Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
NCT ID: NCT04882618
Last Updated: 2021-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2019-11-08
2021-11-08
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICG group
ICG injection before LRRP via cystoscopy
Indocyanine green
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
Interventions
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Indocyanine green
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Abdullah Demirtas
MD, Professor in Urology
Principal Investigators
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Abdullah A Demirtaş, Md, Prof
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
Locations
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Department of Urology, Ercieys University, Faculty Of Medicine,
Kayseri, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSA-2019-9393
Identifier Type: -
Identifier Source: org_study_id
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