A pilot study of laparoscopic extraperitoneal lymph node dissection in patients with locally advanced cervical cancer: A trial design report

Introduction: Clinical staging of patients with advanced cervical cancer according to International Federation of Gynecology and Obstetrics (FIGO) is often inaccurate. The purpose of this study is to determine the feasibility of performing an extraperitoneal laparoscopic lymphadenectomy in patients with stage IB2-IVA cervical carcinoma. Also, this study will evaluate the rate of histologically-confrmed para-aortic lymph node metastases relative to preoperative regional imaging via positron emission tomography/computed tomography (PET/CT). Finally, we demonstrate the ability to effectively train an inexperienced surgeon to perform extraperitoneal laparoscopic lymphadenectomy within the predefned feasibility parameters of an experienced surgeon. Patients and Methods: Patients with a biopsy-proven stage IB2 to IVA cervical carcinoma who were candidates for treatment with radiation therapy and concurrent chemotherapy were eligible for inclusion. All patients underwent preoperative PET/CT and subsequent extraperitoneal para-aortic lymphadenectomy. The initial phase of the study enrolled 10 patients to determine the feasibility of the procedure. A second cohort of up to 20 patients was prospectively evaluated upon which data were gathered determining successful surgical evaluation and associated complication rates. A third cohort of 30 patients was enrolled from which 10 were to be performed by a second surgeon with no baseline facility with the procedure. The same feasibility criterion was leveraged against this physician. Data on this surgeon's learning experience was gathered and recorded. Conclusion: The accumulated data from this trial awaits presentation at the 2010 Annual Meeting of the Society of Gynecologic Oncologists. However, of equal importance is the formulation of an objective measurement of the acquisition of more advanced surgical skills among experienced surgeons.