"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
GAVAPROSEC
A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
1 other identifier
interventional
104
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedJanuary 16, 2025
January 1, 2025
4.2 years
October 9, 2018
January 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
12 months
death
12 months
Secondary Outcomes (14)
All-cause mortality and liver-related mortality
Day 42
All-cause mortality and liver-related mortality
12 months
Incidence of rebleeding
Day 42
Incidence of rebleeding
Day 90
Incidence of rebleeding
3 months
- +9 more secondary outcomes
Study Arms (2)
early TIPS
OTHERTransjugular portosytemic shunt within 72h
Glue obliteration
OTHERglue obliteration repeated sessions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Publications (1)
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.
PMID: 40517780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 15, 2018
Study Start
January 3, 2019
Primary Completion
March 23, 2023
Study Completion
February 29, 2024
Last Updated
January 16, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share