Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Digestive System Diseases
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- The lesion result before ESD
- Last Updated
- 14 years ago
Overview
Brief Summary
Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.
Detailed Description
Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Submucosal tumor
- •Mucosal tumor (T1) in patients unsuitable for surgery
Exclusion Criteria
- •Endoscopic ultrasound (EUS) or CT signs of metastasis
- •Insufficient access to tumor
Outcomes
Primary Outcomes
The lesion result before ESD
Time Frame: within 7 days before ESD
Including the location, morphology and size under endoscopy and narrow banding image of lesion.
Short-term result after ESD
Time Frame: whithin 7 days after ESD
Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion.
Secondary Outcomes
- The safety of ESD procedure(3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD)