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Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Hepatic Metastases

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Trial Information

Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Authority:

Austria: Agency for Health and Food Safety

Study ID:

INS-621000-0274-002

NCT ID:

NCT01457599

Start Date:

July 2011

Completion Date:

December 2012

Related Keywords:

  • Colorectal Hepatic Metastases
  • liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete response
  • Feasibility, safety
  • Neoplasm Metastasis
  • Liver Neoplasms

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