Intraoperative Parathyroid Scores SystemIPSSNCT03191344
Extended Application of Intraoperative Parathyroid Scores System(IPSS) in Thyroidectomy
An observational study of Intraoperative Parathyroid Scores System, run by Fujian Medical University at 1 site in China.
Trial summary
after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment decisions of calcium treatment time and improve recognition skills of parathyroid in Clinicians 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?
- with IPSS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jul 2019
- 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: the patients with thyroid tumors and require surgery In accordance with the guidelines.
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.
China1 site, 1 recruiting
- Recruiting
Wen-xin ZHAO
Fuzhou, Fujian, 350001
Wen-xin ZHAO, MD, 8613365910359, zhaowx@fjmu.edu.cn
Bo WANG, MS, 8613705947900, wangbo@fjmu.edu.cn
About this study
after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment decisions of calcium treatment time and improve recognition skills of parathyroid in Clinicians
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. We expand IPSS, including the description of the location of parathyroid after postoperative.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.and after that we further evaluate the relationship Between IPSS and calcium supplement time.and Whether IPSS enhance ability of parathyroid recognition for clinical doctors.
- Conditions
- Intraoperative Parathyroid Scores System
- Being tested
- with IPSS
- 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.
with IPSSBehavioural
all patient in one group use IPSS to record the parathyroid status. the other group operation as ordinary. record the parathyroid status in verbal description
| Study group | Role | What they receive |
|---|---|---|
| with IPSS record/IPSS | the surgoen use the IPSS in all thyroidectomy Receives: Behavioral: with IPSS | |
| Traditionaldescription Group/TD | the surgoen without the IPSS，use Traditional description |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of parathyroid records between IPSS and TD
The percentage of recorded integrity of the parathyroid gland and the number of recognizable parathyroids were compared between the two groups.
Measured: 1 year
Secondary outcomes (2)
The effect of IPSS on the level of parathyroid recognition of surgeons
Comparison of the number of parathyroid gland found in the pathology and the number of postoperative hypoparathyroidism between the two groups
Measured: 1 year
differences of the number of parathyroid glands found in the pathology betwen IPSS and TD
differences of the number of parathyroid glands found in the pathology betwen IPSS and TD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191344
- Sponsor's protocol ID
- IPSS
- Acronym
- IPSS
- Status last verified
- Sep 2018
- First submitted
- 15 Jun 2017
- Last updated
- 18 Sep 2018
- 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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Application of Intraoperative Parathyroid Scores System(IPSS) in Thyroidectomy
- ClinicalTrials.gov ID
- NCT03191344
- Acronym / sponsor ID
- IPSS / IPSS
- Conditions
- Intraoperative Parathyroid Scores System
- Keywords
- Intraoperative Parathyroid Scores System, total thyroidectomy, thyroid cancer, hypoparathyroidism, prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 19 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.
after established the Intraoperative Parathyroid Scores System (IPSS) for thyroidectomy we further extented the clinical value of Intraoperative Parathyroid Scores System in Treatment decisions of calcium treatment time and improve recognition skills of parathyroid in Clinicians
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. We expand IPSS, including the description of the location of parathyroid after postoperative.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.and after that we further evaluate the relationship Between IPSS and calcium supplement time.and Whether IPSS enhance ability of parathyroid recognition for clinical doctors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with IPSS record/IPSS | – | Behavioral: with IPSSthe surgoen use the IPSS in all thyroidectomy |
| Traditionaldescription Group/TD | – | –the surgoen without the IPSS，use Traditional description |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- the patients with thyroid tumors and require surgery In accordance with the guidelines.
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 |
|---|---|---|
| with IPSSall patient in one group use IPSS to record the parathyroid status. the other group operation as ordinary. record the parathyroid status in verbal description | Behavioural | with IPSS record/IPSS |
Primary outcome
Differences of parathyroid records between IPSS and TD
Time frame: 1 year
The percentage of recorded integrity of the parathyroid gland and the number of recognizable parathyroids were compared between the two groups.
2 secondary outcomes
The effect of IPSS on the level of parathyroid recognition of surgeons
Time frame: 1 year
differences of the number of parathyroid glands found in the pathology betwen IPSS and TD
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- 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.
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: status not confirmed, as of the sponsor's last update on 18 Sep 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?
Contact BO WANG, MS (13705947900, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of parathyroid records between IPSS and TD (time frame: 1 year). 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 18 Sep 2018.