The Research of the Evaluation of Clinical Procedures in Gastroesophageal Varices in Patients With Liver Cirrhosis
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ligation and Cyanoacrylate Group
|
Procedure: Ligation and Cyanoacrylate
Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
|
| Experimental: Ligation plus Sclerotherapy and Cyanoacrylate Group
|
Procedure: Ligation plus Sclerotherapy and Cyanoacrylate Group
Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The extent of the varices range from Moderate to Severe.
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The age of the patients range from 18 to 72 years old.
Exclusion Criteria:
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Patients who had other causes for portal hypertention(CTPV,Budd-Chiari syndrome,etc.)
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Patients with severe systemic disease (renal failure, heart failure,carcinoma other than liver cancer,etc.)
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Patients who had contraindications for ligation,sclerotherapy or cyanoacrylate.
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Patients who have previously received shunt or devascularization operation,TIPS.
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Patients who had portosystemic shunt according to the results of CT scan.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 180 Fenglin Road | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Director: Shiyao Chen, professor, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSY-CJ-2012