Prostate Cancer Clinical Trial
Official title:
Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?
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?
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 8, 2021 |
Est. primary completion date | November 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Department of Urology, Ercieys University, Faculty Of Medicine, | Kayseri |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indocyanine green postive lymph node numbers | total number of dissected lymph nodes which are indocyanine green positive | 15 day after surgery | |
Primary | Total lymph node numbers of conventional extended lymph node dissection | total number of dissected lymph nodes during conventional extended lymph node dissection | 15 day after surgery | |
Primary | pathology of indocyanine green positive lymph nodes | Indocyanine green positvie lymph nodes are malign or benign | 15 day after surgery | |
Primary | pathology of lymph nodes | Pathology of material from conventional extended lymph node dissection | 15 day after surgery |
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