Laparoscopic Gastrectomy for Advanced Gastric Cancer
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 9, 2017
January 1, 2017
3.7 years
September 25, 2011
January 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
3 year recurrence free survival
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.
Postoperative 3 year
Study Arms (1)
Laparoscopic gastrectomy
EXPERIMENTALLaparoscopic gastrectomy procedure: D2 lymphadenectomy \& total omentectomy in case of tumor with serosa exposure under laparoscopic exploration
Interventions
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Eligibility Criteria
You may qualify if:
- Age 20-80
- informed consent
- no other malignancies
- cT2N0-cT3N2 according to JGCA 2nd edition
- ASA score\<3
You may not qualify if:
- distant metastasis(P1 or M1) under laparoscopic exploration
- Conglomerated N2
- early gastric cancer in permanent pathologic report
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (3)
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.
PMID: 33970027DERIVEDAhn 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.
PMID: 30944763DERIVEDLee 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.
PMID: 23404155DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 25, 2011
First Posted
September 27, 2011
Study Start
November 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2015
Last Updated
January 9, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share