Young Kyu Park1, Hong Man Yoon2, Young-Woo Kim3, Ji Yeon Park2, Keun Won Ryu2, Young-Joon Lee4, Oh Jeong1, Ki Young Yoon5, Jun Ho Lee2, Sang Eok Lee6, Wansik Yu7, Sang-Ho Jeong4, Taebong Kim8, Sohee Kim9, Byoung-Ho Nam9. 1. Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun-gun, Republic of Korea. 2. Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea. 3. Graduate School of Cancer Science and Policy, National Cancer Center, Goyang-si, Republic of Korea. 4. Department of Surgery, Gyeongsang National University Hospital, Jinju-si, Republic of Korea. 5. Department of Surgery, Kosin University Gospel Hospital, Busan, Republic of Korea. 6. Department of Surgery, Konyang University Hospital, Daejeon, Republic of Korea. 7. Department of Surgery, Kyungpook National University Hospital, Daegu, Republic of Korea. 8. Department of Surgery, Dae Gu Veterans Hospital, Daegu, Republic of Korea. 9. Biometric Research Branch, National Cancer Center, Goyang-si, Republic of Korea.
Abstract
OBJECTIVE: This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC). SUMMARY OF BACKGROUND DATA: D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet. METHODS:Patients with cT2-T4a and cN0-2 (AJCC 7 staging system) distal gastric cancer were randomly but not blindingly assigned to LADG or ODG groups using fixed block sizes with a 1:1 allocation ratio. The primary endpoint was the noncompliance rate of the lymph node dissection, which was used to evaluate feasibility. Secondary endpoints included 3-year disease-free survival (DFS), 5-year overall survival, complications, and surgical stress response. RESULTS:Between June 2010 and October 2011, 204 patients enrolled and underwent eitherLADG (n = 105) or ODG (n = 99). Of these, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the overall noncompliance rate of lymph node dissection between LADG and ODG groups (47.0% and 43.2%, respectively; P = 0.648). In the subgroup analysis, the noncompliance rate in the LADG group was significantly higher than the ODG group for clinical stage III disease (52.0% vs 25.0%, P = 0.043). No difference was found in the 3-year DFS rate between the groups (LADG, 80.1%; ODG, 81.9%; P = 0.448). Differences in postoperative complication rates and surgical stress response were found to be insignificant between the 2 arms. CONCLUSIONS:LADG was feasible for AGC treatment based on the noncompliance rate of D2 lymph node dissection. Subgroups analysis data suggest that further studies are needed for stage III gastric cancer.
RCT Entities:
OBJECTIVE: This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC). SUMMARY OF BACKGROUND DATA: D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet. METHODS:Patients with cT2-T4a and cN0-2 (AJCC 7 staging system) distal gastric cancer were randomly but not blindingly assigned to LADG or ODG groups using fixed block sizes with a 1:1 allocation ratio. The primary endpoint was the noncompliance rate of the lymph node dissection, which was used to evaluate feasibility. Secondary endpoints included 3-year disease-free survival (DFS), 5-year overall survival, complications, and surgical stress response. RESULTS: Between June 2010 and October 2011, 204 patients enrolled and underwent either LADG (n = 105) or ODG (n = 99). Of these, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the overall noncompliance rate of lymph node dissection between LADG and ODG groups (47.0% and 43.2%, respectively; P = 0.648). In the subgroup analysis, the noncompliance rate in the LADG group was significantly higher than the ODG group for clinical stage III disease (52.0% vs 25.0%, P = 0.043). No difference was found in the 3-year DFS rate between the groups (LADG, 80.1%; ODG, 81.9%; P = 0.448). Differences in postoperative complication rates and surgical stress response were found to be insignificant between the 2 arms. CONCLUSIONS:LADG was feasible for AGC treatment based on the noncompliance rate of D2 lymph node dissection. Subgroups analysis data suggest that further studies are needed for stage III gastric cancer.
Authors: Andreas Andreou; Sebastian Knitter; Sascha Chopra; Christian Denecke; Moritz Schmelzle; Benjamin Struecker; Ann-Christin Heilmann; Johanna Spenke; Tobias Hofmann; Peter C Thuss-Patience; Marcus Bahra; Johann Pratschke; Matthias Biebl Journal: J Gastrointest Surg Date: 2018-10-03 Impact factor: 3.452