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

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Several lymph node staging strategies have been proposed as a response to the high morbidity seen after standard inguinal lymphadenectomy for penile cancer. A video-endoscopic (laparoscopic and robotic) approach has been proposed as a less morbid procedure in several retrospective studies. To date, none has evaluated the oncological adequacy with regard to whether all relevant nodes have been removed. To the authors' knowledge this is the first prospective study of a robotic or laparoscopic inguinal lymphadenectomy that evaluates the oncological adequacy of this approach for penile cancer. The study shows that robotic inguinal lymphadenectomy allowed adequate staging of disease in the inguinal region by removing all relevant lymph nodes as assessed by an independent evaluating urological oncologist.

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.