Secondary Hyperparathyroidism;ParathyroidectomyNCT04922892
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
A study testing Parathyroidectomy in people with Secondary Hyperparathyroidism;Parathyroidectomy, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Secondary Hyperparathyroidism;Parathyroidectomy
- What is being tested?
- Parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Severe renal secondary hyperparathyroidism
Who cannot join
- Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
NanjingMU
Nanjing
Mingxia XIONG, Ph.D, 13951880995
About this study
Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.
Read the detailed description
The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.
- Being tested
- Parathyroidectomy
- Keywords
- Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParathyroidectomyProcedure or surgery
Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone
| Study group | Role | What they receive |
|---|---|---|
| Total Parathyroidectomy Alone | Experimental | Total Parathyroidectomy Alone , without autotransplantation Receives: Procedure: Parathyroidectomy |
| Total Parathyroidectomy With Autotransplantation | Active comparator | Total Parathyroidectomy With Autotransplantation Receives: Procedure: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recurrent
the rate of recurrent
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Secondary Hyperparathyroidism;ParathyroidectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxia XIONG, Ph.D, Study director, Nanjing Medcial university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922892
- Sponsor's protocol ID
- TOTAR-2021-05-31
- Status last verified
- May 2021
- First submitted
- 7 Jun 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schlosser K, Bartsch DK, Diener MK, Seiler CM, Bruckner T, Nies C, Meyer M, Neudecker J, Goretzki PE, Glockzin G, Konopke R, Rothmund M. Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial. Ann Surg. 2016 Nov;264(5):745-753. doi: 10.1097/SLA.0000000000001875.
PubMed 27741007Schlosser K, Veit JA, Witte S, Fernandez ED, Victor N, Knaebel HP, Seiler CM, Rothmund M. Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial. Trials. 2007 Sep 18;8:22. doi: 10.1186/1745-6215-8-22.
PubMed 17877805Abruzzo A, Gioviale MC, Damiano G, Palumbo VD, Buscemi S, Lo Monte G, Gulotta L, Buscemi G, Lo Monte AI. Reoperation for persistent or recurrent secondary hyperparathyroidism. Acta Biomed. 2017 Oct 23;88(3):325-328. doi: 10.23750/abm.v88i3.4722.
PubMed 29083339Coulston JE, Egan R, Willis E, Morgan JD. Total parathyroidectomy without autotransplantation for renal hyperparathyroidism. Br J Surg. 2010 Nov;97(11):1674-9. doi: 10.1002/bjs.7192.
PubMed 20641052
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT04922892
- Acronym / sponsor ID
- TOTAR-2021-05-31
- Keywords
- Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 11 Jun 2021 (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.
Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.
Detailed description
The trial was performed as a nonconfirmatory randomized controlled pilot trial with 200 patients on long-term dialysis with otherwise uncontrollable SHPT to generate data on the rate of recurrent disease within a 5-year follow-up period after TPTX or TPTX+AT. Parathyroid hormone (PTH) and calcium levels, recurrent or persistent hyperparathyroidism, parathyroid reoperations, morbidity, and mortality were evaluated during a 5-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Parathyroidectomy Alone | Experimental | Procedure: ParathyroidectomyTotal Parathyroidectomy Alone , without autotransplantation |
| Total Parathyroidectomy With Autotransplantation | Active comparator | Procedure: ParathyroidectomyTotal Parathyroidectomy With Autotransplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe renal secondary hyperparathyroidism
Key exclusion criteria (1 listed)
- Patients with diabetes a history of chronic inflammatory disease a history of malignant tumor a history of kidney transplantation a history of neck surgery a history of alcohol abuse a history of drug abuse inability to cooperate with the participants refusal to participate in the study
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 |
|---|---|---|
| ParathyroidectomyTotal Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone | Procedure or surgery | Total Parathyroidectomy Alone, Total Parathyroidectomy With Autotransplantation |
Primary outcome
the rate of recurrent
Time frame: 60 months
the rate of recurrent
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Results publication: PubMed 27741007Schlosser K, Bartsch DK, Diener MK, Seiler CM, Bruckner T, Nies C, Meyer M, Neudecker J, Goretzki PE, Glockzin G, Konopke R, Rothmund M. Total Parathyroidectomy With Routine Thymectomy and Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism: Results of a Nonconfirmatory Multicenter Prospective Randomized Controlled Pilot Trial. Ann Surg. 2016 Nov;264(5):745-753. doi: 10.1097/SLA.0000000000001875.
- Results publication: PubMed 17877805Schlosser K, Veit JA, Witte S, Fernandez ED, Victor N, Knaebel HP, Seiler CM, Rothmund M. Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial. Trials. 2007 Sep 18;8:22. doi: 10.1186/1745-6215-8-22.
- Results publication: PubMed 29083339Abruzzo A, Gioviale MC, Damiano G, Palumbo VD, Buscemi S, Lo Monte G, Gulotta L, Buscemi G, Lo Monte AI. Reoperation for persistent or recurrent secondary hyperparathyroidism. Acta Biomed. 2017 Oct 23;88(3):325-328. doi: 10.23750/abm.v88i3.4722.
- Results publication: PubMed 20641052Coulston JE, Egan R, Willis E, Morgan JD. Total parathyroidectomy without autotransplantation for renal hyperparathyroidism. Br J Surg. 2010 Nov;97(11):1674-9. doi: 10.1002/bjs.7192.
- 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.
Mingxia XIONG, Ph.D study director
Nanjing Medcial university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroidectomy in people with Secondary Hyperparathyroidism;Parathyroidectomy, run by The Second Hospital of Nanjing 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 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: looking for participants now, as of the sponsor's last update on 27 Sep 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingxia XIONG, Ph.D (13951880995, xiongmingxia@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of recurrent (time frame: 60 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 NCT04922892, which also lists 4 linked publications.
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 27 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.