Status:

COMPLETED

Angiography for Evaluation of the Feeder Vessel in EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices

Lead Sponsor:

Instituto Ecuatoriano de Enfermedades Digestivas

Conditions:

Gastric Varices

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

INTRODUCTION: Bleeding from gastric varices (GV) is associated with a high mortality rate. Injection of cyanoacrylate (CYA) using standard gastroscope has demonstrated to achieve higher hemostasis and...

Detailed Description

On the other hand, despite the EUS-injection of coils and CYA have shown very promising results, it is extremely important to have experience performing this technique, as the injection in a wrong ves...

Eligibility Criteria

Inclusion

  • Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled. GV will be classified
  • Only gastro-esophageal varices type II (GOV II) (fundal varices communicating with esophageal varices) and isolated gastric varices type I (IGV I) (fundal varices within a few centimeters of the gastric cardia) will be included (according to Sarin and Kumar classification).
  • Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis)
  • Patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus.

Exclusion

  • Gastro-esophageal varices type I (GOV I) will be excluded as they can be successfully treated by endoscopic band ligation.
  • Pregnancy,
  • Hepatorenal syndrome
  • Multi-organ failure,
  • platelet count less than 50,000/ml
  • International Normalized Rate (INR) \>2,
  • esophageal stricture,
  • Splenic vein thrombosis
  • Portal vein thrombosis
  • Allergy to iodine.

Key Trial Info

Start Date :

July 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2018

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03277937

Start Date

July 1 2015

End Date

June 1 2018

Last Update

November 20 2018

Active Locations (1)

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1

Ecuadorian Institute of Digestive Diseases, Omnihospital

Guayaquil, Guayas, Ecuador, 090505