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open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

laparoscopy assisted distal gastrectomy

open distal gastrectomy

Young-Woo Kim, MD,PhD

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.

Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer

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

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.

the day when a patient relieve gastrointestinal gas

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer	NCT01088204	Gastric Cancer	laparoscopy ass... open distal gas...	20 Years - 80 Years	National Cancer Center, Korea
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer	NCT01088204	Gastric Cancer	laparoscopy ass... open distal gas...	20 Years - 80 Years	National Cancer Center, Korea
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer	NCT01088204	Gastric Cancer	laparoscopy ass... open distal gas...	20 Years - 80 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for laparoscopy assisted distal gastrectomy