Status:
COMPLETED
Endoscopic Submucosal Dissection Registry
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Olympus
Conditions:
Gastrointestinal Neoplasms
Gastric Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.
Eligibility Criteria
Inclusion
- Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures:
- Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification)
- Flat depressed lesion \< 2cm in size (llc by Paris Classification)
- Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound
- Upon resection, the criteria for curative ESD include:
- Non-invasive neoplasia of differentiated carcinoma
- No lymphovascular invasion
- Intramucosal cancer or minute submucosal cancer \<1 mm invasion (sm1)
- Negative deep and lateral margins.
Exclusion
- Use of antiplatelet(e.g. clopidrogel) or anticoagulation (e.g. Coumadin) agents that cannot be withheld for at least 7 days prior to the procedure. Aspirin use is accepted according to the American Society for Gastrointestinal Endoscopy for these procedures.
- Patients who refuse or who are unable to consent.
- Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
- Lesion location in a segment of the colon not conducive to ESD, including significant narrowing, tortuosity and/or extensive diverticular disease, as determined by the endoscopist.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01415609
Start Date
August 1 2010
End Date
March 1 2012
Last Update
November 9 2012
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224