Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, laparoscopic surgery, survival, preoperative staging, morbidity, quality of life, acute inflammatory reaction, cost
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: laparoscopy-assisted distal gastrectomy Type: Procedure
Name: open distal gastrectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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
Locations
Chonbuk National University Hospital
Chonjoo, Chonbuk, Korea, Republic of
Status: Recruiting
Contact: Chan Young Kim, MD - happyhill@chonbuk.ac.kr
Chungnam National University Hospital
Daejun, Chungnam, Korea, Republic of
Status: Recruiting
Contact: Sang Il Lee, MD
Catholic University Holy Family Hospital
Bucheon, Korea, Republic of
Status: Recruiting
Contact: Wook Kim, MD, PhD - 82-32-340-2114 - kimwook@catholic.ac.kr
Soonchunhyang University College of Medicine
Bucheon, Korea, Republic of
Status: Recruiting
Contact: Gyu Seok Cho, MD, PhD - 82-32-621-5114 - gschogs@schbc.ac.kr
Keimyung University College of Medicine
Daegu, Korea, Republic of
Status: Recruiting
Contact: Seung-Wan Ryu, MD, PhD - 82-53-250-7114 - gsman@dsmc.or.kr
Dong-A University College of Medicine
Pusan, Korea, Republic of
Status: Recruiting
Contact: Min Chan Kim, MD, PhD - 82-51-240-2000 - mckim@donga.ac.kr
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Status: Recruiting
Contact: Hyung-Ho Kim, MD, PhD - 82-31-787-7095 - hhkim@snubh.org
Catholic University Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Kyo Young Song, MD, PhD - 82-2-590-1114 - skygs@catholic.ac.kr
Ewha Womans University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo Ho Lee, MD
Kangnam Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Seung Ho Choi, MD
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Tae Sung Sohn, MD
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Hyuk-Joon Lee, MD, PhD - 82-2-2072-1957 - appe98@snu.ac.kr
Yonsei University College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Woo Jin Hyung, MD, PhD - 82-2-2227-0114 - wjhyung@yumc.yonsei.ac.kr
Ajou University College of Medicine
Suwon, Korea, Republic of
Status: Recruiting
Contact: Sang-Uk Han, MD, PhD - 82-31-219-5114 - hansu@ajou.ac.kr
St. Vincent's Hospital
Suwon, Korea, Republic of
Status: Recruiting
Contact: Hyung Min Jin, MD
Ulsan University Hospital
Ulsan, Korea, Republic of
Status: Recruiting
Contact: Kyu Yeol Kim, MD - kim9107798@dreamwiz.com
Start Date
February 2006
Completion Date
May 2014
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page