Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parathyroid Function Low Adverse Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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New treatment

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.

Group Type EXPERIMENTAL

No postoperative parathyroid dosage and supplementation

Intervention Type PROCEDURE

The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.

ICG parathyroid angiography

Intervention Type PROCEDURE

Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.

Standart treatment

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.

Group Type ACTIVE_COMPARATOR

Postoperative parathyroid function test

Intervention Type PROCEDURE

Calcium and parathormone dosage at 24 hours and ten day after surgery

ICG parathyroid angiography

Intervention Type PROCEDURE

Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.

Parathyroid supplementation

Intervention Type DRUG

Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.

Interventions

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Postoperative parathyroid function test

Calcium and parathormone dosage at 24 hours and ten day after surgery

Intervention Type PROCEDURE

No postoperative parathyroid dosage and supplementation

The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.

Intervention Type PROCEDURE

ICG parathyroid angiography

Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.

Intervention Type PROCEDURE

Parathyroid supplementation

Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.

Intervention Type DRUG

Other Intervention Names

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Parathiroid function testing Indoyanine green angiography Indoyanine green fluoroscopy Hypocalcemia post thyroidectomy treatment

Eligibility Criteria

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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