Anesthesia and Cancer Recurrence im Malignant Melanoma
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
1 other identifier
interventional
230
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedDecember 11, 2014
December 1, 2014
7 years
March 13, 2012
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
five years
Secondary Outcomes (6)
Changes of the total amount of immune cells
15 minutes before end of surgery
Changes of the total amount of immune cells
24 hours postoperatively
Changes of the total amount of immune cells
Five days postoperatively
Potential predictive biomarkers
15 minutes before end of surgery
Potential predictive biomarkers
24 hours postoperatively
- +1 more secondary outcomes
Study Arms (2)
Regional anesthesia
EXPERIMENTALGeneral anesthesia
ACTIVE COMPARATORInterventions
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Eligibility Criteria
You may qualify if:
- Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
- Signed informed consent
You may not qualify if:
- Age \< 18 years
- Female patients who are pregnant or nursing
- Multiple organ failure
- Contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
Münster, D-48157, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hugo K Van Aken, MD PhD
University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
May 1, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
December 11, 2014
Record last verified: 2014-12