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Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296217
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : March 4, 2011
Sponsor:
Information provided by:
Centre René Gauducheau

Brief Summary:
In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: lymph nod detection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Official Title: "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: lymph nod detection Procedure: lymph nod detection



Primary Outcome Measures :
  1. detection rate and false-negative rate for the sentinel lymph node detection [ Time Frame: The day of at laparoscopy (Day 1) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296217


Locations
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France
Centre René Gauducheau
Nantes, France, 44805
Sponsors and Collaborators
Centre René Gauducheau
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ClinicalTrials.gov Identifier: NCT01296217    
Other Study ID Numbers: BRD 07/11-M
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: February 2011
Keywords provided by Centre René Gauducheau:
Patients with infiltrant prostatic carcinoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases