Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

• Status: Recruiting
• Trial end date: 2021-11-08
• Target enrollment: 0
• Participant gender: Male

Summary

Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost.

It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TC Erciyes University
• Collaborator: TC Erciyes University Scientific Research Projects Coordination Unit

Criteria

Inclusion Criteria:

• Histologically confirmed locally limited prostate cancer;

• Intermediate or high risk tumor

• Recommended and planned prostatectomy;

• Completed and signed written consent;

• Voluntarily agreement to participate in this study

• Age of the study participants ≥ 18 years.

Exclusion Criteria:

• Allergic reaction to active ingredient (indocyanine green);

• Iodine allergy;

• Hyperthyroidism;

• High-grade renal impairment;

• High-grade hepatic insufficiency;

• Unwillingness to the storage and disclosure of pseudonymous disease and personal data

• psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question