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

NCT06779760 | Completed

• 1 other identifier: NIRAF MIVAP study
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

primary hyperparathyroidism; parathyroid adenoma; near-infrared autofluorescence; minimally invasive parathyroidectomy

Outcome Measures

Primary Outcomes (1)

• patterns of autofluorescence in parathyroid adenomas

  during surgery

Secondary Outcomes (3)

• specific autofluorescence patterns correlated with the dominant cell type of a parathyroid adenoma

  during surgery

• specific autofluorescence patterns correlated with adenoma size

  during surgery

• specific autofluorescence patterns correlated with adenoma location

  during surgery

Interventions

parathyroidectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with parathyroid adenoma undergoing surgery and age \>18 years old

You may qualify if:

• patients diagnosed with parathyroid adenoma undergoing surgery

You may not qualify if:

• patients \<18 years old

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• The Hashemite University: collaborator

Study Sites (1)

the Hashemite Univesity

Zarqa, Jordan

Location

Related Publications (1)

• Bakkar S, Chorti A, Papavramidis T, Donatini G, Miccoli P. Assessing the feasibility of near infrared autofluorescence imaging in minimally-invasive video assisted parathyroidectomy and the autofluorescence signature of parathyroid adenomas. A single center surgical case series. Surg Endosc. 2025 May;39(5):2964-2972. doi: 10.1007/s00464-025-11675-8. Epub 2025 Mar 21.

  PMID: 40119064 DERIVED

MeSH Terms

Conditions

Parathyroid Neoplasms; Hyperparathyroidism, Primary

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: January 17, 2025
• Study Start: September 20, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 20, 2024
• Last Updated: January 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)