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

TC Erciyes University

Status and phase: Unknown; Phase 4

Conditions: Lymph Node Metastases; Prostate Cancer

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT04882618

TSA-2019-9393

Details and patient eligibility

About

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?

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ICG group

Experimental group

Description:

ICG injection before LRRP via cystoscopy

Treatment:

Drug: Indocyanine green