Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total thyroidectomy with the PTeye™ parathyroid detection system | Active Comparator | PTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery. |
|
| Conventional total thyroidectomy | No Intervention | Total thyroidectomy without PTeye™ |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTeye™ parathyroid detection system | Device | The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) | Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of inadvertent parathyroidectomy (in %) | Rate of inadvertent parathyroidectomy (in %) | within 4 weeks from operation |
| Rate of parathyroid auto-transplantation (in %) | Rate of parathyroid auto-transplantation (in %) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man Him, Matrix Fung, MBBS | Contact | +852 2255 4232 | mmhfung@hku.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15: | ||
| Background | Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14: | ||
| 34116859 | Background | Lui DTW, Fung MMH, Lee CH, Fong CHY, Woo YC, Lang BHH. A territory-wide assessment of the incidence of persistent hypoparathyroidism after elective thyroid surgery and its impact on new fracture risk over time. Surgery. 2021 Nov;170(5):1369-1375. doi: 10.1016/j.surg.2021.05.004. Epub 2021 Jun 8. | |
| 24402815 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
Not provided
Not provided
The study design and sample size calculation was validated by an experienced biostatistician. Preliminary data showed rate of significant post-operative hypoparathyroidism (SPH) was 17.7% lower with PTeye use.
A sample size of 89 per group will achieve 80% power to detect between-group difference of 17.7%. The calculations are based on a one-sided Z-Test with the significance level of 0.05. Allowing for a 15% loss to followup, 105 patients per arm (210 in total) will be recruited for the trial. Eligible patients will be first stratified to benign and malignant diseases, then randomly assigned at a 1:1 ratio to receive either PTeye-assisted or conventional surgery according to a pre-generated block randomization list. Allocation sequence will be concealed in sequentially numbered, opaque, sealed, and stapled envelopes. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments, just before surgery.
Not provided
Not provided
Not provided
| within operation |
| Day 0 PTH | Day 0 Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative Day 0 |
| Day 1 Post-operative serum parathyroid hormone levels (pmol/L) | Day 1 Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative Day 1 |
| 3-month Post-operative serum parathyroid hormone levels (pmol/L) | 3-month Post-operative serum parathyroid hormone levels (pmol/L) | Post-operative 3 months |
| 6-month Post-operative serum parathyroid hormone levels (pmol/L) | 6-month Post-operative serum parathyroid hormone levels | Post-operative 6 months |
| Background |
| Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. |
| 4758544 | Background | Payne RB, Little AJ, Williams RB, Milner JR. Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J. 1973 Dec 15;4(5893):643-6. doi: 10.1136/bmj.4.5893.643. |
| 31804401 | Background | Solorzano CC, Thomas G, Baregamian N, Mahadevan-Jansen A. Detecting the Near Infrared Autofluorescence of the Human Parathyroid: Hype or Opportunity? Ann Surg. 2020 Dec;272(6):973-985. doi: 10.1097/SLA.0000000000003700. |
| 29122325 | Background | Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6. |
| 30710614 | Background | Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31. |
| 31693081 | Background | Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613. |
| 31305127 | Background | DiMarco A, Chotalia R, Bloxham R, McIntyre C, Tolley N, Palazzo FF. Does fluoroscopy prevent inadvertent parathyroidectomy in thyroid surgery? Ann R Coll Surg Engl. 2019 Sep;101(7):508-513. doi: 10.1308/rcsann.2019.0065. Epub 2019 Jul 15. |
| 26454675 | Background | McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9. |
| 21721833 | Background | Paras C, Keller M, White L, Phay J, Mahadevan-Jansen A. Near-infrared autofluorescence for the detection of parathyroid glands. J Biomed Opt. 2011 Jun;16(6):067012. doi: 10.1117/1.3583571. |
| 27635137 | Background | Manatakis DK, Balalis D, Soulou VN, Korkolis DP, Plataniotis G, Gontikakis E. Incidental Parathyroidectomy during Total Thyroidectomy: Risk Factors and Consequences. Int J Endocrinol. 2016;2016:7825305. doi: 10.1155/2016/7825305. Epub 2016 Aug 18. |
| 38880699 | Background | Luk Y, Fung MMH, Lui DTW, Liu X, Li L, Wong CKH, Lang BHH. Long-term kidney outcomes in patients with permanent hypoparathyroidism after total thyroidectomy for benign disease: A population-based study. Surgery. 2024 Sep;176(3):700-707. doi: 10.1016/j.surg.2024.05.005. Epub 2024 Jun 15. |
| 38886971 | Background | Ivanovic-Zuvic D, Chelebifski S, Uribe B, Quintana C, Dominguez JM, Olmos R, Florenzano P. Impaired Quality of Life in Patients with Post-Surgical Hypoparathyroidism. J Bone Metab. 2024 May;31(2):140-149. doi: 10.11005/jbm.2024.31.2.140. Epub 2024 May 31. |
| 36184675 | Background | Hillary SL, Chooi JE, Wadsley J, Newell-Price JD, Brown NJ, Balasubramanian SP. Quality of Life in Post-Surgical Hypoparathyroidism (PoSH) in Thyroid and Parathyroid Surgery. World J Surg. 2022 Dec;46(12):3025-3033. doi: 10.1007/s00268-022-06730-7. Epub 2022 Oct 2. |
| 38578400 | Background | Buttner M, Singer S, Taylor K. Quality of life in patients with hypoparathyroidism receiving standard treatment: an updated systematic review. Endocrine. 2024 Jul;85(1):80-90. doi: 10.1007/s12020-024-03807-2. Epub 2024 Apr 5. |
| 36153665 | Background | Pasieka JL, Wentworth K, Yeo CT, Cremers S, Dempster D, Fukumoto S, Goswami R, Houillier P, Levine MA, Pasternak JD, Perrier ND, Sitges-Serra A, Shoback DM. Etiology and Pathophysiology of Hypoparathyroidism: A Narrative Review. J Bone Miner Res. 2022 Dec;37(12):2586-2601. doi: 10.1002/jbmr.4714. Epub 2022 Nov 23. |
| 33869995 | Background | Jorgensen CU, Homoe P, Dahl M, Hitz MF. Postoperative Chronic Hypoparathyroidism and Quality of Life After Total Thyroidectomy. JBMR Plus. 2021 Mar 16;5(4):e10479. doi: 10.1002/jbm4.10479. eCollection 2021 Apr. |
| 34353986 | Background | Frey S, Figueres L, Pattou F, Le Bras M, Caillard C, Mathonnet M, Hamy A, Brunaud L, Lifante JC, Tresallet C, Sebag F, Menegaux F, Blanchard C, Leroy M, Mirallie E; Qol-Hypopara Study Group. Impact of Permanent Post-thyroidectomy Hypoparathyroidism on Self-evaluation of Quality of Life and Voice: Results From the National QoL-Hypopara Study. Ann Surg. 2021 Nov 1;274(5):851-858. doi: 10.1097/SLA.0000000000005129. |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |