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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligation and Cyanoacrylate Group | Active Comparator |
| |
| Ligation plus Sclerotherapy and Cyanoacrylate Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligation and Cyanoacrylate | Procedure | Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyao Chen, professor | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26517621 | Derived | Chen J, Zeng XQ, Ma LL, Li B, Tseng YJ, Lian JJ, Gao H, Wang J, Luo TC, Chen SY. Randomized controlled trial comparing endoscopic ligation with or without sclerotherapy for secondary prophylaxis of variceal bleeding. Eur J Gastroenterol Hepatol. 2016 Jan;28(1):95-100. doi: 10.1097/MEG.0000000000000499. |
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| Ligation plus Sclerotherapy and Cyanoacrylate Group | Procedure | Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary |
|
| 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. |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008026 | Ligation |
| D003487 | Cyanoacrylates |
| D015911 | Sclerotherapy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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