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

NCT03853720 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-26

No results posted yet for this study

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

Conditions

  • Gastric Varices Bleeding
  • Gastric Varix

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Alban Denys, MD · Full Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2021-04-30
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853720 on ClinicalTrials.gov