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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311595
Recruitment Status : Unknown
Verified December 2014 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: reduced port laparoscopic distal gastrectomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
Study Start Date : December 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: reduced port
gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection
Procedure: reduced port laparoscopic distal gastrectomy



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311595


Contacts
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Contact: Jun Ho Lee, M.D. ph.D 82-2-3410-3463 gsjunholee@gmail.com
Contact: Jieun Kim, M.D. 82-2-3410-1735 wldmsld.kim@samsung.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Jun Ho Lee, M.D. ph.D Samsung Medical Center
Publications:
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02311595    
Other Study ID Numbers: 2014-10-032
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Samsung Medical Center:
gastric cancer
laparoscope
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases