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

This study has been completed.
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital Identifier:
First received: August 7, 2013
Last updated: January 4, 2016
Last verified: January 2016
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.

Condition Intervention
Gastric Varices
Portal Hypertension
Drug: Lipiodol
Drug: Lauromacrogol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Shiyao Chen, Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • bleeding rate of the puncture site [ Time Frame: 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:
  • Rebleeding rate after endoscopic treatment [ Time Frame: 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.

Other Outcome Measures:
  • incidence rate of ulcer formation [ Time Frame: 2 months after the initial endoscopic treatment ]
    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.

  • eradication rate of gastric varices [ Time Frame: 2 months after the initial endoscopic treatment ]
    Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.

  • incidence rate of complications [ Time Frame: 6 months ]
    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.

Enrollment: 96
Study Start Date: October 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01923064

China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 0086200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Study Director: Shiyao Chen, MD Zhongshan Hospital, Shanghai
  More Information

Responsible Party: Shiyao Chen, professor, Shanghai Zhongshan Hospital Identifier: NCT01923064     History of Changes
Other Study ID Numbers: chen2013
Study First Received: August 7, 2013
Last Updated: January 4, 2016

Additional relevant MeSH terms:
Hypertension, Portal
Varicose Veins
Esophageal and Gastric Varices
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Ethiodized Oil
Antineoplastic Agents processed this record on May 25, 2017