Identification of the parathyroid glands during surgery
| ISRCTN | ISRCTN99868253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99868253 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Department of Science and Technology of Shandong Province |
| Funder | Science and Technology Bureau of Qingdao City, Shandong Province |
- 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
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
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 |
| sunj@sibet.ac.cn |
Principal investigator
Suzhou Institute of Biomedical Engineering and Technology
88 Keling Road, Suzhou City, Jiangsu Province
Suzhou
215163
China
| Phone | +86 13402617742 |
|---|---|
| jiangcy@sibet.ac.cn |
Public
Suzhou Institute of Biomedical Engineering and Technology
88 Keling Road, Suzhou City, Jiangsu Province
Suzhou
215163
China
| Phone | 18253121729 |
|---|---|
| songbh@sibet.ac.cn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational case-control study |
| Secondary study design | Case-control study |
| 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(s) |
Fluorescence intensity value. The developed parathyroid detection instrument based on fluorescence-induced spectroscopy technology measured during each surgical procedure |
| Key secondary outcome measure(s) |
Fluorescence intensity value. Fluorescence-induced laser spectroscopy technique by PTeye system during each surgical procedure |
| Completion date | 05/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 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 City, Shandong Province
266100
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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.
