We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296217
First Posted: February 15, 2011
Last Update Posted: March 4, 2011
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.
Information provided by:
Centre René Gauducheau
  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) ]

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
France
Centre René Gauducheau
Nantes, France, 44805
Sponsors and Collaborators
Centre René Gauducheau
  More Information

ClinicalTrials.gov Identifier: NCT01296217     History of Changes
Other Study ID Numbers: BRD 07/11-M
First Submitted: February 11, 2011
First Posted: February 15, 2011
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases