Endoscopic Submucosal Dissection Registry (ESD Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415609
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : November 9, 2012
Information provided by:
Mayo Clinic

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.

Condition or disease
Gastrointestinal Neoplasms Gastric Cancer

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia
Study Start Date : August 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Primary Outcome Measures :
  1. Ease of use of the overall procedure and Time of procedure. [ Time Frame: 1 Year ]
    • 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.

Secondary Outcome Measures :
  1. Complications and Rate of Completion [ Time Frame: 1 Year ]
    • Minor and Major Bleeding
    • Minor and Major perforation
    • Post-polypectomy syndrome (defined as the presence of moderate or severe pain persisting more than 2 hours following completion of the procedure).
    • Other(any other adverse event which the investigator feels is potentially attributable to the procedure).
    • Enbloc resection of all endoscopically visible neoplasia
    • Pathologically negative for lateral and/or deep margins
    • Absence of residual neoplasia confirmed by repeat standard colonscopy and biopsy of ESD site 3-6 months following the index procedure.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for endoscopic treatment of 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415609

United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida

Responsible Party: Michael B Wallace, MD, MPH, Mayo Clinic Florida Identifier: NCT01415609     History of Changes
Other Study ID Numbers: 10-000160
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Mayo Clinic:
Gastrointestinal neoplasia
Submucosal resection

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases