Near-infrared Autofluorescence (NIRAF) in Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Centers

Sponsor

Regional Hospital West Jutland (Other)

Overall Status

Recruiting

CT.gov ID

NCT05043584

Collaborator

Hospital of South West Jutland (Other)

Enrollment

Locations

Arm

29.5

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid centers.

Condition or Disease	Intervention/Treatment	Phase
Autofluorescence Thyroidectomy Hypoparathyroidism Hypocalcemia	Device: Fluobeam LX	N/A

Detailed Description

Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX).

PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and 6 months following surgery. The rates of transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective cohort studyProspective cohort study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Postoperative Hypoparathyroidism Following Thyroid Surgery by Using Intraoperative Autofluorescence

Actual Study Start Date :

Sep 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (A): NIRAF-assisted surgery Patients undergoing NIRAF-assisted total thyroidectomy	Device: Fluobeam LX See arm description

Arm

Intervention/Treatment

Experimental: (A): NIRAF-assisted surgery

Patients undergoing NIRAF-assisted total thyroidectomy

Device: Fluobeam LX

See arm description

Outcome Measures

Primary Outcome Measures

Rate of permanent hypoparathyroidism [Will be assessed one year following surgery]

Secondary Outcome Measures

Rate of transient hypoparathyroidism [Will be assessed one year following surgery]
Parathyroid identification rate [Will be assessed at the time of surgery]
Autoimplantation rate [Will be assessed at the time of surgery]
Rate of inadvertently excised parathyroid glands [Will be assessed 1 month following surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients referred for total thyroidectomy
Age > 18
Able to understand patient information
Able to give informed consent

Exclusion Criteria:

Completion lobectomy
Need for accelerated surgery
Insufficient biochemical profile

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Otorhinolaryngology, Hospital South West Jutland	Esbjerg		Denmark	6700
2	Department of Otorhinolaryngology, Regional Hospital West Jutland	Holstebro		Denmark	7500

Sponsors and Collaborators

Regional Hospital West Jutland
Hospital of South West Jutland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Abood, MD, Regional Hospital West Jutland

ClinicalTrials.gov Identifier:

NCT05043584

Other Study ID Numbers:

Autofluorescence1.0

First Posted:

Sep 14, 2021

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypocalcemia

Hypoparathyroidism

Study Results

No Results Posted as of Sep 21, 2021