search
Back to results

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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
reduced port laparoscopic distal gastrectomy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, laparoscope

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    reduced port

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2014
    Last Updated
    December 5, 2014
    Sponsor
    Samsung Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02311595
    Brief Title
    A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
    Official Title
    A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    March 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    gastric cancer, laparoscope

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    67 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    reduced port
    Arm Type
    Experimental
    Arm Description
    gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection
    Intervention Type
    Procedure
    Intervention Name(s)
    reduced port laparoscopic distal gastrectomy
    Primary Outcome Measure Information:
    Title
    Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
    Description
    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
    Time Frame
    1 month after enrollment of the patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Ho Lee, M.D. ph.D
    Phone
    82-2-3410-3463
    Email
    gsjunholee@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jieun Kim, M.D.
    Phone
    82-2-3410-1735
    Email
    wldmsld.kim@samsung.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Ho Lee, M.D. ph.D
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17705092
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25227307
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10089184
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs