Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

March 3, 2011 updated by: Centre René Gauducheau

"Evaluation of the Sentinel Lymph Node Technic of the Prostate by Laparoscopy"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44805
        • Centre René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lymph nod detection
Procedure: lymph nod detection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre René Gauducheau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 07/11-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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