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

NCT ID: NCT03853720

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2023-04-30

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.

Conditions

Gastric Varices Bleeding; Gastric Varix

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

combined and simultaneous balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices

Group Type: EXPERIMENTAL

balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Alban Denys

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alban Denys, MD

Role: PRINCIPAL_INVESTIGATOR

Full Professor

Central Contacts

Alban Denys, MD

Role: CONTACT

alban.denys@chuv.ch

0041213149768

Nils Degrauwe, MD-PhD

Role: CONTACT

nils.degrauwe@gmail.com

0041795560995

Other Identifiers

2018-02183

Identifier Type: -

Identifier Source: org_study_id