Thyroid CancerNCT03514251
Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
A study testing The suture marks the location of the parathyroid gland in people with Thyroid Cancer and Hypoparathyroidism, run by Bo Wang,MD at 1 site in China.
Trial summary
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Hypoparathyroidism, Marker; Structural
- What is being tested?
- The suture marks the location of the parathyroid gland
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with thyroid cancer who need central compartment dissection
- Routine neck incision surgery
- Patients undergoing primary neck surgery
Who cannot join
- Benign thyroid tumor patients
- Selecting patients with endoscopes, small incisions, or robotic surgery
- Patients with hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
bo wang, md, 13705947900, wangbo@fjmu.edu.cn
About this study
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery
Read the detailed description
This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .
- Conditions
- Thyroid Cancer, Hypoparathyroidism, Marker; Structural, Complication of Surgical Procedure, Parathyroid Function Low Adverse Event
- Being tested
- The suture marks the location of the parathyroid gland
- Keywords
- Thyroid Cancer, Hypoparathyroidism, parathyroid marker
- Medical subject headings
- Thyroid Neoplasms, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The suture marks the location of the parathyroid glandProcedure or surgery
When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine thyroidectomy and central lymph node dissection |
| Parathyroid marker group | Experimental | When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Receives: Procedure: The suture marks the location of the parathyroid gland |
What is being measured
The primary outcome is the main question the study is designed to answer.
The stitch marking operation time
The time required for making a parathyroid marker by a suture method
Measured: During surgery
Specimen inspection time
The time required for finding parathyroid glands in surgical specimens
Measured: During surgery
The number of transplanted parathyroid glands
The number of parathyroid glands required for autotransplantation of parathyroid glands
Measured: When the surgery is completed
Parathyroid hormone level testing
Parathyroid hormone levels before and after surgery
Measured: 0 days, 1 day, 2 weeks after surgery
Calcium levels
Calcium level before and after surgery to detect
Measured: 0 days, 1 day, 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514251
- Sponsor's protocol ID
- PT Marker
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Application of Suturing Parathyroid Markers in Thyroid Cancer Surgery
- ClinicalTrials.gov ID
- NCT03514251
- Acronym / sponsor ID
- PT Marker
- Conditions
- Thyroid Cancer, Hypoparathyroidism, Marker; Structural, Complication of Surgical Procedure, Parathyroid Function Low Adverse Event
- Keywords
- Thyroid Cancer, Hypoparathyroidism, parathyroid marker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bo Wang,MDUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the protective effect of suture parathyroid marker method on the function of parathyroid gland in thyroid cancer surgery
Detailed description
This is a prospective randomized controlled study.In the experimental group, the suture parathyroid marker method was used to mark the parathyroid gland at the first time when it shows, and this marker was further used to identify and locating the inferior parathyroid marker in subsequent central region dissection. In the control group, the central area was routinely cleaned without suture parathyroid marker .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine thyroidectomy and central lymph node dissection |
| Parathyroid marker group | Experimental | Procedure: The suture marks the location of the parathyroid glandWhen the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with thyroid cancer who need central compartment dissection
- Routine neck incision surgery
- Patients undergoing primary neck surgery
Key exclusion criteria (3 listed)
- Benign thyroid tumor patients
- Selecting patients with endoscopes, small incisions, or robotic surgery
- Patients with hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The suture marks the location of the parathyroid glandWhen the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection. | Procedure or surgery | Parathyroid marker group |
Primary outcome
The stitch marking operation time
Time frame: During surgery
The time required for making a parathyroid marker by a suture method
Specimen inspection time
Time frame: During surgery
The time required for finding parathyroid glands in surgical specimens
The number of transplanted parathyroid glands
Time frame: When the surgery is completed
The number of parathyroid glands required for autotransplantation of parathyroid glands
Parathyroid hormone level testing
Time frame: 0 days, 1 day, 2 weeks after surgery
Parathyroid hormone levels before and after surgery
Calcium levels
Time frame: 0 days, 1 day, 2 weeks after surgery
Calcium level before and after surgery to detect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The suture marks the location of the parathyroid gland in people with Thyroid Cancer and Hypoparathyroidism, run by Bo Wang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The stitch marking operation time (time frame: During surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.