EUS-guided Obturation of High Risk Gastric Varices Versus Standard Endoscopic Treatment
EUS-Guided Cyanoacrylate Injection Versus Standard Endoscopic Technique in the Obturation of High Risk Gastric Varices
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJanuary 9, 2020
January 1, 2020
1 year
October 5, 2019
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment emergent adverse events & oblitration rate
measure the technical success rate defined as complete variceal obliteration and complications rate including bleeding, pulmonary embolism (PE), ulcers, fever, paravariceal injection \& rebleeding.
6 months
Secondary Outcomes (2)
Amount of glue used
6 months
Number of sessions
6 months
Study Arms (2)
EUS-guided injection of CYA of GVs
EXPERIMENTALEUS-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
Direct endoscopic injection of CYA of GVs
EXPERIMENTALDirect endoscopic injection of CYA of the gastric varix using standard endoscopy
Interventions
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
Direct endoscopic injection of gastric varix by CYA
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Specialized Medical hospital
Al Mansurah, Dakahlia Governorate, +2050, Egypt
Related Publications (2)
Romero-Castro R, Pellicer-Bautista FJ, Jimenez-Saenz M, Marcos-Sanchez F, Caunedo-Alvarez A, Ortiz-Moyano C, Gomez-Parra M, Herrerias-Gutierrez JM. EUS-guided injection of cyanoacrylate in perforating feeding veins in gastric varices: results in 5 cases. Gastrointest Endosc. 2007 Aug;66(2):402-7. doi: 10.1016/j.gie.2007.03.008.
PMID: 17643723BACKGROUNDWang AJ, Li BM, Zheng XL, Shu X, Zhu X. Utility of endoscopic ultrasound in the diagnosis and management of esophagogastric varices. Endosc Ultrasound. 2016 Jul-Aug;5(4):218-24. doi: 10.4103/2303-9027.187840.
PMID: 27503152BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2019
First Posted
January 9, 2020
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
June 1, 2020
Last Updated
January 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share