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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06432244
Other study ID # NO.SWYX2024-279
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date May 1, 2024

Study information

Verified date May 2024
Source Shandong Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collected data from patients who underwent thyroidectomy in the Breast and Thyroid Surgery Department of Shandong Provincial Hospital from January 2020 to December 2023 by reviewing medical records. The main calculation indicator was the changes in PTH before and after surgery. This study grouped patients based on the number of central lymph nodes under postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function, and to provide reference for surgical selection in thyroid cancer patients with multiple cervical lymph node metastases.


Description:

The central lymph nodes of the thyroid gland refer to the lymph nodes located around the thyroid and trachea. The central lymph nodes are the primary site of thyroid cancer metastasis, and therefore play an important role in thyroid surgery. In thyroid surgery, preventive central lymph node dissection is a routine procedure, but during this process, the parathyroid gland may be impaired due to surgical injury or insufficient blood supply. Hypothyroidism, also known as parathyroidism, is a common complication of thyroid surgery. When the parathyroid gland is accidentally injured or its blood supply is disrupted, it can lead to insufficient production of parathyroid hormone. Parathyroid hormone is a key hormone that regulates blood calcium levels. Insufficient levels can lead to hypocalcemia, manifested as hand and foot spasms, muscle spasms, and even arrhythmia. From a surgical perspective, the number of lymph nodes in the central region of the thyroid gland may affect the preservation and functional protection of the parathyroid gland. A large number of lymph nodes indicates that they may have a wider range of disease invasion, requiring more thorough lymph node dissection, thereby increasing the risk of damaging the parathyroid gland or its blood supply.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date May 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All cases were the first to undergo thyroidectomy surgery. - All clinical data and research materials of the cases are complete. - All cases underwent thyroid function examination before and after surgery. - All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital. Exclusion Criteria: - Except for cases of recurrence. - Cases with incomplete clinical data and research materials are excluded. - Cases that have not undergone thyroid function tests before and after surgery are excluded. - Excluding cases of secondary surgery. - Cases that have not undergone thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital before surgery are excluded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shandong provincial hospital Jinan Shandong

Sponsors (2)

Lead Sponsor Collaborator
Shandong Provincial Hospital Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTH level This study grouped the central lymph nodes based on postoperative paraffin pathology, and statistically analyzed the changes and differences in PTH before and after surgery in different groups to verify the relationship between the number of central lymph nodes in the thyroid gland and parathyroid function. 4 weeks
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