Journal of Gastric Cancer

The Korean Gastric Cancer Association (대한위암학회)
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Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001)

  • Nam, Byung Ho (Biometric Research Branch, Research Institute for National Cancer Control & Evaluation, National Cancer Center) ;
  • Kim, Young-Woo (Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center) ;
  • Reim, Daniel (Department of Surgery, Klinikum Rechts der Isar der Technischen Universitat Munchen) ;
  • Eom, Bang Wool (Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center) ;
  • Yu, Wan Sik (Department of Surgery, Kyungpook National University Medical Center) ;
  • Park, Young Kyu (Department of Surgery, Chonnam National University Hwasun Hospital) ;
  • Ryu, Keun Won (Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center) ;
  • Lee, Young Joon (Department of Surgery, Gyeongsang National University Hospital) ;
  • Yoon, Hong Man (Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center) ;
  • Lee, Jun Ho (Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center) ;
  • Jeong, Oh (Department of Surgery, Chonnam National University Hwasun Hospital) ;
  • Jeong, Sang Ho (Department of Surgery, Gyeongsang National University Hospital) ;
  • Lee, Sang Eok (Department of Surgery, Konyang University Hospital) ;
  • Lee, Sang Ho (Department of Surgery, Kosin University Gospel Hospital) ;
  • Yoon, Ki Young (Department of Surgery, Kosin University Gospel Hospital) ;
  • Seo, Kyung Won (Department of Surgery, Kosin University Gospel Hospital) ;
  • Chung, Ho Young (Department of Surgery, Kyungpook National University Medical Center) ;
  • Kwon, Oh Kyoung (Department of Surgery, Kyungpook National University Medical Center) ;
  • Kim, Tae Bong (Department of Surgery, Daegu Veterans Hospital) ;
  • Lee, Woon Ki (Department of Surgery, Gachon University Gil Medical Center) ;
  • Park, Seong Heum (Department of Surgery, Korea University Anam Hospital) ;
  • Sul, Ji-Young (Department of Surgery, Chungnam National University Hospital) ;
  • Yang, Dae Hyun (Department of Surgery, Hallym University Kangnam Sacred Hearted Hospital) ;
  • Lee, Jong Seok (Department of Radiology, Asan Medical Center, Ulsan University College of Medicine)
  • Received : 2013.08.13
  • Accepted : 2013.09.13
  • Published : 2013.09.30
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Abstract

Purpose: Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Materials and Methods: Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopyassisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Discussion: Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

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References

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