Anesthesia and Cancer Recurrence im Malignant Melanoma

Study Overview
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Brief Summary
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Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination. The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

Detailed Description
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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.

Official Title
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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

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
* Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional anesthesia<br> | Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %<br>* Spinal anesthesia with Bupivacaine hyperbar 0.5 %<br>* Other names: Regional anesthesia;|
| Active Comparator: General anesthesia<br> | Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane<br>* General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane<br>* Other names: General anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the total amount of immune cells | Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgery | 15 minutes before end of surgery | 
| Changes of the total amount of immune cells | Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively | 24 hours postoperatively | 
| Changes of the total amount of immune cells | Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively | Five days postoperatively | 
| Potential predictive biomarkers | Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively | 15 minutes before end of surgery | 
| Potential predictive biomarkers | Change of potential predictive biomarkers from baseline until 24 hours postoperatively | 24 hours postoperatively | 
| Potential predictive biomarkers | Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively | Five days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative immunoediting, potential predictive biomarkers, lymph node dissection