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

A Pilot Study Evaluating Efficacy and Safety of Combined and Simultaneous Balloon-occluded Retrograde Transvenous and Endoscopic Obliteration of High-risk Gastric Varices

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Varix; Gastric Varices Bleeding
• Intervention / Treatment: Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alban Denys, MD; Phone Number: 0041213149768; Email: alban.denys@chuv.ch
• Study Contact Backup: Name: Nils Degrauwe, MD-PhD; Phone Number: 0041795560995; Email: nils.degrauwe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention arm; combined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices

Procedure: balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices; Catheterization of the left renal vein and the inferior diaphragmatic vein and occlusion with a balloon placed in the distal portion of this vein. Endoscopic access to the gastric cavity, gastric varices identification and flow measurement, including velocity, by endoscopic Doppler ultrasound (US). The balloon in the draining vein will be inflated and the velocity will be reassessed. Endoscopic puncture of the varices will be done and the embolization will be conducted under balloon-occlusive conditions (Injection of Cyanoacrylate: Lipiodol mixture 1:1 slowly and gradually). Balloon will be kept inflated and a microcatheter will be used through its lumen inside the variceal bed to inject occlusive agent (cyanoacrylate) mixed with Lipiodol. At the end of the procedure an occlusion device (plug amplatzer 2) will be placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric varice eradication following intervention (at 4 weeks)	Gastric varice eradication following intervention (at 4 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric varice eradication following intervention	Gastric varice eradication following intervention (at 12 weeks) assessed by esophagogastroduodenoscopy (complete eradication or incomplete eradication)	12 weeks
Recurrence of gastric varices	Recurrence of gastric varices (defined as recurrence of gastric varices after complete eradication (at 4 weeks))	4 weeks
Bleeding rates following procedure	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)	2 years
Effect of procedure on esophageal varices	Effect of procedure on esophageal varices. Classification of "Paquet" with evaluation before procedure and at 2 years after procedure (Paquet Grade 1 to 4)	2 years
Effect of procedure on portal pressures	Effect of procedure on portal pressures at 3 months assessed by endovascular hepatic pressure measurment (and compared with pressure before procedure).	3 months
Effect of procedure on liver function	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.	2 years
Description of procedural complications	Description of procedural complications (bleeding, pulmonary embolism)	2 years
Description of pre-treatment variceal anatomy/classification	Description of pre-treatment variceal anatomy/classification according to Sarin Classification	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Alban Denys, MD, Full Professor

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins
• Other Study ID Numbers: 2018-02183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No