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

Portal Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923064
• Other study ID #: chen2013
• Status: Completed
• Phase: N/A
• First received: August 7, 2013
• Last updated: January 4, 2016
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices
• Hypertension, Portal
• Portal Hypertension
• Varicose Veins

Intervention

Drug:
• Lipiodol
endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
• Lauromacrogol
endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence rate of ulcer formation	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.	2 months after the initial endoscopic treatment
Other	eradication rate of gastric varices	Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.	2 months after the initial endoscopic treatment
Other	incidence rate of complications	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.	6 months
Primary	bleeding rate of the puncture site	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.	time period since the beginning of the injection, until up to 24 hours after the procedure
Secondary	Rebleeding rate after endoscopic treatment	Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.	6 months from the date of enrollment