Back to resultsProtective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
Primary Purpose
Parathyroid, Intraoperative Monitoring, Thyroid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative parathyroid gland auxiliary recognition system
Sponsored by
About this trial
This is an interventional other trial for Parathyroid
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Naked eyes & Instrument assistance
Naked eyes only
Arm Description
Identify the parathyroid glands through the experience of surgeons and assistance of instrument.
Identify the parathyroid glands only through the experience of surgeons.
Outcomes
Primary Outcome Measures
Serum Calcium level
Patients' serum Calcium level at 24 hours after surgery.
Serum Calcium level
Patients' serum Calcium level at 1 month after surgery.
PTH
Patients' serum PTH level at 24 hours after surgery.
PTH
Patients' serum PTH level at 1 month after surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04560426
Brief Title
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
Official Title
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid, Intraoperative Monitoring, Thyroid Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Naked eyes & Instrument assistance
Arm Type
Experimental
Arm Description
Identify the parathyroid glands through the experience of surgeons and assistance of instrument.
Arm Title
Naked eyes only
Arm Type
No Intervention
Arm Description
Identify the parathyroid glands only through the experience of surgeons.
Intervention Type
Device
Intervention Name(s)
Intraoperative parathyroid gland auxiliary recognition system
Intervention Description
The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.
Primary Outcome Measure Information:
Title
Serum Calcium level
Description
Patients' serum Calcium level at 24 hours after surgery.
Time Frame
24 hours after surgery
Title
Serum Calcium level
Description
Patients' serum Calcium level at 1 month after surgery.
Time Frame
1 month after surgery
Title
PTH
Description
Patients' serum PTH level at 24 hours after surgery.
Time Frame
24 hours after surgery
Title
PTH
Description
Patients' serum PTH level at 1 month after surgery.
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, Doctor
Phone
+86 13817311886
Email
neck130@sina.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
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