Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

Parathyroid Function Low Adverse Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249780
• Other study ID #: 14-160
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: April 15, 2016
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Parathyroid Function Low Adverse Event

Intervention

Procedure:
• Postoperative parathyroid function test
Calcium and parathormone dosage at 24 hours and ten day after surgery
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospitals Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Geneva University, School of medicine

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic impact	Compare the costs of both procedures: standard procedure and new treatment and then evaluate the economic impact of this preventig mesure, and the possibility to undergo ambulatory surgery	From surgery day to 10 days after surgery	No
Primary	Postoperative parathyroid function	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.	10 days after surgery	Yes
Secondary	Calcium and parathormone dosage 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.	10 days after surgery	Yes