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
  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:


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 April 16, 2014