Clinical trial NCT03853720: Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO
Official title: A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varices Bleeding
Gastric Varix
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-RTO) for the treatment of high-risk gastric varices

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 gastric varices, including endoscopic and interventional radiology techniques. Endoscopic variceal obliteration (EVO) is currently considered as standard of care for the treatment of gastric varices in most centers. However, this technique is associated with significant rebleeding rates and incomplete obliteration is observed in about 50% of patients. Alternatively, few centers also use an interventional radiology technique, called balloon-occluded retrograde transvenous obliteration (B-RTO) to treat gastric varices, which has been shown to be associated with less recurrence of gastric varices and high rates of eradication of about 90%. Both techniques have their inherent weaknesses, such as frequent incomplete eradication of varices and thromboembolic events for EVO, while data suggest that B-RTO may aggravate esophageal varices.

The aim of this pilot study is to evaluate the efficacy and safety of combined and simultaneous endoscopic variceal obliteration together with (modified) B-RTO. Stopping the outflow of gastric varices by endovascular balloon occlusion may allow better endoscopic visualization, blood stagnation and thus eradication of varices, while preventing thromboembolic events. Furthermore, during study follow-up, the eradication rates and recurrence of varices, short-term and long term complications, effects of the procedure on portal pressures/hemodynamics and liver function will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Informed Consent as documented by signature (Appendix "Fiche d'information aux patients et formulaire de consentement éclairé")
2. 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)
3. Portal hypertension secondary to cirrhosis
4. Age \>18

Exclusion Criteria:

1. Acute gastric or esophageal varice bleeding
2. GOV1 varices according to Sarin classification
3. Hemodynamic instability
4. Uncompensated cirrhosis
5. Contraindication to general anesthesia
6. Contraindication to CT-scan/angiography (impaired kidney function, allergy to iodine based contrast)
7. Allergy to cyanoacrylate, drugs or material used during procedures
8. Absence of gastro-renal shunt
9. Pregnancy
10. Participation to another study involving ionizing radiation (dose superior to 5mSV) without direct benefice for patient during the 12 last months

Primary outcomes:
measure: Gastric varice eradication following intervention (at 4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
measure: Gastric varice eradication following intervention
timeFrame: 12 weeks
measure: Recurrence of gastric varices
timeFrame: 4 weeks
measure: Bleeding rates following procedure
timeFrame: 2 years
measure: Effect of procedure on esophageal varices
timeFrame: 2 years
measure: Effect of procedure on portal pressures
timeFrame: 3 months
measure: Effect of procedure on liver function
timeFrame: 2 years
measure: Description of procedural complications
timeFrame: 2 years
measure: Description of pre-treatment variceal anatomy/classification
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Full Professor
name: Alban Denys, MD
role: PRINCIPAL_INVESTIGATOR
References: