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
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
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
NCT ID
NCT04327050
First Posted
March 26, 2020
Last Updated
March 27, 2020
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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
We'll reach out to this number within 24 hrs