Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

April 15, 2016 updated by: JORDI VIDAL FORTUNY, University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • University Hospitals Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New treatment
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.
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.
Other Names:
  • Parathiroid function testing
Procedure: ICG parathyroid angiography
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
Active Comparator: Standart treatment
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.
Procedure: ICG parathyroid angiography
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
Procedure: Postoperative parathyroid function test
Calcium and parathormone dosage at 24 hours and ten day after surgery
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.
Other Names:
  • Hypocalcemia post thyroidectomy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From surgery day to 10 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Geneva University, School of medicine

Investigators

  • Study Director: Frédéric Triponez, Professor, University Hospital, Geneva
  • Principal Investigator: Wolfram Karenovics, SPR, University Hospital, Geneva
  • Principal Investigator: Frédéric Ris, Consultant, University Hospital, Geneva
  • Principal Investigator: Valentina Belfontali, Resident, University Hospital, Geneva
  • Study Chair: Jordi Vidal Fortuny, SPR, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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