Clinical trial NCT02249780: Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy
Official title: The Use of Indocyanine Green Fluorescence to Assses the Vascularisation of the Parathyroid Glands During Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parathyroid Function Low Adverse Event
Keywords: Parathyroid gland angiography
Parathyroid gland indocyanine green angiography
Parathyroid gland indocyanine green fluoroscopy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Geneva University, School of medicine
First posted: 2014-09-26
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative parathyroid function
timeFrame: 10 days after surgery
Secondary outcomes:
measure: Calcium and parathormone dosage after surgery
timeFrame: 10 days after surgery
Other outcomes:
measure: Economic impact
timeFrame: From surgery day to 10 days after surgery
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Frédéric Triponez, Professor
role: STUDY_DIRECTOR
affiliation: University Hospital, Geneva
name: Wolfram Karenovics, SPR
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Frédéric Ris, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Valentina Belfontali, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Jordi Vidal Fortuny, SPR
role: STUDY_CHAIR
References:
citation: Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.