Gastric GIST
Conditions
Brief summary
This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST
Detailed description
To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited
Interventions
PROCEDUREEndoscopic Full Thickness Resection
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 and ≤ 80 2. Gastric submucosal tumors located at cardia, lesser curvature and antrum 3. Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic
Exclusion criteria
1. Patients who are considered as unfit for general anesthesia 2. ASA class ≥ IV or moribund patients 3. Pregnancy 4. Gastric submucosal tumors located at greater curvature and fundus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete resection of GIST | 30 days | Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 30 days | Adverse event as defined by presence of either postoperative bleeding or leakage after closure |
| Perioperative mortality | 30 days | Death within 30 days after procedure |
| Histolology assessment | 30 days | Histology outcome as defined by any involvement of the tumor margins after resection |
| Hospital stay | 30 days | Length of stay in hospital |
| technical success in complete resection | 1 day | Technical success defined by complete endoscopic resection, closure of the defect and delivery of the specimen per orally without need of conversion to laparoscopic surgery |
Countries
China
Contacts
Primary ContactPhilip Wai Yan Y Chiu, MD, FRCSEd
Backup ContactMan Yee Yung
Outcome results
None listed