Anesthesia and Cancer Recurrence im Malignant Melanoma | NCT01588847

Studies
Anesthesia and Cancer Recurrence im Malignant Melanoma

NCT01588847

Sponsor

University Hospital Muenster

Status

Unknown status

Last Update Posted

Dec 11, 2014Estimated

Enrollment

230Estimated

Phase

Not Applicable

Conditions

Malignant Melanoma

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Mar 13, 2012

First Submission Date that Met QC Criteria

Apr 30, 2012

First Posted Date

May 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regional anesthesia	Experimental		Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %
General anesthesia	Active Comparator		Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinal anesthesia with Bupivacaine hyperbar 0.5 %	Procedure	Spinal anesthesia with Bupivacaine hyperbar 0.5 %	Regional anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		five years

Secondary Outcomes

Measure	Description	Time Frame
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
Changes of the total amount of immune cells

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gerhard Brodner, Prof. Dr.	Contact	+49-251-3287-0

Overall Officials

Name	Affiliation	Role
Hugo K Van Aken, MD PhD	University Hospital Muenster, Department of Anesthesia, Intensive Care and Pain Therapy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy	Recruiting	Münster		D-48157	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000775	Anesthesia, Spinal
D000765	Anesthesia, Conduction
D000768	Anesthesia, General
D017409	Sufentanil
D015742	Propofol
D000077123	Rocuronium
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia
D005283	Fentanyl
D010880	Piperidines

Browse Leaves

Not provided

Browse Branches

Not provided