NCT05758025

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 24, 2023

Last Update Submit

February 24, 2023

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    the incidence of hypothyroidism

    Postoperative day 1

Secondary Outcomes (1)

  • Secondary outcome

    Postoperative day 1

Other Outcomes (1)

  • Other outcome

    3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery

Study Arms (2)

Resection based on "thymus-vascular-inferior parathyroid" complex

EXPERIMENTAL
Procedure: Resection based on "thymus-vascular-inferior parathyroid" complex

Traditional thyroidectomy method

NO INTERVENTION

Interventions

Resection based on "thymus-vascular-inferior parathyroid" complexPROCEDURE

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.

Resection based on "thymus-vascular-inferior parathyroid" complex

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • initial thyroid surgery; thyroidectomy with/without central lymph node dissection

You may not qualify if:

  • coexisting parathyroid disease; need lateral neck dissection; history of radio-iodine ablation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, ZJ, 310009, China

Location

Related 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.

    PMID: 28782797BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Qunzi Zhao, M.D.

    Second Affiliated Hospital Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunzi Zhao, M.D.

CONTACT

13615814643qzhao@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

March 7, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)