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Trial record 20 of 562 for:    varicose veins

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

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ClinicalTrials.gov Identifier: NCT03277937
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
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.
Other Names:
  • Drug: cyanoacrylate
  • Device: coils




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Carlos A Robles-Medranda, MD (+593) 989158865 carlosoakm@yahoo.es
Contact: Manuel Valero, MD (+54) 2914429990 valero.manuel@hotmail.com

Locations
Ecuador
Ecuadorian Institute of Digestive Diseases, Omnihospital Recruiting
Guayaquil, Guayas, Ecuador, 090505
Contact: Carlos A Robles-Medranda, MD    +593989158865    carlosoakm@yahoo.es   
Contact: Manuel Valero, MD    +59342109180 ext 105    valero.manuel@hotmail.com   
Principal Investigator: Carlos A Robles-Medranda, MD         
Principal Investigator: Manuel Valero, MD         
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
Principal Investigator: Carlos A Robles-Medranda, MD Ecuadorian Institute of Digestive Diseases

Publications of Results:

Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT03277937     History of Changes
Other Study ID Numbers: JULY 20-2017
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Ecuatoriano de Enfermedades Digestivas:
gastric varices
endoscopic ultrasound
coils
cyanoacrylate

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs