Cure RateNCT06708871
Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism
An observational study of Cure Rate and Complication Rate, run by Chinese PLA General Hospital.
Trial summary
This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cure Rate, Complication Rate, Efficacy and Safety
- What is being tested?
- Thermal ablation and Parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2024to 26 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must have a confirmed diagnosis of PHPT based on biochemical and clinical evaluations. Biochemical evidence includes elevated parathyroid hormone (PTH) levels in conjunction with hypercalcemia (serum calcium above the normal reference range). Clinical manifestations may include, but are not limited to, bone pain, osteoporosis, kidney stones, or other symptoms related to the disease.All patients must provide written informed consent after a detailed discussion of the study procedures, potential risks, and benefits of both thermal ablation and surgical treatment options. This ensures that patients are fully aware of what participation in the study entails and have voluntarily agreed to take part.
Who may be able to join
- Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.
- Asymptomatic PHPT patients with any of the following conditions:
- ① Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);
- ② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level > 400 mg/dL) on renal imaging, or impaired renal function (glomerular filtration rate < 60 mL/min);
- ③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures.
- ④ Age < 50 years
- ⑤ The patient cannot accept routine follow - up observation.
- Imaging examination shows that at least one parathyroid gland is enlarged.
Who cannot join
- diagnosis of secondary or tertiary HPT
- severe coagulation disorder
- severe cardiopulmonary insufficiency
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study
This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.
- Conditions
- Cure Rate, Complication Rate, Efficacy and Safety
- Being tested
- Thermal ablation, Parathyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationProcedure or surgery
Thermal ablation is a minimally invasive procedure used to treat primary hyperparathyroidism, a condition where one or more of the parathyroid glands produce excessive amounts of parathyroid hormone (PTH). The treatment involves using heat to destroy the overactive parathyroid tissue. This can be done through various methods such as radiofrequency ablation (RFA) and microwave ablation(MWA).
ParathyroidectomyProcedure or surgery
Parathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism.
| Study group | Role | What they receive |
|---|---|---|
| Therma ablation | Not described Receives: Procedure: Thermal ablation | |
| Parathyroidectomy | Not described Receives: Procedure: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.
Measured: 6 months after surgery or ablation
Secondary outcomes (4)
complication rate
The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.
Measured: within 30 days after surgery or ablation
symptom remission rate
The symptom remission rate refers to the proportion of the number of patients whose symptoms have been alleviated to the total number of patients treated in the treatment of primary hyperparathyroidism, either by surgery or ablation.
Measured: 1 year after treatment initiation
Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery
The probability of normal serum calcium and serum phosphorus levels after ablation or surgical treatment for primary hyperparathyroidism is defined as the proportion of patients in whom the levels of blood calcium and blood phosphorus return to the normal physiological range among all the patients who have received either ablation or surgical procedures for this condition.
Measured: 6 months post-treatment
Bone mineral density change
Bone mineral density change after treatment is defined as the alteration in bone density measured by DEXA in patients with primary hyperparathyroidism after surgery or ablation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start26 Nov 2024 (estimated)
- Primary completion26 Nov 2028 (estimated)
- Study completion26 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cure RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708871
- Sponsor's protocol ID
- S2024-546-01
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study
- ClinicalTrials.gov ID
- NCT06708871
- Acronym / sponsor ID
- S2024-546-01
- Conditions
- Cure Rate, Complication Rate, Efficacy and Safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 26 Nov 2024 (estimated)
- Primary completion
- 26 Nov 2028 (estimated)
- Study completion
- 26 Dec 2028 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therma ablation | – | Procedure: Thermal ablation |
| Parathyroidectomy | – | Procedure: Parathyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must have a confirmed diagnosis of PHPT based on biochemical and clinical evaluations. Biochemical evidence includes elevated parathyroid hormone (PTH) levels in conjunction with hypercalcemia (serum calcium above the normal reference range). Clinical manifestations may include, but are not limited to, bone pain, osteoporosis, kidney stones, or other symptoms related to the disease.All patients must provide written informed consent after a detailed discussion of the study procedures, potential risks, and benefits of both thermal ablation and surgical treatment options. This ensures that patients are fully aware of what participation in the study entails and have voluntarily agreed to take part.
Key inclusion criteria (8 listed)
- Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.
- Asymptomatic PHPT patients with any of the following conditions:
- ① Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);
- ② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level > 400 mg/dL) on renal imaging, or impaired renal function (glomerular filtration rate < 60 mL/min);
- ③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures.
Key exclusion criteria (3 listed)
- diagnosis of secondary or tertiary HPT
- severe coagulation disorder
- severe cardiopulmonary insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablationThermal ablation is a minimally invasive procedure used to treat primary hyperparathyroidism, a condition where one or more of the parathyroid glands produce excessive amounts of parathyroid hormone (PTH). The treatment involves using heat to destroy the overactive parathyroid tissue. This can be done through various methods such as radiofrequency ablation (RFA) and microwave ablation(MWA). | Procedure or surgery | Therma ablation |
| ParathyroidectomyParathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism. | Procedure or surgery | Parathyroidectomy |
Primary outcome
cure rate
Time frame: 6 months after surgery or ablation
The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.
4 secondary outcomes
complication rate
Time frame: within 30 days after surgery or ablation
symptom remission rate
Time frame: 1 year after treatment initiation
Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery
Time frame: 6 months post-treatment
Bone mineral density change
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cure Rate and Complication Rate, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu (+8616601565730, yang2818025107@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 6 months after surgery or ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.