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

January 15, 2025 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • University hospital of Angers
      • Besançon, France
        • University Hospital of Besancon
      • Bondy, France
        • Univerity Hospital of Bondy
      • Bordeaux, France
        • University Hospital of Bordeaux
      • Brest, France
        • CHRU Brest
      • Caen, France
        • University hospital of Caen
      • Dijon, France
        • University Hospital of Dijon
      • Lille, France
        • University Hospital of Lille
      • Lyon, France
        • CHU Lyon
      • Marseille, France
        • University Hospital of Marseille
      • Montpellier, France
        • University Hospital of Montpellier
      • Nantes, France
        • University Hospital of Nantes
      • Nice, France
        • University Hospital of Nice
      • Paris, France
        • Pitie Salpetriere Hospital
      • Paris, France
        • St Antoine Hospital
      • Rennes, France
        • University Hospital of Rennes
      • Toulouse, France
        • University Hospital of Toulouse
      • Tours, France
        • University hospital of Tours
      • Villejuif, France
        • PAUL BROUSSE HOSPITAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: early TIPS
Transjugular portosytemic shunt within 72h
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.
Other: Glue obliteration
glue obliteration repeated sessions
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
death
Time Frame: 12 months
12 months
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality and liver-related mortality
Time Frame: Day 42
Day 42
All-cause mortality and liver-related mortality
Time Frame: 12 months
12 months
Incidence of rebleeding
Time Frame: Day 42
Day 42
Incidence of rebleeding
Time Frame: Day 90
Day 90
Incidence of rebleeding
Time Frame: 3 months
3 months
Incidence of rebleeding
Time Frame: 12 months
12 months
Cumulative number of packed red blood cells
Time Frame: Day 42
Day 42
Cumulative number of packed red blood cells
Time Frame: 12 months
12 months
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up
Time Frame: 12 months
12 months
Frequency of TIPS complications
Time Frame: 12 months
12 months
Frequency of glue obliteration complications
Time Frame: 12 months
12 months
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
6 months
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
6 months
Number of days of hospitalization
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N/2018/76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis

Clinical Trials on Transjugular Portosytemic Shunt (TIPS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings