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A New Surgical Strategy to Protect the Inferior Parathyroid

Primary Purpose

Thyroid Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resection based on "thymus-vascular-inferior parathyroid" complex
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Traditional thyroidectomy method

Arm Description

Outcomes

Primary Outcome Measures

Primary outcome
the incidence of hypothyroidism

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2023
Last Updated
February 24, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05758025
Brief Title
A New Surgical Strategy to Protect the Inferior Parathyroid
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resection based on "thymus-vascular-inferior parathyroid" complex
Arm Type
Experimental
Arm Title
Traditional thyroidectomy method
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Resection based on "thymus-vascular-inferior parathyroid" complex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome
Description
the incidence of hypothyroidism
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Secondary outcome
Description
the incidence of parathyroid hormone reduced greater than 50% than parathyroid hormone level before surgery
Time Frame
Postoperative day 1
Other Pre-specified Outcome Measures:
Title
Other outcome
Description
time to recover from hypoparathyroidism
Time Frame
3 weeks after surgery, then every 3 month during the first year after surgery until 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qunzi Zhao, M.D.
Phone
13615814643
Email
qzhao@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qunzi Zhao, M.D.
Organizational Affiliation
Second Affiliated Hospital Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28782797
Citation
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.
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A New Surgical Strategy to Protect the Inferior Parathyroid

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