18 Years
N/A
Both
Hepatic Metastases, Colorectal Cancer
Trial Information
Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver
metastases may improve outcome of further patients due to the presence of micrometastases
that have been shown to be of prognostic relevance. While previous studies highlight the
clinical significance of perihepatic lymph node metastases, the outcome of patients with and
without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about
the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of
liver metastases can be drawn from present data.
As disease recurrence occurs frequently and may affect up to 75 % of patients, further
strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may
offer an effective approach to remove residual disease and by this to reduce disease
recurrence with little additional morbidity. For this reason it is the aim of the present
prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent
disease in patients undergoing resection of colorectal liver metastases.
Inclusion Criteria:
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma
skin cancer
- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for ≥ 5 years prior to randomisation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
rate of disease recurrence
Outcome Time Frame:
2 years after surgery
Safety Issue:
Yes
Principal Investigator
Jürgen Weitz, MD, MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg
Authority:
Germany: Ethics Commission
Study ID:
NNR-5
NCT ID:
NCT01073358
Start Date:
February 2010
Completion Date:
October 2014
Related Keywords:
- Hepatic Metastases
- Colorectal Cancer
- resectable hepatic metastases of colorectal cancer
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
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