Identification of the parathyroid glands during surgery

ISRCTN	ISRCTN99868253
DOI	https://doi.org/10.1186/ISRCTN99868253

Submission date: 10/07/2025
Registration date: 16/07/2025
Last edited: 15/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
How to quickly and accurately identify and localize living parathyroid tissue, protect its functional integrity, and reduce the risk of intraoperative parathyroid function damage is a great challenge for clinicians and a technical challenge for researchers in the field of life and health. This study aims to develop methods to accurately identify the parathyroid glands to reduce intraoperative injury.

Who can participate?
Patients aged 18-99 years with parathyroid disorders

What does the study involve?
This study involves real-time detection of parathyroid glands during surgery using autofluorescence.

What are the possible benefits and risks of participating?
Possible benefits of participation: Can effectively prevent damage and misresection of parathyroid glands during the surgery.
The possible risks involved are that the blood stains and the protective film covering the parathyroid gland surface may prevent an accurate identification.

Where is the study run from?
Qingdao University Affiliated Hospital, China

When is the study starting and how long is it expected to run for?
The research started on January 15, 2025 and is expected to last for 6 months.

Who is funding the study?
1. The Shandong Provincial Science and Technology Department
2. The Qingdao Science and Technology Bureau

Who is the main contact?
Dr Sun Jing, sunj@sibet.ac.cnBackground and study aims

Contact information

Dr Jing Sun
Scientific

Building 3, Jinan Yaogu, 100 meters west of Gangxing Third Road, Licheng District
Suzhou
215163
China

ORCID ID	0000-0001-6722-252X
Phone	+86 18253121729
Email	sunj@sibet.ac.cn

Prof Chenyu Jiang
Principal Investigator

Suzhou Institute of Biomedical Engineering and Technology
88 Keling Road, Suzhou City, Jiangsu Province
Suzhou
215163
China

Phone	+86 13402617742
Email	jiangcy@sibet.ac.cn

Dr Binghong Song
Public

Suzhou Institute of Biomedical Engineering and Technology
88 Keling Road, Suzhou City, Jiangsu Province
Suzhou
215163
China

Phone	18253121729
Email	songbh@sibet.ac.cn

Study information

Study design	Observational case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital, Laboratory
Study type	Diagnostic
Scientific title	Real-time detection of parathyroid glands during surgery using a highly sensitive autofluorescence-based system
Study acronym	RDPGs
Study objectives	The laser-induced fluorescence detection system that utilizes the tissue's own fluorescence is more conducive to accurately identifying the parathyroid glands during surgery, thereby reducing intraoperative damage.
Ethics approval(s)	Approved 28/05/2025, Medical Ethics Committee of the Affilliated Hospital of Qingdao University (16 Jiangsu Road, Shinan District, Qingdao, 266000, China; +86 0532 82911869; wanglin@qdu.edu.cn), ref: QYFYEC2024-75
Health condition(s) or problem(s) studied	Accurate identification of the parathyroid glands during surgery
Intervention	After being enrolled, the participants underwent detection intervention using a parathyroid detector and were compared and verified with the gold standard (such as intraoperative rapid pathology or postoperative pathology results, as well as the detection results of the PTeye system). The surgical process strictly followed the methods and procedures outlined in the "Expert Consensus on Parathyroid Protection during Thyroid Surgery". The trial required the test group and the control group to simultaneously identify the suspected parathyroid tissue of the same subject, reach a conclusion on whether it was parathyroid tissue, and record the judgment results and test response times of both groups of tests, and conduct an assessment and analysis of the statistical indicators of the data information. The detection process was carried out during the surgery, and usually lasted for a few hours on the same day. The total duration of observation is the period of intraoperative monitoring and immediate postoperative assessment, which lasts approximately 1 day; the total duration of follow-up is within 7 days after the surgery, used to assess postoperative complications (such as hypocalcemia) or other related adverse events. The entire research process, from enrollment to the last follow-up, lasts approximately 7 days.
Intervention type	Procedure/Surgery
Primary outcome measure	Fluorescence intensity value. The developed parathyroid detection instrument based on fluorescence-induced spectroscopy technology measured during each surgical procedure
Secondary outcome measures	Fluorescence intensity value. Fluorescence-induced laser spectroscopy technique by PTeye system during each surgical procedure
Overall study start date	20/12/2024
Completion date	05/07/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Both
Target number of participants	150
Total final enrolment	106
Key inclusion criteria	1. Thyroid diseases 2. Aged between 18 and 99
Key exclusion criteria	Secondary hyperparathyroidism
Date of first enrolment	05/04/2025
Date of final enrolment	01/07/2025

Locations

Countries of recruitment

China

Study participating centre

Qingdao University Affiliated Hospital

No. 59, Haier Road, Laishan District
Qingdao City, Shandong Province
266100
China

Sponsor information

Department of Science and Technology of Shandong Province
Government

No. 607, Shunhua Road, High-tech Zone
Jinan City, Shandong Province
250101
China

Phone	+86 0531-51751020
Email	yuxiaolin@jn.shandong.cn
Website	http://kjt.shandong.gov.cn/index.html
"ROR"	https://ror.org/01b9fvd84

Funders

Funder type

Government

Science and Technology Bureau of Qingdao City, Shandong Province
Government organisation / Local government

Alternative name(s): Qingdao Science and Technology Bureau, Qingdao Municipal Science and Technology Commission, 青岛市科学技术局
Location: China

Results and Publications

Intention to publish date	10/10/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated and/or analyzed during the current study will be provided upon request from Jing Sun, sunj@sibet.ac.cn • Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences songyuxiao@sibet.ac.cn • Individual participant data that under liethe results reported in this article, after deidentification (text,tables,figures, andappendices). • Beginning 9 months and ending 36 months following article publication.

Editorial Notes

10/07/2025: Study's exitence confirmed by the Medical Ethics Committee of the Affilliated Hospital of Qingdao University.