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

Gastroesophageal Varice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01592578
• Other study ID #: CSY-CJ-2012
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2012
• Last updated: April 25, 2013
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2012
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastroesophageal Varice
• Liver Cirrhosis

Intervention

Procedure:
• Ligation and Cyanoacrylate
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
• Ligation plus Sclerotherapy and Cyanoacrylate Group
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate of variceal hemorrhage	recurrence rate of variceal hemorrhage	Participants will be followed for up to 6 months starting from the date of randomization.	Yes
Secondary	eradication rate of the gastroesophageal varices	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.	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.	Yes
Secondary	recurrence rate of the gastroesophageal varices	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.	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.	Yes
Secondary	mortality rate during the follow-up period	mortality rate during the follow-up period	Participants will be followed for up to 6 months starting from the date of randomization.	Yes
Secondary	incidence rate of complications associated with endoscopic treatments	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.	Participants will be followed for up to 6 months starting from the date of randomization.	Yes