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

September 24, 2023 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

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • 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 Backup

Study Locations

      • 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

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
Intervention / Treatment
Other: early TIPS
Transjugular portosytemic shunt within 72h
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
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

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

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.

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)

January 3, 2019

Primary Completion (Actual)

February 25, 2023

Study Completion (Estimated)

March 18, 2024

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

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.

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