Back to resultsTotal Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism;Parathyroidectomy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parathyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism;Parathyroidectomy focused on measuring Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
Eligibility 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
Sites / Locations
- NanjingMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Total Parathyroidectomy Alone
Total Parathyroidectomy With Autotransplantation
Arm Description
Total Parathyroidectomy Alone , without autotransplantation
Total Parathyroidectomy With Autotransplantation
Outcomes
Primary Outcome Measures
the rate of recurrent
the rate of recurrent
Secondary Outcome Measures
Full Information
NCT ID
NCT04922892
First Posted
June 7, 2021
Last Updated
September 23, 2021
Sponsor
The Second Hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04922892
Brief Title
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Official Title
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism;Parathyroidectomy
Keywords
Secondary Hyperparathyroidism;Parathyroidectomy;hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Parathyroidectomy Alone
Arm Type
Experimental
Arm Description
Total Parathyroidectomy Alone , without autotransplantation
Arm Title
Total Parathyroidectomy With Autotransplantation
Arm Type
Active Comparator
Arm Description
Total Parathyroidectomy With Autotransplantation
Intervention Type
Procedure
Intervention Name(s)
Parathyroidectomy
Intervention Description
Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone
Primary Outcome Measure Information:
Title
the rate of recurrent
Description
the rate of recurrent
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingxia XIONG, Ph.D
Phone
13951880995
Email
xiongmingxia@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingxia XIONG, Ph.D
Organizational Affiliation
Nanjing Medcial university
Official's Role
Study Director
Facility Information:
Facility Name
NanjingMU
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxia XIONG, Ph.D
Phone
13951880995
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27741007
Citation
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.
Results Reference
result
PubMed Identifier
17877805
Citation
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.
Results Reference
result
PubMed Identifier
29083339
Citation
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.
Results Reference
result
PubMed Identifier
20641052
Citation
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.
Results Reference
result
Learn more about this trial
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
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