Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy

NCT06288750 | Recruiting

• 1 other identifier: sdllycyyqx001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Thyroidectomy; Parathyroid Function Low Adverse Event; Parathyroid Glands--Diseases; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast

  İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)

  1 year

Secondary Outcomes (1)

• Central lymph node dissetion (CLND)

  1 year

Study Arms (2)

Indocyanine green group

EXPERIMENTAL

Identification of parathyroid glands (PGs) Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Device: Indocyanine Green

Traditional surgery group

ACTIVE COMPARATOR

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.

Device: No indocyanine green

Interventions

Indocyanine Green DEVICE

ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Also known as: Near Infrared Fluorescence Imaging

Indocyanine green group

No indocyanine green DEVICE

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.

Traditional surgery group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients, aged 18 years and above
• Scheduled for elective total or hemi thyroidectomy
• Normal liver and renal function
• No known hypersensitivity for iodine or ICG
• Able to understand the nature of the study procedures
• Willing to participate and give written informed consent

You may not qualify if:

• Age \< 18 years
• Liver or renal insufficiency
• Known ICG, iodine, penicillin or sulfa hypersensitivity
• Pregnancy or breastfeeding
• Not able to understand the nature of the study procedure
• Not willing to participate

Sponsors & Collaborators

• Shandong Linglong Yingcheng Hospital: lead

Study Sites (1)

Shandong Linglong Yingcheng Hospital

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Conditions

Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Xuan Qiu, MD

  Shandong Linglong Yingcheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Qiu, MD

CONTACT

8618354280081; qiuxuan100@163.com

Ni Wang, MD,PD

CONTACT

8618705353551; wangni1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)