Hypocalcemia, Hypoparathyroidism Postprocedural, Total Thyroidectomy
Conditions
Keywords
Hypocalcemia post-thyroidectomy, Indocyanine green, Fluorescence guided surgery, Parathyroid fluorescence
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: * To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels). * To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia. * To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.
Interventions
DRUGIndocyanine Green
Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
Sponsors
Universitat de les Illes Balears
Hospital Son Espases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection. * Visualization of 2 or more parathyroid glands during the surgical act. * Normal renal and hepatic functions. * Absence of a history of hypersensitivity reactions to iodine or indocyanine green. * Able to understand the nature and protocol of the study and its procedures * Willingness to participate with the subsequent signing of informed consent.
Exclusion criteria
* Age \<18 years * Hepatic or renal insufficiency * Hypersensitivity to iodine or to indocyanine green. * Pregnancy or lactation * Inability to understand the nature and procedures of the study. * Patients with known preoperative hyperparathyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calcemia | Day 1 after surgery | Serum calcium level at 24 hours postoperatively |
| Subjective parathyroid fluorescence | Intraoperatively | Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence). |
| Objective parathyroid fluorescence | Intraoperatively | Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery date | Baseline | Day when surgery takes place |
| Preoperative diagnosis | Baseline | Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis) |
| Vitamin D | Preoperative blood test | Preoperative vitamin D level |
| PTH preop | Immediately before surgery | Preoperative PTH level |
| PTH 10 min | 10 minutes post-thyroidectomy | PTH levels 10 minutes post-thyroidectomy |
| Surgery | Inmediately after surgery | Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection |
| Time | Inmediately after surgery | Duration of surgery |
| Parathyroid glands | During surgery | Number of parathyroid glands located during surgery, |
| Age | Baseline | Patient's age |
| Pathologic result | during the first month after surgery | Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis) |
| Thyroid weight | during the first month after surgery | Thyroid weight |
| PG in piece | during the first month after surgery | Presence of parathyroid glands in the surgical piece and number |
| Stay | During the first month after surgery | Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours |
| Drain | Inmediately after surgery | Presence and number of surgical drainages |
| PTH day 1 | Day 1 after surgery | PTH levels in the postoperative follow-up, |
| Complications | During the first month after surgery | Emergence of postoperative complications. |
| Parathyroid gland location | During surgery | Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left). |
| Sex | Baseline | Patient's gender |
| Body mass index | Baseline | Patient's BMI |
Countries
Spain
Contacts
Primary ContactJaime Bonnín Pascual, MD
Outcome results
None listed