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
Procedure: Ligation and Cyanoacrylate
Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
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Full eligibility criteria for NCT01592578
Ages eligible for Study
18 Years to 72 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01592578
180 Fenglin Road
Shanghai, Shanghai, China, 200032
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View full eligibility
Tris trial is registered with FDA with number: NCT01592578. The sponsor of the trial is Shanghai Zhongshan Hospital and it is looking for 96 volunteers for the current phase.
Official trial title: A Randomized Controlled Trial of Ligation Versus Ligation Plus Sclerotherapy in Addition to Cyanoacrylate in Patients With Gastroesophageal Varices
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