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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01588847

Enrollment

230

Registered

2012-05-01

Start date

2012-03-31

Completion date

2019-03-31

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

perioperative immunoediting, potential predictive biomarkers, lymph node dissection

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.

Interventions

PROCEDURESpinal anesthesia with Bupivacaine hyperbar 0.5 %

Spinal anesthesia with Bupivacaine hyperbar 0.5 %

PROCEDUREGeneral anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall survival	five years

Secondary

Measure	Time frame	Description
Changes of the total amount of immune cells	15 minutes before end of surgery	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
Potential predictive biomarkers	15 minutes before end of surgery	Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively

Countries

Germany

Contacts

Primary ContactGerhard Brodner, Prof. Dr.

+49-251-3287-0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026