Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
- Registration Number
- NCT04882618
- Lead Sponsor
- TC Erciyes University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 50
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICG group Indocyanine green ICG injection before LRRP via cystoscopy
- Primary Outcome Measures
Name Time Method pathology of indocyanine green positive lymph nodes 15 day after surgery İndocyanine green positvie lymph nodes are malign or benign
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 lymph nodes 15 day after surgery Pathology of material from conventional extended lymph node dissection
Indocyanine green postive lymph node numbers 15 day after surgery total number of dissected lymph nodes which are indocyanine green positive
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Urology, Ercieys University, Faculty Of Medicine,
🇹🇷Kayseri, Turkey