A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
NCT ID: NCT02311595
Last Updated: 2014-12-08
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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UNKNOWN
PHASE2
67 participants
INTERVENTIONAL
2014-12-31
2015-03-31
Brief Summary
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67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.
The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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reduced port
gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection
reduced port laparoscopic distal gastrectomy
Interventions
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reduced port laparoscopic distal gastrectomy
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,
* signed informed consent
* location of the primary tumor in the antrum, angle and lower body
* no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration
Exclusion Criteria
* previous history of malignancy in any organ
* any co-morbidity obviating major surgery
20 Years
80 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jun Ho Lee, M.D. ph.D
Role: STUDY_CHAIR
Samsung Medical Center
Central Contacts
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References
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Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17.
Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
Other Identifiers
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2014-10-032
Identifier Type: -
Identifier Source: org_study_id