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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705078
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Bleeding Gastric Varices Cirrhosis Procedure: Transjugular Portosytemic Shunt (TIPS) Procedure: glue obliteration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (systolic pressure above 90 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
  • Patients listed for liver transplantation can be included if the expected time on waiting list is up to 2 months.
  • 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.
  • Any extra hepatic clinical situation with a very poor short-term prognosis (for example multi-organ failure).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705078


Contacts
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Contact: Jean-Paul jpcervoni@chu-besancon.fr, Doctor 0033 381 668 020 jpcervoni@chu-besancon.fr
Contact: Stéphanie François, Master 0033 381 218 988 sfrancois@chu-besancon.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03705078    
Other Study ID Numbers: N/2018/76
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
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
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Varicose Veins
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal