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

March 27, 2020 updated by: First Affiliated Hospital Xi'an Jiaotong University

Prospective Clinical Trial of Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaogang Zhang, MD
  • Phone Number: 0086-028-85323900
  • Email: 47608867@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic-ESD
Patients in MAG arm will be treated using magnetic anchored guided endoscopic submucosal dissection.
Procedure: Magnetic anchored guided endoscopic submucosal dissection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate
Time Frame: through study completion, an average of 1 year
The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: measured at the time of the end of each ESD; up to 1 hour
the complications in magnetic anchored guided endoscopic submucosal dissection
measured at the time of the end of each ESD; up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Yi Lv, MD, First Affiliated Hospital Xi'an Jiaotong University
  • Principal Investigator: Shuixiang He, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJYFY-2017ZD1-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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