Gastrointestinal Neoplasms Clinical Trial
Official title:
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
NCT number | NCT01750619 |
Other study ID # | 2011.090 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Interventional Endoscopy Services | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
California Pacific Medical Center Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 day to 3 months | |
Secondary | 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 | Less than 1 year | |
Secondary | 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 | Greater than 1 year | |
Secondary | Adverse event rate | Adverse events include infection, bleeding, perforation and death. | up to 1 month post procedure. | |
Secondary | 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 | Immediate |
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