Computertomography-guided Wire Marking of the Liver
| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 2011 | ||||
| Last Updated Date | September 17, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01457599 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 | Computertomography-guided Wire Marking of the Liver | ||||
| Official Title ICMJE | Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study | ||||
| Brief Summary | The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible. |
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| Detailed Description | Colorectal Cancer is most common in western countries. In 2007 in Austria 4462 new colorectal cancers were diagnosed. The most common place of metastasis is the liver. Approximately 15% of patients have metastasis at time of diagnosis of primary tumor and further 50% will develop metastases in the further course of the disease.However only 10-25% of patients are candidates for liver resection. New chemotherapeutics, new targeted therapies with monoclonal antibodies and better surgical techniques improved response rates, resection rates and overall survival. Owing to improved response rates metastases in the liver partially respectively completely disappeared, so that these lesions are not more visible in apparative diagnostic like CT-scan and MRI. The question is now what to do with this patients? In the literature there is no evidence how to manage these patients. Conservative management would lead to a reoccurrence of metastases in the liver. On the other side surgical management is difficult, because metastases are preoperatively and intraoperatively not visible and resection is only possible with the removement of greater amounts of healthy tissue. The computer tomography-guided wire marking of the metastases in the liver is a possibility to overcome these problems. All patients with complete radiologic response of metastases in the liver and metastases ≤ 1 cm are included in the study (RECISTE-Criteria). On day of surgical procedure patients will brought to interventional radiologist and based on computer tomography images before neoadjuvant chemotherapy the lesions will be marked computer tomography-guided with a wire(X-Reidy Breast Lesion Localization Needle, Cook Medical). The wire is placed percutaneously and under antibiotic prophylaxis. After the marking procedure, the patient is brought into the operating room to resect the metastases in the liver. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Tertiary care clinic |
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| Condition ICMJE | Colorectal Hepatic Metastases | ||||
| Intervention ICMJE | Procedure: Computertomography-guided marking of colorectal liver metastases
Computertomography-guided marking of colorectal liver metastases |
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| Study Group/Cohort (s) | Marking Liver
Intervention: Procedure: Computertomography-guided marking of colorectal liver metastases |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2012 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01457599 | ||||
| Other Study ID Numbers ICMJE | INS-621000-0274-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kornprat Peter, MD, Medical University of Graz | ||||
| Study Sponsor ICMJE | Medical University of Graz | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Medical University of Graz | ||||
| Verification Date | October 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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