A New Surgical Strategy to Protect the Inferior Parathyroid

February 24, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

506

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital ZheJiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: Postoperative day 1
the incidence of hypothyroidism
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome
Time Frame: Postoperative day 1
the incidence of parathyroid hormone reduced greater than 50% than parathyroid hormone level before surgery
Postoperative day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other outcome
Time Frame: 3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery
time to recover from hypoparathyroidism
3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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