Know Cancer

forgot password

Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

18 Years
Not Enrolling
Gastrointestinal Neoplasms, Gastric Cancer

Thank you

Trial Information

Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Ease of use of the overall procedure and Time of procedure.

Outcome Description:

Ease of use of overall procedure as rated on a 5-point visual analog scale for very easy, easy, neutral, difficult and very difficult. Time (in minutes) needed to resect the lesion completely, as measured from the first injection to final excision of the lesion.

Outcome Time Frame:

1 Year

Safety Issue:


Principal Investigator

Michael B Wallace, MD,MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic Florida


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

March 2012

Related Keywords:

  • Gastrointestinal Neoplasms
  • Gastric Cancer
  • Gastrointestinal neoplasia
  • Submucosal resection
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Stomach Neoplasms



Mayo Clinic Florida Jacksonville, Florida  32224