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)
´ëÇÑÀ§¾ÏÇÐȸÁö 2013³â 13±Ç 3È£ p.164 ~ p.171
³²º´È£(Nam Byung-Ho) - National Cancer Center
±è¿µ¿ì(Kim Young-Woo) - National Cancer Center Research Institute and Hospital Gastric Cancer Branch
(Reim Daniel) - Klinikum rechts der Isar der Technischen Universitaet Muenchen Department of Surgery
¾ö¹æ¿ï(Eom Bang-Wool) - National Cancer Center Research Institute and Hospital Gastric Cancer Branch
À¯¿Ï½Ä(Yu Wan-Sik) - Kyungpook National University Medical Center Department of Surgery
¹Ú¿µ±Ô(Park Young-Kyu) - Chonnam National University Hwasun Hospital Department of Surgery
·ù±Ù¿ø(Ryu Keun-Won) - National Cancer Center Research Institute and Hospital Gastric Cancer Branch
ÀÌ¿µÁØ(Lee Young-Joon) - Gyeongsang National University Hospital Department of Surgery
À±È«¸¸(Yoon Hong-Man) - National Cancer Center Research Institute and Hospital Gastric Cancer Branch
ÀÌÁØÈ£(Lee Jun-Ho) - National Cancer Center Research Institute and Hospital Gastric Cancer Branch
Á¤¿À(Jeong Oh) - Chonnam National University Hwasun Hospital Department of Surgery
Á¤»óÈ£(Jeong Sang-Ho) - Gyeongsang National University Hospital Department of Surgery
ÀÌ»ó¾ï(Lee Sang-Eok) - Konyang University Hospital Department of Surgery
ÀÌ»óÈ£(Lee Sang-Ho) - Kosin University Gospel Hospital Department of Surgery
À±±â¿µ(Yoon Ki-Young) - Kosin University Gospel Hospital Department of Surgery
¼°æ¿ø(Seo Kyung-Won) - Kosin University Gospel Hospital Department of Surgery
Á¤È£¿µ(Chung Ho-Young) - Kyungpook National University Medical Center Department of Surgery
±Ç¿À°æ(Kwon Oh-Kyoung) - Kyungpook National University Medical Center Department of Surgery
±èźÀ(Kim Tae-Bong) - Daegu Veterans Hospital Department of Surgery
ÀÌ¿î±â(Lee Woon-Ki) - Gachon University Gil Medical Center Department of Surgery
¹Ú¼ºÈì(Park Seong-Heum) - Korea University Anam Hospital Department of Surgery
¼³Áö¿µ(Sul Ji-Young) - Chungnam National University Hospital Department of Surgery
¾ç´ëÇö(Yang Dae-Hyun) - Hallym University Kangnam Sacred Hearted Hospital Department of Surgery
ÀÌÁ¾¼®(Lee Jong-Seok) - University of Ulsan College of Medicine Asan Medical Center Department of Radiology
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 laparoscopy-assisted 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.
Å°¿öµå
Gastrectomy, Stomach neoplasms, Lymph node excision
KMID :
0914820130130030164
¿ø¹® ¹× ¸µÅ©¾Æ¿ô Á¤º¸
µîÀçÀú³Î Á¤º¸
À¯È¿¼º°á°ú(Recomendation)
This is a research protocol of prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer.