Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

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

Tracking Information

• First Submitted Date: June 7, 2021
• First Posted Date: June 11, 2021
• Last Update Posted Date: September 27, 2021
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2021)

the rate of recurrent [ Time Frame: 60 months ]

the rate of recurrent

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Secondary Hyperparathyroidism;Parathyroidectomy

Intervention

Procedure: Parathyroidectomy

Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone

Study Arms

• Experimental: Total Parathyroidectomy Alone
  Total Parathyroidectomy Alone , without autotransplantation
  Intervention: Procedure: Parathyroidectomy
• Active Comparator: Total Parathyroidectomy With Autotransplantation
  Total Parathyroidectomy With Autotransplantation
  Intervention: Procedure: Parathyroidectomy

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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 10, 2021): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2028
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04922892
• Other Study ID Numbers: TOTAR-2021-05-31
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: The Second Hospital of Nanjing Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Second Hospital of Nanjing Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Mingxia XIONG, Ph.D; Nanjing Medcial university

• PRS Account: The Second Hospital of Nanjing Medical University
• Verification Date: May 2021