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A New Surgical Strategy to Protect the Inferior Parathyroid

Dissection of Thyroid and Central Lymph Nodes Based on Layer of Thymus-blood Vessel-inferior Parathyroid Gland Complex for Preserving the Inferior Parathyroids

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05758025
Enrollment
506
Registered
2023-03-07
Start date
2023-03-01
Completion date
2024-06-01
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer

Brief 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.

Interventions

PROCEDUREResection based on thymus-vascular-inferior parathyroid complex

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary outcomePostoperative day 1the incidence of hypothyroidism

Secondary

MeasureTime frameDescription
Secondary outcomePostoperative day 1the incidence of parathyroid hormone reduced greater than 50% than parathyroid hormone level before surgery

Other

MeasureTime frameDescription
Other outcome3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgerytime to recover from hypoparathyroidism

Countries

China

Contacts

Primary ContactQunzi Zhao, M.D.
qzhao@zju.edu.cn13615814643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026