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

Sponsor
TC Erciyes University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04882618
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine green
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective single arm studyProspective single arm study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)?
Actual Study Start Date :
Nov 8, 2019
Anticipated Primary Completion Date :
Nov 8, 2021
Anticipated Study Completion Date :
Nov 8, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Indocyanine green postive lymph node numbers [15 day after surgery]

      total number of dissected lymph nodes which are indocyanine green positive

    2. Total lymph node numbers of conventional extended lymph node dissection [15 day after surgery]

      total number of dissected lymph nodes during conventional extended lymph node dissection

    3. pathology of indocyanine green positive lymph nodes [15 day after surgery]

      İndocyanine green positvie lymph nodes are malign or benign

    4. pathology of lymph nodes [15 day after surgery]

      Pathology of material from conventional extended lymph node dissection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Ercieys University, Faculty Of Medicine, Kayseri Turkey 38039

    Sponsors and Collaborators

    • TC Erciyes University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abdullah Demirtas, MD, Professor in Urology, TC Erciyes University
    ClinicalTrials.gov Identifier:
    NCT04882618
    Other Study ID Numbers:
    • TSA-2019-9393
    First Posted:
    May 12, 2021
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abdullah Demirtas, MD, Professor in Urology, TC Erciyes University
    indocyanine green based fluorescence imaging
    extendend lymph node dissection
    prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Lymphatic Metastasis

    Study Results

    No Results Posted as of May 12, 2021