Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452751
Status:
UNKNOWN
Last Update Posted:
2010-09-21
First Post:
2007-03-26
Brief Title:
Comparison of Laparoscopic Versus Open Gastrectomy for Gastric Cancer A Prospective Randomized Trial
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
Multi-institutional Prospective Randomized Trial on the Assessment of Laparoscopic Surgery for Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KLASS
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 RD 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
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 RD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None