Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: Magnetic anchored guided endoscopic submucosal dissection

• Registration Number: NCT04327050
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30
• Study Start: 2020-05-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic-ESD	Magnetic anchored guided endoscopic submucosal dissection	Patients in MAG arm will be treated using magnetic anchored guided endoscopic submucosal dissection.

Primary Outcome Measures

Name	Time	Method
success rate	through study completion, an average of 1 year	The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection

Secondary Outcome Measures

Name	Time	Method
complications	measured at the time of the end of each ESD; up to 1 hour	the complications in magnetic anchored guided endoscopic submucosal dissection