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)?
Overview
- Phase
- Phase 4
- Sponsor
- TC Erciyes University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- pathology of indocyanine green positive lymph nodes
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
ICG group
ICG injection before LRRP via cystoscopy
Intervention: Indocyanine green (Drug)
Outcomes
Primary Outcomes
pathology of indocyanine green positive lymph nodes
Time Frame: 15 day after surgery
İndocyanine green positvie lymph nodes are malign or benign
Total lymph node numbers of conventional extended lymph node dissection
Time Frame: 15 day after surgery
total number of dissected lymph nodes during conventional extended lymph node dissection
pathology of lymph nodes
Time Frame: 15 day after surgery
Pathology of material from conventional extended lymph node dissection
Indocyanine green postive lymph node numbers
Time Frame: 15 day after surgery
total number of dissected lymph nodes which are indocyanine green positive
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdullah Demirtas
MD, Professor in Urology
TC Erciyes University