An observational study in Thyroid, Thyroid Cancer and Hypoparathyroidism, sponsored by IRCCS San Raffaele. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by IRCCS San Raffaele · Observational
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.
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.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's enrollment of 22 is below the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Compared within Thyroid Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inpatients who need surgical treatment for thyroid disease.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who undergo thyroid surgery and receive indocyanine green angiography
Drug: Indocyanine green · Device: SPY Portable Handheld Imaging (SPY-PHI)
Indocyanine green is used to perform intraoperative angiography.
The device is used to perform intraoperative angiography.
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.
Time frame: Intraoperatively
Plan to share: No
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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