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Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

Primary Purpose

Gastric Cancer, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isoperistaltic Billroth II + Braun anastomosis
Antiperistaltic Billroth II + Braun anastomosis
Sponsored by
Shanghai Minimally Invasive Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologically diagnosed as gastric cancer before surgery
  • Clinical staging: cT1-4aN0-3M0
  • Postoperative evaluation concluded B-II B anastomosis
  • Consent assigned

Exclusion Criteria:

  • Diagnosed with other malignancies within 2 years
  • Gastric cancer with clinical staging: cT4b or M1
  • Women with pregnancy or breast-feeding
  • Emergency procedures
  • Consent not assigned

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Antiperistaltic

    Isoperistaltic

    Arm Description

    In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis

    In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis

    Outcomes

    Primary Outcome Measures

    Postoperative Reflux Rate
    The rate of bile reflux within 1yrs postoperation

    Secondary Outcome Measures

    Disease-free survival
    3yrs DFS
    Overall survival
    3yrs OS
    Surgery-related reflux gastritis rate
    The rate of surgery-related reflux gastritis rate
    Surgery-related reflux esophagitis rate
    The rate of surgery-related reflux esophagitis rate

    Full Information

    First Posted
    December 10, 2017
    Last Updated
    December 10, 2017
    Sponsor
    Shanghai Minimally Invasive Surgery Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03372681
    Brief Title
    Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux
    Official Title
    A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Minimally Invasive Surgery Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Postoperative Complications
    Keywords
    Distal Gastrectomy, Postoperative Reflux Rate, Gastric Cance, Laparoscopic Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    214 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antiperistaltic
    Arm Type
    Experimental
    Arm Description
    In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis
    Arm Title
    Isoperistaltic
    Arm Type
    Active Comparator
    Arm Description
    In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis
    Intervention Type
    Procedure
    Intervention Name(s)
    Isoperistaltic Billroth II + Braun anastomosis
    Intervention Description
    Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction
    Intervention Type
    Procedure
    Intervention Name(s)
    Antiperistaltic Billroth II + Braun anastomosis
    Intervention Description
    Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction
    Primary Outcome Measure Information:
    Title
    Postoperative Reflux Rate
    Description
    The rate of bile reflux within 1yrs postoperation
    Time Frame
    1 yrs
    Secondary Outcome Measure Information:
    Title
    Disease-free survival
    Description
    3yrs DFS
    Time Frame
    3yrs
    Title
    Overall survival
    Description
    3yrs OS
    Time Frame
    3 yrs
    Title
    Surgery-related reflux gastritis rate
    Description
    The rate of surgery-related reflux gastritis rate
    Time Frame
    1yrs
    Title
    Surgery-related reflux esophagitis rate
    Description
    The rate of surgery-related reflux esophagitis rate
    Time Frame
    1 yrs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologically diagnosed as gastric cancer before surgery Clinical staging: cT1-4aN0-3M0 Postoperative evaluation concluded B-II B anastomosis Consent assigned Exclusion Criteria: Diagnosed with other malignancies within 2 years Gastric cancer with clinical staging: cT4b or M1 Women with pregnancy or breast-feeding Emergency procedures Consent not assigned
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Minhua Zheng, M.D. PhD.
    Phone
    +86-13564119545
    Email
    zmhtiger@yeah.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jing Sun, M.D. PhD.
    Phone
    +86-13524284622
    Email
    sj11788@rjh.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Minhua Zheng, M.D. PhD.
    Organizational Affiliation
    MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28163716
    Citation
    Cui LH, Son SY, Shin HJ, Byun C, Hur H, Han SU, Cho YK. Billroth II with Braun Enteroenterostomy Is a Good Alternative Reconstruction to Roux-en-Y Gastrojejunostomy in Laparoscopic Distal Gastrectomy. Gastroenterol Res Pract. 2017;2017:1803851. doi: 10.1155/2017/1803851. Epub 2017 Jan 9.
    Results Reference
    background
    PubMed Identifier
    27067234
    Citation
    In Choi C, Baek DH, Lee SH, Hwang SH, Kim DH, Kim KH, Jeon TY, Kim DH. Comparison Between Billroth-II with Braun and Roux-en-Y Reconstruction After Laparoscopic Distal Gastrectomy. J Gastrointest Surg. 2016 Jun;20(6):1083-90. doi: 10.1007/s11605-016-3138-7. Epub 2016 Apr 11.
    Results Reference
    background

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    Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

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