NCT04222127|Unknown
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
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EUS-Guided Cyanoacrylate Injection Versus Standard Endoscopic Technique in the Obturation of High Risk Gastric Varices
Sponsor study identifier
interventional
42
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)October 5, 2019
Actual (reported)January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 9, 2020
Actual (reported)June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Amount of glue used
6 months
Number of sessions
6 months
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 CYA of the gastric varix using standard endoscopy
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
Specialized Medical hospital
Al Mansurah, Dakahlia Governorate, +2050, Egypt
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.
Wang 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.
Fady S Karam, Master
Mansoura University
Ahmed Y Altonbary, MD
Mansoura University
Hazim H Almenshawy, Professor
Mansoura University
Ayman A Aldosoky, Professor
Mansoura University
First Submitted
October 5, 2019
First Posted
January 9, 2020
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Seham M Seif, Professor
Mansoura University
Study Completion
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 9, 2020
Record last verified: 2020-01
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