ThyroidICGPREDICTNCT03910049
Does Indocyanine Imaging Scoring Predicts Postoperative Parathormone Levels at 24 Hours After Total Thyroidectomy
An observational study of Thyroid and Parathyroid; Deficiency, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid, Parathyroid; Deficiency
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesGreece
- Study dates
- 3 Dec 2018to 26 Apr 2019
- 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: All patients that are going to have a total thyroidectomy regardless of the underlying pathology
Who may be able to join
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient eligible for total thyroidectomy
Who cannot join
- Patient is participating in another clinical trial which may affect this study's outcomes
- Prior operation in the neck
- Primary or secondary hyperparathyroidism
- Vitamin D deficiency
- Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Unit of Endocrine Surgery, Interbalkan Medical Center, Thessaloniki, Greece
Thessaloniki, Please Enter the State Or Province, 54655
1st Propedeutic Department of Surgery, AHEPA University General Hospital, Aristotle University of Thessaloniki
Thessaloniki, 54621
About this study
Official title: Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy
The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.
Read the detailed description
Study objectives are:
- Detecting the changes of practice in performing total thyroidectomy with ICG.
- Comparing ICG-performed minimal invasive total thyroidectomy
- Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)
- Identifying and analyzing problematic groups of patients The study is designed as a prospective observational multi-center study. Any patient that has indication for a total thyroidectomy will be considered eligible.
The study will be conducted until 60 subjects are included. It is estimated that it will take up to 3 months to enroll the patients.
Pre-Surgery: Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded:
- Demographic information including: name, age, gender, ethnicity
- Height, weight, BMI and American Society of Anesthesiologists physical status classification system (I-VI)
- Behavioral history (Smoking, alcohol or drug use)
- Preoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH, VitD)
- Diagnosis including clinical observations and previous imaging results
- Pre-operative characteristics of the adenoma
- Medications
- Current and past history of surgical and medical comorbidities
Intra-operative: The surgeon will perform the preplanned operation. The following intraoperative variables will be recorded for all patients:
- Surgery date
- Duration of surgery
- Operation performed
- Procedure related comments
- Number and location of the visualized glands
- Intra-operative ICG score (ranging from 1 to 3 [5]) for each grand
Pathology data form: The following pathology data will be recorded for all patients:
- Post-operative diagnosis including pathology report
- Possible parathyroids excised Postoperative follow-up: Follow-up evaluation will be performed during hospitalization
1 Postoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH)
- Conditions
- Thyroid, Parathyroid; Deficiency
- Being tested
- Indocyanine Green
- Keywords
- Indocyanine Green, Near Infrared Imaging, Total Thyroidectomy
- Medical subject headings
- Thyroid Diseases, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called indocyanine green solution
Indocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative ICG fluarangiography predicts post-operative PTH values
Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH
Measured: 24 hours
Secondary outcomes (1)
ICG improves the intraoperative recognizability of the parathyroids
To assess the ability of ICG flurangiography to increase recognizability of parathyroid glands during total thyroidectomy based on ICG score of the parathyroids.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start3 Dec 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papavramidis Theodossis, Aristotle University Of Thessaloniki
- Investigators
- Theodosios S Papavramidis, PhD, Study director, Assistant Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910049
- Sponsor's protocol ID
- ICG002
- Acronym
- ICGPREDICT
- Status last verified
- Aug 2019
- First submitted
- 19 Feb 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Indocyanine Imaging Scoring Predicts Postoperative PTH Levels at 24 Hours After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT03910049
- Acronym / sponsor ID
- ICGPREDICT / ICG002
- Conditions
- Thyroid, Parathyroid; Deficiency
- Keywords
- Indocyanine Green, Near Infrared Imaging, Total Thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 10 Apr 2019 (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.
The aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative PTH levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.
Detailed description
Study objectives are:
- Detecting the changes of practice in performing total thyroidectomy with ICG.
- Comparing ICG-performed minimal invasive total thyroidectomy
- Identifying the cut-off points that predict low PTH levels (less than 20pg/ml)
- Identifying and analyzing problematic groups of patients The study is designed as a prospective observational multi-center study. Any patient that has indication for a total thyroidectomy will be considered eligible.
The study will be conducted until 60 subjects are included. It is estimated that it will take up to 3 months to enroll the patients.
Pre-Surgery: Procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. The following pre-surgery information will be recorded:
- Demographic information including: name, age, gender, ethnicity
- Height, weight, BMI and American Society of Anesthesiologists physical status classification system (I-VI)
- Behavioral history (Smoking, alcohol or drug use)
- Preoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH, VitD)
- Diagnosis including clinical observations and previous imaging results
- Pre-operative characteristics of the adenoma
- Medications
- Current and past history of surgical and medical comorbidities
Intra-operative: The surgeon will perform the preplanned operation. The following intraoperative variables will be recorded for all patients:
- Surgery date
- Duration of surgery
- Operation performed
- Procedure related comments
- Number and location of the visualized glands
- Intra-operative ICG score (ranging from 1 to 3 [5]) for each grand
Pathology data form: The following pathology data will be recorded for all patients:
- Post-operative diagnosis including pathology report
- Possible parathyroids excised Postoperative follow-up: Follow-up evaluation will be performed during hospitalization
1 Postoperative labs (WBC, Ht, Hgb, Ca2+, P, fT3, fT4, TSH, PTH)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Indocyanine GreenThe group will include all adult patients that will sign ICF and will be operated for total thyroidectomy regardless of the undelying disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are going to have a total thyroidectomy regardless of the underlying pathology
Key inclusion criteria (3 listed)
- Patient is over 18 years old
- Patient scheduled for a non-emergency operation
- Patient eligible for total thyroidectomy
Key exclusion criteria (5 listed)
- Patient is participating in another clinical trial which may affect this study's outcomes
- Prior operation in the neck
- Primary or secondary hyperparathyroidism
- Vitamin D deficiency
- Use of drugs that influences calcium metabolism (Vitamin D analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)
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 GreenAlso: indocyanine green solutionIndocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism. | Drug | Study group |
Primary outcome
Intra-operative ICG fluarangiography predicts post-operative PTH values
Time frame: 24 hours
Whether ICG score of parathyroid glands after total thyroidectomy correlates with 24 post-operative values of PTH
1 secondary outcome
ICG improves the intraoperative recognizability of the parathyroids
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Theodosios S Papavramidis, PhD study director
Assistant Professor of Surgery
2 sites 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 Parathyroid; Deficiency, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
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 5 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: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-operative ICG fluarangiography predicts post-operative PTH values (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2019.