CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
EUS-guided injection of coils with cyanoacrylate +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT03155256
NCT03155256N/ACompleted

Comparative EUS Guided Techniques in Treatment of Gastric Varice: a Prospective, Ranzomized Study

Instituto Ecuatoriano de Enfermedades Digestivas·interventional·Posted May 16, 2017·Updated Feb 26, 2019

In Brief

A clinical study evaluating EUS-guided injection of coils with cyanoacrylate and EUS-guided injection of coils for Gastric Varix. Completed, enrolled 59 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Varix
CountriesEcuador
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 16, 2017
Enrollment StartMar 1, 2016
Primary CompletionAug 31, 2017
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago

Interventions

EUS-guided injection of coils with cyanoacrylateprocedure

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)

EUS-guided injection of coilsprocedure

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).