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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04327050
Other study ID # XJYFY-2017ZD1-09
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date April 30, 2021

Study information

Verified date March 2020
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Xiaogang Zhang, MD
Phone 0086-028-85323900
Email 47608867@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 complications the complications in magnetic anchored guided endoscopic submucosal dissection measured at the time of the end of each ESD; up to 1 hour
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