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Comparison of Delta-Shaped and Billroth II After TLDG (TLDG)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delta-shaped anastomosis
Billroth II anastomosis
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring Totally laparoscopic gastrectomy, laparoscopic distal gastrectomy, Intracorporeal anastomosis, Delta-Shaped Anastomosis, Billroth II Anastomosis, Gastric cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • carcinoma located in the lower 1/3 of gastric body or antrum of stomach
  • diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
  • diameter of the tumor <3cm
  • no pyloric obstruction

Exclusion Criteria:

  • diameter of the tumor ≥3cm
  • associated with obstruction, bleeding, emergency surgery or surgical intervention
  • tumor with extensive metastasis
  • patient had previously undergone gastrostomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Delta-shaped anastomosis group

    Billroth II anastomosis group

    Arm Description

    The patients in DS group underwent Delta-shaped anastomosis after TLDG.

    The patients in B-II group underwent Billroth-II anastomosis after TLDG.

    Outcomes

    Primary Outcome Measures

    Stage distribution
    Resected margin
    Operative time
    Anastomosis time
    The number of stapler cartridges used
    Median estimated blood loss
    Red blood cell transfusion
    Length of the incision

    Secondary Outcome Measures

    Postoperative complication
    Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.

    Full Information

    First Posted
    January 22, 2015
    Last Updated
    February 21, 2015
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02372747
    Brief Title
    Comparison of Delta-Shaped and Billroth II After TLDG
    Acronym
    TLDG
    Official Title
    Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).
    Detailed Description
    Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    Totally laparoscopic gastrectomy, laparoscopic distal gastrectomy, Intracorporeal anastomosis, Delta-Shaped Anastomosis, Billroth II Anastomosis, Gastric cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Delta-shaped anastomosis group
    Arm Type
    Experimental
    Arm Description
    The patients in DS group underwent Delta-shaped anastomosis after TLDG.
    Arm Title
    Billroth II anastomosis group
    Arm Type
    Experimental
    Arm Description
    The patients in B-II group underwent Billroth-II anastomosis after TLDG.
    Intervention Type
    Procedure
    Intervention Name(s)
    Delta-shaped anastomosis
    Intervention Description
    The patients in DS group underwent Delta-shaped anastomosis after TLDG.
    Intervention Type
    Procedure
    Intervention Name(s)
    Billroth II anastomosis
    Intervention Description
    The patients in B-II group underwent Billroth-II anastomosis after TLDG.
    Primary Outcome Measure Information:
    Title
    Stage distribution
    Time Frame
    up to 7 days after the operation
    Title
    Resected margin
    Time Frame
    up to 7 days after the operation
    Title
    Operative time
    Time Frame
    up to 7 days after the operation
    Title
    Anastomosis time
    Time Frame
    up to 7 days after the operation
    Title
    The number of stapler cartridges used
    Time Frame
    up to 7 days after the operation
    Title
    Median estimated blood loss
    Time Frame
    up to 7 days after the operation
    Title
    Red blood cell transfusion
    Time Frame
    up to 7 days after the operation
    Title
    Length of the incision
    Time Frame
    up to 7 days after the operation
    Secondary Outcome Measure Information:
    Title
    Postoperative complication
    Description
    Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.
    Time Frame
    up to 30 days after the operation

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: carcinoma located in the lower 1/3 of gastric body or antrum of stomach diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan diameter of the tumor <3cm no pyloric obstruction Exclusion Criteria: diameter of the tumor ≥3cm associated with obstruction, bleeding, emergency surgery or surgical intervention tumor with extensive metastasis patient had previously undergone gastrostomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quan Wang, Doctor
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Comparison of Delta-Shaped and Billroth II After TLDG

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