NCT07655674Not yet recruitingNot Applicable
Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
The First Affiliated Hospital of Soochow University0 sites110 target enrollmentStarted: July 1, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 110
Study Overview
Brief Summary
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?
Detailed Description
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •American Society of Anesthesiologists (ASA) physical status class I-III;
- •Voluntarily signed written informed consent.
Exclusion Criteria
- •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;
- •Pregnant or breastfeeding women;
- •Failure to cooperate with follow-up.
Investigators
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