Gastric Cancer
Conditions
Keywords
gastric cancer, laparoscopic surgery, survival, preoperative staging, morbidity, quality of life, acute inflammatory reaction, cost
Brief summary
The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.
Detailed description
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.
Interventions
PROCEDUREopen distal gastrectomy
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. pathologically proven gastric adenocarcinoma 2. age: 20 \ 80 years 3. preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0 4. no history of other cancer 5. no history of chemotherapy or radiotherapy 6. written informed consent
Exclusion criteria
1. ASA \>3 2. combined resection 3. total gastrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival | — |
| morbidity and mortality | — |
| quality of life | — |
| inflammatory and immune response | — |
| cost-effectiveness | — |
Countries
South Korea
Contacts
Primary ContactHyung-Ho Kim, MD, PhD
Outcome results
None listed