Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

• Sponsor: The Second Hospital of Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04922892
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism;Parathyroidectomy	Procedure: Parathyroidectomy	N/A

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

• Study Type: Interventional
• Anticipated 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: Jun 1, 2021
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2028

Arms and Interventions

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

Primary Outcome Measures

1. the rate of recurrent [60 months]

   the rate of recurrent

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NanjingMU	Nanjing		China

Sponsors and Collaborators

• The Second Hospital of Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT04922892
• Other Study ID Numbers: TOTAR-2021-05-31
• First Posted: Jun 11, 2021
• Last Update Posted: Sep 27, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

No Results Posted as of Sep 27, 2021