Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
|ClinicalTrials.gov Identifier: NCT01923064|
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Varices Portal Hypertension||Drug: Lipiodol Drug: Lauromacrogol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: NBCA-lipiodol
Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices
endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices
endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
- bleeding rate of the puncture site [ Time Frame: time period since the beginning of the injection, until up to 24 hours after the procedure ]We tend to observe the immediate puncture site bleed on the injection of cyanoacrylate and lipiodol or lauromacrogol and withdrawal of needle catheter during endoscopic treatment of gastric varices.
- Rebleeding rate after endoscopic treatment [ Time Frame: 6 months from the date of enrollment ]Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.
- incidence rate of ulcer formation [ Time Frame: 2 months after the initial endoscopic treatment ]The patients will be assessed if ulceration is formed on the site of the injection when they have gastroscopy review in 2 months after the initial endoscopic treatment.
- eradication rate of gastric varices [ Time Frame: 2 months after the initial endoscopic treatment ]Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.
- incidence rate of complications [ Time Frame: 6 months ]Participants will be followed for up to 6 months starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923064
|Shanghai, Shanghai, China, 0086200032|
|Study Director:||Shiyao Chen, MD||Zhongshan Hospital, Shanghai|