Trial record 12 of 88 for:    Open Studies | "Varicose Veins"

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

This study is currently recruiting participants.
Verified April 2013 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01923064
First received: August 7, 2013
Last updated: August 13, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 96
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01923064

Contacts
Contact: Shiyao CHEN, MD 8613601767310 chen.shiyao@zs-hospital.sh.cn
Contact: Jie CHEN, MD 8613764633539 chen.jie5@zs-hospital.sh.cn

Locations
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 0086200032
Contact: Shiyao CHEN, MD    8613601767319    chen.shiyao@zs-hospital.sh.cn   
Contact: Jie Chen, MD    8613764633539    chen.jie5@zs-hospital.sh.cn   
Principal Investigator: Shiyao CHEN, MD         
Sub-Investigator: Jie CHEN, MD         
Sub-Investigator: Xiaoqing ZENG, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Director: Shiyao Chen, MD Zhongshan Hospital, Shanghai
  More Information

No publications provided

Responsible Party: Shiyao Chen, professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01923064     History of Changes
Other Study ID Numbers: chen2013
Study First Received: August 7, 2013
Last Updated: August 13, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Varicose Veins
Hypertension
Hypertension, Portal
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
Ethiodized Oil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014