EUS-guided Combined Therapy of Coiling and 2-octyl-cyanoacrylate Injection With Beta Blocker Therapy Versus Beta Blocker Alone for the Primary Prophylaxis of GOV II and IGV I
Sponsor study identifier
interventional
26
1 country
1
Study Start
August 1, 2019
Actual (reported)Primary Completion
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The EUS-guided combined therapy of coilingand 2-octyl-cyanoacrylate in patients with gastric varices reduced rebleeding and need for reintervention in comparison to EUS-guided coiling alone.The purpose of this study is to determine the efficacy of the primary prophylaxis of GOV II and IGV I with the EUS combined therapy versus beta blocker therapy in patients GOV II and IGV that have never bleed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2020
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2019
Actual (reported)August 29, 2019
Actual (reported)September 3, 2019
Actual (reported)August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Bleeding rate secondary to gastric varices
Number of patients with melena or hematemesis accompanied by Hemoglobin drop \> 2g/dL
12 months
Mortality secondary to gastrointestinal bleeding
mortality rate
12 months
Number of reinterventions
12 months
Patients with endoscopic and EUS documented GOV II and IGV I will be included. Procedure will be performed under general anesthesia using a linear array therapeuthic echoendoscope, coils and cyanoacrylate will be injected within the feeder vessel under EUS and fluroscopic guidance.
o Beta-blocker (propranolol) will be started at dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose will be increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \> 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \< 90 mm Hg or pulse rate \< 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication will be attempted if cessation of the medication did not result in improvement of the reported side-effect.
EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group.
A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \> 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \< 90 mm Hg or pulse rate \< 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, 090505, Ecuador
Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
Carlos Robles-Medranda, M.D.
Instituto Ecuatoriano de Enfermedades Digestivas
First Submitted
August 29, 2019
First Posted
September 3, 2019
Study Start
August 1, 2019
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Primary Completion
August 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 10, 2019
Record last verified: 2019-10
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