4D CT-guided focused parathyroidectomy: a paradigm shift from experience-based surgery in end-stage renal disease patients with medically refractory secondary hyperparathyroidism
| ISRCTN | ISRCTN18282884 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18282884 |
| Secondary identifying numbers | 202201157B0 |
- Submission date
- 10/07/2025
- Registration date
- 14/07/2025
- Last edited
- 14/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The main aim of this study is to investigate whether a 4D CT scan can be used for gland localization before surgery for end-stage renal disease (ESRD) patients with secondary or tertiary hyperparathyroidism, replacing traditional surgeon experience-based surgery. Hyperparathyroidism is an increase in parathyroid hormone levels in the blood.
Who can participate?
ESRD patients with secondary or tertiary hyperparathyroidism who have not previously undergone any parathyroid surgery
What does the study involve?
Patients who received 4D CT-guided focused parathyroidectomy and those who underwent experience-based surgery. The study will compare surgical outcomes, biochemical control, and perioperative complications between the two groups at 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively.
What are the possible benefits and risks of participating?
The potential benefits include reduced surgical time and unnecessary anesthetic risks. Patients may be exposed to higher doses of radiation as part of the imaging protocol.
Where is the study run from?
Linkou Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
October 2024 to June 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Yungyuan Chan, isc@cgmh.org.tw
Contact information
Public, Scientific, Principal Investigator
No. 5, Fuxing Street
Guishan District
Taoyuan City
333
Taiwan
| Phone | +886 (0)33281200 |
|---|---|
| isc@cgmh.org.tw |
Study information
| Study design | Retrospective comparative cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 4D CT-guided focused parathyroidectomy versus experience-based surgery in end-stage renal disease patients with medically refractory secondary hyperparathyroidism: impact on surgical outcomes and biochemical control |
| Study objectives | To evaluate the effectiveness of 4D CT-guided focused parathyroidectomy compared to experience-based surgery in end-stage renal disease (ESRD) patients with medically refractory secondary hyperparathyroidism in terms of biochemical control and surgical success rate. |
| Ethics approval(s) |
Approved 10/10/2024, Institutional Review Board of Linkou Chang Gung Memorial Hospital (No. 5, Fuxing St., Guishan Dist., Taoyuan City, 333, Taiwan; +886 (0)33281200; isc@cgmh.org.tw), ref: 202201157B0 |
| Health condition(s) or problem(s) studied | End-stage renal disease (ESRD) patients with medically refractory secondary hyperparathyroidism |
| Intervention | This is a retrospective comparative cohort study analyzing end-stage renal disease (ESRD) patients with medically refractory secondary hyperparathyroidism who underwent parathyroidectomy. Patients will be divided into two groups based on the surgical approach: those who received 4D CT-guided focused parathyroidectomy and those who underwent experience-based surgery. The study will compare surgical outcomes, biochemical control, and perioperative complications between the two groups. Study Arm 1: 4D CT-Guided Focused Parathyroidectomy Group Intervention: Preoperative 4D CT imaging for parathyroid localization followed by focused parathyroidectomy Procedure: Patients undergo a 4D CT scan within 2-4 weeks before surgery. Based on imaging results, a targeted surgical approach is performed focusing on the identified abnormal parathyroid glands Duration: Single surgical procedure with immediate postoperative monitoring Follow-up: 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively Study Arm 2: Experience-Based Surgery Group Intervention: Conventional parathyroidectomy based on the surgeon's clinical experience and intraoperative findings Procedure: Traditional surgical exploration without preoperative localization imaging, relying on the surgeon's experience for gland identification and removal Duration: Single surgical procedure with immediate postoperative monitoring Follow-up: 1 week, 1 month, 3 months, 6 months, and 12 months postoperatively Randomization Process: This is a retrospective comparative study; therefore, no randomization was performed. Patient allocation to study arms was based on the surgical approach used during their treatment period (before and after implementation of 4D CT-guided protocol at our institution). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Operative time measured using surgical records documenting time from skin incision to completion of surgery as recorded in operative reports at the time of surgery 2. Intraoperative frozen section requirements measured using the number of frozen section pathology reports obtained during surgery at the time of surgery |
| Secondary outcome measures | Diagnostic accuracy and positive predictive value of preoperative CT imaging for parathyroid gland identification, measured using comparison of preoperative CT-identified parathyroid gland count with total parathyroid gland count in final pathological report, with true positive defined as: preoperative prediction of ≥4 glands AND final pathology report showing ≥4 glands AND postoperative day 1 iPTH concentration <300 pg/dl, at preoperative CT imaging and postoperative day 1 iPTH measurement |
| Overall study start date | 10/10/2024 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 135 |
| Total final enrolment | 103 |
| Key inclusion criteria | 1. Diagnosed with secondary or tertiary hyperparathyroidism 2. Dialysis-dependent due to end-stage renal disease (ESRD) 3. Underwent parathyroidectomy between January 2023 and December 2024 4. Underwent a primary parathyroidectomy (i.e., no previous parathyroid surgery) 5. Underwent removal of multiple parathyroid glands during the procedure |
| Key exclusion criteria | 1. Reoperation for recurrent hyperparathyroidism 2. Underwent concurrent surgical procedures 3. Had only one parathyroid gland removed during surgery |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 30/12/2024 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Guishan District
Taoyuan City
333
Taiwan
Sponsor information
Hospital/treatment centre
No. 5, Fuxing Street
Guishan District
Taoyuan
333
Taiwan
| Website | http://www1.cgmh.org.tw/branch/lnk/e/index.aspx |
|---|---|
"ROR" |
https://ror.org/02dnn6q67 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan | Participant-level data will not be made available for sharing due to patient safety and institutional security concerns. Patient Privacy Protection: Individual patient data contains sensitive medical information that could potentially compromise patient confidentiality, even when de-identified. Institutional Data Security Policy: Our hospital's data governance policy restricts the sharing of raw clinical data to protect patient privacy and maintain institutional security standards. Regulatory Compliance: Sharing of detailed medical records may violate local healthcare data protection regulations and patient consent agreements. Alternative Data Access: Aggregated and anonymized summary statistics will be made available upon reasonable request for research purposes, following appropriate ethical approval and data use agreements. |
Editorial Notes
11/07/2025: Study's existence confirmed by the Chang Gung Medical Foundation Human Experimentation Ethics Committee.
