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Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

This study has been completed.
Sponsor:
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01296217
First received: February 11, 2011
Last updated: March 3, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention
Prostatic Neoplasms
 Procedure: lymph nod detection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: "Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre René Gauducheau:

Primary Outcome Measures:
  • detection rate and false-negative rate for the sentinel lymph node detection [ Time Frame: The day of at laparoscopy (Day 1) ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Arms Assigned Interventions
Experimental: lymph nod detection Procedure: lymph nod detection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296217

Locations
France
Centre René Gauducheau
Nantes, France, 44805
Sponsors and Collaborators
Centre René Gauducheau
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01296217     History of Changes
Other Study ID Numbers: BRD 07/11-M
Study First Received: February 11, 2011
Last Updated: March 3, 2011
Health Authority: France : AFSSAPS

Keywords provided by Centre René Gauducheau:
Patients with infiltrant prostatic carcinoma

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013