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Trial Title:
A New Surgical Strategy to Protect the Inferior Parathyroid
NCT ID:
NCT05758025
Condition:
Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Parathyroid Hormone
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Resection based on "thymus-vascular-inferior parathyroid" complex
Description:
Before clearing the central lymph nodes, looking for the thyro-thymic ligament first,
looking for the inferior parathyroid along the thyro-thymic ligament. Dissect and leave
the "thymus-vascular-inferior parathyroid" complex laterally; the inner side of this
layer is the tissue of the central area. Then remove the central lymph nodes. Check for
parathyroids in the removed specimen, transplant the parathyroids which are removed by
accident.
Arm group label:
Resection based on "thymus-vascular-inferior parathyroid" complex
Summary:
The incidence of temporary hypoparathyroidism after thyroid surgery is 14%-60%, and the
incidence of permanent hypoparathyroidism is 4%-11%. The protection of parathyroids has
always been the focus and difficulty of thyroid surgery. The anatomical position of the
superior parathyroids is relatively fixed, and can be preserved in situ easily; while the
anatomical position of inferior parathyroids varies greatly between patients. It is
always difficult to look for, identify, and protect them. Concepts such as thyro-thymic
ligament and "thymus-vascular-inferior parathyroid plane" were raised to help identify
the inferior parathyroids. We found that this surgical strategy can protect inferior
parathyroids in situ effectively in our retrospective studies. Thus, we are going to
carry out a prospective study to compare the new method and the traditional method of
thyroidectomy, to see if more inferior parathyroids can be protected in situ through the
new surgical strategy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- initial thyroid surgery; thyroidectomy with/without central lymph node dissection
Exclusion Criteria:
- coexisting parathyroid disease; need lateral neck dissection; history of
radio-iodine ablation treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Start date:
March 1, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758025
