Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

Phase 4

• Conditions: Hypocalcemia; Total Thyroidectomy; Hypoparathyroidism Postprocedural
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT04012476
• Lead Sponsor: Hospital Son Espases

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2019-06-28
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-07
• Last Update Submitted: 2019-07-07
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09
• Primary Completion: 2020-03
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG	Indocyanine Green	Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green

Primary Outcome Measures

Name	Time	Method
Calcemia	Day 1 after surgery	Serum calcium level at 24 hours postoperatively
Objective parathyroid fluorescence	Intraoperatively	Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.
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).

Secondary Outcome Measures

Name	Time	Method
Vitamin D	Preoperative blood test	Preoperative vitamin D level
Preoperative diagnosis	Baseline	Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)
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
Parathyroid glands	During surgery	Number of parathyroid glands located during surgery,
PTH preop	Immediately before surgery	Preoperative PTH level
Time	Inmediately after surgery	Duration of surgery
Sex	Baseline	Patient's gender
Surgery date	Baseline	Day when surgery takes place
Age	Baseline	Patient's age
Body mass index	Baseline	Patient's BMI
Thyroid weight	during the first month after surgery	Thyroid weight
Drain	Inmediately after surgery	Presence and number of surgical drainages
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
Complications	During the first month after surgery	Emergence of postoperative complications.
PTH day 1	Day 1 after surgery	PTH levels in the postoperative follow-up,
Parathyroid gland location	During surgery	Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left).
Pathologic result	during the first month after surgery	Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis)
PG in piece	during the first month after surgery	Presence of parathyroid glands in the surgical piece and number

Trial Locations

Locations (1)

Hospital Universitari Son Espases; 🇪🇸 Palma De Mallorca, Illes Balears, Spain