Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

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)?

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?

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Lymph Node Metastases
• Intervention / Treatment: Drug: Indocyanine green

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abdullah A Demirtaş, MD, PRof; Phone Number: +905325094494; Email: mesane@gmail.com
• Study Contact Backup: Name: Şevket TOLGA T Tombul, MD; Phone Number: 05364774525; Email: sevkettolgatombul@hotmail.com

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Recruiting
    • Department of Urology, Ercieys University, Faculty Of Medicine,
    • Contact: Abdullah Demirtas, MD; Phone Number: +905325094494; Email: mesane@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG group; ICG injection before LRRP via cystoscopy	Drug: Indocyanine green; indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy; Other Names: Conventional ELND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Abdullah A Demirtaş, Md, Prof, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Anticipated): November 8, 2021
• Study Completion (Anticipated): November 8, 2021

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; indocyanine green based fluorescence imaging; extendend lymph node dissection
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Prostatic Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: TSA-2019-9393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No