Lymph Node Metastases, Prostate Cancer
Conditions
Keywords
indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer
Brief 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?
Detailed description
50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study. Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy. Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately. Positive LN yield pf ICG guided LND and conventional LND is compared.
Interventions
DRUGIndocyanine green
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
Sponsors
TC Erciyes University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single arm study
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indocyanine green postive lymph node numbers | 15 day after surgery | total number of dissected lymph nodes which are indocyanine green positive |
| Total lymph node numbers of conventional extended lymph node dissection | 15 day after surgery | total number of dissected lymph nodes during conventional extended lymph node dissection |
| pathology of indocyanine green positive lymph nodes | 15 day after surgery | İndocyanine green positvie lymph nodes are malign or benign |
| pathology of lymph nodes | 15 day after surgery | Pathology of material from conventional extended lymph node dissection |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAbdullah A Demirtaş, MD, PRof
Backup ContactŞevket TOLGA T Tombul, MD
Outcome results
None listed