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Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer

Phase 3
20 Years
80 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Principal Investigator

Hyung-Ho Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea


South Korea: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

May 2014

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • laparoscopic surgery
  • survival
  • preoperative staging
  • morbidity
  • quality of life
  • acute inflammatory reaction
  • cost
  • Stomach Neoplasms