Intraoperative near-infrared fluorescence imaging can identify pelvic nerves in patients with cervical cancer in real time during radical hysterectomy

Abstract

Purpose Radical hysterectomy combined with pelvic lymphadenectomy is the standard treatment for early-stage cervical cancer, but unrecognized pelvic nerves are vulnerable to irreversible damage during surgery. This early clinical trial investigated the feasibility and safety of intraoperative near-infrared (NIR) fluorescence imaging (NIR-FI) with indocyanine green (ICG) for identifying pelvic nerves during radical hysterectomy for cervical cancer. Methods Sixty-six adults with cervical cancer were enrolled in this prospective, open-label, single-arm, single-center clinical trial. NIR-FI was performed in vivo to identify genitofemoral (GN), obturator (ON), and hypogastric (HN) nerves intraoperatively. The primary endpoint was the presence of fluorescence in pelvic nerves. Secondary endpoints were the ICG distribution in a nerve specimen and potential underlying causes of fluorescence emission in pelvic nerves. Results In total, 63 patients were analyzed. The ON was visualized bilaterally in 100% (63/63) of patients, with a mean fluorescence signal-to-background ratio (SBR) of 5.3±2.1. The GN was identified bilaterally in 93.7% (59/63) of patients and unilaterally in the remaining 4 patients, with a mean SBR of 4.1±1.9. The HN was identified bilaterally in 81.0% (51/63) of patients and unilaterally in 7.9% (5/63) of patients, with a mean SBR of 3.5±1.3. ICG fluorescence was detected in frozen sections of a nerve specimen, and was mainly distributed in axons. No ICG-related complications were observed. Conclusion This early clinical trial demonstrated the feasibility and safety of NIR-FI to visualize pelvic nerves intraoperatively. Thus, NIR-FI may help surgeons adjust surgical decision-making, avoid nerve damage, and improve surgical outcomes. Trial registration ClinicalTrials.gov NCT04224467

Robot‐assisted modified radical hysterectomy with removal of lymphatic vessel using indocyanine green: A new method

“…The obturator, genitofemoral, and hypogastric nerves were identified bilaterally in 100%, 93.7%, and 81.0% of patients, respectively. They concluded that ICG prevented nerve damage 19 . Kanno et al.…”

Intraoperative fluorescence molecular imaging accelerates the coming of precision surgery in China

“…The retrospective data from 142 patients verified that the ICG nerve imaging is safe and practical to help reduce complication rates [ 92 ]. There is also a noticeable ongoing trial aiming at preserving pelvic nerves in radical hysterectomy of cervical cancer [ 93 ]. Similar ICG FMI strategy was introduced in the registration (NCT04224467, recruiting in Nanfang Hospital).…”

“…There is an urgent need of precision surgery. We can foresee that the application of intraoperative FMI would be rapidly expanded [ 93 , 136 ]. So far, the clinical value of non-specific fluorophores has been widely explored.…”

“…So far, the clinical value of non-specific fluorophores has been widely explored. Some promising results like nerve imaging have also been studied in the clinic [ 93 ]. Nevertheless, the accuracy of malignancy imaging remains unsatisfied.…”

Precision surgery

“…Artificial intelligence can also be used to predict cancer development in patients with premalignant conditions, dictating the ideal timing for surgery, or to anticipate the risk of surgery, providing the opportunity for accurate risk stratification [11]. Precision surgery is also the ability to detect occult tumor deposits by means of near-infrared spectroscopy based on indocyanine green fluorescence [12] or radiomics [13], and to increase the ability to selectively identify nerves in procedures aiming at nerve sparing [14]. As shown in dermatology [15] and in endoscopy [16], image recognition by artificial intelligence can enhance the ability to detect and classify small lesions that otherwise could be missed.…”