Clinical trial NCT01923064: Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Varices
Portal Hypertension
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
* The age of the patients range from 18 to 80 years old.

Exclusion Criteria:

* Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
* Patients who have abnormal portosystemic shunt according to the imaging results.
* Patients who have no previous upper gastrointestinal bleeding history.
* Patients who have multiple endoscopic treatments for esophagogastric varices before.

Primary outcomes:
measure: bleeding rate of the puncture site
timeFrame: time period since the beginning of the injection, until up to 24 hours after the procedure
Secondary outcomes:
measure: Rebleeding rate after endoscopic treatment
timeFrame: 6 months from the date of enrollment
Other outcomes:
measure: incidence rate of ulcer formation
timeFrame: 2 months after the initial endoscopic treatment
measure: eradication rate of gastric varices
timeFrame: 2 months after the initial endoscopic treatment
measure: incidence rate of complications
timeFrame: 6 months
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Shanghai
name: Shiyao Chen, MD
role: STUDY_DIRECTOR
References: