Impact of Intraoperative Arteriography with Indocyanine Green in Preserving the Parathyroid Glands During Total Thyroidectomy With or Without Central Cervical Lymph Node Dissection. A Multicenter Prospective Randomized Trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bellvitge University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Decision date (initial)

2024-01-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To study whether using green indocyanine (ICG) arteriography before thyroidectomy to identify the parathyroid glands (PG) vascular pattern decreases the rate of permanent hypoparathyroidism.

Secondary objectives 6

1. To study whether using ICG arteriography before thyroidectomy to identify the PG vascular pattern decreases the overall rate of postoperative hypoparathyroidism.
2. To study whether using ICG arteriography before thyroidectomy to identify the PG vascular pattern increases the rate of adequately vascularized glands preserved in situ (score 2 in the black and white system) at the end of surgery.
3. To study the influence of using ICG arteriography before thyroidectomy to identify the PG vascular pattern on their functionality during the postoperative period in terms of corrected PTH and total calcium in the morning after the intervention.
4. To study the influence of using ICG arteriography before thyroidectomy in identifying the PG vascular pattern.
5. To analyze the influence of the potential PG vascular patterns on the aforementioned parameters.
6. To describe the safety profile of performing ICG arteriography.

Conditions and MedDRA coding

Hypothyroidism

Regulatory references

Plan to share IPD

Yes

IPD plan description

Deidentified IPD related to demographics, baseline characteristics, and primary and secondary outcomes will be made available by the Principal Investigator (PI), upon reasonable request from qualified academic researchers who submit a methodologically sound proposal. Access will be granted after approval of the proposal by the PI and, if applicable, an ethics committee. A data sharing agreement will be required.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Patients ≥18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid disease.
2. The patient or legal guardian can understand the study and agrees to participate by signing the written informed consent.

Exclusion criteria 3

1. Previous surgical intervention on the thyroid or parathyroid gland.
2. Evidence of associated hyperparathyroidism requiring a parathyroidectomy in the same surgical procedure.
3. Patients with known contraindications to ICG.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number (percentage) of PG preserved with intraoperative ICG arteriography and the number (percentage) of preserved PG without it.

Secondary endpoints 8

1. Preoperative calcium, total protein, vitamin D, and PTH serum levels
2. Number of well perfused GP in situ
3. GP score according to the black and white system
4. Surgery duration
5. Intraoperative PTH serum level
6. Serum PTH, calcium, and total protein levels at 24h after surgery
7. Serum PTH levels 1, 3, 6 and 12 months after surgery
8. Presence or absence of hypoparathyroidism during the one-year follow-up. Hypoparathyroidism is defined as undetectable or inappropriately low serum PTH levels in the context of hypocalcemia.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bellvitge University Hospital

Sponsor organisation

Bellvitge University Hospital

Address

Carrer De La Feixa Llarga Sn

City

L'hospitalet De Llobregat

Postcode

08907

Country

Spain

Scientific contact point

Organisation

Bellvitge University Hospital

Contact name

Mireia Pascua Solé

Public contact point

Organisation

Bellvitge University Hospital

Contact name

Mireia Pascua Solé

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications