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

NCT07168395 | Not Yet Recruiting

• 1 other identifier: 25-1721
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Varices

Keywords

varices; stomach; gastric; hepatic encephalopathy; gastric variceal bleeding; bleeding; retrograde transvenous obliteration

Outcome Measures

Primary Outcomes (1)

• Episodes of variceal bleeding

  To monitor and assess the effectiveness of decreasing gastric variceal bleeding episodes between those receiving pre-emptive retrograde transvenous obliteration versus conservative management with non-selective beta blockers.

  2 years

Secondary Outcomes (2)

• Complications

  2 years

• Transplant-free survival

  Two years

Study Arms (2)

Non-selective beta blockers

ACTIVE COMPARATOR

Non-selective beta blockers prescribed according to standard of care treatment guidelines. These may include propranolol, nadolol, and timolol.

Drug: Non-selective beta blockers

Retrograde transvenous obliteration (RTO)

ACTIVE COMPARATOR

Pre-emptive treatment with retrograde transvenous obliteration

Procedure: Retrograde transvenous obliteration

Interventions

Non-selective beta blockers DRUG

Non-selective beta blockers are used in patients who have not had a previous variceal bleed to prevent bleeding by reducing blood pressure in the liver. These drugs also work by blocking beta receptors that reduce cardiac output and by causing vessel constriction in the abdominal organs, which lowers blood flow to the liver and the existing varices.

Non-selective beta blockers

Retrograde transvenous obliteration PROCEDURE

Pre-emptive retrograde transvenous obliteration will be performed in patients randomized to this arm to evaluate the effectiveness in decreasing gastric variceal bleeding. Either CARTO or PARTO (coil or plug-assisted retrograde transvenous obliteration) will be performed using EMBOLIZATION COILS or VASCULAR PLUGS of different sizes based on the size of the shunt. Additionally, Gelfoam (collagen sponges) slurry will be injected into the shunt and varices to completely obliterate them.

Also known as: CARTO, PARTO, BRTO, RTO, RTOs

Retrograde transvenous obliteration (RTO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients with compensated cirrhosis with a higher risk of decompensation based on AASLD 2023 Practice Guidance (Kaplan et al) - no ascites with endoscopic visualization of varices
• Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.
• No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy
• MELD \< 20
• First de novo RTO procedure
• Taking NSBB
• Patent internal jugular or right common femoral vein
• Willing to provide the hepatology service information for F/U
• No known diagnosis of hypercoagulopathy
• Patent portal vein or portal vein cavernous transformation

You may not qualify if:

• Age \<18 years
• Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
• Cardiac failure
• Active variceal bleeding
• History of gastroesophageal variceal bleeding
• Previous TIPS, BRTO, CARTO or PARTO procedure
• No right jugular or right common femoral venous access
• No portal vein flow
• Malignancy
• Life expectancy of less than 6 months

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (9)

• 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.

  PMID: 32537683 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.

  PMID: 23481167 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.

  PMID: 25273155 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.

  PMID: 1951242 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.

  PMID: 2899760 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.

  PMID: 18029851 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.

  PMID: 8672742 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.

  PMID: 1446890 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.

  PMID: 26958057 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices; Varicose Veins; Hepatic Encephalopathy; Hemorrhage

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Vascular Diseases; Cardiovascular Diseases; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward W. Lee, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward W. Lee, MD, PhD

CONTACT

310-267-8771; edwardlee@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 11, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share