Computertomography-guided Wire Marking of the Liver

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Kornprat Peter, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01457599
First received: October 18, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention
Colorectal Hepatic Metastases
Procedure: Computertomography-guided marking of colorectal liver metastases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Sensitivity [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Sensitivity of wire marking to find liver metastases with complete response to neoadjuvant chemotherapy


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Marking Liver Procedure: Computertomography-guided marking of colorectal liver metastases
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Tertiary care clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457599

Contacts
Contact: Peter Kornprat, MD +43/316/385/12755 peter.kornprat@medunigraz.at

Locations
Austria
Department of Surgery Recruiting
Graz, Styria, Austria, 8036
Contact: Peter Kornprat, MD, Clinical Professor    +43/316/385/12755    peter.kornprat@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
  More Information

No publications provided

Responsible Party: Kornprat Peter, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01457599     History of Changes
Other Study ID Numbers: INS-621000-0274-002
Study First Received: October 18, 2011
Last Updated: June 2, 2014
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 28, 2014