Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Neoplasms
- Sponsor
- California Pacific Medical Center Research Institute
- Enrollment
- 8000
- Locations
- 1
- Primary Endpoint
- Technical success.
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.
Investigators
Kenneth Binmoeller
Interventional Endoscopy Services Program Director
California Pacific Medical Center Research Institute
Eligibility Criteria
Inclusion Criteria
- •Patients age \>18 years that have been referred for endoscopic treatment of GI lesions.
Exclusion Criteria
- •Patients for whom endoscopic treatment was not performed.
Outcomes
Primary Outcomes
Technical success.
Time Frame: 1 day to 3 months
Technical success is defined as complete resection confirmed by the endoscopic absence of adenomatous tissue after inspection with high-definition white light and narrow-band imaging.
Secondary Outcomes
- Short term recurrence rate(Less than 1 year)
- Long term recurrence rate(Greater than 1 year)
- Adverse event rate(up to 1 month post procedure.)
- Endoscopic en bloc resection rate(Immediate)