Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy

Contribution of indocyanine green angiography in the detection of parathyroids and the prevention of hypoparathyroidism post total thyroidectomy - HYPOCAAVI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005189-32-FR

Enrollment

242

Registered

2020-12-04

Start date

2021-02-09

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy total MedDRA version: 20.0 Level: LLT Classification code 10043777 Term: Thyroidectomy total System Organ Class: 100000004865

Interventions

Trade Name: Infracyanine Pharmaceutical Form: Powder and solution for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient having to undergo a total thyroidectomy - Signed consent - Patient beneficiary of a social security regimen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 181 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 61

Exclusion criteria

Exclusion criteria: - Minor patient under 18 years old - Major patient protected by law or unable to give informed consent - Pregnant or breastfeeding woman - Thyroidectomy totalization - History of thyroid or parathyroid surgery - Participation refusal - Known allergy to ICG

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the frequency of postoperative hypocalcemia corrected by albumin (below 2 mmol/L, sign associated to hypoparathyroidism) between control group and group with use of ICG.;Secondary Objective: 1/ To assess the contribution of angiography with ICG in the modification of definitive hypoparathyroidism rate post total thyroidectomy (D8, M1, M6). 2/ To determine the contribution of angiography with ICG during the total thyroidectomy for the identification in vivo and the preservation of parathyroids. 3/ To assess the contribution of angiography with ICG in the prediction of postoperative hypocalcemia. 4/ To determine the benefit of angiography with ICG in the prediction of post total thyroidectomy hypoparathyroidism. 5/ To compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate, severe), between both groups. 6/ To assess the tolerance at ICG in patient.;Primary end point(s): Occurrence (yes/no) of hypocalcemia corrected by albumin under or equal to 2 mmol/L in the 48h postoperative.;Timepoint(s) of evaluation of this end point: 48h postoperative	—

Measure

Time frame

Main Objective: To compare the frequency of postoperative hypocalcemia corrected by albumin (below 2 mmol/L, sign associated to hypoparathyroidism) between control group and group with use of ICG.;Secondary Objective: 1/ To assess the contribution of angiography with ICG in the modification of definitive hypoparathyroidism rate post total thyroidectomy (D8, M1, M6). 2/ To determine the contribution of angiography with ICG during the total thyroidectomy for the identification in vivo and the preservation of parathyroids. 3/ To assess the contribution of angiography with ICG in the prediction of postoperative hypocalcemia. 4/ To determine the benefit of angiography with ICG in the prediction of post total thyroidectomy hypoparathyroidism. 5/ To compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate, severe), between both groups. 6/ To assess the tolerance at ICG in patient.;Primary end point(s): Occurrence (yes/no) of hypocalcemia corrected by albumin under or equal to 2 mmol/L in the 48h postoperative.;Timepoint(s) of evaluation of this end point: 48h postoperative

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Secondary

Measure	Time frame
Secondary end point(s): 1/ Occurrence (yes/no) of hypocalcemia corrected by albumin under 2 mmol/L at day 8, month 1 and month 6 postoperative. 2/ Modification (yes/no) of surgical gesture by the improvement of the detection of parathyroids or their vascularisation during total thyroidectomy with angiography with ICG. 3/ Peroperative vitality score of parathyroids when using angiography with ICG. 4/ Occurrence (yes/no) of hypoparathormone at Day 1 and Day 2 postopérative (under 10ng/L). 5/ Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/L), moderate (symptomatic and >1.7mmol/L) and severe (<1.7mmol/L) hypocalcemia in the 48h postoperative 6/ Occurrence of adverse effect related to injection of ICG;Timepoint(s) of evaluation of this end point: Day 0, Day 1, Day 2, Day 8, Month 1 and Month 6 postoperative	—

Measure

Time frame

Secondary end point(s): 1/ Occurrence (yes/no) of hypocalcemia corrected by albumin under 2 mmol/L at day 8, month 1 and month 6 postoperative. 2/ Modification (yes/no) of surgical gesture by the improvement of the detection of parathyroids or their vascularisation during total thyroidectomy with angiography with ICG. 3/ Peroperative vitality score of parathyroids when using angiography with ICG. 4/ Occurrence (yes/no) of hypoparathormone at Day 1 and Day 2 postopérative (under 10ng/L). 5/ Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/L), moderate (symptomatic and >1.7mmol/L) and severe (<1.7mmol/L) hypocalcemia in the 48h postoperative 6/ Occurrence of adverse effect related to injection of ICG;Timepoint(s) of evaluation of this end point: Day 0, Day 1, Day 2, Day 8, Month 1 and Month 6 postoperative

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Countries

France

Contacts

Public ContactPELOUIN

CHRU de Brest

promotion-interne@chu-brest.fr00330229020117

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026