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Completed

NCT Number: NCT03705078

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

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.

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Key information

Conditions

Bleeding Gastric Varices Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Exclusion period from another biomedical study.

Treatment and study plan

Transjugular Portosytemic Shunt (TIPS)

Procedure

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

Procedure

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.

Primary outcomes

  1. Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)

    Time frame: 12 months

    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

  2. death

    Time frame: 12 months

Secondary outcomes

  1. All-cause mortality and liver-related mortality

    Time frame: Day 42

  2. All-cause mortality and liver-related mortality

    Time frame: 12 months

  3. Incidence of rebleeding

    Time frame: Day 42

  4. Incidence of rebleeding

    Time frame: Day 90

  5. Incidence of rebleeding

    Time frame: 3 months

  6. Incidence of rebleeding

    Time frame: 12 months

  7. Cumulative number of packed red blood cells

    Time frame: Day 42

  8. Cumulative number of packed red blood cells

    Time frame: 12 months

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

    Time frame: 12 months

  10. Frequency of TIPS complications

    Time frame: 12 months

  11. Frequency of glue obliteration complications

    Time frame: 12 months

  12. MELD score (Model for End Stage Liver Disease) in TIPS group

    Time frame: 6 months

    MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43

  13. MELD score (Model for End Stage Liver Disease) in glue obliteration group

    Time frame: 6 months

    MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43

  14. Number of days of hospitalization

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: GAVAPROSEC

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2018
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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