NCT04922892

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2021May 2028

Study Start

First participant enrolled

June 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Expected
Last Updated

September 27, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

June 7, 2021

Last Update Submit

September 23, 2021

Conditions

Secondary Hyperparathyroidism;Parathyroidectomy

Keywords

Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis

Outcome Measures

Primary Outcomes (1)

  • the rate of recurrent

    the rate of recurrent

    60 months

Study Arms (2)

Total Parathyroidectomy Alone

EXPERIMENTAL

Total Parathyroidectomy Alone , without autotransplantation

Procedure: Parathyroidectomy

Total Parathyroidectomy With Autotransplantation

ACTIVE COMPARATOR

Total Parathyroidectomy With Autotransplantation

Procedure: Parathyroidectomy

Interventions

ParathyroidectomyPROCEDURE

Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

Total Parathyroidectomy AloneTotal Parathyroidectomy With Autotransplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe renal secondary hyperparathyroidism

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanjingMU

Nanjing, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27741007RESULT

  • 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.

    PMID: 17877805RESULT

  • 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.

    PMID: 29083339RESULT

  • 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.

    PMID: 20641052RESULT

MeSH Terms

Interventions

Parathyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mingxia XIONG, Ph.D

    Nanjing Medcial university

    STUDY DIRECTOR

Central Study Contacts

Mingxia XIONG, Ph.D

CONTACT

13951880995xiongmingxia@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

June 1, 2021

Primary Completion

May 31, 2023

Study Completion (Estimated)

May 31, 2028

Last Updated

September 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)