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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
The TIPS is placed under radiologic guidance. A branch of the intrahepatic portal vein is punctured; afterwards, the splenic vein is catheterized so that a portal venography and pressure measurements can be performed. Then, the parenchymal track is dilated and a stent is placed. A final portography and pressure measurement in the main portal vein and the inferior caval vein are performed.
The standard protocol uses cyanoacrylate and lipiodol in 1:1 ratio injecting with no more than 1 mL at the varix each time. In most cases, cyanoacrylate is usually extruded into the stomach lumen within 1-3 months after injection. The French observational survey observed that a large majority (78%) of practitioners diluted glue with lipiodol and most (68%) proposed a proportion of glue to lipiodol of 1:1 the total volume injected per varix (from 1mL to 20 mL) varied substantially. Regarding the type of glue, although the majority of published data concern Histoacryl®, nearly half of practitioners used Glubran®. This lack of preference for one glue over the other may be explained by the fact that only Glubran® is approved in this indication in Europe.
CHU Amiens
Amiens, France
University Hospital of Angers
Angers, France
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
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
Time frame: 12 months
death
Time frame: 12 months
All-cause mortality and liver-related mortality
Time frame: Day 42
All-cause mortality and liver-related mortality
Time frame: 12 months
Incidence of rebleeding
Time frame: Day 42
Incidence of rebleeding
Time frame: Day 90
Incidence of rebleeding
Time frame: 3 months
Incidence of rebleeding
Time frame: 12 months
Cumulative number of packed red blood cells
Time frame: Day 42
Cumulative number of packed red blood cells
Time frame: 12 months
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up
Time frame: 12 months
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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
...and 10 more locations
Frequency of TIPS complications
Time frame: 12 months
Frequency of glue obliteration complications
Time frame: 12 months
MELD score (Model for End Stage Liver Disease) in TIPS group
MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
Time frame: 6 months
MELD score (Model for End Stage Liver Disease) in glue obliteration group
MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
Time frame: 6 months
Number of days of hospitalization
Time frame: 12 months