A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
Sponsor study identifier
interventional
96
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
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.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2012
Actual (reported)May 7, 2012
Actual (reported)August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
recurrence rate of variceal hemorrhage
recurrence rate of variceal hemorrhage
Participants will be followed for up to 6 months starting from the date of randomization.
eradication rate of the gastroesophageal varices
Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
recurrence rate of the gastroesophageal varices
Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.
mortality rate during the follow-up period
Participants will be followed for up to 6 months starting from the date of randomization.
incidence rate of complications associated with endoscopic treatments
Participants will be followed for up to 6 months starting from the date of randomization.
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032, China
Chen J, Zeng XQ, Ma LL, Li B, Tseng YJ, Lian JJ, Gao H, Wang J, Luo TC, Chen SY. Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding. Eur J Gastroenterol Hepatol. 2016 Jan;28(1):95-100. doi: 10.1097/MEG.0000000000000499.
Shiyao Chen, professor
Shanghai Zhongshan Hospital
First Submitted
May 1, 2012
First Posted
May 7, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 29, 2013
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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