Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (HYPOCAAVI)
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ClinicalTrials.gov Identifier: NCT04785443 |
Recruitment Status :
Not yet recruiting
First Posted : March 5, 2021
Last Update Posted : March 5, 2021
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Tracking Information | |||||||||||
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First Submitted Date ICMJE | February 25, 2021 | ||||||||||
First Posted Date ICMJE | March 5, 2021 | ||||||||||
Last Update Posted Date | March 5, 2021 | ||||||||||
Estimated Study Start Date ICMJE | April 2021 | ||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group. [ Time Frame: Day 2 ] Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||
Change History | No Changes Posted | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy | ||||||||||
Official Title ICMJE | Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy | ||||||||||
Brief Summary |
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Detailed Description | Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life. The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands. The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge. The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism. In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates. |
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Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Monocentric, comparative, randomized, single-blind, controlled trial against the reference method Masking: Single (Participant)Masking Description: Simple blind (only participant) Primary Purpose: Prevention
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Condition ICMJE | Thyroid Diseases | ||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||
Estimated Enrollment ICMJE |
242 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | December 2024 | ||||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT04785443 | ||||||||||
Other Study ID Numbers ICMJE | 29BRC20.0208 | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Hospital, Brest | ||||||||||
Study Sponsor ICMJE | University Hospital, Brest | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | University Hospital, Brest | ||||||||||
Verification Date | February 2021 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |