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The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis

This study is currently recruiting participants.
Verified May 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01592578
First received: May 1, 2012
Last updated: April 25, 2013
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of two different endoscopic treatment in gastroesophageal varices in patients with liver cirrhosis: ligation versus ligation plus sclerotherapy in addition to cyanoacrylates


Condition Intervention
Gastroesophageal Varice
 Procedure: Ligation and Cyanoacrylate
Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group

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 Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • recurrence rate of variceal hemorrhage [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ] [ Designated as safety issue: Yes ]
    recurrence rate of variceal hemorrhage


Secondary Outcome Measures:
  • eradication rate of the gastroesophageal varices [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months. ] [ Designated as safety issue: Yes ]
    We intend to set eradication rate of the gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Eradication of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.

  • recurrence rate of the gastroesophageal varices [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months. ] [ Designated as safety issue: Yes ]
    We intend to set recurrence rate of gastroesophageal varices as one of our secondary outcomes. Participants will be followed for up to 6 months starting from the date of randomization.Recurrence rate of the gastroesophageal varices will be measured according to the results of endoscopy at the end of the 6 months.

  • mortality rate during the follow-up period [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ] [ Designated as safety issue: Yes ]
    mortality rate during the follow-up period

  • incidence rate of complications associated with endoscopic treatments [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ] [ Designated as safety issue: Yes ]
    We intend to set incidence rate of complications associated with endoscopic treatments,to be specific,which include trasient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. Participants will be followed for up to 6 months starting from the date of randomization.


Estimated Enrollment: 96
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ligation and Cyanoacrylate Group Procedure: Ligation and Cyanoacrylate
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary

Detailed Description:

Gastroesophageal variceal bleeding, which often results from portal hypertention, is known as one of the most frequent death causes of patients with liver cirrhosis. When a patient has bleeding episode, it's very likely that he/she will develop another one in the future. Endoscopic treatments such as ligation, sclerotherapy or cyanocrylates are proved to decrease the risk of re-bleeding. The purpose of this study is to evaluate the efficacy of two different endoscopic treatments in patients who have both gastric and esophageal varices with liver cirrhosis: In addition to cyanoacrylates, ligation versus ligation plus sclerotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with portal hypertension caused by liver cirrhosis who presented with an acute or recent episode of gastroesophageal variceal bleeding and have previously received endoscopic treatments of ligation and cyanoacrylate. Diagnosis of liver cirrhosis or mixed cirrhosis was based on results of liver biopsy or biochemical tests and liver imaging by ultrasonography.
  • The extent of the varices range from Moderate to Severe.
  • The age of the patients range from 18 to 72 years old.

Exclusion Criteria:

  • Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
  • Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
  • Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
  • Patients who have previously received shunt or devascularization operation,TIPS.
  • Patients who had portosystemic shunt according to the results of CT scan.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592578

Locations
China, Shanghai
180 Fenglin Road Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jie Chen, doctor     86-13764633539     Angelin8716@yahoo.com.cn , 0556289@fudan.edu.cn    
Principal Investigator: Shiyao Chen, Professor            
Sub-Investigator: Jie Chen, doctor            
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Director: Shiyao Chen, professor Shanghai Zhongshan Hospital
  More Information

No publications provided

Responsible Party: Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01592578     History of Changes
Other Study ID Numbers: CSY-CJ-2012
Study First Received: May 1, 2012
Last Updated: April 25, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Zhongshan Hospital:
gastroesophgeal variceal bleeding
liver cirrhosis
portal hypertension

Additional relevant MeSH terms:
Liver Cirrhosis
Varicose Veins
Esophageal and Gastric Varices
Liver Diseases
Digestive System Diseases
 Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal

ClinicalTrials.gov processed this record on June 13, 2013