Angiography for Evaluation of the Feeder Vessel in EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03277937|
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
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 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. These patients usually have respiratory symptom, however this complication can be present in asymptomatic patients, being demonstrated only by a pathological CT scan. On the other hand, it has been described that the risk of glue embolism dependent on the volume of CYA injected, being significantly greater with high volumes. Other complications related to CYA injection are hemorrhage from injection site ulcers, fever, peritonitis, needle impaction, and even death. Also the injection material can cause serious damage to the endoscope.
Currently, endoscopic injection of CYA can be performed by direct visualization using a standard gastroscope or guided by Endoscopic Ultrasound (EUS) with injection of CYA alone or in combination with coils. The injection of coils in conjunction with CYA may reduce or eliminate the risk of glue embolization as coils can function as a scaffold to retain CYA within the varix and may decrease the amount of glue injection needed to achieve obliteration. It has been previously demonstrated that treatment under EUS guidance may have some benefits. It allows a precise targeting of the varix lumen or afferent feeding veins, being the vessel obstructed with less amount of CYA than used for the "blind" injection by standard endoscopy, reducing the risk of glue embolism. EUS can confirm varix obliteration by Doppler effect and also the visualization of GV is not impaired by blood or food in the stomach, thus it can be used in the setting of active hemorrhage.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Varices||Procedure: angiography in EUS-injection of coils + CYA||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Angiography for Determination and Confirmation of the Feeder Vessel as a Modification of the Original EUS-guided Coils and Cyanoacrylate Therapy for Gastric Varices|
|Actual Study Start Date :||July 1, 2015|
|Estimated Primary Completion Date :||October 1, 2017|
|Estimated Study Completion Date :||November 1, 2017|
Experimental: Patients with gastric varices
Patients above 18 years old with gastric varices (GV) on the initial standard diagnostic upper endoscopy will be enrolled and treated using angiography in EUS-injection of coils + CYA. GV will be classified according to Sarin and Kumar classification. 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. Gastro-esophageal varices type I (GOV I) will be excluded. Patients with active bleeding and history of previous bleeding due to GV (secondary prophylaxis) will be included as well as patients with high-risk GV suitable for primary prophylaxis according to Baveno VI consensus. T
Procedure: angiography in EUS-injection of coils + CYA
Doppler imaging will be used to allow direct visualization of the varices flow. The gastric vessels will be followed from the cardia to the proximal part of the esophagus, to detect the feeding vessel (FV). Once the FV has been found, a 19-gauge EUS-FNA will be used to access the vessel. An angiography will be performed using 5-10 ml of water-soluble contrast under fluoroscopy, to ensure intravascular location and study varix flow direction. Finally, patients will be treated by EUS-deployment of coils followed by CYA injection. The coils will be delivered into the vessel through the FNA needle, using the stylet as a pusher. The 2-Octyl-CYA will be used. It will be injected always after the coils deployment and then 1 mL of saline solution will be used to flush the glue completely.
- efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment. [ Time Frame: 12 months ]efficacy will be considered be the complete occlusion and/or disappearance of the GV and will be determinate by follow-up controls using EUS and upper endoscopy. Treatment failure and early rebleeding will be considered when bleeding occurred the first five days.
- safety of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate and confirm the feeder vessel in GV treatment [ Time Frame: 12 months ]all adverse events related to the technique during the procedure or the follow-up will be described.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277937
|Contact: Carlos A Robles-Medranda, MD||(+593) email@example.com|
|Contact: Manuel Valero, MD||(+54) firstname.lastname@example.org|
|Ecuadorian Institute of Digestive Diseases, Omnihospital||Recruiting|
|Guayaquil, Guayas, Ecuador, 090505|
|Contact: Carlos A Robles-Medranda, MD +593989158865 email@example.com|
|Contact: Manuel Valero, MD +59342109180 ext 105 firstname.lastname@example.org|
|Principal Investigator: Carlos A Robles-Medranda, MD|
|Principal Investigator: Manuel Valero, MD|
|Principal Investigator:||Carlos A Robles-Medranda, MD||Ecuadorian Institute of Digestive Diseases|