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

Not Applicable

Completed

• Conditions: Bleeding Gastric Varices; Cirrhosis
• Interventions: Procedure: Transjugular Portosytemic Shunt (TIPS); Procedure: glue obliteration

• Registration Number: NCT03705078
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2019-01-03
• Primary Completion: 2023-03-23
• Study Completion: 2024-02-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early TIPS	Transjugular Portosytemic Shunt (TIPS)	Transjugular portosytemic shunt within 72h
Glue obliteration	glue obliteration	glue obliteration repeated sessions

Primary Outcome Measures

Name	Time	Method
death	12 months
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)	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

Secondary Outcome Measures

Name	Time	Method
Incidence of rebleeding	12 months
All-cause mortality and liver-related mortality	12 months
Frequency of TIPS complications	12 months
MELD score (Model for End Stage Liver Disease) in TIPS group	6 months	MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
Frequency of glue obliteration complications	12 months
MELD score (Model for End Stage Liver Disease) in glue obliteration group	6 months	MELD score = 9.57\*LN(creatinin in mg/dl) + 3.78\*LN(Bilirubin in mg/dl) + 11.2\*LN(INR) + 6.43
Cumulative number of packed red blood cells	12 months
Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up	12 months
Number of days of hospitalization	12 months

Trial Locations

Locations (20)

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

University Hospital of Dijon; 🇫🇷 Dijon, 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 Angers; 🇫🇷 Angers, France

CHU Amiens; 🇫🇷 Amiens, France

University Hospital of Besançon; 🇫🇷 Besançon, France

Univerity Hospital of Bondy; 🇫🇷 Bondy, France

CHRU Brest; 🇫🇷 Brest, France

University Hospital of Caen; 🇫🇷 Caen, France

University Hospital of Lille; 🇫🇷 Lille, France

CHU Lyon; 🇫🇷 Lyon, France

University Hospital of Marseille; 🇫🇷 Marseille, France

University Hospital of Rennes; 🇫🇷 Rennes, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France

University Hospital of Tours; 🇫🇷 Tours, France

Paul Brousse Hospital; 🇫🇷 Villejuif, France