Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
1 other identifier
interventional
200
1 country
1
Brief Summary
This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedStudy Start
First participant enrolled
October 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedSeptember 23, 2020
September 1, 2020
1 year
August 29, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Serum Calcium level
Patients' serum Calcium level at 24 hours after surgery.
24 hours after surgery
Serum Calcium level
Patients' serum Calcium level at 1 month after surgery.
1 month after surgery
PTH
Patients' serum PTH level at 24 hours after surgery.
24 hours after surgery
PTH
Patients' serum PTH level at 1 month after surgery.
1 month after surgery
Study Arms (2)
Naked eyes & Instrument assistance
EXPERIMENTALIdentify the parathyroid glands through the experience of surgeons and assistance of instrument.
Naked eyes only
NO INTERVENTIONIdentify the parathyroid glands only through the experience of surgeons.
Interventions
The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.
Eligibility Criteria
You may qualify if:
- Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
- No history of neck surgery and radiotherapy.
- There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
- No abnormal calcium metabolism disease.
- No abnormalities in blood calcium and blood PTH before operation.
- No allergy to contrast agents.
- The patient or his agent signs an informed consent statement.
You may not qualify if:
- Does not meet the entry criteria;
- Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2020
First Posted
September 23, 2020
Study Start
October 31, 2020
Primary Completion
October 31, 2021
Study Completion
October 31, 2022
Last Updated
September 23, 2020
Record last verified: 2020-09