Abstract
PurposeRadical 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.MethodsSixty-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.ResultsIn 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.ConclusionThis 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 registrationClinicalTrials.gov NCT04224467
Highlights
Cervical cancer is the fourth most common cancer in women worldwide [1]
One patient was intraoperatively diagnosed with suspected lymph node metastasis, which was confirmed by frozen pathology after lymph node biopsy; systematic pelvic lymphadenectomy and radical hysterectomy were not performed
We investigated the feasibility and safety of intraoperative NIR-FI using the DPM-I system with indocyanine green (ICG) to identify the pelvic nerves in a prospective trial
Summary
Cervical cancer is the fourth most common cancer in women worldwide [1]. The 5-year survival rate of stage III or IV cervical cancer is less than 30%, and its incidence tends to occur in younger ages in recent years [2]. Radical hysterectomy combined with pelvic lymphadenectomy is one of the most effective treatments for cervical cancer [3]. Damage to the pelvic nerves can result in severe motor, sensory, and autonomic dysfunction. The incidence of genitofemoral nerve (GN) damage is 3.5%, and causes paresthesia in the groin and perineum [5]. 30–80% of patients undergoing traditional radical hysterectomy have bladder, rectal, or sexual dysfunction, mainly caused by pelvic autonomic nerve injury [4]. The identification of pelvic nerves mainly depends on visual inspection, which relies heavily on the surgeon’s experience [8]. Methods such as nerve stimulation have been employed to identify nerves; the procedure is complex and the effect is limited. There has been a growing desire to develop novel nerve visualization methods [9, 10]
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