Sentinel Lymph Node Detection in Prostate Surgery by Lapa... | NCT01296217

Studies
Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

NCT01296217

Sponsor

Centre René Gauducheau

Status

Completed

Last Update Posted

Mar 4, 2011Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Prostatic Neoplasms

Interventions

lymph nod detection

Countries

France

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 11, 2011

First Submission Date that Met QC Criteria

Feb 14, 2011

First Posted Date

Feb 15, 2011Estimated

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

Mar 3, 2011

Last Update Posted Date

Mar 4, 2011Estimated

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

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

24Estimated

Label	Type	Description	Intervention Names
lymph nod detection	Experimental		Procedure: lymph nod detection

Name	Type	Description	Arm Group Labels	Other Names
lymph nod detection	Procedure		lymph nod detection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection rate and false-negative rate for the sentinel lymph node detection		The day of at laparoscopy (Day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age> 18 years
Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
PSA ≥ 4,
Gleason ≥ 6
No treatment prior to surgery
Indication of lymphadenectomy by coeliscopique
ECOG or Karnofsky index 2
Patient information and signed informed consent

Exclusion Criteria:

neoadjuvant hormone therapy
Interventions prior pelvic
Patients who received anterior resection of part of prostate
Patient or denied having an altered mental status
Any contre indication to laparoscopy

Accepts Healthy Volunteers

Sex

Male

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

Facility	Status	City	State	ZIP	Country	Contacts
Centre René Gauducheau		Nantes		44805	France

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided