腹腔鏡下で行う早期子宮頸癌に対するセンチネルリンパ節生検の適切性と妥当性の検討

抄録

Objective: To assess the feasibility and validity of sentinel node (SN) biopsy to determine whether pelvic lymph node dissection (PLND) in patients with early stage cervical cancer should be performed.

Materials and methods: Between January 2011 and May 2019, 28 cervical cancer patients with stage IA2 or IB1 were enrolled in this study. For identification of SN, technetium phytate, indocyanine green and/or 1% patent blue were administrated. If tumor tissue could not be pathologically identified in the excised SN, PLND was omitted. We call this called SN navigated surgery (SNNS). To validate the non-inferiority of SNNS in cases of recurrence in patients receiving SNNS compared with standard PLND, a C-language based computer program that estimates the required number of SNNS was developed.

Results: Total detection rate and bilateral detection rate of SN was 100% and 84.7%, respectively. At present, the median follow-up period is 36 months, and only one patient presented with lung metastasis as recurrence. To demonstrate non-inferiority, the computer simulated model showed that the required number of SNNS to be performed was 64 with a 5% error rate of cases with no recurrence in residual lymph nodes.

Conclusion: Data obtained in the present study by SN biopsy and SNNS were feasible and without complications. Our computer simulations demonstrated that at least 64 trials of no recurrence in patients of SNNS would be required to show non-inferiority.