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

Primary Purpose

Bleeding Gastric Varices, Cirrhosis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transjugular Portosytemic Shunt (TIPS)
glue obliteration
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Gastric Varices focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Amiens
  • University Hospital of Angers
  • University Hospital of Besançon
  • Univerity Hospital of Bondy
  • University Hospital of Bordeaux
  • CHRU Brest
  • University Hospital of Caen
  • University Hospital of Dijon
  • University Hospital of Lille
  • CHU Lyon
  • University Hospital of Marseille
  • University Hospital of Montpellier
  • University Hospital of Nantes
  • University Hospital of Nice
  • Pitié Salpétrière Hospital
  • St Antoine Hospital
  • University Hospital of Rennes
  • University Hospital of Toulouse
  • University Hospital of Tours
  • Paul Brousse Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

early TIPS

Glue obliteration

Arm Description

Transjugular portosytemic shunt within 72h

glue obliteration repeated sessions

Outcomes

Primary Outcome Measures

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
death

Secondary Outcome Measures

All-cause mortality and liver-related mortality
All-cause mortality and liver-related mortality
Incidence of rebleeding
Incidence of rebleeding
Incidence of rebleeding
Incidence of rebleeding
Cumulative number of packed red blood cells
Cumulative number of packed red blood cells
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up
Frequency of TIPS complications
Frequency of glue obliteration complications
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
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
Number of days of hospitalization

Full Information

First Posted
October 9, 2018
Last Updated
September 24, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03705078
Brief Title
"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
Acronym
GAVAPROSEC
Official Title
A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
March 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Gastric Varices, Cirrhosis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early TIPS
Arm Type
Other
Arm Description
Transjugular portosytemic shunt within 72h
Arm Title
Glue obliteration
Arm Type
Other
Arm Description
glue obliteration repeated sessions
Intervention Type
Procedure
Intervention Name(s)
Transjugular Portosytemic Shunt (TIPS)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
glue obliteration
Intervention Description
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 Outcome Measure Information:
Title
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
Description
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
Time Frame
12 months
Title
death
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause mortality and liver-related mortality
Time Frame
Day 42
Title
All-cause mortality and liver-related mortality
Time Frame
12 months
Title
Incidence of rebleeding
Time Frame
Day 42
Title
Incidence of rebleeding
Time Frame
Day 90
Title
Incidence of rebleeding
Time Frame
3 months
Title
Incidence of rebleeding
Time Frame
12 months
Title
Cumulative number of packed red blood cells
Time Frame
Day 42
Title
Cumulative number of packed red blood cells
Time Frame
12 months
Title
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up
Time Frame
12 months
Title
Frequency of TIPS complications
Time Frame
12 months
Title
Frequency of glue obliteration complications
Time Frame
12 months
Title
MELD score (Model for End Stage Liver Disease) in TIPS group
Description
MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43
Time Frame
6 months
Title
MELD score (Model for End Stage Liver Disease) in glue obliteration group
Description
MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43
Time Frame
6 months
Title
Number of days of hospitalization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Name
University Hospital of Angers
City
Angers
Country
France
Facility Name
University Hospital of Besançon
City
Besançon
Country
France
Facility Name
Univerity Hospital of Bondy
City
Bondy
Country
France
Facility Name
University Hospital of Bordeaux
City
Bordeaux
Country
France
Facility Name
CHRU Brest
City
Brest
Country
France
Facility Name
University Hospital of Caen
City
Caen
Country
France
Facility Name
University Hospital of Dijon
City
Dijon
Country
France
Facility Name
University Hospital of Lille
City
Lille
Country
France
Facility Name
CHU Lyon
City
Lyon
Country
France
Facility Name
University Hospital of Marseille
City
Marseille
Country
France
Facility Name
University Hospital of Montpellier
City
Montpellier
Country
France
Facility Name
University Hospital of Nantes
City
Nantes
Country
France
Facility Name
University Hospital of Nice
City
Nice
Country
France
Facility Name
Pitié Salpétrière Hospital
City
Paris
Country
France
Facility Name
St Antoine Hospital
City
Paris
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
Country
France
Facility Name
University Hospital of Tours
City
Tours
Country
France
Facility Name
Paul Brousse Hospital
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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