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Treatment of Gastric Varices Using EUS Guided Techniques

NCT03155256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-02-26

No results posted yet for this study

Summary

Bleeding from gastric varices (GV) is associated with high mortality. Injection of cyanoacrylate (CYA) using standard gastroscopes has demonstrated higher hemostasis and lower rebleeding rates compared to band ligation or sclerotherapy. Nevertheless CYA treatment is known to be associated with significant adverse events. Pulmonary embolism due to CYA injection is a serious and sometimes fatal complication of this therapy. Romero-Garcia et al. recently showed that, even these patients usually have respiratory symptom, this complication can be present in asymptomatic patients and with only CT pathological images showing it. On the other hand, risk of glue embolism, has been described to be dependent on the volume of CYA injected, being significantly greater with high volume. Other complications related to CYA injection are, hemorrhage from post injection ulcers, fever, peritonitis, needle impaction, and even death. Also the injection material can cause serious damage to the endoscope.

Currently endoscopic treatments are CYA injection under direct visualization using a standard gastroscope and treatment under EUS guidance with injection of CYA, coils or both. However, to date, it is unknown whether one of these techniques is technically more feasible or causes less adverse events than the other.

Treatment under EUS guidance may improve results because of precise targeting of the varix lumen or afferent feeding veins. This allows the vein to be obstructed with a small amount of CYA, less than used for the "blind" injection of GV with standard endoscopic technique and may reduce the risk of glue embolism. EUS can confirm varix obliteration by using Doppler. Also visualization of GV by using EUS is not impaired by blood or food in the stomach and thus can be performed in the setting of active hemorrhage.

Conditions

  • Gastric Varix

Interventions

PROCEDURE

EUS-guided injection of coils with cyanoacrylate

First a standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient is conceder a candidate will be treated with Coils plus CYA (Group A)

PROCEDURE

EUS-guided injection of coils

First a standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient is conceder a candidate will be treated with only coils (Group B).

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos A Robles-medranda, MD · Ecuadorian Institute of Digestive Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-08-31
Completion
2018-10-31

Countries

  • Ecuador

Study Locations

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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 NCT03155256 on ClinicalTrials.gov