Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2010 | ||||
| Last Updated Date | September 13, 2010 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis | ||||
| Official Title ICMJE | Multicentric Retrospective Case Control Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis | ||||
| Brief Summary | The purpose of this study is to investigate the impact of splenectomy coupled with portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope to find a new idear and method to prevent or cure HCC. |
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| Detailed Description | A case-control study was carried out. The factors studied include age, gender, ascites, hepatic encephalopathy, ALT, AST, TBIL, ALP, GGT, Child-Pugh classification of liver function, and history of splenectomy with portal-azygous disconnection during the treatment of portal hypertension. According to the Child-Pugh classification, these cases were graded as A, B, and C. And according to the ranges of the normal reference values of the data, they were categorized into two groups including a normal group and an abnormal group.The data mainly comes from FMMU and Xi'an jiaotong university from the year of 2002 to 2012. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | post-hepatitic cirrhosis with portal hypertension and hypersplenism patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 5000 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01201655 | ||||
| Other Study ID Numbers ICMJE | chenyong | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | chen yong, Xijing Hospital | ||||
| Study Sponsor ICMJE | Xijing Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Xijing Hospital | ||||
| Verification Date | January 2010 | ||||
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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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