"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices (GAVAPROSEC)

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Cirrhosis

Bleeding Gastric Varices

Treatments

Procedure: glue obliteration

Procedure: Transjugular Portosytemic Shunt (TIPS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03705078

N/2018/76

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 > 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.