NCT03705078Completed
"Early TIPS" Versus Glue Obliteration to Prevent Rebleeding From Gastric Varices
A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
Source: ClinicalTrials.gov · Last updated 16 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 9 Oct 2018
- Start date
- 3 Jan 2019
- Primary completion date
- 23 Mar 2023
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Diseases
- High blood pressure
- NCT number
- NCT03705078
What you commit to
- Study type: Interventional
- Participants enrolled: 104
- From 3 Jan 2019 to the primary completion date, 23 Mar 2023
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who have previously received a TIPS procedure.
Other illness
- Non cirrhotic portal hypertension.
- Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
- History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
- Congestive heart failure.
- History or presence of pulmonary hypertension.
- Uncontrolled gastric variceal bleeding.
- Failure to receive clear information in patients without an identified trusted person.
Age
- Minor and patients older than 75 years.
Other
- Pregnant woman or breastfeeding.
- Child Pugh score \> 13.
- Patients with other indication for TIPS.
- Portal vein cavernoma.
- Refusal of the participation agreement by signing the information form and consent as defined.
- Exclusion period from another biomedical study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| University hospital of Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| University hospital of Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Univerity Hospital of Bondy Coordinator of this site? Confirm its status | Bondy | France | Unknown status |
| University Hospital of Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHRU Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| University Hospital of Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| University Hospital of Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| University Hospital of Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Chu Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| University Hospital of Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| University Hospital of Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| University Hospital of NICE Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Pitié Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| St Antoine Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| University Hospital of Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| University Hospital of Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| University Hospital of Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Paul Brousse Hospital Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.