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

Not Applicable

• Conditions: Gastroesophageal Varice
• Interventions: Procedure: Ligation and Cyanoacrylate; Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group

• Registration Number: NCT01592578
• Lead Sponsor: 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

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 Timeline

• Study Start: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-29
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ligation and Cyanoacrylate Group	Ligation and Cyanoacrylate	-
Ligation plus Sclerotherapy and Cyanoacrylate Group	Ligation plus Sclerotherapy and Cyanoacrylate Group	-

Primary Outcome Measures

Name	Time	Method
recurrence rate of variceal hemorrhage	Participants will be followed for up to 6 months starting from the date of randomization.	recurrence rate of variceal hemorrhage

Secondary Outcome Measures

Name	Time	Method
eradication rate of the gastroesophageal varices	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.
recurrence rate of the gastroesophageal varices	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.
mortality rate during the follow-up period	Participants will be followed for up to 6 months starting from the date of randomization.	mortality rate during the follow-up period
incidence rate of complications associated with endoscopic treatments	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.

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China