Transient Elastography in Hepatectomy for Hepatocellular Carcinoma
This study is not yet open for participant recruitment.
Verified September 2011 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Information provided by (Responsible Party):
Matteo Cescon, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01441453
First received: September 24, 2011
Last updated: September 26, 2011
Last verified: September 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 24, 2011 | ||||
| Last Updated Date | September 26, 2011 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Cut-off value of liver stiffness measured in kilopascal (kPa) able to predict the occurrence of postoperative liver failure. [ Time Frame: Participants will be followed for the duration of postoperative hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ] Definition of the cut-off value in kPa able to predict postoperative liver failure, i.e. the presence of at least one of the following variables: ascites causing a delay in the removal of surgical drainages and/or requiring paracentesis; increase of bilirubin levels >3 mg/dL; alteration of coagulation factors requiring plasma infusion with an INR above 1.50 (with serum bilirubin levels <12mg/dL); renal impairment, defined as blood urea nitrogen >2.00 g/L and/or increase of serum creatinine >2.00 mg/dL requiring only loop diuretics, dopamine/terlipressin, or dialysis. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01441453 on ClinicalTrials.gov Archive Site | ||||
| 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 | Transient Elastography in Hepatectomy for Hepatocellular Carcinoma | ||||
| Official Title ICMJE | Value of Transient Elastography in Predicting Postoperative Liver Failure in Patients Undergoing Liver Resection for Hepatocellular Carcinoma. | ||||
| Brief Summary | The purpose of this study is to determine whether liver transient elastography performed before the surgical procedure is able to predict liver failure in patients undergoing hepatectomy for hepatocellular carcinoma. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: FibroScan (Transient Elastography measurement)
Preoperative evaluation of liver stiffness through FibroScan |
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| Study Arm (s) | Preoperative FibroScan
Intervention: Procedure: FibroScan (Transient Elastography measurement) |
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| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01441453 | ||||
| Other Study ID Numbers ICMJE | FibroBoResect-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Matteo Cescon, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | ||||
| Study Sponsor ICMJE | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | ||||
| Verification Date | September 2011 | ||||
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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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