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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 2, 2007 | ||||||||
| Last Updated Date | December 2, 2007 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Rebleeding [ Time Frame: 3 yr ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Complication Survival [ Time Frame: 3 yr ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding | ||||||||
| Official Title ICMJE | A Randomized Tril of Endoscopic Cyanoacrylate Obliteration vs. Nadolol | ||||||||
| Brief Summary | Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate. |
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| Detailed Description | Gastric varies (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate, a requirement for a larger amount of blood transfusion and a higher mortality. Up to date, the treatment of GV bleeding (GVB) is still sub-optimal in contrast to the treatment of EV bleeding. The management of GV has been focused on treatment of acute GVB. Various specific methods are used to control GVB and prevent rebleeding; however they were far from ideal. It is because GV are usually larger vessels formed in deeper submucosa and connect to the spontaneous gastrorenal shunt which creates a fast blood flow. Therefore, voluminous blood in the larger diameter GV leads to exsanguine bleeding when ruptured. A variety of endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate), thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied to control acute GV bleeding with variable successful rates (50~100%) and rebleeding rates (20~90%). The successful rate of endoscopic cyanoacrylate injection to arrest active GVB is more consistent around 90~100% and rebleeding rate is around 30~40%. The recent International Consensus Meeting endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. The embolic complications, either septic & aseptic, are not uncommon. Expertise is also required to reduce the embolic complications and instrumental injuries. Therefore, the efficacy of specific treatment for GVB is sub-optimal, consecutive innovation of new methods are required to improve the prognosis of GVB. Non-selective beta-blocker is effective to reduce rebleeding from esophageal varices. However, its effect on gastric variceal hemorrhage has never been proven. This is an important issues prompted by current portal hypertension experts. We have much experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journal. Therefore, we design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the secondary prevention of acute gastric variceal bleeding. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Nadolol | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00567216 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | nsc96-2314-B-075-037-MY3, IRB-96-04-01 | ||||||||
| Study Sponsor ICMJE | Taipei Veterans General Hospital,Taiwan | ||||||||
| Collaborators ICMJE | National Science Council, Taiwan | ||||||||
| Investigators ICMJE |
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| Information Provided By | Taipei Veterans General Hospital,Taiwan | ||||||||
| Verification Date | December 2007 | ||||||||
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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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