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

NCT03277937 | Completed DMC

• 1 other identifier: JULY 20-2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastric Varices

Keywords

gastric varices; endoscopic ultrasound; coils; cyanoacrylate

Outcome Measures

Primary Outcomes (1)

• efficacy of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate, confirm and target the feeder vessel in GV treatment.

  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.

  12 months

Secondary Outcomes (1)

• safety of adding angiography to the EUS-guided injection of coils + CYA technique, to determinate and confirm the feeder vessel in GV treatment

  12 months

Study Arms (1)

Patients with gastric varices

EXPERIMENTAL

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

Interventions

angiography in EUS-injection of coils + CYA PROCEDURE

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.

Also known as: Drug: cyanoacrylate, Device: coils

Patients with gastric varices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (27)

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  PMID: 15100955 RESULT

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  PMID: 10744834 RESULT

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MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Cyanoacrylates

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Carlos A Robles-Medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: September 11, 2017
• Study Start: July 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

EC (1)