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

Cirrhosis Clinical Trial

— GAVAPROSEC  

Official title:

A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03705078
• Other study ID #: N/2018/76
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: March 18, 2024

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: March 18, 2024
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding Gastric Varices
• Cirrhosis
• Esophageal and Gastric Varices
• Fibrosis
• Varicose Veins

Intervention

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
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	University Hospital of Angers	Angers
France	University Hospital of Besançon	Besançon
France	Univerity Hospital of Bondy	Bondy
France	University Hospital of Bordeaux	Bordeaux
France	CHRU Brest	Brest
France	University Hospital of Caen	Caen
France	University Hospital of Dijon	Dijon
France	University Hospital of Lille	Lille
France	CHU Lyon	Lyon
France	University Hospital of Marseille	Marseille
France	University Hospital of Montpellier	Montpellier
France	University Hospital of Nantes	Nantes
France	University Hospital of Nice	Nice
France	Pitié Salpétrière Hospital	Paris
France	St Antoine Hospital	Paris
France	University Hospital of Rennes	Rennes
France	University Hospital of Toulouse	Toulouse
France	University Hospital of Tours	Tours
France	Paul Brousse Hospital	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	death		12 months
Secondary	All-cause mortality and liver-related mortality		Day 42
Secondary	All-cause mortality and liver-related mortality		12 months
Secondary	Incidence of rebleeding		Day 42
Secondary	Incidence of rebleeding		Day 90
Secondary	Incidence of rebleeding		3 months
Secondary	Incidence of rebleeding		12 months
Secondary	Cumulative number of packed red blood cells		Day 42
Secondary	Cumulative number of packed red blood cells		12 months
Secondary	Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up		12 months
Secondary	Frequency of TIPS complications		12 months
Secondary	Frequency of glue obliteration complications		12 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Number of days of hospitalization		12 months