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This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Full Thickness Resection | Experimental | Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Full Thickness Resection | Procedure | Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection of GIST | Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Adverse event as defined by presence of either postoperative bleeding or leakage after closure | 30 days |
| Perioperative mortality | Death within 30 days after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Wai Yan Y Chiu, MD, FRCSEd | Contact | +85235053952 | philipchiu@surgery.cuhk.edu.hk | |
| Man Yee Yung | Contact | +35052956 | myyung@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Philip Wai Yan Chiu, MD, FRCSEd | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong | Recruiting | Hong Kong | Outside of US & Canada | 00000 | China |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| 30 days |
| Histolology assessment | Histology outcome as defined by any involvement of the tumor margins after resection | 30 days |
| Hospital stay | Length of stay in hospital | 30 days |
| technical success in complete resection | 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 | 1 day |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |