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

Prostate Cancer Clinical Trial

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)?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882618
• Other study ID #: TSA-2019-9393
• Status: Recruiting
• Phase: Phase 4
• Start date: November 8, 2019
• Est. completion date: November 8, 2021

Study information

• Verified date: May 2021
• Source: TC Erciyes University
• Contact: Abdullah A Demirtas, MD, PRof
• Phone: +905325094494
• Email: mesane[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Indocyanine green
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy

Locations

Country	Name	City	State
Turkey	Department of Urology, Ercieys University, Faculty Of Medicine,	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indocyanine green postive lymph node numbers	total number of dissected lymph nodes which are indocyanine green positive	15 day after surgery
Primary	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
Primary	pathology of indocyanine green positive lymph nodes	Indocyanine green positvie lymph nodes are malign or benign	15 day after surgery
Primary	pathology of lymph nodes	Pathology of material from conventional extended lymph node dissection	15 day after surgery