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The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.
To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open distal gastrectomy | Active Comparator | open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
|
| laparoscopy assisted distal gastrectomy | Experimental | laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopy assisted distal gastrectomy | Procedure | laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| noncompliance rate | A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping | postoperative 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative surgical complications | Major and minor, and short term and long term complications related with surgery will be monitored and recorded according to classification of Accordion Severity Classification of Postoperative Complications; Expanded Classification. | postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months |
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Inclusion Criteria:
histologically proven primary gastric adenocarcinoma
T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
No evidence of other distant metastasis
not stump carcinoma,(vi) aged 20-80 year old
performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
adequate organ functions defined as indicated below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Woo Kim, MD,PhD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Hwasun | Chollanam Do | 519-763 | South Korea | ||
| National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28187041 | Derived | Park YK, Yoon HM, Kim YW, Park JY, Ryu KW, Lee YJ, Jeong O, Yoon KY, Lee JH, Lee SE, Yu W, Jeong SH, Kim T, Kim S, Nam BH; COACT group. Laparoscopy-assisted versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: Results From a Randomized Phase II Multicenter Clinical Trial (COACT 1001). Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168. | |
| 24156036 |
| Label | URL |
|---|---|
| National Cancer Center web site | View source |
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|
| open distal gastrectomy | Procedure | open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer |
|
|
| operating time |
From skin incision to wound closure |
| operation day |
| time to first flatus | the day when a patient relieve gastrointestinal gas | postoperative 1 week |
| number of retrieved lymph nodes | postoperative 1 week |
| number of retrieved lymph nodes at each stations | postoperative 1 week |
| proximal resection margin | postoperative 1 week |
| distal resection margin, | postoperative 1 week |
| unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons | Three randomly assigned laparoscopic gastric cancer surgeons would evaluate the uneditted video and photoes and validate the lymph node dissection according to each stations.When the three surgeons agree that D2 lymph node dissection was performed, it is considered as unanimity. | postoperative 3 months |
| 3-year disease free survival | postoperative 3 years |
| Goyang-si |
| Gyeonggi-do |
| 411-764 |
| South Korea |
| Gyengsang National University Hospital | Jinju | Gyeongsangnam-do | 660-702 | South Korea |
| Kyungpook national university hospital | Daegu | 700-721 | South Korea |
| Dae Gu Veterans Hospital | Daegu | 704-802 | South Korea |
| Konyang University Hospital | Daejeon | 302-718 | South Korea |
| Kosin University Gospel Hospital | Pusan | 602-702 | South Korea |
| 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. 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). J Gastric Cancer. 2013 Sep;13(3):164-71. doi: 10.5230/jgc.2013.13.3.164. Epub 2013 Sep 30. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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