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Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial (KLASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00452751
Recruitment Status : Unknown
Verified September 2010 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : March 27, 2007
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
National Cancer Center, Korea

Brief Summary:
The purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: laparoscopy-assisted distal gastrectomy Procedure: open distal gastrectomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
Study Start Date : February 2006
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. disease-free survival
  2. morbidity and mortality
  3. quality of life
  4. inflammatory and immune response
  5. cost-effectiveness


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452751


Contacts
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Contact: Hyung-Ho Kim, MD, PhD 82-31-787-7095 hhkim@snubh.org

Locations
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Korea, Republic of
Chonbuk National University Hospital Recruiting
Chonjoo, Chonbuk, Korea, Republic of
Contact: Chan Young Kim, MD       happyhill@chonbuk.ac.kr   
Principal Investigator: Chan Young Kim, MD         
Chungnam National University Hospital Recruiting
Daejun, Chungnam, Korea, Republic of
Contact: Sang Il Lee, MD         
Principal Investigator: Sang IL Lee, MD         
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         
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         
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         
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         
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         
Sub-Investigator: Do Joong Park, MD         
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         
Sub-Investigator: Han Kwang Yang, 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         
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         
Ewha Womans University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joo Ho Lee, MD         
Principal Investigator: Joo Ho Lee, MD         
Kangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung Ho Choi, MD         
Principal Investigator: Seung Ho Choi, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Tae Sung Sohn, MD         
Principal Investigator: Tae Sung Sohn, MD         
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         
St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of
Contact: Hyung Min Jin, MD         
Principal Investigator: Hyung Min Jin, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Kyu Yeol Kim, MD       kim9107798@dreamwiz.com   
Principal Investigator: Kyu Yeol Kim, MD         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Hyung-Ho Kim, MD, PhD Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00452751    
Other Study ID Numbers: 0520310-2
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Keywords provided by National Cancer Center, Korea:
gastric cancer
laparoscopic surgery
survival
preoperative staging
morbidity
quality of life
acute inflammatory reaction
cost
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases