Endoscopic Submucosal Dissection Registry (ESD Registry)
This study has been completed.
Information provided by:
First received: August 10, 2011
Last updated: November 7, 2012
Last verified: November 2012
The purpose of this study is to monitor the success rates and completion rates for endoscopic submucosal dissection (ESD) for gastrointestinal (GI) cancers.
|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.
|Study Start Date:||August 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415609
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
Sponsors and Collaborators
|Principal Investigator:||Michael B Wallace, MD,MPH||Mayo Clinic Florida|