Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions
1 other identifier
observational
8,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
March 23, 2026
March 1, 2026
19.4 years
December 12, 2012
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (3)
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.
Ampullary tumors
Patients who received endoscopic treatment for noninvasive ampullary tumors.
Eligibility Criteria
Patients referred to Interventional Endoscopy Services at CPMC for treatment of GI tract tumors.
You may qualify if:
- Patients age \>18 years that have been referred for endoscopic treatment of GI lesions.
You may not qualify if:
- Patients for whom endoscopic treatment was not performed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Interventional Endoscopy Services
San Francisco, California, 94115, United States
Related Publications (2)
Binmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD. Underwater EMR of adenomas of the appendiceal orifice (with video). Gastrointest Endosc. 2016 Mar;83(3):638-42. doi: 10.1016/j.gie.2015.08.079. Epub 2015 Sep 14.
PMID: 26375437DERIVEDBinmoeller KF, Hamerski CM, Shah JN, Bhat YM, Kane SD, Garcia-Kennedy R. Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video). Gastrointest Endosc. 2015 Mar;81(3):713-8. doi: 10.1016/j.gie.2014.10.044.
PMID: 25708759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth F Binmoeller, M.D.
California Pacific Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Interventional Endoscopy Services Program Director
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 17, 2012
Study Start
July 1, 2011
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
March 23, 2026
Record last verified: 2026-03