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Sponsored by: |
National Cancer Center, Korea |
Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00452751 |
The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.
Condition | Intervention | Phase |
Gastric Cancer |
Procedure: laparoscopy-assisted distal gastrectomy Procedure: open distal gastrectomy |
Phase III |
MedlinePlus related topics: | Cancer Stomach Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer |
Estimated Enrollment: | 1400 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | May 2014 |
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hyung-Ho Kim, MD, PhD | 82-31-787-7095 | hhkim@snubh.org |
Korea, Republic of | |||||
Seoul National University Bundang Hospital | Recruiting | ||||
Seongnam, Korea, Republic of, 463-707 | |||||
Contact: Hyung-Ho Kim, MD, PhD 82-31-787-7095 hhkim@snubh.org | |||||
Principal Investigator: Hyung-Ho Kim, MD, PhD | |||||
Yonsei University College of Medicine | Recruiting | ||||
Seoul, Korea, Republic of, 120-752 | |||||
Contact: Woo Jin Hyung, MD, PhD 82-2-2227-0114 wjhyung@yumc.yonsei.ac.kr | |||||
Principal Investigator: Woo Jin Hyung, MD, PhD | |||||
Soonchunhyang University College of Medicine | Recruiting | ||||
Bucheon, Korea, Republic of, 420-767 | |||||
Contact: Gyu Seok Cho, MD, PhD 82-32-621-5114 gschogs@schbc.ac.kr | |||||
Principal Investigator: Gyu Seok Cho, MD, PhD | |||||
Dong-A University College of Medicine | Recruiting | ||||
Pusan, Korea, Republic of, 602-715 | |||||
Contact: Min Chan Kim, MD, PhD 82-51-240-2000 mckim@donga.ac.kr | |||||
Principal Investigator: Min Chan Kim, MD, PhD | |||||
Catholic University Kangnam St. Mary's Hospital | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Kyo Young Song, MD, PhD 82-2-590-1114 skygs@catholic.ac.kr | |||||
Principal Investigator: Kyo Young Song, MD, PhD | |||||
Catholic University Holy Family Hospital | Recruiting | ||||
Bucheon, Korea, Republic of | |||||
Contact: Wook Kim, MD, PhD 82-32-340-2114 kimwook@catholic.ac.kr | |||||
Principal Investigator: Wook Kim, MD, PhD | |||||
Seoul National University Hospital | Recruiting | ||||
Seoul, Korea, Republic of, 110-744 | |||||
Contact: Hyuk-Joon Lee, MD, PhD 82-2-2072-1957 appe98@snu.ac.kr | |||||
Principal Investigator: Hyuk-Joon Lee, MD, PhD | |||||
Keimyung University College of Medicine | Recruiting | ||||
Daegu, Korea, Republic of, 700-712 | |||||
Contact: Seung-Wan Ryu, MD, PhD 82-53-250-7114 gsman@dsmc.or.kr | |||||
Principal Investigator: Seung-Wan Ryu, MD, PhD | |||||
Ajou University College of Medicine | Recruiting | ||||
Suwon, Korea, Republic of | |||||
Contact: Sang-Uk Han, MD, PhD 82-31-219-5114 hansu@ajou.ac.kr | |||||
Principal Investigator: Sang-Uk Han, MD, PhD |
National Cancer Center, Korea |
Principal Investigator: | Hyung-Ho Kim, MD, PhD | Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea |
Study ID Numbers: | 0520310-2 |
First Received: | March 26, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00452751 |
Health Authority: | South Korea: Institutional Review Board |
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