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Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT04922892
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism;Parathyroidectomy Procedure: Parathyroidectomy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Total Parathyroidectomy Alone
Total Parathyroidectomy Alone , without autotransplantation
 Procedure: Parathyroidectomy
Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone
Active Comparator: Total Parathyroidectomy With Autotransplantation
Total Parathyroidectomy With Autotransplantation
 Procedure: Parathyroidectomy
Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone


Outcome Measures
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Primary Outcome Measures :
  1. the rate of recurrent [ Time Frame: 60 months ]
    the rate of recurrent


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Severe renal secondary hyperparathyroidism

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922892


Contacts
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Contact: Mingxia XIONG, Ph.D 13951880995 xiongmingxia@njmu.edu.cn

Locations
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China
NanjingMU Recruiting
Nanjing, China
Contact: Mingxia XIONG, Ph.D    13951880995      
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Study Director: Mingxia XIONG, Ph.D Nanjing Medcial university
More Information
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Publications of Results:

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Responsible Party: The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04922892    
Other Study ID Numbers: TOTAR-2021-05-31
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Hospital of Nanjing Medical University:
Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
 Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases