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

May 1, 2012
April 25, 2013
March 2012
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01592578 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis
A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Varice
  • Procedure: Ligation and Cyanoacrylate
    Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
  • Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
    Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary
  • Active Comparator: Ligation and Cyanoacrylate Group
    Intervention: Procedure: Ligation and Cyanoacrylate
  • Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group
    Intervention: Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 72 Years
No
Not Provided
China
 
NCT01592578
CSY-CJ-2012
No
Shiyao Chen, Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
Not Provided
Study Director: Shiyao Chen, professor Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP