NCT03853720

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

February 20, 2019

Last Update Submit

February 21, 2019

Conditions

Gastric Varices BleedingGastric Varix

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Gastric varice eradication following intervention

    12 weeks

  • Recurrence of gastric varices

    4 weeks

  • Bleeding rates following procedure

    2 years

  • Effect of procedure on esophageal varices

    2 years

  • Effect of procedure on portal pressures

    3 months

  • +3 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

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

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 arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Alban Denys, MD

    Full Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alban Denys, MD

CONTACT

0041213149768alban.denys@chuv.ch

Nils Degrauwe, MD-PhD

CONTACT

0041795560995nils.degrauwe@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 26, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2023

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share