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Endoscopic Submucosal Dissection Registry (ESD Registry)

This study has been completed.
Sponsor:
Collaborator:
Olympus
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01415609
First received: August 10, 2011
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Gastrointestinal Neoplasms
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ease of use of the overall procedure and Time of procedure. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    • 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:
  • Complications and Rate of Completion [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 17
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred for endoscopic treatment of gastrointestinal neoplasia.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415609

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Olympus
Investigators
Principal Investigator: Michael B Wallace, MD,MPH Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Michael B Wallace, MD, MPH, Mayo Clinic Florida
ClinicalTrials.gov Identifier: NCT01415609     History of Changes
Other Study ID Numbers: 10-000160
Study First Received: August 10, 2011
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Gastrointestinal neoplasia
Submucosal resection

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

ClinicalTrials.gov processed this record on May 23, 2013