A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection

Overview

The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible. 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.

Full Title of Study: “A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Interventions

  • Procedure: reduced port laparoscopic distal gastrectomy

Arms, Groups and Cohorts

  • Experimental: reduced port
    • gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection

Clinical Trial Outcome Measures

Primary Measures

  • Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
    • Time Frame: 1 month after enrollment of the patients
    • Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping

Participating in This Clinical Trial

Inclusion Criteria

  • histologically confirmed adenocarcinoma of the stomach – 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:

  • metastatic disease – previous history of malignancy in any organ – any co-morbidity obviating major surgery

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jun Ho Lee, M.D. ph.D, Study Chair, Samsung Medical Center
  • Overall Contact(s)
    • Jun Ho Lee, M.D. ph.D, 82-2-3410-3463, gsjunholee@gmail.com

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.