Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Magnetic anchored guided endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic anchored guidance, early gastric cancer, endoscopic submucosal dissection