Comparing two surgical methods for treating secondary hyperparathyroidism
Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism
NA · The Second Hospital of Nanjing Medical University · NCT04922892
This study is testing whether a surgery that includes transplanting parathyroid tissue works better than just removing the parathyroid glands alone for people with secondary hyperparathyroidism who are on long-term dialysis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University (other) |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT04922892 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the long-term outcomes of total parathyroidectomy with autotransplantation (TPTX+AT) versus total parathyroidectomy alone (TPTX) in patients with secondary hyperparathyroidism who are on long-term dialysis. It is a randomized controlled pilot trial involving 200 patients, aiming to assess the rates of recurrent disease over a 5-year follow-up period. Key metrics evaluated include parathyroid hormone and calcium levels, as well as rates of recurrent or persistent hyperparathyroidism, reoperations, morbidity, and mortality.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe renal secondary hyperparathyroidism who are on long-term dialysis.
Not a fit: Patients with a history of diabetes, chronic inflammatory diseases, malignant tumors, kidney transplantation, neck surgery, alcohol or drug abuse, or those unable to cooperate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for managing secondary hyperparathyroidism in dialysis patients.
How similar studies have performed: Previous studies have explored similar surgical interventions, but this specific comparison of TPTX versus TPTX+AT in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing
- NanjingMU — Nanjing, China (RECRUITING)
Study contacts
- Study coordinator: Mingxia XIONG, Ph.D
- Email: xiongmingxia@njmu.edu.cn
- Phone: 13951880995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Secondary Hyperparathyroidism, Parathyroidectomy, hemodialysis