EVL Plus Drug to Prevent Variceal Rebleeding
| Tracking Information | |||||
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| First Received Date ICMJE | September 1, 2006 | ||||
| Last Updated Date | September 14, 2006 | ||||
| Start Date ICMJE | July 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
rebleeding rate | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00371943 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
complications | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | EVL Plus Drug to Prevent Variceal Rebleeding | ||||
| Official Title ICMJE | A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding | ||||
| Brief Summary | Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved. |
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| Detailed Description | Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality (1). Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding. In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3). On the other hand, nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding (4-5). The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6). Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8). It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding. This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Bleeding | ||||
| Intervention ICMJE | Procedure: band ligation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00371943 | ||||
| Other Study ID Numbers ICMJE | EVL | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Science Council, Taiwan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Science Council, Taiwan | ||||
| Verification Date | September 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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