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Endoscopic Submucosal Dissection Registry

NCT ID: NCT01415609

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.

Detailed Description

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Conditions

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Gastrointestinal Neoplasms Gastric Cancer

Keywords

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Gastrointestinal neoplasia Submucosal resection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification)
2. Flat depressed lesion \< 2cm in size (llc by Paris Classification)
3. Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound
4. 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 Criteria

1. 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.
2. Patients who refuse or who are unable to consent.
3. Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
4. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic Florida

Principal Investigators

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Michael B Wallace, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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10-000160

Identifier Type: -

Identifier Source: org_study_id