Gastric Cancer Clinical Trial
Official title:
Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.
Recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be
reproduced laparoscopically. However, many controversies exist due to no evidence and no
long-term results. There was no prospective multi-center large-scale randomized controlled
trial in the world on the long-term outcome of laparoscopic gastric cancer surgery.
Korean Laparoscopic Gastrointestinal Surgery Study Group, therefore, proposed a
multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus
open distal gastrectomy for gastric cancer (KLASS Trial) after the feasibility and validity
of these procedures had been evaluated by analyzing retrospective multi-center large series.
This KLASS trial is supported by a grant for 2005 from the National R&D Program for Cancer
Control, Ministry of Health & Welfare, Republic of Korea. Nine surgeons from 9 centers are
participating in this trial. All the participants performed more than 50 cases of open and
laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of
gastric cancer surgeries per year. Primary endpoint of this trial is to elucidate that there
is no difference of overall and disease-free survivals between laparoscopic and open groups.
The KLASS trial consists of 5 major subjects: comparison of 5-year overall and disease-free
survivals, standardization of preoperative diagnosis, assessment of the quality of life,
evaluation of postoperative inflammatory response and immune function, and
cost-effectiveness. The KLASS trial will be able to validate and verify laparoscopic gastric
cancer surgery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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