Back to resultsLaparoscopic Gastrectomy for Advanced Gastric Cancer
Primary Purpose
Advanced Gastric Cancer, Laparoscopic Gastrectomy
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 20-80
- informed consent
- no other malignancies
- cT2N0-cT3N2 according to JGCA 2nd edition
- ASA score<3
Exclusion Criteria:
- distant metastasis(P1 or M1) under laparoscopic exploration
- Conglomerated N2
- early gastric cancer in permanent pathologic report
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic gastrectomy
Arm Description
Laparoscopic gastrectomy procedure: D2 lymphadenectomy & total omentectomy in case of tumor with serosa exposure under laparoscopic exploration
Outcomes
Primary Outcome Measures
3 year recurrence free survival
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01441336
First Posted
September 25, 2011
Last Updated
January 6, 2017
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01441336
Brief Title
Laparoscopic Gastrectomy for Advanced Gastric Cancer
Official Title
Laparoscopic Gastrectomy for Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.
Detailed Description
Prospective phase II clinical trial to evaluate technical and oncological safety of LG for AGC
LG procedure for AGC:
D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic exploration
Primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern
Study duration: 7 years(enrollment: 4year, follow-up: 3year)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer, Laparoscopic Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic gastrectomy
Arm Type
Experimental
Arm Description
Laparoscopic gastrectomy procedure:
D2 lymphadenectomy & total omentectomy in case of tumor with serosa exposure under laparoscopic exploration
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastrectomy
Intervention Description
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Primary Outcome Measure Information:
Title
3 year recurrence free survival
Description
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.
Time Frame
Postoperative 3 year
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:
Age 20-80
informed consent
no other malignancies
cT2N0-cT3N2 according to JGCA 2nd edition
ASA score<3
Exclusion Criteria:
distant metastasis(P1 or M1) under laparoscopic exploration
Conglomerated N2
early gastric cancer in permanent pathologic report
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33970027
Citation
Zhang L, Hong H, Zang L, Dong F, Lu A, Feng B, He Z, Xue P, Cai Z, Zheng M, Ma J. Application Value of 4K High-Definition System in Laparoscopic Gastrectomy: Preliminary Results and Initial Experience. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):137-141. doi: 10.1089/lap.2020.0931. Epub 2021 May 7.
Results Reference
derived
PubMed Identifier
30944763
Citation
Ahn SH, Kang SH, Lee Y, Min SH, Park YS, Park DJ, Kim HH. Long-term Survival Outcomes of Laparoscopic Gastrectomy for Advanced Gastric Cancer: Five-year Results of a Phase II Prospective Clinical Trial. J Gastric Cancer. 2019 Mar;19(1):102-110. doi: 10.5230/jgc.2019.19.e6. Epub 2019 Mar 12.
Results Reference
derived
PubMed Identifier
23404155
Citation
Lee JH, Son SY, Lee CM, Ahn SH, Park DJ, Kim HH. Morbidity and mortality after laparoscopic gastrectomy for advanced gastric cancer: results of a phase II clinical trial. Surg Endosc. 2013 Aug;27(8):2877-85. doi: 10.1007/s00464-013-2848-0. Epub 2013 Feb 13.
Results Reference
derived
Learn more about this trial
Laparoscopic Gastrectomy for Advanced Gastric Cancer
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