Endoscopic Submucosal Dissection Registry (ESD Registry)

Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms; Gastric Cancer

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for endoscopic treatment of gastrointestinal neoplasia.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use of the overall procedure and Time of procedure.	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.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications and Rate of Completion	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.	1 Year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Olympus
• Investigators: Principal Investigator: Michael B Wallace, MD,MPH, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Gastrointestinal neoplasia; Submucosal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 10-000160