Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

Not Applicable

Completed

• Conditions: Parathyroid Function Low Adverse Event
• Interventions: Procedure: No postoperative parathyroid dosage and supplementation; Procedure: Postoperative parathyroid function test; Procedure: ICG parathyroid angiography; Drug: Parathyroid supplementation

• Registration Number: NCT02249780
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-26
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New treatment	No postoperative parathyroid dosage and supplementation	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.
New treatment	ICG parathyroid angiography	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.
Standart treatment	Postoperative parathyroid function test	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.
Standart treatment	ICG parathyroid angiography	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.
Standart treatment	Parathyroid supplementation	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.

Primary Outcome Measures

Name	Time	Method
Postoperative parathyroid function	10 days after surgery	All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium \< 2mmol/l, and PTH \< 1.1 pmol/l.

Secondary Outcome Measures

Name	Time	Method
Calcium and parathormone dosage after surgery	10 days after surgery	Number of patients with good calcium and parathormone values at 10 days after surgery without calcium and vitamin D supplementation in the selected group.

Trial Locations

Locations (1)

University Hospitals Geneva; 🇨🇭 Geneva, Switzerland