NCT03705078CompletedNot Applicable
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 enrollmentStarted: January 3, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 104
- Locations
- 20
- Primary Endpoint
- Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Portal vein cavernoma.
- •Patient who have previously received a TIPS procedure.
- •Failure to receive clear information in patients without an identified trusted person.
- •Refusal of the participation agreement by signing the information form and consent as defined.
- •Exclusion period from another biomedical study.
Arms & Interventions
early TIPS
Other
Transjugular portosytemic shunt within 72h
Intervention: Transjugular Portosytemic Shunt (TIPS) (Procedure)
Glue obliteration
Other
glue obliteration repeated sessions
Intervention: glue obliteration (Procedure)
Outcomes
Primary Outcomes
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
death
Time Frame: 12 months
Secondary Outcomes
- All-cause mortality and liver-related mortality(12 months)
- Incidence of rebleeding(12 months)
- Frequency of TIPS complications(12 months)
- MELD score (Model for End Stage Liver Disease) in TIPS group(6 months)
- Frequency of glue obliteration complications(12 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)
- All-cause mortality and liver-related mortality(Day 42)
- Incidence of rebleeding(Day 42)
- Incidence of rebleeding(Day 90)
- Incidence of rebleeding(3 months)
- Cumulative number of packed red blood cells(Day 42)
Investigators
Study Sites (20)
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