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

NACompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

January 3, 2019

Primary Completion Date

March 23, 2023

Study Completion Date

February 29, 2024

Conditions
Bleeding Gastric VaricesCirrhosis
Interventions
PROCEDURE

Transjugular Portosytemic Shunt (TIPS)

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.

PROCEDURE

glue obliteration

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.

Trial Locations (20)

Unknown

CHU Amiens, Amiens

University Hospital of Angers, Angers

University Hospital of Besançon, Besançon

Univerity Hospital of Bondy, Bondy

University Hospital of Bordeaux, Bordeaux

CHRU Brest, Brest

University Hospital of Caen, Caen

University Hospital of Dijon, Dijon

University Hospital of Lille, Lille

CHU Lyon, Lyon

University Hospital of Marseille, Marseille

University Hospital of Montpellier, Montpellier

University Hospital of Nantes, Nantes

University Hospital of Nice, Nice

Pitié Salpétrière Hospital, Paris

St Antoine Hospital, Paris

University Hospital of Rennes, Rennes

University Hospital of Toulouse, Toulouse

University Hospital of Tours, Tours

Paul Brousse Hospital, Villejuif

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER

NCT03705078 - "Early TIPS Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices" | Biotech Hunter | Biotech Hunter