Investigation of the use of special camera technology during thyroid surgery to avoid the need for calcium supplementation after surgery
| ISRCTN | ISRCTN17501072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17501072 |
| Secondary identifying numbers | 35/26-04-2021 |
- Submission date
- 12/06/2021
- Registration date
- 24/06/2021
- Last edited
- 30/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Autofluorescence is the natural emission of light by biological structures. The use of autofluorescence in endocrine surgery is a new, innovative and promising technique that can help the surgeon identify and protect the parathyroid glands during surgery, reducing the likelihood of the need for daily calcium and vitamin D supplements after surgery.
The use of this technology is increasing internationally. Although its safety has been confirmed, there is still not much data on its effectiveness. The aim of this study is to show whether the use of the autofluorescence method reduces the risk of temporary or permanent hypocalcemia (low blood calcium), one of the most serious complications after thyroid surgery.
Who can participate?
Patients aged over 18 years who are scheduled to undergo total thyroidectomy (removal of the thyroid gland), with or without neck lymph node dissection
What does the study involve?
Participants will be randomly allocated to receive thyroid surgery with or without the use of the autofluorescence camera. For the study's validity, the selection of patients must be random and automated by a special algorithm, which means that nor the patient or the doctor will choose if the autofluorescence camera will be used.
What are the possible benefits and risks of participating?
The results of this study will help surgeons internationally to make better use of this new technology. This technique is entirely safe for the patient since it does not require any additional intervention on the patient (surgical or pharmaceutical), the patient does not receive ionizing radiation, it does not endanger their health in any way, and it does not increase surgery time.
Where is the study run from?
Henry Dunant Hospital Center (Greece)
When is the study starting and how long is it expected to run for?
April 2021 to April 2023
Who is funding the study?
Henry Dunant Hospital Center (Greece)
Who is the main contact?
Dr Kyriakos Vamvakidis
info@drvamvakidis.gr
Contact information
Scientific
59 Skoufa Street
Athens
106 72
Greece
 ORCID ID |
0000-0002-1663-4839 |
|---|---|
| Phone | +30 (0)6944254801 |
| info@drvamvakidis.gr |
Study information
| Study design | Single-centre interventional prospective randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prospective randomized clinical trial for the evaluation of the use of autoFLUorescence technology in the prevention of postoperative hypoPARathyroidism in patients undergoing thyroidectomy with or without neck dissection |
| Study acronym | PARFLU |
| Study hypothesis | The use of autofluorescence may assist the surgeon to earlier identify the parathyroid glands during thyroid operations, and as a result, this may reduce the possibility of postoperative temporary or permanent hypoparathyroidism. |
| Ethics approval(s) | Approved 09/06/2021, Board of Ethics of Henry Dunant Hospital Center (107 Mesogeion Ave P.C. 115 26, Athens, Greece; +30 (0)2106979090; g.papazoglou@dunant.gr), ref: none provided |
| Condition | Prevention of postoperative hypoparathyroidism in patients undergoing thyroid operations |
| Intervention | This study will include patients undergoing total thyroidectomy, with or without neck lymph node dissection. In the first arm, the autofluorescence technique will be used for the intraoperative detection of parathyroid glands. In the second arm, patients will have a conventional operation. The allocation of the patients will be random with the use of computer software, neither the patient nor the surgeon will have a choice. Postoperatively, all patients will have the required blood tests and clinical examination, required to identify those who may develop hyperparathyroidism. The final follow up will take place 6 months after the operation to conclude if the possible postoperative hyperparathyroidism is temporary or permanent. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Autofluorescence system - Viron X Maxer Endoscopy |
| Primary outcome measure | 1. Total calcium levels measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 2. Albumin measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 3. Phosphorous measured using a blood test (colorimetric method) at baseline, 1 day, 1 week, and 6 months 4. Intact parathormone levels measured using a blood test (chemiluminescence immunoassay) at baseline, 1 day, 1 week, and 6 months 5. 25-OH-Vit D measured using a blood test (chemiluminescence immunoassay) at baseline |
| Secondary outcome measures | 1. Number of parathyroid glands detected intraoperatively measured using autofluorescence or direct visualisation during the operation 2. Number of unintentional removals of parathyroid glands measured using the histopathology report at 1 month (after receiving the official report) 3. Number of autotransplantation of parathyroid glands measured using operation notes at day 1 |
| Overall study start date | 20/04/2021 |
| Overall study end date | 20/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | Patients over 18 years old undergoing total thyroidectomy with or without neck lymph node dissection |
| Participant exclusion criteria | 1. Patients undergoing reoperation for thyroid pathology 2. Patients undergoing less than total thyroidectomy (lobectomy, hemithyroidectomy, subtotal thyroidectomy) 3. Patients who have hyperthyroidism 4. Patients who simultaneously with thyroidectomy have an operation for primary, secondary or tertiary hyperparathyroidism |
| Recruitment start date | 28/06/2021 |
| Recruitment end date | 30/09/2022 |
Locations
Countries of recruitment
- Greece
Study participating centre
Athens
115 26
Greece
Sponsor information
Hospital/treatment centre
107 Mesogeion Avenue
Athens
115 26
Greece
| Phone | +30 (0)2106972000 |
|---|---|
| endocrinesurgery@dunant.gr | |
| Website | http://www.dunant.gr/default.aspx?id=84&aid=7698&lang=english |
"ROR" |
https://ror.org/05n7t4h40 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | 30/12/2021 | 30/12/2021 | No | No |
Editorial Notes
30/12/2021: A protocol link has been added to the trial outputs.
22/06/2021: Trial's existence confirmed by the Board of Ethics of Henry Dunant Hospital Center.
