Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288750
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-25
Brief Title:
Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
Sponsor:
Shandong Linglong Yingcheng Hospital
Organization:
Shandong Linglong Yingcheng Hospital
Study Overview
Official Title:
Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Accurate identification and evaluation of the parathyroid glands PGs intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy Near-infrared fluorescence imaging NIFI including the autofluorescence AF and indocyanine green fluorescence ICGF imaging is a promising technique to protect PGs This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy
Detailed Description:
Postoperative hypoparathyroidism or hypocalcemia is the most frequent complication after total thyroidectomy TT The median incidence of transient and permanent postoperative hypoparathyroidism is 27 19-38 and 1 0-3 respectively Transient hypoparathyroidism can increase the length of hospital stay and the costs of hospitalization for patients Permanent hypoparathyroidism leads to lifelong medication use which may severely impair the quality of life of patients Therefore identifying the parathyroid glands PGs and preserving those with adequate blood perfusion intraoperatively has always been a crucial procedure during thyroidectomy
Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance color shape etc by the naked eye However this visual inspection is often influenced by the experience of the surgeon intraoperative hemorrhage ectopic PGs and so on which makes it difficult to fully protect the PGs
Currently there has been an emergence of near-infrared fluorescence imaging NIFI that can be applied during thyroid or parathyroid surgery for the evaluation and identification of PGs This technique mainly exploits the autofluorescence AF of PGs and indocyanine green fluorescence ICGF imagingPGs could exhibit stronger AF than the surrounding tissue under near-infrared light which can be exploited to accurately identify PGs in real time Subsequent studies have demonstrated that AF can not only detect PGs intraoperatively in real time and improve the intraoperative identification of PGs but also reduce the incidence of postoperative hypoparathyroidism However AF cannot assess the status of PG blood perfusion and consequently is not useful when determining whether PGs need to be autotransplanted
Indocyanine green ICG fluorescence imaging may be a great solution to this problem ICG is a safe fluorescent dye with fast metabolism and few adverse effects that can quickly combine with plasma proteins after intravenous injection and is widely used in angiography in multiple surgical disciplines In recent years several studies have shown that ICGF may be superior in evaluating blood perfusion and predicting the function of PGs in situ subsequently guiding their autotransplantation However ICGF may not be very suitable for the identification of PGs before dissection as the thyroid gland would also emit intense fluorescence after the injection of ICG which may lead to difficulties in distinguishing them Thus AF and ICGF have their own advantages and disadvantages in the identification and evaluation of PGs respectively These two methods can be considered complementary
In the present study the investigators used AF in combination with ICGF imaging by one fluorescence imaging system during different steps of the surgical procedure At the beginning of the operation AF was used to identify the PGs before any dissection Then after the thyroid gland was removed AF was used again to locate the PGs in situ Finally ICGF was applied to evaluate the blood perfusion of the PGs in situ and guide their autotransplantation The aim of this randomized controlled trial was to assess whether this strategy could reduce the incidence of postoperative hypoparathyroidism and benefit the identification and evaluation of PGs during total thyroidectomy
Conventional means of identification and assessment of PGs are mainly based on surgeon-dependent identification of their anatomical location and appearance color shape etc by the naked eye However this visual inspection is often influenced by the experience of the surgeon intraoperative hemorrhage ectopic PGs and so on which makes it difficult to fully protect the PGs
Currently there has been an emergence of near-infrared fluorescence imaging NIFI that can be applied during thyroid or parathyroid surgery for the evaluation and identification of PGs This technique mainly exploits the autofluorescence AF of PGs and indocyanine green fluorescence ICGF imagingPGs could exhibit stronger AF than the surrounding tissue under near-infrared light which can be exploited to accurately identify PGs in real time Subsequent studies have demonstrated that AF can not only detect PGs intraoperatively in real time and improve the intraoperative identification of PGs but also reduce the incidence of postoperative hypoparathyroidism However AF cannot assess the status of PG blood perfusion and consequently is not useful when determining whether PGs need to be autotransplanted
Indocyanine green ICG fluorescence imaging may be a great solution to this problem ICG is a safe fluorescent dye with fast metabolism and few adverse effects that can quickly combine with plasma proteins after intravenous injection and is widely used in angiography in multiple surgical disciplines In recent years several studies have shown that ICGF may be superior in evaluating blood perfusion and predicting the function of PGs in situ subsequently guiding their autotransplantation However ICGF may not be very suitable for the identification of PGs before dissection as the thyroid gland would also emit intense fluorescence after the injection of ICG which may lead to difficulties in distinguishing them Thus AF and ICGF have their own advantages and disadvantages in the identification and evaluation of PGs respectively These two methods can be considered complementary
In the present study the investigators used AF in combination with ICGF imaging by one fluorescence imaging system during different steps of the surgical procedure At the beginning of the operation AF was used to identify the PGs before any dissection Then after the thyroid gland was removed AF was used again to locate the PGs in situ Finally ICGF was applied to evaluate the blood perfusion of the PGs in situ and guide their autotransplantation The aim of this randomized controlled trial was to assess whether this strategy could reduce the incidence of postoperative hypoparathyroidism and benefit the identification and evaluation of PGs during total thyroidectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None