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

Not Applicable

Completed

• Conditions: Gastric Varices; Portal Hypertension
• Interventions: Drug: Lauromacrogol; Drug: Lipiodol

• Registration Number: NCT01923064
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Study Start: 2013-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBCA-lauromacrogol	Lauromacrogol	Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices
NBCA-lipiodol	Lipiodol	Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices

Primary Outcome Measures

Name	Time	Method
bleeding rate of the puncture site	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.

Secondary Outcome Measures

Name	Time	Method
Rebleeding rate after endoscopic treatment	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.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China