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)

Byung Ho Nam, Young Woo Kim, Daniel Reim, Bang Wool Eom, Wan Sik Yu, Young Kyu Park, Keun Won Ryu, Young Joon Lee, Hong Man Yoon, Jun Ho Lee, Oh Jeong, Sang Ho Jeong, Sang Eok Lee, Sang Ho Lee, Ki Young Yoon, Kyung Won Seo, Ho Young Chung, Oh Kyoung Kwon, Tae Bong Kim, Woon Ki Lee & 4 others Seong-Heum Park, Ji Young Sul, Dae Hyun Yang, Jong Seok Lee

Research output: Contribution to journalArticle

19 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)164-171
Number of pages8
JournalJournal of Gastric Cancer
Volume13
Issue number3
DOIs
Publication statusPublished - 2013 Oct 10

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Gastrectomy
Lymph Node Excision
Laparoscopy
Multicenter Studies
Stomach Neoplasms
Randomized Controlled Trials
Safety
Disease-Free Survival
Dissection
Korea
Informed Consent
Documentation
Sample Size
Endoscopy
Length of Stay
Tomography

Keywords

  • Gastrectomy
  • Lymph node excision
  • Stomach neoplasms

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

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; Kim, Young Woo; Reim, Daniel; Wool Eom, Bang; Sik Yu, Wan; Park, Young Kyu; Ryu, Keun Won; Joon Lee, Young; Man Yoon, Hong; Lee, Jun Ho; Jeong, Oh; Ho Jeong, Sang; Lee, Sang Eok; Ho Lee, Sang; Young Yoon, Ki; Won Seo, Kyung; Young Chung, Ho; Kyoung Kwon, Oh; Bong Kim, Tae; Ki Lee, Woon; Park, Seong-Heum; Sul, Ji Young; Hyun Yang, Dae; Seok Lee, Jong.

In: Journal of Gastric Cancer, Vol. 13, No. 3, 10.10.2013, p. 164-171.

Research output: Contribution to journalArticle

Nam, BH, Kim, YW, Reim, D, Wool Eom, B, Sik Yu, W, Park, YK, Ryu, KW, Joon Lee, Y, Man Yoon, H, Lee, JH, Jeong, O, Ho Jeong, S, Lee, SE, Ho Lee, S, Young Yoon, K, Won Seo, K, Young Chung, H, Kyoung Kwon, O, Bong Kim, T, Ki Lee, W, Park, S-H, Sul, JY, Hyun Yang, D & Seok Lee, J 2013, '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)', Journal of Gastric Cancer, vol. 13, no. 3, pp. 164-171. https://doi.org/10.5230/jgc.2013.13.3.164
Nam, Byung Ho ; Kim, Young Woo ; Reim, Daniel ; Wool Eom, Bang ; Sik Yu, Wan ; Park, Young Kyu ; Ryu, Keun Won ; Joon Lee, Young ; Man Yoon, Hong ; Lee, Jun Ho ; Jeong, Oh ; Ho Jeong, Sang ; Lee, Sang Eok ; Ho Lee, Sang ; Young Yoon, Ki ; Won Seo, Kyung ; Young Chung, Ho ; Kyoung Kwon, Oh ; Bong Kim, Tae ; Ki Lee, Woon ; Park, Seong-Heum ; Sul, Ji Young ; Hyun Yang, Dae ; Seok Lee, Jong. / 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). In: Journal of Gastric Cancer. 2013 ; Vol. 13, No. 3. pp. 164-171.
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T2 - Design and rationale of a phase II randomized controlled multicenter trial (COACT 1001)

AU - Nam, Byung Ho

AU - Kim, Young Woo

AU - Reim, Daniel

AU - Wool Eom, Bang

AU - Sik Yu, Wan

AU - Park, Young Kyu

AU - Ryu, Keun Won

AU - Joon Lee, Young

AU - Man Yoon, Hong

AU - Lee, Jun Ho

AU - Jeong, Oh

AU - Ho Jeong, Sang

AU - Lee, Sang Eok

AU - Ho Lee, Sang

AU - Young Yoon, Ki

AU - Won Seo, Kyung

AU - Young Chung, Ho

AU - Kyoung Kwon, Oh

AU - Bong Kim, Tae

AU - Ki Lee, Woon

AU - Park, Seong-Heum

AU - Sul, Ji Young

AU - Hyun Yang, Dae

AU - Seok Lee, Jong

PY - 2013/10/10

Y1 - 2013/10/10

N2 - 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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KW - Gastrectomy

KW - Lymph node excision

KW - Stomach neoplasms

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