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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG group | Experimental | ICG injection before LRRP via cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Indocyanine green postive lymph node numbers | total number of dissected lymph nodes which are indocyanine green positive | 15 day after surgery |
| 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 |
| pathology of indocyanine green positive lymph nodes | İndocyanine green positvie lymph nodes are malign or benign | 15 day after surgery |
| pathology of lymph nodes | Pathology of material from conventional extended lymph node dissection | 15 day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah A DemirtaÅŸ, MD, PRof | Contact | +905325094494 | mesane@gmail.com | |
| Åževket TOLGA T Tombul, MD | Contact | 05364774525 | sevkettolgatombul@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Abdullah A DemirtaÅŸ, Md, Prof | TC Erciyes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Ercieys University, Faculty Of Medicine, | Recruiting | Kayseri | 38039 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Prospective single arm study
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |