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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroesophageal Varice

Intervention / Treatment
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* Procedure: Ligation and Cyanoacrylate
* Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligation and Cyanoacrylate Group<br> | Procedure: Ligation and Cyanoacrylate<br>* Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.<br>|
| Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group<br> | Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group<br>* Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroesophgeal variceal bleeding, liver cirrhosis, portal hypertension