Phase 1 prospective evaluation of the oncological adequacy of robotic assisted video-endoscopic inguinal lymphadenectomy in patients with penile carcinoma

Objective To prospectively determine the oncological adequacy of robotic assisted video-endoscopic inguinal lymphadenectomy (RAVEIL). Patients and Methods Patients with T1-3N0 penile cancer were enrolled into a prospective phase I trial at a tertiary care institution from March 2010 to January 2012. All patients underwent an initial RAVEIL approach. Verification of adequacy of dissection was performed by an independent surgeon via a separate open incision at the conclusion of the RAVEIL procedure. Out of 10 patients, if more than two superficial inguinal fields with ≥2 nodes or more than four with ≥1 node remained within the superficial dissection field, the study would not proceed to phase II. Results Of 10 enrolled patients two had inguinal metastases and all positive nodes were detected by RAVEIL. The remaining eight patients had no metastases, with a mean of nine (range 5-21) left and nine (range 6-17) right nodes removed. One inguinal field RAVEIL was converted to an open dissection. The verifying surgeon confirmed that 18 of 19 inguinal fields (94.7% in nine patients) had an adequate dissection. Two benign nodes were found just beneath Scarpa's fascia above the inguinal dissection field. Limitations of the study include an inability to determine decisively what specific wound complications were related to RAVEIL because of the protocol-specified creation of a small inguinal incision for verification of adequate dissection. Conclusion RAVEIL allowed adequate staging of disease in the inguinal region among patients with penile cancer at risk for inguinal metastases.