Clinical trial NCT04327050: Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner
Official title: Prospective Clinical Trial of Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: magnetic anchored guidance
early gastric cancer
endoscopic submucosal dissection
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: success rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: complications
timeFrame: measured at the time of the end of each ESD; up to 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yi Lv, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Shuixiang He, MD
role: PRINCIPAL_INVESTIGATOR
References: