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Completed

NCT Number: NCT02249780

Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Geneva

Geneva, Canton of Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Postoperative parathyroid function test

Procedure

Calcium and parathormone dosage at 24 hours and ten day after surgery

No postoperative parathyroid dosage and supplementation

Procedure

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.

Other names: Parathiroid function testing

ICG parathyroid angiography

Procedure

Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.

Other names: Indoyanine green angiography, Indoyanine green fluoroscopy

Parathyroid supplementation

Drug

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 names: Hypocalcemia post thyroidectomy treatment

Primary outcomes

  1. Postoperative parathyroid function

    Time frame: 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 outcomes

  1. Calcium and parathormone dosage after surgery

    Time frame: 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.

Other outcomes

  1. Economic impact

    Time frame: From surgery day to 10 days after surgery

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2014
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.