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Treatment of Gastric Varices Using EUS Guided Techniques

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03155256
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

Brief 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.


Condition or disease Intervention/treatment Phase
Gastric Varix Procedure: EUS-guided injection of coils with cyanoacrylate Procedure: EUS-guided injection of coils Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative EUS Guided Techniques in Treatment of Gastric Varice: a Prospective, Ranzomized Study
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Experimental: Coils + Cyanoacrylate Group
Patients with Gastric Varices GOV II or IGV I and with active bleeding, history of previous bleeding due to GV (secondary prophylaxis) or high-risk GV according to Baveno VI consensus for primary prophylaxis will be treated using EUS-guided injection of coils with cyanoacrylate
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)
Other Names:
  • Drug: cyanoacrilate
  • Device: coils

Experimental: Coils Group
Patients with Gastric Varices GOV II or IGV I and with active bleeding, history of previous bleeding due to GV (secondary prophylaxis) or high-risk GV according to Baveno VI consensus for primary prophylaxis will be treated using EUS-guided injection of coils
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).
Other Name: Device: coils




Primary Outcome Measures :
  1. Efficacy of EUS guided techniques (Coils + CYA vs Coils alone) for GFV treatment [ Time Frame: 12 month ]
    Efficacy will be measure by technical success defined as successful technique performance and funcional success defined as complete obliteration of the varix and absence of Doppler flow on EUS.


Secondary Outcome Measures :
  1. Safety of EUS guided techniques (Coils + CYA vs Coils alone) for GFV treatment [ Time Frame: 12 month ]
    Safety will be determinated by measure of adverse events related to the procedure or gastric varices within and after 30 days of the procedure.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 18 years old patients
  • Who agree to participate in the study
  • Proven GV (GOV II or IGV I) on initial standard diagnostic upper endoscopy
  • Active bleeding, history of previous bleeding (secondary prophylaxis) and primary prophylaxis
  • Patient preference for EUS-guided therapy

Exclusion Criteria:

  • Inability to provide informed consent for the procedure
  • Concurrent hepato-renal syndrome and/or multi-organ failure
  • Pregnancy
  • Platelet count less than 50,000/ml or International Normalized Rate (INR) >2
  • Esophageal stricture
  • Splenic or Portal vein thrombosis because an increase risk of failure

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): NCT03155256


Locations
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Ecuador
Ecuadorian Institute of Digestive Diseases, Omnihospital
Guayaquil, Guayas, Ecuador, 090505
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
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Principal Investigator: Carlos A Robles-medranda, MD Ecuadorian Institute of Digestive Diseases
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT03155256    
Other Study ID Numbers: Dec-18-2016
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Instituto Ecuatoriano de Enfermedades Digestivas:
EUS, cyanoacrylate, coils, gastric varices
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases