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Near Infrared Autofluorescence Imaging in Minimally-Invasive Video-Assisted Parathyroidectomy (NIRAF MIVAP Study)

NCT06779760 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2025-01-17

No results posted yet for this study

Summary

The role of near-infrared autofluorescence (NIRAF)-imaging as an adjunct in thyroid surgery is well established. However, its diagnostic role in hyperparathyroidism surgery is yet to be defined due to the lack of consensus regarding the autofluorescence (AF) pattern of pathological parathyroid glands. Furthermore, its utility via a direct minimal access has not been assessed.

To assess the AF pattern of parathyroid adenomas (PAs) utilizing NIRAF-imaging in minimally invasive video-assisted parathyroidectomy (MIVAP).

The clinical records of patients who underwent MIVAP for hyperparathyroidism between February and October 2024 were retrospectively reviewed. The primary endpoint was to assess the AF pattern of PAs. Secondary endpoints included the feasibility of applying NIRAF imaging in MIVAP and whether certain AF patterns of PAs correlated with cell type, size, and/or location. Furthermore, operative-time and cost implications were assessed.

Conditions

  • Primary Hyperparathyroidism Due to Adenoma

Interventions

PROCEDURE

parathyroidectomy

The FLUOBEAM® LX apparatus consists of a camera with a built-in light emitter (750-800 nm) and detector (800-830 nm) connected to a processor with an indication-oriented software (Fluosoft®). The processor captures the emitted light, allowing display of PTG images in real time. The camera is placed in a sterile sheath and is held perpendicularly at 8 cm from the target tissue with operating lights, all background lights, and any ambient light being extinguished. The reported depth of tissue penetration of near-infrared light is limited to a maximum of 3 mm only with no observed differences between superior and inferior PTGs \[10\]. This highlights the importance of a major surgical technical point "reaching the correct plane of dissection" namely, the pre-vertebral fascia to maximize the chances of eliciting an adequate signal from parathyroid tissue. The correct application of the technology has demonstrated a success rate of signal elicitation of 90%-100% \[11\]. The ability of near-infr

Sponsors & Collaborators

  • The Hashemite University

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2024-10-15
Completion
2024-10-20

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779760 on ClinicalTrials.gov