Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
204 participants
INTERVENTIONAL
2008-11-30
2015-07-31
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laparoscopic gastrectomy
Laparoscopic gastrectomy procedure:
D2 lymphadenectomy \& total omentectomy in case of tumor with serosa exposure under laparoscopic exploration
Laparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Interventions
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Laparoscopic gastrectomy
Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
Eligibility Criteria
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Inclusion Criteria
* informed consent
* no other malignancies
* cT2N0-cT3N2 according to JGCA 2nd edition
* ASA score\<3
Exclusion Criteria
* Conglomerated N2
* early gastric cancer in permanent pathologic report
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Hyung-Ho Kim
Principal Investigator
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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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.
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.
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.
Other Identifiers
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SNUBHGS02
Identifier Type: -
Identifier Source: org_study_id
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