"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
- Conditions
- Bleeding Gastric VaricesCirrhosis
- Registration Number
- NCT03705078
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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 > 13.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin) 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 hemoglobindeath 12 months
- Secondary Outcome Measures
Name Time Method Incidence of rebleeding 12 months All-cause mortality and liver-related mortality 12 months Frequency of TIPS complications 12 months MELD score (Model for End Stage Liver Disease) in TIPS group 6 months MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
Frequency of glue obliteration complications 12 months MELD score (Model for End Stage Liver Disease) in glue obliteration group 6 months MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
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
Trial Locations
- Locations (20)
CHU Amiens
🇫🇷Amiens, France
University Hospital of Angers
🇫🇷Angers, France
University Hospital of Besançon
🇫🇷Besançon, France
Univerity Hospital of Bondy
🇫🇷Bondy, France
University Hospital of Bordeaux
🇫🇷Bordeaux, France
CHRU Brest
🇫🇷Brest, France
University Hospital of Caen
🇫🇷Caen, France
University Hospital of Dijon
🇫🇷Dijon, France
University Hospital of Lille
🇫🇷Lille, France
CHU Lyon
🇫🇷Lyon, France
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