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

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 Overview

• Status: Completed
• Conditions: Portal Hypertension; Gastric Varices
• Intervention / Treatment: Drug: Lipiodol; Drug: Lauromacrogol

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 0086200032
      • ZhongShan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: NBCA-lipiodol; Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices	Drug: Lipiodol; endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
EXPERIMENTAL: NBCA-lauromacrogol; Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices	Drug: Lauromacrogol; endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Shiyao Chen, MD, Zhongshan Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (ESTIMATE): August 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Esophageal and Gastric Varices; Hypertension, Portal; Varicose Veins; Antineoplastic Agents; Pharmaceutical Solutions; Sclerosing Solutions; Polidocanol; Ethiodized Oil
• Other Study ID Numbers: chen2013