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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
Chonnam National University Hwasun Hospital
Hwasun, Chollanam Do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Gyengsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Kyungpook national university hospital
Daegu, South Korea
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
Time frame: postoperative 1 week
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.
Time frame: postoperative 1 day, 1 week, 1 months, 3 months, 6 months, 12 months
operating time
From skin incision to wound closure
Time frame: operation day
time to first flatus
the day when a patient relieve gastrointestinal gas
Time frame: postoperative 1 week
number of retrieved lymph nodes
Time frame: postoperative 1 week
number of retrieved lymph nodes at each stations
Time frame: postoperative 1 week
proximal resection margin
Time frame: postoperative 1 week
distal resection margin,
Time frame: postoperative 1 week
unanimity rate of 3 randomly assigned laparoscopic gastric cancer surgeons
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Dae Gu Veterans Hospital
Daegu, South Korea
Konyang University Hospital
Daejeon, South Korea
Kosin University Gospel Hospital
Pusan, South Korea
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.
Time frame: postoperative 3 months
3-year disease free survival
Time frame: postoperative 3 years