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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
laparoscopy-assisted distal gastrectomy
open distal gastrectomy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, laparoscopic surgery, survival, preoperative staging, morbidity, quality of life, acute inflammatory reaction, cost

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonbuk National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Soonchunhyang University College of MedicineRecruiting
  • Catholic University Holy Family HospitalRecruiting
  • Keimyung University College of MedicineRecruiting
  • Dong-A University College of MedicineRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Yonsei University College of MedicineRecruiting
  • Catholic University Kangnam St. Mary's HospitalRecruiting
  • Ewha Womans University HospitalRecruiting
  • Kangnam Severance HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Ajou University College of MedicineRecruiting
  • St. Vincent's HospitalRecruiting
  • Ulsan University HospitalRecruiting

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival
morbidity and mortality
quality of life
inflammatory and immune response
cost-effectiveness

Full Information

First Posted
March 26, 2007
Last Updated
September 20, 2010
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00452751
Brief Title
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Prospective Randomized Trial
Acronym
KLASS
Official Title
Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, laparoscopic surgery, survival, preoperative staging, morbidity, quality of life, acute inflammatory reaction, cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
laparoscopy-assisted distal gastrectomy
Intervention Type
Procedure
Intervention Name(s)
open distal gastrectomy
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
disease-free survival
Title
morbidity and mortality
Title
quality of life
Title
inflammatory and immune response
Title
cost-effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pathologically proven gastric adenocarcinoma age: 20 ~ 80 years preoperative stage: cT1N0M0, cT1N1M0, cT2aN0M0 no history of other cancer no history of chemotherapy or radiotherapy written informed consent Exclusion Criteria: ASA >3 combined resection total gastrectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyung-Ho Kim, MD, PhD
Phone
82-31-787-7095
Email
hhkim@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Chonjoo
State/Province
Chonbuk
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Young Kim, MD
Email
happyhill@chonbuk.ac.kr
First Name & Middle Initial & Last Name & Degree
Chan Young Kim, MD
Facility Name
Chungnam National University Hospital
City
Daejun
State/Province
Chungnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Il Lee, MD
First Name & Middle Initial & Last Name & Degree
Sang IL Lee, MD
Facility Name
Soonchunhyang University College of Medicine
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyu Seok Cho, MD, PhD
Phone
82-32-621-5114
Email
gschogs@schbc.ac.kr
First Name & Middle Initial & Last Name & Degree
Gyu Seok Cho, MD, PhD
Facility Name
Catholic University Holy Family Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wook Kim, MD, PhD
Phone
82-32-340-2114
Email
kimwook@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Wook Kim, MD, PhD
Facility Name
Keimyung University College of Medicine
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Wan Ryu, MD, PhD
Phone
82-53-250-7114
Email
gsman@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Seung-Wan Ryu, MD, PhD
Facility Name
Dong-A University College of Medicine
City
Pusan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Chan Kim, MD, PhD
Phone
82-51-240-2000
Email
mckim@donga.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Chan Kim, MD, PhD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, MD, PhD
Phone
82-31-787-7095
Email
hhkim@snubh.org
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Do Joong Park, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, MD, PhD
Phone
82-2-2072-1957
Email
appe98@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Han Kwang Yang, MD, PhD
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo Jin Hyung, MD, PhD
Phone
82-2-2227-0114
Email
wjhyung@yumc.yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Woo Jin Hyung, MD, PhD
Facility Name
Catholic University Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyo Young Song, MD, PhD
Phone
82-2-590-1114
Email
skygs@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyo Young Song, MD, PhD
Facility Name
Ewha Womans University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Ho Lee, MD
First Name & Middle Initial & Last Name & Degree
Joo Ho Lee, MD
Facility Name
Kangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Ho Choi, MD
First Name & Middle Initial & Last Name & Degree
Seung Ho Choi, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Sung Sohn, MD
First Name & Middle Initial & Last Name & Degree
Tae Sung Sohn, MD
Facility Name
Ajou University College of Medicine
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, MD, PhD
Phone
82-31-219-5114
Email
hansu@ajou.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, MD, PhD
Facility Name
St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Min Jin, MD
First Name & Middle Initial & Last Name & Degree
Hyung Min Jin, MD
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Yeol Kim, MD
Email
kim9107798@dreamwiz.com
First Name & Middle Initial & Last Name & Degree
Kyu Yeol Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30730546
Citation
Kim HH, Han SU, Kim MC, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer: The KLASS-01 Randomized Clinical Trial. JAMA Oncol. 2019 Apr 1;5(4):506-513. doi: 10.1001/jamaoncol.2018.6727.
Results Reference
derived
PubMed Identifier
26352529
Citation
Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.
Results Reference
derived
PubMed Identifier
23396494
Citation
Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Prospective randomized controlled trial (phase III) to comparing laparoscopic distal gastrectomy with open distal gastrectomy for gastric adenocarcinoma (KLASS 01). J Korean Surg Soc. 2013 Feb;84(2):123-30. doi: 10.4174/jkss.2013.84.2.123. Epub 2013 Jan 29.
Results Reference
derived
PubMed Identifier
20160637
Citation
Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.
Results Reference
derived
PubMed Identifier
18663532
Citation
Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.
Results Reference
derived

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

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