"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
NCT ID: NCT03705078
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2019-01-03
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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early TIPS
Transjugular portosytemic shunt within 72h
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.
Glue obliteration
glue obliteration repeated sessions
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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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
University Hospital of Marseille
Marseille, , France
University Hospital of Montpellier
Montpellier, , France
University Hospital of Nantes
Nantes, , France
University Hospital of Nice
Nice, , France
Pitié Salpétrière Hospital
Paris, , France
St Antoine Hospital
Paris, , France
University Hospital of Rennes
Rennes, , France
University Hospital of Toulouse
Toulouse, , France
University Hospital of Tours
Tours, , France
Paul Brousse Hospital
Villejuif, , France
Countries
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References
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Cervoni JP, Weil D, Desmarets M, Lannes A, D'Alteroche L, Bouzbib C, Larrue H, Lemaitre E, Faure S, Latournerie M, Jezequel C, Billioud C, Carbonell N, Saliba F, Tanne F, Hiriart JB, Olivier-Hourmand I, Nguyen Khac E, Archambeaud I, Hilleret MN, Oberti F, Elkrief L, Meunier L, Gerster T, Rode A, Bardou-Jacquet E, Robic MA, Ozenne V, Sacleux SC, Reboux N, Chermak F, Calame P, Borentain P, Thevenot T, Di Martino V, Thabut D, Louvet A, Rudler M, Bureau C; le Club Francophone pour l'Etude de l'Hypertension Portale, and the GAVAPROSEC study group. Pre-emptive TIPS for gastric variceal bleeding in patients with cirrhosis (GAVAPROSEC): an open-label randomised clinical trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):726-733. doi: 10.1016/S2468-1253(25)00156-6. Epub 2025 Jun 12.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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N/2018/76
Identifier Type: -
Identifier Source: org_study_id
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