NCT02249780

Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

The Use of Indocyanine Green Fluorescence to Assses the Vascularisation of the Parathyroid Glands During Thyroid Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parathyroid Function Low Adverse Event

Interventions

Type	Name	Description
PROCEDURE	Postoperative parathyroid function test	Calcium and parathormone dosage at 24 hours and ten day after surgery
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.
PROCEDURE	ICG parathyroid angiography	Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.
DRUG	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-09-26
• Last updated: 2016-04-18

Locations

1 site across 1 country: Switzerland