Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

University Hospitals (UH)

Status: Completed

Conditions: Parathyroid Function Low Adverse Event

Treatments: Drug: Parathyroid supplementation; Procedure: ICG parathyroid angiography; Procedure: Postoperative parathyroid function test; Procedure: No postoperative parathyroid dosage and supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02249780

14-160

Details and patient eligibility

About

Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin D in case of good perfusion.

Full description

Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify the procedure the investigators have classified images into three categories: ICG 2: good blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish color) and ICG 0: the gland is not vascularized (she has a black color). The investigators have applied the same criteria for visual values.

The investigators will randomize 138 patients with good ICG test values (at least one gland that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800 IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes place between day 10 and 15. Depending on the results of blood tests patients will also be given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but without any blood dosage or systematic supplementation. If signs and / or symptoms of hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed and patients will be substituted by the usual protocol. All patients will be reviewed at 10 - 15 days of the intervention with the relevant balance sheet.

Enrollment: 146 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.
• Patients capable of understanding and able to understand the study.
• Values visually 2 and ICG 2

Exclusion criteria

• Parathyroid disease or prior parathyroidectomy
• Lack of informed consent
• Altered mental status of the patient.
• ICG values <2.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

New treatment

Experimental group

Description:

In patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery.

Treatment:

Procedure: No postoperative parathyroid dosage and supplementation

Procedure: ICG parathyroid angiography

Standart treatment

Active Comparator group

Description:

In those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given.

Treatment:

Procedure: ICG parathyroid angiography

Procedure: Postoperative parathyroid function test

Drug: Parathyroid supplementation