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

Shanghai Zhongshan Hospital96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Varice

Interventions

Ligation and CyanoacrylatePROCEDURE

Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.

Ligation plus Sclerotherapy and Cyanoacrylate GroupPROCEDURE

Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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.

Locations (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

recurrence rate of variceal hemorrhage

Time frame: Participants will be followed for up to 6 months starting from the date of randomization.

Secondary Outcomes

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.

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.

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.

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.

mortality rate during the follow-up period

Time frame: Participants will be followed for up to 6 months starting from the date of randomization.

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.

Data from ClinicalTrials.gov

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