Intraoperative Parathyroid Scores SystemIPSSNCT03172312
Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy
An observational study of Intraoperative Parathyroid Scores System, run by Fujian Medical University at 1 site in China.
Trial summary
Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Intraoperative Parathyroid Scores System
- What is being tested?
- Different range of thyroid surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who need thyroid surgery
Who may be able to join
- postoperative pathology confirmed as thyroid papillary carcinoma;
- for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;
- preoperative serum calcium, parathyroid hormone levels were normal;
- intraoperative and postoperative clinical data integrity, standardized follow-up patients;
- parathyroid is a tumor violation.
Who cannot join
- serious underlying disease;
- age greater than 60 years of age or combined with arteriosclerotic disease;
- patients with postoperative loss;
- patients with parathyroid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.
Read the detailed description
IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.
- Conditions
- Intraoperative Parathyroid Scores System
- Being tested
- Different range of thyroid surgery
- Keywords
- Intraoperative Parathyroid Scores System, total thyroidectomy, thyroid cancer, hypoparathyroidism, prediction
- 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.
Different range of thyroid surgeryProcedure or surgery
Observe and record parathyroid status during thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Total thyroidectomy | Patients need to do total thyroidectomy According to guidelines Receives: Procedure: Different range of thyroid surgery | |
| Hemithyroidectomy | Patients need to do Hemithyroidectomy According to guidelines Receives: Procedure: Different range of thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
transplantation Parathyroid Scores correlated with transplanted parathyroid function
relation with transplantation Parathyroid Scores and transplanted parathyroid hormone
Measured: 2014-2016
the value of IPSS and in situ Parathyroid Scores
relation with Intraoperative Parathyroid Scores and in situ Parathyroid Scores
Measured: 2014-2016
predicted function of IPSS
IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested
Measured: 2014-2016
value of IPSS in low PTH patients
IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested
Measured: 2014-2016
Secondary outcomes (1)
value of IPSS for Surgeon and patient
description the clinic value
Measured: 2014-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Parathyroid Scores SystemStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangbo, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172312
- Sponsor's protocol ID
- IPSSforZHAO
- Acronym
- IPSS
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Intraoperative Parathyroid Scores System in Thyroidectomy
- ClinicalTrials.gov ID
- NCT03172312
- Acronym / sponsor ID
- IPSS / IPSSforZHAO
- Conditions
- Intraoperative Parathyroid Scores System
- Keywords
- Intraoperative Parathyroid Scores System, total thyroidectomy, thyroid cancer, hypoparathyroidism, prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 1 Jun 2017 (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.
Ready to establish the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy and study the clinical value of Intraoperative Parathyroid Scores System for thyroidectomy.
Detailed description
IPSS includes transplantation Parathyroid Scores and in situ Parathyroid Scores, the investigators will establish the Intraoperative Parathyroid Scores System by parathyroid size and Blood supply, and recording IPSS, according to certain rules. Parathyroid hormone and calcium were test in d0, d1, d14, d60 post operation. The correlation between Intraoperative Parathyroid Scores and PTH calcium were calculated, and ROC curve and logistic regression were tested for the prediction value.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total thyroidectomy | – | Procedure: Different range of thyroid surgeryPatients need to do total thyroidectomy According to guidelines |
| Hemithyroidectomy | – | Procedure: Different range of thyroid surgeryPatients need to do Hemithyroidectomy According to guidelines |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who need thyroid surgery
Key inclusion criteria (5 listed)
- postoperative pathology confirmed as thyroid papillary carcinoma;
- for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy;
- preoperative serum calcium, parathyroid hormone levels were normal;
- intraoperative and postoperative clinical data integrity, standardized follow-up patients;
- parathyroid is a tumor violation.
Key exclusion criteria (4 listed)
- serious underlying disease;
- age greater than 60 years of age or combined with arteriosclerotic disease;
- patients with postoperative loss;
- patients with parathyroid disease.
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 |
|---|---|---|
| Different range of thyroid surgeryObserve and record parathyroid status during thyroid surgery | Procedure or surgery | Hemithyroidectomy, Total thyroidectomy |
Primary outcome
transplantation Parathyroid Scores correlated with transplanted parathyroid function
Time frame: 2014-2016
relation with transplantation Parathyroid Scores and transplanted parathyroid hormone
the value of IPSS and in situ Parathyroid Scores
Time frame: 2014-2016
relation with Intraoperative Parathyroid Scores and in situ Parathyroid Scores
predicted function of IPSS
Time frame: 2014-2016
IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested
value of IPSS in low PTH patients
Time frame: 2014-2016
IPSS and in suit PSS be recoded and D1，D14 PTH Ca2+ were tested
1 secondary outcome
value of IPSS for Surgeon and patient
Time frame: 2014-2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Parathyroid Scores System, run by Fujian Medical University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transplantation Parathyroid Scores correlated with transplanted parathyroid function (time frame: 2014-2016). The study lists 4 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 1 Jun 2017.