Clinical trial NCT04882618: Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
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)?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prostate Cancer
Lymph Node Metastases
Keywords: indocyanine green based fluorescence imaging
extendend lymph node dissection
prostate cancer
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single arm study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Indocyanine green postive lymph node numbers
timeFrame: 15 day after surgery
measure: Total lymph node numbers of conventional extended lymph node dissection
timeFrame: 15 day after surgery
measure: pathology of indocyanine green positive lymph nodes
timeFrame: 15 day after surgery
measure: pathology of lymph nodes
timeFrame: 15 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Ercieys University, Faculty Of Medicine,
Study officials:
affiliation: TC Erciyes University
name: Abdullah A Demirtaş, Md, Prof
role: PRINCIPAL_INVESTIGATOR
References: