Parathyroid Autologous TransplantationNCT02906748
Parathyroid Auto-transplantation: Prospective Randomized Trial of the Personalized Site
A study testing injection with a syringe in new-site for parathyroid autografting and injection with a syringe in traditional site for parathyroid autografting in people with Parathyroid Autologous Transplantation, run by Tongji Hospital at 1 site in China.
Trial summary
The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Parathyroid Autologous Transplantation
- What is being tested?
- injection with a syringe in new-site for parathyroid autografting and injection with a syringe in traditional site for parathyroid autografting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with indications for PA treatment during cervical surgery
Who cannot join
- patients suffering secondary hypoparathyroidism with forearm fistulization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Gaosong Wu, PhD, 0086-138-7144-4606, wugaosongtj@163.com
About this study
Official title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.
- Conditions
- Parathyroid Autologous Transplantation
- Being tested
- injection with a syringe in new-site for parathyroid autografting, injection with a syringe in traditional site for parathyroid autografting
- Keywords
- parathyroid autografting, thyroidectomy, survival rate, hypoparathyroidism
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection with a syringe in new-site for parathyroid autograftingProcedure or surgery
Also called parathyroid autotransplantation, parathyroid auto-implantation, parathyroid auto-graft
new-site for parathyroid autografting, close to the antecubital vein
injection with a syringe in traditional site for parathyroid autograftingProcedure or surgery
traditional-site for parathyroid autografting,not intensively close to the antecubital vein
| Study group | Role | What they receive |
|---|---|---|
| new site for parathyroid auto-graft | Experimental | choose the site fairly close to the antecubital vein for parathyroid auto-transplantation Receives: Procedure: injection with a syringe in new-site for parathyroid autografting |
| traditional parathyroid autograft | Active comparator | choose not intensely close to antecubital vein for parathyroid auto-transplantation Receives: Procedure: injection with a syringe in traditional site for parathyroid autografting |
What is being measured
The primary outcome is the main question the study is designed to answer.
parahthyroid hormone gradient by comparing between grafted and non-grafted forearm
The survival criteria is that the gradient of parathyroid hormone reaches 1.5 time or greater by comparing between grafted and non-grafted forearm
Measured: 1 months, 3 months and 6 months
Secondary outcomes (1)
hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parathyroid Autologous TransplantationStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaosong Wu, Tongji Hospital
- Investigators
- Gaosong Wu, PhD, Study director, Department of Thyroid and Breast Surgery Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906748
- Sponsor's protocol ID
- PA in Tongji Hospital
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cui Q, Kong D, Li Z, Wang K, Zhang D, Tang J, Liao X, Yuan Q, Gong Y, Wu G. Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial. Trials. 2019 Jan 31;20(1):96. doi: 10.1186/s13063-019-3195-9.
PubMed 30704522
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT02906748
- Acronym / sponsor ID
- PA in Tongji Hospital
- Conditions
- Parathyroid Autologous Transplantation
- Keywords
- parathyroid autografting, thyroidectomy, survival rate, hypoparathyroidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- 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.
The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new site for parathyroid auto-graft | Experimental | Procedure: injection with a syringe in new-site for parathyroid autograftingchoose the site fairly close to the antecubital vein for parathyroid auto-transplantation |
| traditional parathyroid autograft | Active comparator | Procedure: injection with a syringe in traditional site for parathyroid autograftingchoose not intensely close to antecubital vein for parathyroid auto-transplantation |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with indications for PA treatment during cervical surgery
Key exclusion criteria (1 listed)
- patients suffering secondary hypoparathyroidism with forearm fistulization
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 |
|---|---|---|
| injection with a syringe in new-site for parathyroid autograftingAlso: parathyroid autotransplantation, parathyroid auto-implantation, parathyroid auto-graftnew-site for parathyroid autografting, close to the antecubital vein | Procedure or surgery | new site for parathyroid auto-graft |
| injection with a syringe in traditional site for parathyroid autograftingtraditional-site for parathyroid autografting,not intensively close to the antecubital vein | Procedure or surgery | traditional parathyroid autograft |
Primary outcome
parahthyroid hormone gradient by comparing between grafted and non-grafted forearm
Time frame: 1 months, 3 months and 6 months
The survival criteria is that the gradient of parathyroid hormone reaches 1.5 time or greater by comparing between grafted and non-grafted forearm
1 secondary outcome
hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Derived from this study: PubMed 30704522Cui Q, Kong D, Li Z, Wang K, Zhang D, Tang J, Liao X, Yuan Q, Gong Y, Wu G. Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial. Trials. 2019 Jan 31;20(1):96. doi: 10.1186/s13063-019-3195-9.
Related trials for Parathyroid Autologous Transplantation
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Recruiting
Intramuscular Injection of Mashed Parathyroid Tissue Into a Forearm During Thyroid Surgery to Prevent Permanent Postoperative Parathyroid Insufficiency (IMIPAT Study)
Graft Function
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.
Gaosong Wu, PhD study director
Department of Thyroid and Breast Surgery Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection with a syringe in new-site for parathyroid autografting and injection with a syringe in traditional site for parathyroid autografting in people with Parathyroid Autologous Transplantation, run by Tongji Hospital 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 1 inclusion and 1 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 20 Sep 2016. 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 Gaosong Wu, PhD (0086-138-7144-4606, wugaosongtj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parahthyroid hormone gradient by comparing between grafted and non-grafted forearm (time frame: 1 months, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906748, which also lists 1 linked publication.
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 20 Sep 2016.