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Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner (MAGESD)

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetic anchored guided endoscopic submucosal dissection
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring magnetic anchored guidance, early gastric cancer, endoscopic submucosal dissection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy sampling

Exclusion Criteria:

  • Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases
  • Patients without informed consent
  • Patients with other malignant tumors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Magnetic-ESD

    Arm Description

    Patients in MAG arm will be treated using magnetic anchored guided endoscopic submucosal dissection.

    Outcomes

    Primary Outcome Measures

    success rate
    The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection

    Secondary Outcome Measures

    complications
    the complications in magnetic anchored guided endoscopic submucosal dissection

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    March 27, 2020
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04327050
    Brief Title
    Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner
    Acronym
    MAGESD
    Official Title
    Prospective Clinical Trial of Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    April 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study uses magnetic anchored guidance system to treat early gastric cancer by endoscopic mucosal dissection to test the advantages of magnetically anchored guidance system for surgical field exposure during endoscopic mucosal dissection.
    Detailed Description
    Gastric cancer is the second most common malignant tumor in China, with the highest mortality rate among all types of malignant tumors. Surgical resection is still the most effective treatment for gastric cancer. Minimally invasive surgery breaks the traditional surgical concept that the laparotomy must be performed by laparotomy. It can complete the operation that required a large incision with minimal incision trauma, and has the advantages of less trauma, faster recovery and fewer complications. At present, the application of gastroscopy and laparoscopy for early gastric cancer has reached consensus at home and abroad. Endoscopic mucosal resection of early gastric cancer is suitable for patients with intramucosal cancer and no lymph node metastasis. However, the unclear exposure of the surgical field during the operation causes difficulty in operation or conversion to open surgery is a difficult problem facing this technique. The project designed a magnetic pulling unit that can be connected through an endoscope, including external abdominal magnets, internal abdominal magnets, connecting hooks, and micro surgical tweezers. Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa. This method increases the operating space of the main hand of the endoscope, and at the same time, the magnetic clamp is used to connect the clamps so that they can move in all directions, so as to achieve the desired traction of the tumor tissue site, fully expose the surgical field, and facilitate surgical anatomy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    magnetic anchored guidance, early gastric cancer, endoscopic submucosal dissection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    No masking required
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnetic-ESD
    Arm Type
    Experimental
    Arm Description
    Patients in MAG arm will be treated using magnetic anchored guided endoscopic submucosal dissection.
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic anchored guided endoscopic submucosal dissection
    Intervention Description
    Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa.
    Primary Outcome Measure Information:
    Title
    success rate
    Description
    The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    complications
    Description
    the complications in magnetic anchored guided endoscopic submucosal dissection
    Time Frame
    measured at the time of the end of each ESD; up to 1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy sampling Exclusion Criteria: Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases Patients without informed consent Patients with other malignant tumors
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaogang Zhang, MD
    Phone
    0086-028-85323900
    Email
    47608867@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi Lv, MD
    Organizational Affiliation
    First Affiliated Hospital Xi'an Jiaotong University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Shuixiang He, MD
    Organizational Affiliation
    First Affiliated Hospital Xi'an Jiaotong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

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