Comparison of Laparoscopic Versus Open Gastrectomy for Ga... | NCT00452751

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

May 2014Estimated

First Submitted Date

Mar 26, 2007

First Submission Date that Met QC Criteria

Mar 26, 2007

First Posted Date

Mar 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2010

Last Update Posted Date

Sep 21, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Gastric Cancer

Keywords

gastric cancer
laparoscopic surgery
survival
preoperative staging
morbidity
quality of life
acute inflammatory reaction
cost

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopy-assisted distal gastrectomy	Procedure
open distal gastrectomy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival

Secondary Outcomes

Measure	Description	Time Frame
disease-free survival
morbidity and mortality
quality of life

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyung-Ho Kim, MD, PhD	Contact	82-31-787-7095		hhkim@snubh.org

Overall Officials

Name	Affiliation	Role
Hyung-Ho Kim, MD, PhD	Seoul National University Bundang Hospital, 300 Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungnam National University Hospital	Recruiting	Daejun	Chungcheongnam-do		South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30730546	Derived	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.
26352529

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D013272	Stomach Diseases