Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
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|ClinicalTrials.gov Identifier: NCT01750619|
Recruitment Status : Recruiting
First Posted : December 17, 2012
Last Update Posted : December 20, 2017
|Condition or disease|
|Gastrointestinal Neoplasms Benign Neoplasm of Intestinal Tract|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Mucosal tumors of the colon
Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon.
Nonampullary tumors of the duodenum
Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum.
Patients who received endoscopic treatment for noninvasive ampullary tumors.
- 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.
- Short term recurrence rate [ Time Frame: Less than 1 year ]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 [ Time Frame: Greater than 1 year ]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 [ Time Frame: up to 1 month post procedure. ]Adverse events include infection, bleeding, perforation and death.
- Endoscopic en bloc resection rate [ Time Frame: Immediate ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750619
|Contact: Jona Calitis||415-600-1151|
|United States, California|
|Interventional Endoscopy Services||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Jona Calitis CalitiJ@sutterhealth.org|
|Principal Investigator:||Kenneth F Binmoeller, M.D.||California Pacific Medical Center|