About this trial
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 80 years old;
Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
Tumor diameter ranging from 1.0 cm to 3.0 cm;
No active ulcer or bleeding on the lesion surface before operation;
Disqualifiers
Tumor adhesion to serosa with unclear interface shown on EUS;
High-risk GIST or distant metastasis indicated by imaging or endoscopy;
History of gastric surgery or radiotherapy;
High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
Trial design
Parallel
Treatments tested in this trial
Robot system
DeviceAfter Marking and mucosal incision,Grasp the tumor or its pedicle with the robotic flexible arm, apply continuous and steady traction toward the luminal side to dynamically expose the anatomical space between the tumor capsule and normal muscular layer.
Non-robotic conventional endoscopy
DeviceConventional endoscopy without Robot
Treatment groups
Trial outcomes
Primary outcomes
Serosa integrity rate
En bloc resection rate with serosa preserved
Secondary outcomes
Duration of the surgical procedure
Total duration of the surgical procedure
Dissection time
Dissection time of tumor
Intraoperative blood loss
Intraoperative blood loss during surgury
Postoperative fever rate
Postoperative fever is defined as a body temperature ≥ 37.5 ℃ within 7 days after surgery. All febrile cases during this period are included, including non-infectious absorption fever.
Locations
Sponsors and contacts
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