Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation

NCT ID: NCT04560426

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parathyroid Intraoperative Monitoring Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Naked eyes & Instrument assistance

Identify the parathyroid glands through the experience of surgeons and assistance of instrument.

Group Type EXPERIMENTAL

Intraoperative parathyroid gland auxiliary recognition system

Intervention Type DEVICE

The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.

Naked eyes only

Identify the parathyroid glands only through the experience of surgeons.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intraoperative parathyroid gland auxiliary recognition system

The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
2. No history of neck surgery and radiotherapy.
3. There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
4. No abnormal calcium metabolism disease.
5. No abnormalities in blood calcium and blood PTH before operation.
6. No allergy to contrast agents.
7. The patient or his agent signs an informed consent statement.

Exclusion Criteria

1. Does not meet the entry criteria;
2. Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Yu Wang, Doctor

Role: CONTACT

+86 13817311886

Other Identifiers

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PTIOP1.0

Identifier Type: -

Identifier Source: org_study_id

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