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RecruitingNCT04922892Updated Sep 27, 2021

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

An interventional study of Parathyroidectomy in Secondary Hyperparathyroidism;Parathyroidectomy, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Secondary Hyperparathyroidism;Parathyroidectomy

Keywords

  • Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
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In context

Hyperparathyroidism, Secondary

188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.

This study's planned enrollment of 200 is above the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.

Browse Hyperparathyroidism, Secondary studies →

Lead sponsor

The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Severe renal secondary hyperparathyroidism

Exclusion criteria

Exclusion Criteria:

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Total Parathyroidectomy Alone

    Total Parathyroidectomy Alone , without autotransplantation

    Procedure: Parathyroidectomy

  • Active comparator
    Total Parathyroidectomy With Autotransplantation

    Total Parathyroidectomy With Autotransplantation

    Procedure: Parathyroidectomy

Interventions

  • ProcedureParathyroidectomy

    Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

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What researchers measure

Primary outcomes

  1. the rate of recurrent

    the rate of recurrent

    Time frame: 60 months

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Study locations

1 of 1 sites recruiting
  • NanjingMU
    Nanjing, China
    Recruiting
    • Mingxia XIONG, Ph.D · Contact13951880995
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References and documents

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 27741007 ↗
  • Schlosser 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 17877805 ↗
  • Abruzzo 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 29083339 ↗
  • Coulston 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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2021 (actual). Primary completion is estimated for May 2023, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2021
First posted
Jun 11, 2021
StartActual
Jun 1, 2021
Primary completionEst.
May 31, 2023
CompletionEst.
May 31, 2028
Last update
Sep 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04922892
Lead sponsor
The Second Hospital of Nanjing Medical University
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Jun 1, 2021
Primary completion
May 31, 2023 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Sep 27, 2021

Study contacts

Mingxia XIONG, Ph.D
Contact
xiongmingxia@njmu.edu.cn
13951880995
Mingxia XIONG, Ph.D
study director · Nanjing Medcial university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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