Gastric Submucosal Tumors
Conditions
Keywords
gastric submucosal tumors, Robotic endoscope
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.
Interventions
DEVICERobot 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.
DEVICENon-robotic conventional endoscopy
Conventional endoscopy without Robot
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 80 years old; 2. 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); 3. Tumor diameter ranging from 1.0 cm to 3.0 cm; 4. No active ulcer or bleeding on the lesion surface before operation; 5. American Society of Anesthesiologists (ASA) physical status class I-III; 6. Voluntarily signed written informed consent.
Exclusion criteria
1. Tumor adhesion to serosa with unclear interface shown on EUS; 2. High-risk GIST or distant metastasis indicated by imaging or endoscopy; 3. History of gastric surgery or radiotherapy; 4. High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications; 5. Pregnant or breastfeeding women; 6. Failure to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serosa integrity rate | perioperative | En bloc resection rate with serosa preserved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the surgical procedure | Intraoperative | Total duration of the surgical procedure |
| Dissection time | perioperative | Dissection time of tumor |
| Intraoperative blood loss | perioperative | Intraoperative blood loss during surgury |
| Postoperative fever rate | Within 7 days after surgery | 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. |
| Postoperative infection | Within 30 days after surgery | Postoperative infection is diagnosed when body temperature reaches ≥ 38.5 ℃, or temperature ≥ 38.0 ℃ persists for more than 3 consecutive days starting from postoperative day 3. Diagnosis shall be confirmed by clinical symptoms, abnormal laboratory inflammatory indicators or positive microbial culture results. Simple absorption fever is excluded. |
Contacts
CONTACTChenhuan Tan
PRINCIPAL_INVESTIGATORRui Li
The First Affiliated Hospital of Soochow University
Outcome results
None listed