Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy
NCT ID: NCT04424485
Last Updated: 2020-06-11
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
NA
100 participants
INTERVENTIONAL
2020-06-01
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy
Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC)
Standard TT+CLND procedure only
Total thyroidectomy (TT)
Standard TT procedure for thyroid carcinoma, for both groups
Central lymph node dissection (CLND)
Standard CLND for thyroid carcinoma, for both groups
Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node
Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG
Total thyroidectomy (TT)
Standard TT procedure for thyroid carcinoma, for both groups
Central lymph node dissection (CLND)
Standard CLND for thyroid carcinoma, for both groups
Sentinel lymph node (SLN) bopsy
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Identification of parathyroid glands (PGs)
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Interventions
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Total thyroidectomy (TT)
Standard TT procedure for thyroid carcinoma, for both groups
Central lymph node dissection (CLND)
Standard CLND for thyroid carcinoma, for both groups
Sentinel lymph node (SLN) bopsy
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Identification of parathyroid glands (PGs)
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
Eligibility Criteria
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Inclusion Criteria
* Patients at or over 17 years
Exclusion Criteria
* Patients below 17 years
17 Years
80 Years
ALL
No
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic
A. Prof. of General Surgery and Surgical Oncology
Locations
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Umraniye Education and Research Hospital, Department of General Surgery
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof.
Role: CONTACT
Facility Contacts
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Ethem Unal, MD, PhD, A. Prof. of Surgery & Surgical Oncology
Role: primary
References
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Zhang X, Shen YP, Li JG, Chen G. Clinical feasibility of imaging with indocyanine green combined with carbon nanoparticles for sentinel lymph node identification in papillary thyroid microcarcinoma. Medicine (Baltimore). 2019 Sep;98(36):e16935. doi: 10.1097/MD.0000000000016935.
Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
Related Links
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Other Identifiers
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B.10.1.TKH.4.34.H.GP.0.01/213
Identifier Type: -
Identifier Source: org_study_id
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