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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01592578
Recruitment Status : Unknown
Verified May 2012 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : May 7, 2012
Last Update Posted : April 29, 2013
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

Brief Summary:
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 or disease Intervention/treatment
Gastroesophageal Varice Procedure: Ligation and Cyanoacrylate Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.

  3. mortality rate during the follow-up period [ Time Frame: Participants will be followed for up to 6 months starting from the date of randomization. ]
    mortality rate during the follow-up period

  4. 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. ]
    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.



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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01592578     History of Changes
Other Study ID Numbers: CSY-CJ-2012
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: May 2012

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

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases