Endoscopic Submucosal Dissection Registry

Completed

• Conditions: Gastrointestinal Neoplasms; Gastric Cancer

• Registration Number: NCT01415609
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Complications and Rate of Completion	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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States