Noriyuki Inaki1, Tsuyoshi Etoh2, Tetsuji Ohyama3, Kazuhisa Uchiyama4, Natsuya Katada5, Keisuke Koeda6, Kazuhiro Yoshida7, Akinori Takagane8, Kazuyuki Kojima9, Shinichi Sakuramoto10, Norio Shiraishi11, Seigo Kitano12. 1. Department of Gastroenterological Surgery, Ishikawa Prefectural Central Hospital, Kanazawa, Japan. 2. Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Hasama-machi, Oita, 879-5593, Japan. teto@oita-u.ac.jp. 3. Department of Mathematics and Statistics, Oita University Faculty of Medicine, Oita, Japan. 4. Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki, Japan. 5. Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan. 6. Department of Surgery, Iwate Medical University School of Medicine, Morioka, Japan. 7. Department of Surgical Oncology, Gifu University, Gifu, Japan. 8. Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan. 9. Center for Minimally Invasive Surgery, Tokyo Medical and Dental University, Bunkyō, Japan. 10. Department of Gastroenterological Surgery, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama, Japan. 11. Center for Community Medicine, Oita University Faculty of Medicine, Oita, Japan. 12. Oita University, Oita, Japan.
Abstract
BACKGROUND: The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated. METHODS:Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0-2 and M0. Patients aged 20-80 years were pre-operatively randomized. RESULTS: In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwentlaparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge. CONCLUSIONS: The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 ( www.umin.ac.jp/ctr/).
RCT Entities:
BACKGROUND: The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated. METHODS: Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0-2 and M0. Patients aged 20-80 years were pre-operatively randomized. RESULTS: In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge. CONCLUSIONS: The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 ( www.umin.ac.jp/ctr/).
Authors: Jaffer A Ajani; David J Bentrem; Stephen Besh; Thomas A D'Amico; Prajnan Das; Crystal Denlinger; Marwan G Fakih; Charles S Fuchs; Hans Gerdes; Robert E Glasgow; James A Hayman; Wayne L Hofstetter; David H Ilson; Rajesh N Keswani; Lawrence R Kleinberg; W Michael Korn; A Craig Lockhart; Kenneth Meredith; Mary F Mulcahy; Mark B Orringer; James A Posey; Aaron R Sasson; Walter J Scott; Vivian E Strong; Thomas K Varghese; Graham Warren; Mary Kay Washington; Christopher Willett; Cameron D Wright; Nicole R McMillian; Hema Sundar Journal: J Natl Compr Canc Netw Date: 2013-05-01 Impact factor: 11.908