Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- bleeding rate of the puncture site [ Time Frame: time period since the beginning of the injection, until up to 24 hours after the procedure ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01923064
|Contact: Shiyao CHEN, MDfirstname.lastname@example.org|
|Contact: Jie CHEN, MDemail@example.com|
|Shanghai, Shanghai, China, 0086200032|
|Contact: Shiyao CHEN, MD 8613601767319 firstname.lastname@example.org|
|Contact: Jie Chen, MD 8613764633539 email@example.com|
|Principal Investigator: Shiyao CHEN, MD|
|Sub-Investigator: Jie CHEN, MD|
|Sub-Investigator: Xiaoqing ZENG, MD|
|Study Director:||Shiyao Chen, MD||Zhongshan Hospital, Shanghai|