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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04882618
Other study ID # TSA-2019-9393
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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