Autofluorescence in Surgery for Primary Hyperparathyroidism

NCT06230380 | Recruiting DMC

• 1 other identifier: 1-10-72-121-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to test if autofluorescence imaging (AF) is a useful surgical aid during parathyroidectomy (PTX) for primary hyperthyroidism (PHPT).

Conditions

Hyperparathyroidism, Primary

Outcome Measures

Primary Outcomes (1)

• Operating time

  Time elapsed from skin incision to skin closure in patients who achieve normocalcemia after one operation.

  During surgery

Secondary Outcomes (7)

• Normocalcemia

  2 months

• Extent of surgery

  During surgery

• Number of ioPTH measurements

  During surgery

• ioPTH reduction

  During surgery

• Complications

  1 month

Study Arms (2)

Control group

NO INTERVENTION

Patients will be operated with a standard exploratory PTX, with visual identification of PTGs. Unilateral or bilateral parathyroid exploration will be determined by the surgeon, depending on preoperative imaging and intraoperative findings. Usually, the procedure will be terminated when intraoperative parathyroid hormone (PTH) measurement shows a \>50% decline, after removal of suspected pathological PTGs.

Surgery with EleVision IR camera system

EXPERIMENTAL

Patients randomized to the experimental group will have surgery performed in the exact same manner as in the control group. In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PTGs during surgery. The surgical field will be visualized with AF as a minimum of two times during surgery on each side of the neck: First upon exposing the undersurface of the thyroid gland, and secondly before removal of a pathological PTG. Also, removed PTGs will be examined ex vivo to document AF pattern.

Procedure: Surgery with autofluorescence

Interventions

Surgery with autofluorescence PROCEDURE

In the experimental group, the surgeon will use the EleVision IR camera system (Medtronic, USA) to visualize PTGs during surgery. The surgical field will be visualized with AF as a minimum of two times during surgery on each side of the neck: First upon exposing the undersurface of the thyroid gland, and secondly before removal of a pathological PTG. Also, removed PTGs will be examined ex vivo to document AF pattern.

Surgery with EleVision IR camera system

Eligibility Criteria

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

You may qualify if:

• Age\>18 years and able to give informed consent.
• A diagnosis of PHPT.
• Planned exploratory PTX with ioPTH measurement.

You may not qualify if:

• Concordant high-confidence imaging; planned focused/selective PTX
• Previous thyroid or parathyroid surgery.
• Planned simultaneous thyroid surgery.
• MEN, lithium induced hyperparathyroidism.
• eGFR \< 30.
• Kidney transplant.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Jacob K Lilja-Fischer, MD

CONTACT

+4540460399; jaclil@rm.dk

Lars Rolighed, MD,PhD

CONTACT

larsroli@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Model Details: Randomized, controlled trial.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

DK (1)