NCT03471273UnknownNot Applicable
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric
Nanfang Hospital, Southern Medical University1 site in 1 country900 target enrollmentStarted: September 18, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- recur or not in 2 years after endoscopic surgical procedure or surgery
Study Overview
Brief Summary
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-70 years old Chinese;
- •Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
- •Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
Exclusion Criteria
- •Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
- •Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
- •gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
- •The investigator considers that it is not suitable for this test.
Arms & Interventions
surgery
Other
Intervention: endoscopic management, surgery and follow up (Procedure)
endoscopic management
Other
Intervention: endoscopic management, surgery and follow up (Procedure)
follow up
Other
Intervention: endoscopic management, surgery and follow up (Procedure)
Outcomes
Primary Outcomes
recur or not in 2 years after endoscopic surgical procedure or surgery
Time Frame: 2 years after endoscopic surgical procedure or surgery
Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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