Anesthesia and Cancer Recurrence im Malignant Melanoma

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01588847
• Other study ID #: 02-AnIt-11
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2012
• Last updated: December 10, 2014
• Start date: March 2012
• Est. completion date: March 2019

Study information

• Verified date: December 2014
• Source: University Hospital Muenster
• Contact: Gerhard Brodner, Prof. Dr.
• Phone: +49-251-3287-0
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Procedure:
• Spinal anesthesia with Bupivacaine hyperbar 0.5 %
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
• General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Locations

Country	Name	City	State
Germany	Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		five years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Potential predictive biomarkers	Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively	15 minutes before end of surgery	No
Secondary	Potential predictive biomarkers	Change of potential predictive biomarkers from baseline until 24 hours postoperatively	24 hours postoperatively	No
Secondary	Potential predictive biomarkers	Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively	Five days postoperatively	No