Endoscopic Submucosal Dissection Registry (ESD Registry)

Mayo Clinic

Status: Completed

Conditions: Gastric Cancer; Gastrointestinal Neoplasms

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01415609

10-000160

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures:

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.