- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705078
"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
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
- Name: Jean-Paul jpcervoni@chu-besancon.fr, Doctor
- Phone Number: 0033 381 668 020
- Email: jpcervoni@chu-besancon.fr
Study Contact Backup
- Name: Noémie NMINEJ, Master
- Phone Number: 0033 381 218 518
- Email: nnminej@chu-besancon.fr
Study Locations
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-
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Amiens, France
- CHU Amiens
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Angers, France
- University Hospital of Angers
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Besançon, France
- University Hospital of Besancon
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Bondy, France
- Univerity Hospital of Bondy
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Bordeaux, France
- University Hospital of Bordeaux
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Brest, France
- CHRU Brest
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Caen, France
- University Hospital Of Caen
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Dijon, France
- University Hospital of Dijon
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Lille, France
- University Hospital of Lille
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Lyon, France
- CHU Lyon
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Marseille, France
- University Hospital of Marseille
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Montpellier, France
- University Hospital of Montpellier
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Nantes, France
- University Hospital of Nantes
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Nice, France
- University Hospital of Nice
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Paris, France
- Pitie Salpetriere Hospital
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Paris, France
- St Antoine Hospital
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Rennes, France
- University Hospital of Rennes
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Toulouse, France
- University Hospital of Toulouse
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Tours, France
- University hospital of Tours
-
Villejuif, France
- PAUL BROUSSE HOSPITAL
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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:
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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
|
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Frequency of TIPS complications
Time Frame: 12 months
|
12 months
|
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Frequency of glue obliteration complications
Time Frame: 12 months
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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
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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