Laparoscopic Gastrectomy for Advanced Gastric Cancer

NCT ID: NCT01441336

Last Updated: 2017-01-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2015-07-31

Brief Summary

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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

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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)

Conditions

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Advanced Gastric Cancer Laparoscopic Gastrectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Laparoscopic gastrectomy

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Ho Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

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.

Reference Type DERIVED
PMID: 33970027 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30944763 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23404155 (View on PubMed)

Other Identifiers

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SNUBHGS02

Identifier Type: -

Identifier Source: org_study_id

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