NCT04224467

The Application of Real-Time Near-infrared Imaging in Gynecological Surgery

Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Chen Chunlin · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Removing in situ and metastasis lesions completely during gynecological surgery is central to reduce the recurrence and death, and the identification of lesions in traditional gynecological surgery often depends on the experience of surgeons. The identification of nerves is often needed in gynecological surgery, such as the obturator nerves in pelvic lymphadenectomy, and the pelvic autonomic nerves in nerve-sparing radical hysterectomy for cervical cancer. Nerve identification also relies heavily on the experience of surgeons. This project aims to realize the identification of lesions and nerves under the navigation of indocyanine green fluorescent imaging, and evaluate the accuracy of fluorescent imaging of lesions and the effectiveness of nerves identification by near-infrared imaging. This project may reduce the recurrence or death caused by residual lesions and postoperative dysfunction caused by nerves injury, thus, improve the survival rate and quality of life for patients with gynecological diseases.

Conditions

• Cervical Cancer
• Ovarian Tumor
• Endometrial Carcinoma
• Uterine Myomatosis
• Adenomyosis
• Ovarian Cyst Benign
• Ovarian Cyst Malignant
• Endometriosis
• Uterine Sarcoma

Interventions

Type	Name	Description
OTHER	Intravenous ICG and Real-Time Near-infrared Imaging	Patients will be intravenously injected ICG (Yichuang Pharmaceutical Limited Liability Company, Dandong, China) at a dose of 2-5 mg per kg of body weight before surgery or 0.25-0.5 mg per kg of body weight during surgery. Then real-time near-infrared imaging will be conducted during surgery.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-01-13
• Last updated: 2020-01-14

Locations

1 site across 1 country: China