Combined and Simultaneous Approach for the Treatment of High-risk Gastric Varices Using B-RTO and EVO

Not Applicable

• Conditions: Gastric Varices Bleeding; Gastric Varix
• Interventions: Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices

• Registration Number: NCT03853720
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26
• Study Start: 2019-04
• Primary Completion: 2021-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices	combined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices

Primary Outcome Measures

Name	Time	Method
Gastric varice eradication following intervention (at 4 weeks)	4 weeks	Gastric varice eradication following intervention (at 4 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)

Secondary Outcome Measures

Name	Time	Method
Recurrence of gastric varices	4 weeks	Recurrence of gastric varices (defined as recurrence of gastric varices after complete eradication (at 4 weeks))
Effect of procedure on portal pressures	3 months	Effect of procedure on portal pressures at 3 months assessed by endovascular hepatic pressure measurment (and compared with pressure before procedure).
Effect of procedure on liver function	2 years	Effect of procedure on liver function and cirrhosis assessed by CHILD-PUGH score ((albumin (g/l) : \>35 = 1 point ; 28-35 = 2 points ; \<28 = 3 points); (total bilirubin (umol/l)\<34 = 1 point ; 34-50 = 2 points; \>50 = 3 points); (INR : \<1.7 = 1 point; 1.71-2.30 = 2 points; \>2.30 = 3 points), (Ascites: none = 1 point; mild = 2 points, moderate/severe= 3 points); (Hepatic Encephalopathy: none = 1 point; Grade I-II = 2 points; Grade III-IV = 3 points). Total score : 5-6 = A ; 7-9 = B; 10-15 = C.
Description of procedural complications	2 years	Description of procedural complications (bleeding, pulmonary embolism)
Effect of procedure on esophageal varices	2 years	Effect of procedure on esophageal varices. Classification of "Paquet" with evaluation before procedure and at 2 years after procedure (Paquet Grade 1 to 4)
Bleeding rates following procedure	2 years	Bleeding rates following procedure (% of patients that had a bleeding at 2 years of follow-up following eradication and mean time to bleeding after procedure)
Description of pre-treatment variceal anatomy/classification	1 day	Description of pre-treatment variceal anatomy/classification according to Sarin Classification
Gastric varice eradication following intervention	12 weeks	Gastric varice eradication following intervention (at 12 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)