A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

Centre Hospitalier Universitaire de Besancon20 sites in 1 country104 target enrollmentJanuary 3, 2019

ConditionsBleeding Gastric Varices Cirrhosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bleeding Gastric Varices
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 104
Locations: 20
Primary Endpoint: death
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.

Registry

clinicaltrials.gov

Start Date

January 3, 2019

End Date

February 29, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used.
•Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following criteria: endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources.
•Hemodynamically stable patient (Mean arterial pressure above 65 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
•Written informed consent obtained.

Exclusion Criteria

•Pregnant woman or breastfeeding.
•Minor and patients older than 75 years.
•Non cirrhotic portal hypertension.
•Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
•Child Pugh score \>
•History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
•Congestive heart failure.
•History or presence of pulmonary hypertension.
•Patients with other indication for TIPS.
•Uncontrolled gastric variceal bleeding.

Outcomes

Primary Outcomes

death

Time Frame: 12 months

Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)

Time Frame: 12 months

Defined by Baveno VI consens group as a recurrent melena or hematemesis resulting in any of the following: * Hospital admission * Blood transfusion * 3 g/dL drop in hemoglobin

Secondary Outcomes

Frequency of glue obliteration complications(12 months)
Incidence of rebleeding(12 months)
Frequency of TIPS complications(12 months)
All-cause mortality and liver-related mortality(12 months)
MELD score (Model for End Stage Liver Disease) in TIPS group(6 months)
MELD score (Model for End Stage Liver Disease) in glue obliteration group(6 months)
Cumulative number of packed red blood cells(12 months)
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up(12 months)
Number of days of hospitalization(12 months)