Computertomography-guided Wire Marking of the Liver

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01457599
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : August 16, 2016
Information provided by (Responsible Party):
Kornprat Peter, MD, Medical University of Graz

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.

Condition or disease Intervention/treatment
Secondary Malignant Neoplasm of Liver Procedure: Computertomography-guided marking of colorectal liver metastases

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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study
Study Start Date : July 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Group/Cohort Intervention/treatment
Marking Liver Procedure: Computertomography-guided marking of colorectal liver metastases
Computertomography-guided marking of colorectal liver metastases

Primary Outcome Measures :
  1. Sensitivity [ Time Frame: One Year ]
    Sensitivity of wire marking to find liver metastases with complete response to neoadjuvant chemotherapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic

Inclusion Criteria:

  • Histologic verified cancer of the colon and rectum with metastases into the liver
  • Neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm.
  • Technically Resectability
  • Age ≥ 18 Years
  • Written informed consent

Exclusion Criteria:

  • Age < 18 Years
  • Technically Irresectability
  • Neoadjuvant chemotherapy and response of metastases, however with a diameter > 1 cm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01457599

Department of Surgery
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz

Responsible Party: Kornprat Peter, MD, MD, Medical University of Graz Identifier: NCT01457599     History of Changes
Other Study ID Numbers: INS-621000-0274-002
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kornprat Peter, MD, Medical University of Graz:
liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete response
Feasibility, safety

Additional relevant MeSH terms:
Neoplasms, Second Primary
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts