Achievement RateNCT06709586
Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism
An observational study of Achievement Rate and Efficacy and Safety, run by Chinese PLA General Hospital.
Trial summary
Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achievement Rate, Efficacy and Safety, PTH
- What is being tested?
- Thermal ablation and parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 612 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2024to 30 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 secondary hyperparathyroidism based on clinical symptoms (such as bone pain, fractures, pruritus), biochemical parameters (elevated parathyroid hormone, abnormal calcium, phosphorus, and alkaline phosphatase levels), and relevant medical history (especially those with underlying chronic kidney disease or other relevant disorders). All patients must provide written informed consent after a detailed discussion of the study purpose, procedures, potential risks, and benefits of both treatment options by the research team.
Who may be able to join
- persistent serum iPTH (intact parathyroid hormone) levels > 800 pg/mL；
- resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment；
- severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life；
- imaging examinations indicating the presence of at least one enlarged parathyroid gland
Who cannot join
- severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia
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 Secondary Hyperparathyroidism: a Multicenter Study
Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.
- Conditions
- Achievement Rate, Efficacy and Safety, PTH, Calcium, Clinical Symptoms
- 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 treatment for secondary hyperparathyroidism. There are radiofrequency ablation (RFA) and microwave ablation (MWA). For RFA, an electrode needle is inserted into the parathyroid under imaging guidance. High - frequency current heats the tissue to cause necrosis. MWA uses electromagnetic waves to generate heat by friction. Before ablation, imaging and lab tests are done for evaluation. During the process, precise positioning and real - time monitoring are key. After that, patients are observed for bleeding, swelling and other symptoms, and tests are repeated to assess the effect.
parathyroidectomyProcedure or surgery
Parathyroidectomy for secondary hyperparathyroidism is a common approach. The surgeon first makes an incision in the neck area under general or local anesthesia. Then, the enlarged parathyroid glands are carefully identified and dissected. Precise surgical skills are required to avoid damaging nearby structures such as the recurrent laryngeal nerve and blood vessels. After the removal of the abnormal parathyroid tissue, the wound is closed.
| 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.
Achievement rate of target PTH value
Measured: 6 months 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
Secondary outcomes (5)
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
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
Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation
Changes in Bone Metabolism Markers will be evaluated by measuring specific biochemical parameters. These include serum levels of bone-specific alkaline phosphatase (BALP), which is a biomarker reflecting osteoblast activity. Another important marker is N-terminal propeptide of type I collagen (PINP), which is involved in collagen synthesis and provides insights into bone formation. ALP is a well-known enzyme related to bone metabolism and its elevation can be indicative of increased osteoblastic activity. The levels of these markers will be determined using enzyme-linked immunosorbent assay (ELISA) kits, which are highly sensitive and specific laboratory assays.
Measured: 1 year
All - cause mortality rate
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 posted29 Nov 2024
- Study start26 Nov 2024 (estimated)
- Primary completion26 Nov 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achievement 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
- 612 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
- NCT06709586
- Sponsor's protocol ID
- S2024-11-10
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2024
- Last updated
- 29 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism: a Multicenter Study
- ClinicalTrials.gov ID
- NCT06709586
- Acronym / sponsor ID
- S2024-11-10
- Conditions
- Achievement Rate, Efficacy and Safety, PTH, Calcium, Clinical Symptoms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 612 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
- 30 Dec 2028 (estimated)
- First posted
- 29 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.
Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.
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 secondary hyperparathyroidism based on clinical symptoms (such as bone pain, fractures, pruritus), biochemical parameters (elevated parathyroid hormone, abnormal calcium, phosphorus, and alkaline phosphatase levels), and relevant medical history (especially those with underlying chronic kidney disease or other relevant disorders). All patients must provide written informed consent after a detailed discussion of the study purpose, procedures, potential risks, and benefits of both treatment options by the research team.
Key inclusion criteria (4 listed)
- persistent serum iPTH (intact parathyroid hormone) levels > 800 pg/mL；
- resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment；
- severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life；
- imaging examinations indicating the presence of at least one enlarged parathyroid gland
Key exclusion criteria (1 listed)
- severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia
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 treatment for secondary hyperparathyroidism. There are radiofrequency ablation (RFA) and microwave ablation (MWA). For RFA, an electrode needle is inserted into the parathyroid under imaging guidance. High - frequency current heats the tissue to cause necrosis. MWA uses electromagnetic waves to generate heat by friction. Before ablation, imaging and lab tests are done for evaluation. During the process, precise positioning and real - time monitoring are key. After that, patients are observed for bleeding, swelling and other symptoms, and tests are repeated to assess the effect. | Procedure or surgery | Therma ablation |
| parathyroidectomyParathyroidectomy for secondary hyperparathyroidism is a common approach. The surgeon first makes an incision in the neck area under general or local anesthesia. Then, the enlarged parathyroid glands are carefully identified and dissected. Precise surgical skills are required to avoid damaging nearby structures such as the recurrent laryngeal nerve and blood vessels. After the removal of the abnormal parathyroid tissue, the wound is closed. | Procedure or surgery | Parathyroidectomy |
Primary outcome
Achievement rate of target PTH value
Time frame: 6 months after surgery or ablation
Symptom remission rate
Time frame: 1 year after treatment
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.
5 secondary outcomes
complication rate
Time frame: within 30 days after surgery or ablation
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
Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation
Time frame: 1 year
All - cause mortality rate
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 29 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 Achievement Rate and Efficacy and Safety, 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 4 inclusion and 1 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 29 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?
Achievement rate of target PTH value (time frame: 6 months after surgery or ablation). The study lists 2 primary outcomes in all. 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 29 Nov 2024.