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.
Study Type
OBSERVATIONAL
Enrollment
4,000
Interventional Endoscopy Services
San Francisco, California, United States
Technical success.
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.
Time frame: 1 day to 3 months
Short term recurrence rate
Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site
Time frame: Less than 1 year
Long term recurrence rate
Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site
Time frame: Greater than 1 year
Adverse event rate
Adverse events include infection, bleeding, perforation and death.
Time frame: up to 1 month post procedure.
Endoscopic en bloc resection rate
Resection in 1 piece without fragmentation, along or extrinsic to the diathermic markings placed around the perimeter of the lesion before resection, without remnant abnormal tissue visible on HD white-light imaging or NBI
Time frame: Immediate
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