Clinical trial NCT03705078: "Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
Official title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Gastric Varices
Cirrhosis
Keywords: Bleeding gastric varices
cirrhosis
type 2 gastro-esophageal varices
isolated gastric varices
transjugular intra-hepatic porto systemic shunt (TIPS)
portal hypertension
glue obliteration
tissue adhesive
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \> 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.

Primary outcomes:
measure: Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
timeFrame: 12 months
measure: death
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality and liver-related mortality
timeFrame: Day 42
measure: All-cause mortality and liver-related mortality
timeFrame: 12 months
measure: Incidence of rebleeding
timeFrame: Day 42
measure: Incidence of rebleeding
timeFrame: Day 90
measure: Incidence of rebleeding
timeFrame: 3 months
measure: Incidence of rebleeding
timeFrame: 12 months
measure: Cumulative number of packed red blood cells
timeFrame: Day 42
measure: Cumulative number of packed red blood cells
timeFrame: 12 months
measure: Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up
timeFrame: 12 months
measure: Frequency of TIPS complications
timeFrame: 12 months
measure: Frequency of glue obliteration complications
timeFrame: 12 months
measure: MELD score (Model for End Stage Liver Disease) in TIPS group
timeFrame: 6 months
measure: MELD score (Model for End Stage Liver Disease) in glue obliteration group
timeFrame: 6 months
measure: Number of days of hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Besançon
country: France
facility: University Hospital of Besançon
city: Bondy
country: France
facility: Univerity Hospital of Bondy
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Brest
country: France
facility: CHRU Brest
city: Caen
country: France
facility: University Hospital of Caen
city: Dijon
country: France
facility: University Hospital of Dijon
city: Lille
country: France
facility: University Hospital of Lille
city: Lyon
country: France
facility: CHU Lyon
city: Marseille
country: France
facility: University Hospital of Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Paris
country: France
facility: Pitié Salpétrière Hospital
city: Paris
country: France
facility: St Antoine Hospital
city: Rennes
country: France
facility: University Hospital of Rennes
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Tours
country: France
facility: University Hospital of Tours
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
References: