Secondary Hyperparathyroidism Due to Renal CausesNCT04267965
Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy
An observational study of Secondary Hyperparathyroidism Due to Renal Causes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Secondary Hyperparathyroidism Due to Renal Causes
- What is being tested?
- parathyroidectomy plus bilateral thymectomy and autotransplantation
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: We included patients who had symptomatic secondary hyperparathyroidism and were successfully operated during the two years period (Aug 1 2017 - July 31 2019).
Who may be able to join
- age over 20 years
- chronic renal failure with regular dialysis
- iPTH> 800pg/mL, Ca > 10.1 mg/dL, and P > 5.5 mg/dL
- symptoms of bone pain, skin itching, general weakness, insomnia and osteoporosis (T score< -2.5)
Who cannot join
- pregnancy women
- patients after kidney transplantation
- a failure in surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of Pulmonary Function, Voice and Swallowing Symptoms After Total Parathyroidectomy for Secondary Hyperparathyroidism in the Presence of Intact Recurrent Laryngeal Nerve
In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.
Read the detailed description
This was a prospective case-control study. From July 2017 to Dec. 2018, investigators recruited 38 patients, who had undergone a successful operation of total parathyroidectomy and bilateral thymectomy (TPxBT) plus autotransplantation for symptomatic secondary hyperparathyroidism as the study group. In the same period 4 patients who had a surgical failure were excluded from the study. Indications for surgery were patients who had undergone long-term regular hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), with serum levels of Ca > 10.1 mg/dL, P > 5.5 mg/dL, alkaline phosphatase (Alk-ptase) > 94 U/L and intact parathyroid hormone(iPTH) > 800 pg/mL and with symptoms and signs such as skin itching, bone pain, general weakness, insomnia and T-score of bone mineral density (BMD) (the lowest T-score of lumbar spine 1-4, global femur, femoral neck, radial 1/3, and global radius) < -2.5. During surgery, Total parathyroidectomy and bilateral thymectomy was performed plus autotranplantation of 100 mg of hyperplastic parathyroid tissue to the subcutaneous tissue of the forearm without harboring an arteriovenous fistula.
Ten patients with regular hemodialysis who had developed mild secondary hyperparathyroidism (iPTH around 500 pg/mL) but did not undergo parathyroidectomy were recruited as the control group.
Investigators recorded patients' age, symptoms, gender, body mass index (BMI) and measured serum levels of Ca, P, Alk-ptase and iPTH, and BMD (T-score). The Investigators also recorded patients' voice quality, airway invasion during swallowing and pulmonary functions before surgery and 4 months after surgery to find the changes after surgery. In the control group, investigators recorded and measured these items at baseline and 4 months later.
At 1 week after surgery, serum Ca, P, Alk-ptase and iPTH levels were measured again to make sure that the operation was successful. A successful operation was defined as iPTH levels < 72 pg/mL within 1 week after surgery. Four patients were excluded from this study with a surgical failure in the same period.
The perceptual evaluation of voice quality such as speech impairment and speech quality by means of multidimensional clinical measurements based on auditory methods with grade, hoarseness, roughness, breathiness, asthenia, and strain (GRBAS) on a scale (0-3) (normal-high degree) were performed by the ear, nose, and throat specialist (Dr. Lai, C.C.). Voice handicap index (VHI-10) (>11, abnormal) and eating assessment tool (EAT-10) (≥ 3, abnormal) were evaluated by patients themselves.
Acoustic and aerodynamic measurements were applied to recordings of each subject producing sustained vowel productions in a soundproof room. Acoustic variables including jitter (Jitt), shimmer (ShdB), noise-to-harmonic ratio (NHR), fundamental frequency (Fo), and high pitch were measured using computerized speech laboratory (Core Model SCL # 4300B, KayPENTAX Elementries, Lincoln park, NJ).
The maximal phonation time and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system (Aerophone II, Model 6800, KayPENTAX Elementrics). Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels (1-8) (no entry of material into the larynx or trachea-material enter the airway passes below vocal folds and no effort is made to eject) (>1, abnormal). The Yale pharyngeal residue severity rating scale for vallecula (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed by the ENT specialist.
The specialist of chest medicine (Dr. Chang, H.C.) performed pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA). The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).
- Being tested
- parathyroidectomy plus bilateral thymectomy and autotransplantation
- Keywords
- Voice impairment, airway invasion, respiratory function
- Medical subject headings
- Dysphonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomy plus bilateral thymectomy and autotransplantationProcedure or surgery
Patients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who have been successfully operated on with total parathyroidectomy for symptomatic secondary hyperparathyroidism and their PTH levels are below 72 pg/dL within one week after surgery. Receives: Procedure: parathyroidectomy plus bilateral thymectomy and autotransplantation | |
| Group B | Patients who have had regular dialysis and their iPTH levels are around 500 pg/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful surgery is defined as iPTH levels less than 72 pg/dL within one week after surgery
After successful surgery, patients were recruited in the study, and we excluded patients with a surgical failure.
Measured: one week after surgery
Voice impairment(GRBAS)
speech impairment and speech quality were evaluated with GRBAS on a scale (0-3), VHI-10 (>11, abnormal) and (EAT-10) (≥ 3, abnormal) .
*GRBAS (grade, roughness, breathiness, asthenia, strain) scale grades hoarseness, roughness, breathiness, aesthenia (weakness), and strain on a scale of 0-3 0 = normal, 1 = mild degree, 2 = moderate degree, and 3 = high degree
Measured: 4 months after surgery
Voice impairment(VH1-10)
speech impairment and speech quality were evaluated with voice handicap index (VHI-10) (>11, abnormal) 0-4 Rating Scale 0 = Normal
- = Almost Normal
- = Sometimes
- = Abnormal
- = Always
Measured: 4 months after surgery
Voice impairment(EAT-10)
speech impairment and speech quality were evaluated with EAT-10 (≥ 3, abnormal) .
*eating assessment tool (EAT-10) 0 - 4 Rating Scale 0 = No problem
- = Mild Problem
- = Mild to moderate
- = Moderate problem
- = Severe problem
Measured: 4 months after surgery
Acoustic voice analysis
mean frequency (F0, Hz); Noise-to-Harmonic Ratio (NHR), jitter(%), and shimmer (%)
Measured: 4 months after surgery
Vocal cord examination
The maximal phonation time (sec) and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system .
Measured: 4 months later
Fiber optic endoscopic evaluation of swallowing (FEES)
Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels . The Yale pharyngeal residue severity rating scale for vallecula and pyriform sinus (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed.
Measured: 4 months later.
Pulmonary function test
Forced vital capacity (FVC) (L), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC) (L), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) (%) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA).
Measured: 4 months later
6MWT were performed.
The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).
Measured: 4 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Secondary Hyperparathyroidism Due to Renal CausesStudies 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
- 48 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chou Fong-Fu, Chang Gung Memorial Hospital
- Investigators
- Chang Huang-Chih, MD, Study director, Co-hostChen Jib-Bor, MD, Study director, Co-hostLai Chi-Chih, MD, Study director, Co-host
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267965
- Sponsor's protocol ID
- 201601901B0
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okada M, Tominaga Y, Yamamoto T, Hiramitsu T, Narumi S, Watarai Y. Location Frequency of Missed Parathyroid Glands After Parathyroidectomy in Patients with Persistent or Recurrent Secondary Hyperparathyroidism. World J Surg. 2016 Mar;40(3):595-9. doi: 10.1007/s00268-015-3312-1.
PubMed 26563219Wood JM, Athanasiadis T, Allen J. Laryngitis. BMJ. 2014 Oct 9;349:g5827. doi: 10.1136/bmj.g5827. No abstract available.
PubMed 25300640Arffa RE, Krishna P, Gartner-Schmidt J, Rosen CA. Normative values for the Voice Handicap Index-10. J Voice. 2012 Jul;26(4):462-5. doi: 10.1016/j.jvoice.2011.04.006. Epub 2011 Aug 4.
PubMed 21816570Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
PubMed 19140539Eckel FC, Boone DR. The S/Z ratio as an indicator of laryngeal pathology. J Speech Hear Disord. 1981 May;46(2):147-9. doi: 10.1044/jshd.4602.147.
PubMed 7253591Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.
PubMed 26050238Richter DC, Joubert JR, Nell H, Schuurmans MM, Irusen EM. Diagnostic value of post-bronchodilator pulmonary function testing to distinguish between stable, moderate to severe COPD and asthma. Int J Chron Obstruct Pulmon Dis. 2008;3(4):693-9. doi: 10.2147/copd.s948.
PubMed 19281083Single breath carbon monoxide diffusing capacity (transfer factor). Recommendations for a standard technique. Statement of the American Thoracic Society. Am Rev Respir Dis. 1987 Nov;136(5):1299-307. doi: 10.1164/ajrccm/136.5.1299. No abstract available.
PubMed 3674590Waatevik M, Johannessen A, Gomez Real F, Aanerud M, Hardie JA, Bakke PS, Lind Eagan TM. Oxygen desaturation in 6-min walk test is a risk factor for adverse outcomes in COPD. Eur Respir J. 2016 Jul;48(1):82-91. doi: 10.1183/13993003.00975-2015. Epub 2016 Apr 13.
PubMed 27076586
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Pulmonary Function, Voice and Swallowing Symptoms After Total Parathyroidectomy for Secondary Hyperparathyroidism in the Presence of Intact Recurrent Laryngeal Nerve
- ClinicalTrials.gov ID
- NCT04267965
- Acronym / sponsor ID
- 201601901B0
- Keywords
- Voice impairment, airway invasion, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Feb 2020 (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.
In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.
Detailed description
This was a prospective case-control study. From July 2017 to Dec. 2018, investigators recruited 38 patients, who had undergone a successful operation of total parathyroidectomy and bilateral thymectomy (TPxBT) plus autotransplantation for symptomatic secondary hyperparathyroidism as the study group. In the same period 4 patients who had a surgical failure were excluded from the study. Indications for surgery were patients who had undergone long-term regular hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), with serum levels of Ca > 10.1 mg/dL, P > 5.5 mg/dL, alkaline phosphatase (Alk-ptase) > 94 U/L and intact parathyroid hormone(iPTH) > 800 pg/mL and with symptoms and signs such as skin itching, bone pain, general weakness, insomnia and T-score of bone mineral density (BMD) (the lowest T-score of lumbar spine 1-4, global femur, femoral neck, radial 1/3, and global radius) < -2.5. During surgery, Total parathyroidectomy and bilateral thymectomy was performed plus autotranplantation of 100 mg of hyperplastic parathyroid tissue to the subcutaneous tissue of the forearm without harboring an arteriovenous fistula.
Ten patients with regular hemodialysis who had developed mild secondary hyperparathyroidism (iPTH around 500 pg/mL) but did not undergo parathyroidectomy were recruited as the control group.
Investigators recorded patients' age, symptoms, gender, body mass index (BMI) and measured serum levels of Ca, P, Alk-ptase and iPTH, and BMD (T-score). The Investigators also recorded patients' voice quality, airway invasion during swallowing and pulmonary functions before surgery and 4 months after surgery to find the changes after surgery. In the control group, investigators recorded and measured these items at baseline and 4 months later.
At 1 week after surgery, serum Ca, P, Alk-ptase and iPTH levels were measured again to make sure that the operation was successful. A successful operation was defined as iPTH levels < 72 pg/mL within 1 week after surgery. Four patients were excluded from this study with a surgical failure in the same period.
The perceptual evaluation of voice quality such as speech impairment and speech quality by means of multidimensional clinical measurements based on auditory methods with grade, hoarseness, roughness, breathiness, asthenia, and strain (GRBAS) on a scale (0-3) (normal-high degree) were performed by the ear, nose, and throat specialist (Dr. Lai, C.C.). Voice handicap index (VHI-10) (>11, abnormal) and eating assessment tool (EAT-10) (≥ 3, abnormal) were evaluated by patients themselves.
Acoustic and aerodynamic measurements were applied to recordings of each subject producing sustained vowel productions in a soundproof room. Acoustic variables including jitter (Jitt), shimmer (ShdB), noise-to-harmonic ratio (NHR), fundamental frequency (Fo), and high pitch were measured using computerized speech laboratory (Core Model SCL # 4300B, KayPENTAX Elementries, Lincoln park, NJ).
The maximal phonation time and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system (Aerophone II, Model 6800, KayPENTAX Elementrics). Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels (1-8) (no entry of material into the larynx or trachea-material enter the airway passes below vocal folds and no effort is made to eject) (>1, abnormal). The Yale pharyngeal residue severity rating scale for vallecula (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed by the ENT specialist.
The specialist of chest medicine (Dr. Chang, H.C.) performed pulmonary function tests including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA). The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: parathyroidectomy plus bilateral thymectomy and autotransplantationPatients who have been successfully operated on with total parathyroidectomy for symptomatic secondary hyperparathyroidism and their PTH levels are below 72 pg/dL within one week after surgery. |
| Group B | – | –Patients who have had regular dialysis and their iPTH levels are around 500 pg/dL |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We included patients who had symptomatic secondary hyperparathyroidism and were successfully operated during the two years period (Aug 1 2017 - July 31 2019).
Key inclusion criteria (4 listed)
- age over 20 years
- chronic renal failure with regular dialysis
- iPTH> 800pg/mL, Ca > 10.1 mg/dL, and P > 5.5 mg/dL
- symptoms of bone pain, skin itching, general weakness, insomnia and osteoporosis (T score< -2.5)
Key exclusion criteria (3 listed)
- pregnancy women
- patients after kidney transplantation
- a failure in surgery
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 |
|---|---|---|
| parathyroidectomy plus bilateral thymectomy and autotransplantationPatients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation | Procedure or surgery | Group A |
Primary outcome
Successful surgery is defined as iPTH levels less than 72 pg/dL within one week after surgery
Time frame: one week after surgery
After successful surgery, patients were recruited in the study, and we excluded patients with a surgical failure.
Voice impairment(GRBAS)
Time frame: 4 months after surgery
speech impairment and speech quality were evaluated with GRBAS on a scale (0-3), VHI-10 (>11, abnormal) and (EAT-10) (≥ 3, abnormal) . *GRBAS (grade, roughness, breathiness, asthenia, strain) scale grades hoarseness, roughness, breathiness, aesthenia (weakness), and strain on a scale of 0-3 0 = normal, 1 = mild degree, 2 = moderate degree, and 3 = high degree
Voice impairment(VH1-10)
Time frame: 4 months after surgery
speech impairment and speech quality were evaluated with voice handicap index (VHI-10) (>11, abnormal) 0-4 Rating Scale 0 = Normal 1. = Almost Normal 2. = Sometimes 3. = Abnormal 4. = Always
Voice impairment(EAT-10)
Time frame: 4 months after surgery
speech impairment and speech quality were evaluated with EAT-10 (≥ 3, abnormal) . *eating assessment tool (EAT-10) 0 - 4 Rating Scale 0 = No problem 1. = Mild Problem 2. = Mild to moderate 3. = Moderate problem 4. = Severe problem
Acoustic voice analysis
Time frame: 4 months after surgery
mean frequency (F0, Hz); Noise-to-Harmonic Ratio (NHR), jitter(%), and shimmer (%)
Vocal cord examination
Time frame: 4 months later
The maximal phonation time (sec) and s/z ratio were measured with circumferentially vented pneumotachography mask and differential transducers of the Aerophone system .
Fiber optic endoscopic evaluation of swallowing (FEES)
Time frame: 4 months later.
Vocal cord mobility, vocal cord closure (complete or incomplete), airway invasion during swallowing were inspected with fiber-optic endoscopy to show premature spillage, penetration-aspiration scale levels . The Yale pharyngeal residue severity rating scale for vallecula and pyriform sinus (0-4) (non-trace-mild-moderate-severe) and pyriform sinus (0-4) were also performed.
Pulmonary function test
Time frame: 4 months later
Forced vital capacity (FVC) (L), forced expiratory volume in 1 second (FEV1), bronchodilator test (BDT) (a positive response to BDT defined by the American Thoracic Society as an increase in FEV1 or FVC ≥ 12% and 200 ml), total lung capacity (TLC) (L), and alveolar volume (VA) using MasterScope (Jaeger, VIASYS healthcare GmbH, Höchberg, Germany), and diffusion capacity of the lung for carbon monoxide (DLCO) (%) using Vmax Autobox (SensorMedics, a subsidiary of VIASYS healthcare, California, USA).
6MWT were performed.
Time frame: 4 months later
The 6 minutes walking test (6MWT) was also performed to evaluate distance (meter) and O2 desaturation (differences of O2 saturation between pre- and post-tests) (defined as positive if O2 desaturation ≧ 4%).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Results publication: PubMed 26563219Okada M, Tominaga Y, Yamamoto T, Hiramitsu T, Narumi S, Watarai Y. Location Frequency of Missed Parathyroid Glands After Parathyroidectomy in Patients with Persistent or Recurrent Secondary Hyperparathyroidism. World J Surg. 2016 Mar;40(3):595-9. doi: 10.1007/s00268-015-3312-1.
- Results publication: PubMed 25300640Wood JM, Athanasiadis T, Allen J. Laryngitis. BMJ. 2014 Oct 9;349:g5827. doi: 10.1136/bmj.g5827. No abstract available.
- Results publication: PubMed 21816570Arffa RE, Krishna P, Gartner-Schmidt J, Rosen CA. Normative values for the Voice Handicap Index-10. J Voice. 2012 Jul;26(4):462-5. doi: 10.1016/j.jvoice.2011.04.006. Epub 2011 Aug 4.
- Results publication: PubMed 19140539Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
- Results publication: PubMed 7253591Eckel FC, Boone DR. The S/Z ratio as an indicator of laryngeal pathology. J Speech Hear Disord. 1981 May;46(2):147-9. doi: 10.1044/jshd.4602.147.
- Results publication: PubMed 8721066Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
- Results publication: PubMed 26050238Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.
- Results publication: PubMed 19281083Richter DC, Joubert JR, Nell H, Schuurmans MM, Irusen EM. Diagnostic value of post-bronchodilator pulmonary function testing to distinguish between stable, moderate to severe COPD and asthma. Int J Chron Obstruct Pulmon Dis. 2008;3(4):693-9. doi: 10.2147/copd.s948.
- Results publication: PubMed 3674590Single breath carbon monoxide diffusing capacity (transfer factor). Recommendations for a standard technique. Statement of the American Thoracic Society. Am Rev Respir Dis. 1987 Nov;136(5):1299-307. doi: 10.1164/ajrccm/136.5.1299. No abstract available.
- Results publication: PubMed 27076586Waatevik M, Johannessen A, Gomez Real F, Aanerud M, Hardie JA, Bakke PS, Lind Eagan TM. Oxygen desaturation in 6-min walk test is a risk factor for adverse outcomes in COPD. Eur Respir J. 2016 Jul;48(1):82-91. doi: 10.1183/13993003.00975-2015. Epub 2016 Apr 13.
- 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. This study is not recruiting at the moment.
Chang Huang-Chih, MD study director
Co-host
Chen Jib-Bor, MD study director
Co-host
Lai Chi-Chih, MD study director
Co-host
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hyperparathyroidism Due to Renal Causes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful surgery is defined as iPTH levels less than 72 pg/dL within one week after surgery (time frame: one week after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267965, which also lists 10 linked publications.
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 13 Feb 2020.