Endofaster Robot for Gastroesophageal Submucosal Tumors: A Randomized Controlled Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot system, Non-robotic conventional endoscopy.
- Who it may be relevant to
- Registry conditions: Gastric Submucosal Tumors. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
Overview
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.
Interventions
- Device Robot system
After 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. - Device Non-robotic conventional endoscopy
Conventional endoscopy without Robot
Primary outcome measures
- Serosa integrity rate [Time frame: perioperative]
Secondary outcome measures (5)
- Duration of the surgical procedure [Time frame: Intraoperative]
- Dissection time [Time frame: perioperative]
- Intraoperative blood loss [Time frame: perioperative]
- Postoperative fever rate [Time frame: Within 7 days after surgery]
- Postoperative infection [Time frame: Within 30 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07655674 · 2026250