH, Shin JH, Ko HK, Song HY. Gastric varices and hepatic encephalopathy: treatment with vascular plug and gelatin sponge-assisted retrograde transvenous obliteration--a primary report. Radiology. 2013 Jul;268(1):281-7. doi: 10.1148/radiol.13122102. Epub 2013 Mar 12.
• Background Lee EW, Saab S, Gomes AS, Busuttil R, McWilliams J, Durazo F, Han SH, Goldstein L, Tafti BA, Moriarty J, Loh CT, Kee ST. Coil-Assisted Retrograde Transvenous Obliteration (CARTO) for the Treatment of Portal Hypertensive Variceal Bleeding: Preliminary Results. Clin Transl Gastroenterol. 2014 Oct 2;5(10):e61. doi: 10.1038/ctg.2014.12.
• Background Miyoshi H, Ohshiba S, Matsumoto A, Takada K, Umegaki E, Hirata I. Haptoglobin prevents renal dysfunction associated with intravariceal infusion of ethanolamine oleate. Am J Gastroenterol. 1991 Nov;86(11):1638-41.
• Background Hashizume M, Kitano S, Yamaga H, Sugimachi K. Haptoglobin to protect against renal damage from ethanolamine oleate sclerosant. Lancet. 1988 Aug 6;2(8606):340-1. doi: 10.1016/s0140-6736(88)92400-2. No abstract available.
• Background Cho SK, Shin SW, Lee IH, Do YS, Choo SW, Park KB, Yoo BC. Balloon-occluded retrograde transvenous obliteration of gastric varices: outcomes and complications in 49 patients. AJR Am J Roentgenol. 2007 Dec;189(6):W365-72. doi: 10.2214/AJR.07.2266.
• Background Kanagawa H, Mima S, Kouyama H, Gotoh K, Uchida T, Okuda K. Treatment of gastric fundal varices by balloon-occluded retrograde transvenous obliteration. J Gastroenterol Hepatol. 1996 Jan;11(1):51-8. doi: 10.1111/j.1440-1746.1996.tb00010.x.
• Background Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
• Background Wani ZA, Bhat RA, Bhadoria AS, Maiwall R, Choudhury A. Gastric varices: Classification, endoscopic and ultrasonographic management. J Res Med Sci. 2015 Dec;20(12):1200-7. doi: 10.4103/1735-1995.172990.

Drugs

Indications

No indication recorded.