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Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Primary Purpose

Total Laparoscopic Distal Gastrectomy, Locally Advanced Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TLDG or LADG
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Laparoscopic Distal Gastrectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The diagnosis of gastric cancer was confirmed by pathological examination
  • Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th
  • No accompany with another cancer
  • ECOG 0-1
  • ASA I-III
  • Agreement

Exclusion Criteria:

  • Pregnant or suckling period
  • Patients with a history of preoperative chemoradiotherapy
  • Patients with unable to finish D2 lymphadenectomy or R0 resection
  • Laparoscopic surgery contraindications
  • Serious organ disfunction
  • Accompany with serious mental disease
  • Continuous treatment with steroid in 1 month
  • Disagreement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    TLDG or LADG

    Arm Description

    To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG

    Outcomes

    Primary Outcome Measures

    postoperative early anastomotic morbidity

    Secondary Outcome Measures

    Flatus time
    Quality of life
    estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22
    Postoperative hospital stay
    Pain score
    Postoperative inflammation response
    using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days
    Nutrition
    NRS-2002 and PG-SGA in 30 days

    Full Information

    First Posted
    January 23, 2015
    Last Updated
    April 24, 2015
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02365896
    Brief Title
    Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Laparoscopic Distal Gastrectomy, Locally Advanced Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TLDG or LADG
    Arm Type
    Other
    Arm Description
    To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG
    Intervention Type
    Procedure
    Intervention Name(s)
    TLDG or LADG
    Primary Outcome Measure Information:
    Title
    postoperative early anastomotic morbidity
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Flatus time
    Time Frame
    7 days
    Title
    Quality of life
    Description
    estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22
    Time Frame
    30 days
    Title
    Postoperative hospital stay
    Time Frame
    30 days
    Title
    Pain score
    Time Frame
    10 days
    Title
    Postoperative inflammation response
    Description
    using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days
    Time Frame
    10 days
    Title
    Nutrition
    Description
    NRS-2002 and PG-SGA in 30 days
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The diagnosis of gastric cancer was confirmed by pathological examination Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th No accompany with another cancer ECOG 0-1 ASA I-III Agreement Exclusion Criteria: Pregnant or suckling period Patients with a history of preoperative chemoradiotherapy Patients with unable to finish D2 lymphadenectomy or R0 resection Laparoscopic surgery contraindications Serious organ disfunction Accompany with serious mental disease Continuous treatment with steroid in 1 month Disagreement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weidong Zang, Associate chief physician
    Phone
    13600815361
    Email
    fjzangwd@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wenhao Teng, Doctor
    Email
    tengwh@yeah.net

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19263143
    Citation
    Ikeda O, Sakaguchi Y, Aoki Y, Harimoto N, Taomoto J, Masuda T, Ohga T, Adachi E, Toh Y, Okamura T, Baba H. Advantages of totally laparoscopic distal gastrectomy over laparoscopically assisted distal gastrectomy for gastric cancer. Surg Endosc. 2009 Oct;23(10):2374-9. doi: 10.1007/s00464-009-0360-3. Epub 2009 Mar 5.
    Results Reference
    background
    PubMed Identifier
    25061537
    Citation
    Han G, Park JY, Kim YJ. Comparison of short-term postoperative outcomes in totally laparoscopic distal gastrectomy versus laparoscopy-assisted distal gastrectomy. J Gastric Cancer. 2014 Jun;14(2):105-10. doi: 10.5230/jgc.2014.14.2.105. Epub 2014 Jun 30. Erratum In: J Gastric Cancer. 2014 Dec;14(4):284.
    Results Reference
    background
    PubMed Identifier
    22004901
    Citation
    Oki E, Sakaguchi Y, Ohgaki K, Saeki H, Chinen Y, Minami K, Sakamoto Y, Toh Y, Kusumoto T, Maehara Y. Feasibility of delta-shaped anastomoses in totally laparoscopic distal gastrectomy. Eur Surg Res. 2011;47(4):205-10. doi: 10.1159/000332850. Epub 2011 Oct 13.
    Results Reference
    background
    PubMed Identifier
    21561328
    Citation
    Kim BS, Yook JH, Choi YB, Kim KC, Kim MG, Kim TH, Kawada H, Kim BS. Comparison of early outcomes of intracorporeal and extracorporeal gastroduodenostomy after laparoscopic distal gastrectomy for gastric cancer. J Laparoendosc Adv Surg Tech A. 2011 Jun;21(5):387-91. doi: 10.1089/lap.2010.0515. Epub 2011 May 11.
    Results Reference
    background
    PubMed Identifier
    21424875
    Citation
    Kim MG, Kim KC, Kim BS, Kim TH, Kim HS, Yook JH, Kim BS. A totally laparoscopic distal gastrectomy can be an effective way of performing laparoscopic gastrectomy in obese patients (body mass index>/=30). World J Surg. 2011 Jun;35(6):1327-32. doi: 10.1007/s00268-011-1034-6.
    Results Reference
    background
    PubMed Identifier
    22403746
    Citation
    Lee J, Kim D, Kim W. Comparison of laparoscopy-assisted and totally laparoscopic Billroth-II distal gastrectomy for gastric cancer. J Korean Surg Soc. 2012 Mar;82(3):135-42. doi: 10.4174/jkss.2012.82.3.135. Epub 2012 Feb 27.
    Results Reference
    background
    PubMed Identifier
    25395149
    Citation
    Woo J, Lee JH, Shim KN, Jung HK, Lee HM, Lee HK. Does the Difference of Invasiveness between Totally Laparoscopic Distal Gastrectomy and Laparoscopy-Assisted Distal Gastrectomy Lead to a Difference in Early Surgical Outcomes? A Prospective Randomized Trial. Ann Surg Oncol. 2015;22(6):1836-43. doi: 10.1245/s10434-014-4229-x. Epub 2014 Nov 14.
    Results Reference
    background
    PubMed Identifier
    18256884
    Citation
    Song KY, Park CH, Kang HC, Kim JJ, Park SM, Jun KH, Chin HM, Hur H. Is totally laparoscopic gastrectomy less invasive than laparoscopy-assisted gastrectomy?: prospective, multicenter study. J Gastrointest Surg. 2008 Jun;12(6):1015-21. doi: 10.1007/s11605-008-0484-0. Epub 2008 Feb 7.
    Results Reference
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    Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

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