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Anesthesia and Cancer Recurrence im Malignant Melanoma

Primary Purpose

Malignant Melanoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring perioperative immunoediting, potential predictive biomarkers, lymph node dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regional anesthesia

General anesthesia

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

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
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
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
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 24 hours postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively

Full Information

First Posted
March 13, 2012
Last Updated
December 10, 2014
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT01588847
Brief Title
Anesthesia and Cancer Recurrence im Malignant Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
perioperative immunoediting, potential predictive biomarkers, lymph node dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia
Arm Type
Experimental
Arm Title
General anesthesia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Other Intervention Name(s)
Regional anesthesia
Intervention Description
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Intervention Type
Procedure
Intervention Name(s)
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Other Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
five years
Secondary Outcome Measure Information:
Title
Changes of the total amount of immune cells
Description
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
Time Frame
15 minutes before end of surgery
Title
Changes of the total amount of immune cells
Description
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
Time Frame
24 hours postoperatively
Title
Changes of the total amount of immune cells
Description
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
Time Frame
Five days postoperatively
Title
Potential predictive biomarkers
Description
Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
Time Frame
15 minutes before end of surgery
Title
Potential predictive biomarkers
Description
Change of potential predictive biomarkers from baseline until 24 hours postoperatively
Time Frame
24 hours postoperatively
Title
Potential predictive biomarkers
Description
Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
Time Frame
Five days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Brodner, Prof. Dr.
Phone
+49-251-3287-0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo K Van Aken, MD PhD
Organizational Affiliation
University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
City
Münster
ZIP/Postal Code
D-48157
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Brodner, MD PhD

12. IPD Sharing Statement

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Anesthesia and Cancer Recurrence im Malignant Melanoma

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