Abstract P3-13-11: Utility of LigaSureTM vessel-sealing device in axillary dissection for breast cancer surgery: A randomized single center study

Abstract

Abstract Introduction Axillary lymph node dissection is standard therapy for patients with positive-node breast cancer, and can be performed with an electrocautery scalpel and suture ligation in most cases. However, knot slipping can occur during suture ligation and this can spread thermal damage to peripheral tissues. The LigaSureTM Small Jaw vessel-sealing system was developed as an alternative to suture ligatures, staplers, and other energy-dependent devices for sealing blood and lymphatic vessels, but its use in axillary dissection for breast cancer is limited. We prospectively compared the duration until drain removal after surgery, total lymph fluid drainage volume, intraoperative blood loss, and incidence of complications after axillary dissections, between this device and conventional methods. Methods This prospective randomized study was conducted at the Department of Breast and Endocrine Surgery at Tokai University School of Medicine, Kanagawa, Japan, between October 2011 and March 2015. Major eligibility criteria included (1) pathologically confirmed breast cancer diagnosis, (2) age ≥20 and ≤80 years, and (3) a signed informed consent form. The primary endpoint was duration until drain removal after surgery. The secondary endpoints were total lymph fluid drainage volume, intraoperative blood loss, and incidence of postoperative surgical complications. We defined the criterion for drain removal as a lymph fluid drainage volume of <40 mL/day for two consecutive days.The target accrual was 100 patients, with a two-sided error rate of 5%, and 90% power. The assumed duration until drain removal after surgery was 7.2 days in the control group (conventional use of an electrocautery scalpel and suture ligation) and 5.8 days in the study group (use of the LigaSureTM Small Jaw). This clinical study was approved by the Institutional Review Board of the Tokai University School of Medicine and is registered with UMIN (No. 000013034). Results Initially, 100 patients were assigned as eligible; however, two patients were later excluded because of the exclusion criteria. Of 98 patients, 49 were randomized to the study group, and 49 to the control group. The mean duration until drain removal after surgery was 5.2 days in the study group and 5.0 days in the control group (p=0.573). The mean total lymph fluid drainage volumes were 260.3 and 233.5 mL (p=0.502), and the mean intraoperative blood loss volumes were 17.8 and 18.0 mL (p=0.949), for the study and control groups, respectively. No significant differences were found between the two groups regarding drain removal duration, total drainage volume, and intraoperative blood loss volume. Both groups had low incidence rates of postoperative hematoma, wound infection, lymphedema, and pain, and had similar incidence rates of seroma formation after drain removal. Conclusion Our study results indicated that the use of the LigaSureTM Small Jaw in axillary dissection for breast cancer was as safe as conventional methods. However, using the LigaSureTM Small Jaw did not improve surgical outcomes such as duration until drain removal and total lymph fluid drainage volume compared with conventional methods. Citation Format: Okamura T, Niikura N, Yokoyama K, Ogiya R, Oshitanai R, Terao M, Morioka T, Tsuda B, Saito Y, Suzuki Y, Tokuda Y. Utility of LigaSureTM vessel-sealing device in axillary dissection for breast cancer surgery: A randomized single center study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-13-11.