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Bleeding Gastric VaricesGAVAPROSECNCT03705078

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

A study testing Transjugular Portosytemic Shunt (TIPS) and glue obliteration in people with Bleeding Gastric Varices and Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bleeding Gastric Varices, Cirrhosis
What is being tested?
Transjugular Portosytemic Shunt (TIPS) and glue obliteration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
20 sitesFrance
Study dates
3 Jan 2019to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • 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

Other trials in France

About this study

Official title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

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.

Being tested
Transjugular Portosytemic Shunt (TIPS), glue obliteration
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
Medical subject headings
Fibrosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transjugular Portosytemic Shunt (TIPS)Procedure or surgery

    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 obliterationProcedure or surgery

    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.

Study groups in NCT03705078
Study groupRoleWhat they receive
early TIPSOtherTransjugular portosytemic shunt within 72h
Receives: Procedure: Transjugular Portosytemic Shunt (TIPS)
Glue obliterationOtherglue obliteration repeated sessions
Receives: Procedure: glue obliteration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. death

    Measured: 12 months

Secondary outcomes (14)

  1. All-cause mortality and liver-related mortality

    Measured: Day 42

  2. All-cause mortality and liver-related mortality

    Measured: 12 months

  3. Incidence of rebleeding

    Measured: Day 42

  4. Incidence of rebleeding

    Measured: Day 90

  5. Incidence of rebleeding

    Measured: 3 months

  6. Incidence of rebleeding

    Measured: 12 months

  7. Cumulative number of packed red blood cells

    Measured: Day 42

  8. Cumulative number of packed red blood cells

    Measured: 12 months

  9. Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up

    Measured: 12 months

  10. Frequency of TIPS complications

    Measured: 12 months

  11. Frequency of glue obliteration complications

    Measured: 12 months

  12. 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

    Measured: 6 months

  13. 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

    Measured: 6 months

  14. Number of days of hospitalization

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start3 Jan 2019
  3. Primary completion23 Mar 2023
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705078
Sponsor's protocol ID
N/2018/76
Acronym
GAVAPROSEC
Status last verified
Jan 2025
First submitted
9 Oct 2018
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40517780

Questions about this trial

What is this clinical trial studying?

A study testing Transjugular Portosytemic Shunt (TIPS) and glue obliteration in people with Bleeding Gastric Varices and Cirrhosis, run by Centre Hospitalier Universitaire de Besancon at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03705078, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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