Condition or disease | Intervention/treatment | Phase |
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Hypocalcemia Total Thyroidectomy Hypoparathyroidism Postprocedural | Drug: Indocyanine Green | Phase 4 |
The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy |
Actual Study Start Date : | November 2016 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
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Experimental: ICG
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
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Drug: Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Name: ICG
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jaime Bonnín Pascual, MD | 871205959 | jaime.bonnin@ssib.es |
Spain | |
Hospital Universitari Son Espases | Recruiting |
Palma De Mallorca, Illes Balears, Spain, 07120 | |
Contact: Jaime Bonnín Pascual, MD 871205959 jaime.bonnin@ssib.es |
Tracking Information | |||||||
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First Submitted Date ICMJE | June 28, 2019 | ||||||
First Posted Date ICMJE | July 9, 2019 | ||||||
Last Update Posted Date | July 9, 2019 | ||||||
Actual Study Start Date ICMJE | November 2016 | ||||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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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 | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | ||||||
Official Title ICMJE | Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy | ||||||
Brief Summary | The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia. | ||||||
Detailed Description |
The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it. Masking: None (Open Label)Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Indocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Other Name: ICG
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Study Arms ICMJE | Experimental: ICG
Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green
Intervention: Drug: Indocyanine Green
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Publications * |
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* 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 | Recruiting | ||||||
Estimated Enrollment ICMJE |
40 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | October 2020 | ||||||
Estimated Primary Completion Date | March 2020 (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 | Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04012476 | ||||||
Other Study ID Numbers ICMJE | ICG-Parathyroid | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hospital Son Espases | ||||||
Study Sponsor ICMJE | Hospital Son Espases | ||||||
Collaborators ICMJE | Universitat de les Illes Balears | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Hospital Son Espases | ||||||
Verification Date | July 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |