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

NCT04882618 | Unknown Phase 4

• 1 other identifier: TSA-2019-9393
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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?

Conditions

Prostate Cancer; Lymph Node Metastases

Keywords

indocyanine green based fluorescence imaging; extendend lymph node dissection; prostate cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

ICG group

EXPERIMENTAL

ICG injection before LRRP via cystoscopy

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

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

Also known as: Conventional ELND

ICG group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine,

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Abdullah A Demirtaş, Md, Prof

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah A Demirtaş, MD, PRof

CONTACT

+905325094494; mesane@gmail.com

Şevket TOLGA T Tombul, MD

CONTACT

05364774525; sevkettolgatombul@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor in Urology

Model Details: Prospective single arm study

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: May 12, 2021
• Study Start: November 8, 2019
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)