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

September 21, 2020 updated by: Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naked eyes & Instrument assistance
Identify the parathyroid glands through the experience of surgeons and assistance of instrument.
Device: Intraoperative parathyroid gland auxiliary recognition system
The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.
No Intervention: Naked eyes only
Identify the parathyroid glands only through the experience of surgeons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Calcium level
Time Frame: 24 hours after surgery
Patients' serum Calcium level at 24 hours after surgery.
24 hours after surgery
Serum Calcium level
Time Frame: 1 month after surgery
Patients' serum Calcium level at 1 month after surgery.
1 month after surgery
PTH
Time Frame: 24 hours after surgery
Patients' serum PTH level at 24 hours after surgery.
24 hours after surgery
PTH
Time Frame: 1 month after surgery
Patients' serum PTH level at 1 month after surgery.
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 31, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

August 29, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTIOP1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe