Clinical trial NCT04224467: The Application of Real-Time Near-infrared Imaging in Gynecological Surgery
Official title: Real-Time Identification of Lesions and Nerves by Using Indocyanine Green Fluorescent Imaging in Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Ovarian Tumor
Endometrial Carcinoma
Uterine Myomatosis
Adenomyosis
Ovarian Cyst Benign
Ovarian Cyst Malignant
Endometriosis
Uterine Sarcoma
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2020-01-13
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with FIGO (2018) stage IA1(LVSI)-IIA2 cervical cancer，endometrial cancer，ovarian tumor, endometriosis, adenomyosis, uterine myomatosis, ovarian cyst ,or uterine sarcoma
* Patients who consent to receive indocyanine green near-infrared fluorescence-guided gynecological surgery

Exclusion Criteria:

* Less than 6 months expectancy life;
* Patients with iodine allergy.

Primary outcomes:
measure: The value and feasibility of real-time near-infrared imaging in the identification of lesions
timeFrame: 4 years
measure: The value and feasibility of real-time near-infrared imaging in the identification of nerves
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical Universtity, China
state: Guangdong
Study officials:
References:
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