Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy
Condition: Parathyroid Function Low Adverse Event
MeSH terms: Neovascularization, Pathologic
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Postoperative parathyroid function test; No postoperative parathyroid dosage and supplementation; ICG parathyroid angiography; Parathyroid supplementation
Intervention type(s): Procedure; Procedure; Procedure; Drug
Intervention description(s): Calcium and parathormone dosage at 24 hours and ten day after surgery; 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.; Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.; 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.
Other intervention name(s): Parathiroid function testing; Indoyanine green angiography; Indoyanine green fluoroscopy; Hypocalcemia post thyroidectomy treatment
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Parathyroid gland angiography; Parathyroid gland indocyanine green angiography; Parathyroid gland indocyanine green fluoroscopy