A New Surgical Strategy to Protect the Inferior Parathyroid

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758025
• Other study ID #: 2022-0077
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qunzi Zhao, M.D.
• Phone: 13615814643
• Email: qzhao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 506
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Resection 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang JB, Wu K, Shi LH, Sun YY, Li FB, Xie L. In situ preservation of the inferior parathyroid gland during central neck dissection for papillary thyroid carcinoma. Br J Surg. 2017 Oct;104(11):1514-1522. doi: 10.1002/bjs.10581. Epub 2017 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other outcome	time to recover from hypoparathyroidism	3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery
Primary	Primary outcome	the incidence of hypothyroidism	Postoperative day 1
Secondary	Secondary outcome	the incidence of parathyroid hormone reduced greater than 50% than parathyroid hormone level before surgery	Postoperative day 1