Anesthesia and Cancer Recurrence im Malignant Melanoma
This study is currently recruiting participants.
Verified March 2012 by University Hospital Muenster
Sponsor:
University Hospital Muenster
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01588847
First received: March 13, 2012
Last updated: April 30, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Malignant Melanoma |
Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 % Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Propofol
Bupivacaine hydrochloride
Sevoflurane
Bupivacaine
Sufentanil citrate
Rocuronium bromide
Rocuronium
U.S. FDA Resources
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- Overall survival [ Time Frame: five years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes of the total amount of immune cells [ Time Frame: 15 minutes before end of surgery ] [ Designated as safety issue: No ]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 [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]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 [ Time Frame: Five days postoperatively ] [ Designated as safety issue: No ]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 [ Time Frame: 15 minutes before end of surgery ] [ Designated as safety issue: No ]Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
- Potential predictive biomarkers [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]Change of potential predictive biomarkers from baseline until 24 hours postoperatively
- Potential predictive biomarkers [ Time Frame: Five days postoperatively ] [ Designated as safety issue: No ]Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
| Estimated Enrollment: | 230 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | March 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Regional anesthesia |
Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Other Name: Regional anesthesia
|
| Active Comparator: General anesthesia |
Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Other Name: 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588847
Contacts
| Contact: Gerhard Brodner, Prof. Dr. | +49-251-3287-0 |
Locations
| Germany | |
| Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy | Recruiting |
| Münster, Germany, D-48157 | |
| Contact: Gerhard Brodner, MD PhD | |
Sponsors and Collaborators
University Hospital Muenster
Investigators
| Study Chair: | Hugo K Van Aken, MD PhD | University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy |
More Information
No publications provided
| Responsible Party: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT01588847 History of Changes |
| Other Study ID Numbers: | 02-AnIt-11 |
| Study First Received: | March 13, 2012 |
| Last Updated: | April 30, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Muenster:
|
perioperative immunoediting potential predictive biomarkers lymph node dissection |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Anesthetics Bupivacaine Propofol Sevoflurane Sufentanil Rocuronium Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013