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OpenTrials
Completed

NCT Number: NCT01296217

Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

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

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre René Gauducheau

Nantes, 44805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lymph nod detection

Procedure

Primary outcomes

  1. detection rate and false-negative rate for the sentinel lymph node detection

    Time frame: The day of at laparoscopy (Day 1)

Sponsors and collaborators

Lead sponsor

Centre René Gauducheau

Other

Registry information

Official study title

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

Important dates

First posted
Feb 15, 2011
Registry last updated
Mar 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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