Endoscopic Submucosal Dissection Registry (ESD Registry)
|ClinicalTrials.gov Identifier: NCT01415609|
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : November 9, 2012
|Condition or disease|
|Gastrointestinal Neoplasms Gastric Cancer|
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|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|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415609
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Michael B Wallace, MD,MPH||Mayo Clinic Florida|