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EUS-guided Obturation of High Risk Gastric Varices Versus Standard Endoscopic Treatment

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: NCT04222127
Recruitment Status : Unknown
Verified January 2020 by Mansoura University.
Recruitment status was:  Recruiting
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

Gastric varices occur in patients with portal hypertension, mostly secondary to liver cirrhosis. Although they bleed less frequently than oesophageal varices, gastric variceal bleeding tends to be more severe with reported higher mortality.

Endoscopic variceal obliteration (EVO) by direct endoscopic injection (DEI) using tissue adhesives like glue, CYA or histoacryl demonstrated higher hemostasis and lower bleeding rates compared to band ligation or sclerotherapy. Nevertheless, CYA treatment is known to be associated with significant adverse events like para-variceal injection, hemorrhage from post injection ulcer, needle sticking in the varix, intra-peritoneal injection leading to peritonitis and adherence of the glue to the endoscope, fever, embolization into the renal vein, IVC, pulmonary or systemic vessels.

Endoscopic ultrasound (EUS) offers unique access to abdominal arterial and venous vasculature. This has had the most clinical impact on the treatment of gastroesophageal varices, where EUS may play a role both in the management and can deliver therapy in the form of glue injection, endovascular coil placement or a combination of the two. EUS enables an assessment using Doppler to confirm vessel obliteration after treatment. However, targeting the perforating feeder vessel rather than the varix lumen itself may theoretically minimize the amount of CYA needed to achieve obliteration of GVs and thereby reduce the risk of embolization.


Condition or disease Intervention/treatment Phase
Gastric Varix Other: EUS guided injection of gastric varices by CYA Other: Direct endoscopic injection of gastric varices by CYA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EUS-Guided Cyanoacrylate Injection Versus Standard Endoscopic Technique in the Obturation of High Risk Gastric Varices
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EUS-guided injection of CYA of GVs
EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture (1:1) of 2-octyl-cyanoacrylate & lipidol using 19G EUS-FNA needle
Other: EUS guided injection of gastric varices by CYA
EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture (1:1) of 2-octyl-cyanoacrylate & lipidol using 19G EUS-FNA needle

Experimental: Direct endoscopic injection of CYA of GVs
Direct endoscopic injection of CYA of the gastric varix using standard endoscopy
Other: Direct endoscopic injection of gastric varices by CYA
Direct endoscopic injection of gastric varix by CYA




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events & oblitration rate [ Time Frame: 6 months ]
    measure the technical success rate defined as complete variceal obliteration and complications rate including bleeding, pulmonary embolism (PE), ulcers, fever, paravariceal injection & rebleeding.


Secondary Outcome Measures :
  1. Amount of glue used [ Time Frame: 6 months ]
    amount of cyanoacrylate used to complete obliteration in ml.

  2. Number of sessions [ Time Frame: 6 months ]
    calculate the number of sessions needed to achieve oblitration of gastric varices



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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:

  • High risk GOV II and IGV I varices (>10 mm) on initial standard diagnostic upper endoscopy
  • Recent bleeding and primary prophylaxis
  • Patients who are unable or unwilling to undergo alternative therapies for GV [such as transjugular intrahepatic portosystemic shunts (TIPS) or surgery], or prior TIPS had failed.

Exclusion Criteria:

  • Inability to give informed consent for the procedure.
  • Concurrent hepatorenal syndrome and/or multiorgan failure.
  • Presence of HCC &/or portal vein thrombosis.
  • Previous endoscopic treatment for GVs.
  • Platelet count less than 50,000/ml or International Normalized Rate (INR) >2
  • Esophageal stricture
  • Previous esophageal or gastric surgery.
  • Pregnancy.

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): NCT04222127


Contacts
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Contact: Fady S Karam, Master +201028838396 fady-sabry40@yahoo.com
Contact: Ahmed Y Altonbary 01005100091 Altonbary@gmail.com

Locations
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Egypt
Specialized Medical hospital Recruiting
Mansoura, Dakahlia, Egypt, +2050
Contact: Fady S Karam, Master    +201028838396    fady_sabry40@yahoo.com   
Sub-Investigator: Ahmed Y Altonbary, MD         
Sub-Investigator: Hazim H Almenshawy, Professor         
Sub-Investigator: Ayman A Aldesoky, Professor         
Sub-Investigator: Seham M Seif, Professor         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Fady S Karam, Master Mansoura University
Study Director: Ahmed Y Altonbary, MD Mansoura University
Study Director: Hazim H Almenshawy, Professor Mansoura University
Study Director: Ayman A Aldosoky, Professor Mansoura University
Study Chair: Seham M Seif, Professor Mansoura University
  Study Documents (Full-Text)

Documents provided by Mansoura University:
Study Protocol  [PDF] January 1, 2019

Publications:
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04222127    
Other Study ID Numbers: MD.19.03.157
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
Gastric Varices
EUS
Cyanoacrylate
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases