TIPS Plus Transvenous Obliteration for Gastric Varices

NCT04044248 | Completed FDA Device

• 1 other identifier: 2019-0156
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Variceal hemorrhage (VH) from gastric varices (GVs) results in significant morbidity and mortality among patients with liver cirrhosis. In cases of acute bleeding, refractory bleeding, or high risk GVs, the transjugular intrahepatic portosystemic shunt (TIPS) creation and transvenous variceal obliteration procedures have used to treat GVs. While these techniques are effective, each is associated with limitations, including non-trivial rebleeding and hepatic encephalopathy rates for TIPS and aggravation of esophageal varices, development of new or worsening ascites, and formation of difficult to treat ectopic varices for transvenous obliteration. Increasingly, however, TIPS and transvenous obliteration are viewed as complimentary procedures that can be combined to reduce bleeding risk and ameliorate sequelae of portal hypertension. Yet, despite a strong mechanistic basis for their combination, there are few studies investigating the combined effectiveness of TIPS plus transvenous obliteration. Thus, the aim of this single center prospective pilot study is to assess the effectiveness and safety of combined TIPS creation plus transvenous obliteration for the treatment of GVs, with the overall goal of improving the clinical outcomes of patients with VH related to GVs. The work proposed could lead to important advances in the treatment of bleeding complications due to liver cirrhosis.

Conditions

Cirrhosis, Liver; Hypertension, Portal; Esophageal and Gastric Varices; Bleeding Gastric; Encephalopathy

Keywords

Liver cirrhosis; Portal hypertension; Gastric varices; Bleeding; Hepatic encephalopathy; Transjugular intrahepatic portosystemic shunt (TIPS); Transvenous obliteration

Outcome Measures

Primary Outcomes (5)

• Endoscopic gastric varices eradication rate

  Effectiveness outcome

  6-months

• Endoscopic esophageal varices aggravation/resolution rate

  Effectiveness outcome

  6-months

• Imaging gastric variceseradication rate

  Effectiveness outcome

  1-year

• Gastric varices rebleeding rate

  Effectiveness outcome

  1-year

• Ascites incidence/improvement rate

  Effectiveness outcome

  1-year

Secondary Outcomes (6)

• TIPS + transvenous obliteration combined technical success rate

  2-weeks

• TIPS + transvenous obliteration combined hemodynamic success rate

  2-weeks

• Procedure related adverse event rate

  30-days

• Hepatic encephalopathy rate

  1-year

• Post-TIPS liver failure incidence and degree

  1-year

Study Arms (1)

TIPS-obliteration

Patients undergoing combined transjugular intrahepatic portosystemic shunt (TIPS) creation plus transvenous obliteration for the treatment of gastric varices (GVs).

Device: TIPS-obliteration

Interventions

TIPS-obliteration DEVICE

Transjugular intrahepatic portosystemic shunt (TIPS) decompression of portal hypertension coupled with transvenous obliteration of gastric varices (GVs).

TIPS-obliteration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult persons aged ≥ 18 years with liver disease and endoscopically proven acute or recurrent variceal hemorrhage from gastric varices (GVs) or endoscopically proven high risk GVs referred to Interventional Radiology (IR) for minimally invasive variceal therapy.

You may qualify if:

• Aged ≥ 18 years
• Ability to provide written consent
• Endoscopically proven acute or recurrent VH from GVs, or high risk GVs

You may not qualify if:

• Prior indwelling TIPS
• Prior endovascular obliteration procedure
• Elevated heart pressures (left or right)
• Heart failure or severe valvular insufficiency
• Severe pulmonary hypertension
• Rapidly progressive liver failure
• Severe or uncontrolled hepatic encephalopathy
• Uncontrolled systemic infection or sepsis
• Unrelieved biliary obstruction
• Polycystic liver disease
• Extensive primary or metastatic hepatic malignancy
• Severe uncontrolled coagulopathy
• Pregnancy

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• Saad WE, Wagner CC, Lippert A, Al-Osaimi A, Davies MG, Matsumoto AH, Angle JF, Caldwell S. Protective value of TIPS against the development of hydrothorax/ascites and upper gastrointestinal bleeding after balloon-occluded retrograde transvenous obliteration (BRTO). Am J Gastroenterol. 2013 Oct;108(10):1612-9. doi: 10.1038/ajg.2013.232. Epub 2013 Aug 13.

  PMID: 23939627 RESULT

• Gaba RC. Retrograde-Antegrade Accelerated Trap Obliteration: A Modified Approach to Transvenous Eradication of Gastric Varices. J Vasc Interv Radiol. 2017 Feb;28(2):291-294. doi: 10.1016/j.jvir.2016.10.004.

  PMID: 28110759 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices; Brain Diseases; Hemorrhage; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Ron C Gaba, M.D. M.S.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology & Pathology

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 5, 2019
• Study Start: April 4, 2019
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)