Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial

NCT05044351 | Completed

• 1 other identifier: Autofluorescence2.0
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation. In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed: Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.

Conditions

Autofluorescence; Thyroidectomy; Autotransplantation

Outcome Measures

Primary Outcomes (1)

• Parathyroid gland identification rate

  Will be assessed at the time of surgery

Secondary Outcomes (2)

• Rate of inadvertent parathyroid excision

  Will be assessed one month following surgery

• Rate of autotransplantation

  Will be assessed at the time of surgery

Study Arms (2)

(A): NIRAF-assisted surgery

EXPERIMENTAL

Patients undergoing NIRAF-assisted hemithyroidectomy

Device: Fluobeam LX

(B): Conventional surgery

ACTIVE COMPARATOR

Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

Other: Conventional surgery without NIRAF assistance

Interventions

Fluobeam LX DEVICE

See arm description

(A): NIRAF-assisted surgery

Conventional surgery without NIRAF assistance OTHER

Patients undergoing conventional hemithyroidectomy without NIRAF-assistance

(B): Conventional surgery

Eligibility Criteria

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

You may qualify if:

• Patients referred for thyroid lobectomy
• Age \> 18
• Able to understand patient information
• Able to give informed consent

You may not qualify if:

• Completion lobectomy
• Need for accelerated surgery
• Age \< 18
• Unable to understand patient information
• Unable to give informed consent

Sponsors & Collaborators

• Regional Hospital West Jutland: lead

Study Sites (1)

Department of Otorhinolaryngology, Regional Hospital West Jutland

Holstebro, 7500, Denmark

Location

Related Publications (1)

• Abood A, Rolighed L, Ovesen T, Madsen SH, Vestergaard P, Triponez F. Autofluorescence-guided hemithyroidectomy in a low-volume thyroid institution with no experience in parathyroid surgery: randomized clinical trial. Br J Surg. 2024 Apr 3;111(4):znae075. doi: 10.1093/bjs/znae075.

  PMID: 38573333 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and related health care staff will be blinded for the allocated intervention until the day of surgery
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: September 15, 2021
• Primary Completion: September 16, 2023
• Study Completion: October 16, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)