A New Surgical Strategy to Protect the Inferior Parathyroid

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05758025
Collaborator
(none)
506
1
2
15
33.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Resection based on "thymus-vascular-inferior parathyroid" complex
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
506 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Resection based on "thymus-vascular-inferior parathyroid" complex

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.

No Intervention: Traditional thyroidectomy method

Outcome Measures

Primary Outcome Measures

  1. Primary outcome [Postoperative day 1]

    the incidence of hypothyroidism

Secondary Outcome Measures

  1. Secondary outcome [Postoperative day 1]

    the incidence of parathyroid hormone reduced greater than 50% than parathyroid hormone level before surgery

Other Outcome Measures

  1. Other outcome [3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery]

    time to recover from hypoparathyroidism

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Qunzi Zhao, M.D., Second Affiliated Hospital Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05758025
Other Study ID Numbers:
  • 2022-0077
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2023