J Gastric Cancer.  2013 Sep;13(3):164-171.

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 BH
• Kim YW
• Reim D
• Eom BW
• Yu WS
• Park YK
• Ryu KW
• Lee YJ
• Yoon HM
• Lee JH
• Jeong O
• Jeong SH
• Lee SE
• Lee SH
• Yoon KY
• Seo KW
• Chung HY
• Kwon OK
• Kim TB
• Lee WK
• Park SH
• Sul JY
• Yang DH
• Lee JS

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.Trial Registration: NCT01088204 (international), NCCCTS-09-448 (Korea).

Keyword

Gastrectomy; Stomach neoplasms; Lymph node excision

MeSH Terms

Arm
Disease-Free Survival
Endoscopy
Gastrectomy
Humans
Informed Consent
Laparoscopy
Length of Stay
Lymph Node Excision
Lymph Nodes
Postoperative Complications
Prospective Studies
Sample Size
Stomach Neoplasms

Figure

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  Fig. 1 Study scheme. AJCC = American Joint Committee on Cancer.

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