Long-term Outcome After Radical Lymph Node Dissection of Malignant Melanoma. Comparison Between Regional Versus General Anesthesia With Respect to Impact of Perioperative Immunoediting and Validation of New Potential Predictive Biomarkers
18 Years
N/A
Both
Malignant Melanoma
Trial Information
Long-term Outcome After Radical Lymph Node Dissection of Malignant Melanoma. Comparison Between Regional Versus General Anesthesia With Respect to Impact of Perioperative Immunoediting and Validation of New Potential Predictive Biomarkers
Results of basic science indicate that regional anesthesia prevents perioperative
immunosuppression and reduces postoperative metastatic cancer dissemination. If this would
occur in humans, optimised anesthetic management might improve long-term outcome after
cancer surgery.
Inclusion Criteria:
- Patients scheduled for inguinal lymph node dissection because of malignant melanoma
of the lower limb
- Signed informed consent
Exclusion Criteria:
- Age < 18 years
- Female patients who are pregnant or nursing
- Multiple organ failure
- Contraindications
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
five years
Safety Issue:
No
Principal Investigator
Hugo K Van Aken, MD PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
Authority:
Germany: Ethics Commission
Study ID:
02-AnIt-11
NCT ID:
NCT01588847
Start Date:
March 2012
Completion Date:
March 2019
Related Keywords:
- Malignant Melanoma
- perioperative immunoediting
- potential predictive biomarkers
- lymph node dissection
- Melanoma
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