ThyroidANGIO_PARANCT05328076
Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
An observational study of Thyroid and Thyroid Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy. The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid, Thyroid Cancer, Hypoparathyroidism
- What is being tested?
- Indocyanine green and SPY Portable Handheld Imaging (SPY-PHI)
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2022to 19 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients who need surgical treatment for thyroid disease.
Who may be able to join
- Able to sign informed consent
- Indication to total thyroidectomy
- No contraindication to indocyanine green administration
Who cannot join
- Evidence of parathyroid disease
- Allergy to iodinated contrast
- Chronic kidney failure
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography
Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.
The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.
It is planned to enroll 66 patients.
Read the detailed description
Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.
Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.
The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.
In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.
- Conditions
- Thyroid, Thyroid Cancer, Hypoparathyroidism, Vascularization
- Being tested
- Indocyanine green, SPY Portable Handheld Imaging (SPY-PHI)
- Keywords
- Parathyroid, Thyroid surgery, Indocyanine green angiography
- Medical subject headings
- Thyroid Diseases, Thyroid Neoplasms, Hypoparathyroidism, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Indocyanine green is used to perform intraoperative angiography.
SPY Portable Handheld Imaging (SPY-PHI)Device
The device is used to perform intraoperative angiography.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Patients who undergo thyroid surgery and receive indocyanine green angiography Receives: Drug: Indocyanine green; Device: SPY Portable Handheld Imaging (SPY-PHI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularization score
A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism.
The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start2 May 2022
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Why it stopped: We encountered problems in finding the necessary resources in the Institute
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Maggiore, IRCCS San Raffaele
- Investigators
- Riccardo Rosati, Prof., Study director, San Raffaele Hospiral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328076
- Sponsor's protocol ID
- ANGIO PARA
- Acronym
- ANGIO_PARA
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lang BH, Wong CK, Hung HT, Wong KP, Mak KL, Au KB. Indocyanine green fluorescence angiography for quantitative evaluation of in situ parathyroid gland perfusion and function after total thyroidectomy. Surgery. 2017 Jan;161(1):87-95. doi: 10.1016/j.surg.2016.03.037. Epub 2016 Nov 10.
PubMed 27839936Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.
PubMed 29405252Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
PubMed 31882459Puzziello A, Rosato L, Innaro N, Orlando G, Avenia N, Perigli G, Calo PG, De Palma M. Hypocalcemia following thyroid surgery: incidence and risk factors. A longitudinal multicenter study comprising 2,631 patients. Endocrine. 2014 Nov;47(2):537-42. doi: 10.1007/s12020-014-0209-y. Epub 2014 Feb 22.
PubMed 24563161Ji YB, Song CM, Sung ES, Jeong JH, Lee CB, Tae K. Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy. Clin Exp Otorhinolaryngol. 2017 Sep;10(3):265-271. doi: 10.21053/ceo.2016.00724. Epub 2016 Aug 13.
PubMed 27515510Zaidi N, Bucak E, Yazici P, Soundararajan S, Okoh A, Yigitbas H, Dural C, Berber E. The feasibility of indocyanine green fluorescence imaging for identifying and assessing the perfusion of parathyroid glands during total thyroidectomy. J Surg Oncol. 2016 Jun;113(7):775-8. doi: 10.1002/jso.24237. Epub 2016 Apr 4.
PubMed 27041628
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography
- ClinicalTrials.gov ID
- NCT05328076
- Acronym / sponsor ID
- ANGIO_PARA / ANGIO PARA
- Conditions
- Thyroid, Thyroid Cancer, Hypoparathyroidism, Vascularization
- Keywords
- Parathyroid, Thyroid surgery, Indocyanine green angiography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We encountered problems in finding the necessary resources in the Institute
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 14 Apr 2022 (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.
Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.
The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.
It is planned to enroll 66 patients.
Detailed description
Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.
Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.
The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.
In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Drug: Indocyanine green, Device: SPY Portable Handheld Imaging (SPY-PHI)Patients who undergo thyroid surgery and receive indocyanine green angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients who need surgical treatment for thyroid disease.
Key inclusion criteria (3 listed)
- Able to sign informed consent
- Indication to total thyroidectomy
- No contraindication to indocyanine green administration
Key exclusion criteria (4 listed)
- Evidence of parathyroid disease
- Allergy to iodinated contrast
- Chronic kidney failure
- Pregnancy or lactation
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 |
|---|---|---|
| Indocyanine greenIndocyanine green is used to perform intraoperative angiography. | Drug | Surgical group |
| SPY Portable Handheld Imaging (SPY-PHI)The device is used to perform intraoperative angiography. | Device | Surgical group |
Primary outcome
Vascularization score
Time frame: Intraoperatively
A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism. The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.
Results and safety
The study was stopped early (reason given: We encountered problems in finding the necessary resources in the Institute). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 27839936Lang BH, Wong CK, Hung HT, Wong KP, Mak KL, Au KB. Indocyanine green fluorescence angiography for quantitative evaluation of in situ parathyroid gland perfusion and function after total thyroidectomy. Surgery. 2017 Jan;161(1):87-95. doi: 10.1016/j.surg.2016.03.037. Epub 2016 Nov 10.
- Background: PubMed 29405252Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.
- Background: PubMed 31882459Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
- Background: PubMed 24563161Puzziello A, Rosato L, Innaro N, Orlando G, Avenia N, Perigli G, Calo PG, De Palma M. Hypocalcemia following thyroid surgery: incidence and risk factors. A longitudinal multicenter study comprising 2,631 patients. Endocrine. 2014 Nov;47(2):537-42. doi: 10.1007/s12020-014-0209-y. Epub 2014 Feb 22.
- Background: PubMed 27515510Ji YB, Song CM, Sung ES, Jeong JH, Lee CB, Tae K. Postoperative Hypoparathyroidism and the Viability of the Parathyroid Glands During Thyroidectomy. Clin Exp Otorhinolaryngol. 2017 Sep;10(3):265-271. doi: 10.21053/ceo.2016.00724. Epub 2016 Aug 13.
- Background: PubMed 27041628Zaidi N, Bucak E, Yazici P, Soundararajan S, Okoh A, Yigitbas H, Dural C, Berber E. The feasibility of indocyanine green fluorescence imaging for identifying and assessing the perfusion of parathyroid glands during total thyroidectomy. J Surg Oncol. 2016 Jun;113(7):775-8. doi: 10.1002/jso.24237. Epub 2016 Apr 4.
- 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.
Riccardo Rosati, Prof. study director
San Raffaele Hospiral
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 Thyroid and Thyroid Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Jul 2024. 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 Italy. 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 was stopped early (reason given: We encountered problems in finding the necessary resources in the Institute). Results are not available in the source record.
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?
Vascularization score (time frame: Intraoperatively). 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 NCT05328076, which also lists 6 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 5 Jul 2024.