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
Study website
Contact information
Type
Scientific
Contact name
Dr Kyriakos Vamvakidis
ORCID ID
https://orcid.org/0000-0002-1663-4839
Contact details
59 Skoufa Street
Athens
106 72
Greece
+30 (0)6944254801
info@drvamvakidis.gr
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
35/26-04-2021
Study information
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
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
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
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients over 18 years old undergoing total thyroidectomy with or without neck lymph node dissection
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
400
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
Henry Dunant Hospital Center
107 Mesogeion Avenue
Athens
115 26
Greece
Sponsor information
Organisation
Henry Dunant Hospital
Sponsor details
107 Mesogeion Avenue
Athens
115 26
Greece
+30 (0)2106972000
endocrinesurgery@dunant.gr
Sponsor type
Hospital/treatment centre
Website
http://www.dunant.gr/default.aspx?id=84&aid=7698&lang=english
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Henry Dunant Hospital Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
31/12/2023
Individual participant data (IPD) sharing plan
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | 30/12/2021 | 30/12/2021 | No | No |