About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients age >18 years that have been referred for endoscopic treatment of GI lesions.
Disqualifiers
Patients for whom endoscopic treatment was not performed.
Trial population
Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
Adverse event rate
Adverse events include infection, bleeding, perforation and death.
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
Sponsors and contacts
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