Clinical Trials Directory

Trials / Completed

CompletedNCT01923064

Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
96 (actual)
Sponsor
Shanghai Zhongshan Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGLipiodolendoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
DRUGLauromacrogolendoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices

Timeline

Start date
2013-10-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2013-08-14
Last updated
2016-01-05

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01923064. Inclusion in this directory is not an endorsement.