Status:
UNKNOWN
Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Gastric Varices Bleeding
Gastric Varix
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with balloon occluded-retrograde transvenous obliteration (B-R...
Detailed Description
Although less frequent than esophageal varices, gastric varices constitute a severe and potentially life threatening complication of portal hypertension. Various methods have been described to treat g...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature (Appendix "Fiche d'information aux patients et formulaire de consentement éclairé")
- Patients with endoscopically proven high-risk (diameter \>2 cm, mosaic gastropathy, red spots or signs of previous bleeding) and GOV2, IGV1 and IGV2 type of gastric varices (according to Sarin classification)
- Portal hypertension secondary to cirrhosis
- Age \>18
Exclusion
- Acute gastric or esophageal varice bleeding
- GOV1 varices according to Sarin classification
- Hemodynamic instability
- Uncompensated cirrhosis
- Contraindication to general anesthesia
- Contraindication to CT-scan/angiography (impaired kidney function, allergy to iodine based contrast)
- Allergy to cyanoacrylate, drugs or material used during procedures
- Absence of gastro-renal shunt
- Pregnancy
- Participation to another study involving ionizing radiation (dose superior to 5mSV) without direct benefice for patient during the 12 last months
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03853720
Start Date
April 1 2019
End Date
April 1 2023
Last Update
February 26 2019
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