Endoscopic Submucosal Dissection Registry

NCT01415609 | Completed

• 1 other identifier: 10-000160
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasms; Gastric Cancer

Keywords

Gastrointestinal neoplasia; Submucosal resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications and Rate of Completion

  1 Year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for endoscopic treatment of gastrointestinal neoplasia.

You may qualify if:

• Flat dysplastic lesion greater than 2cm(IIa or IIb by Paris classification)
• Flat depressed lesion \< 2cm in size (llc by Paris Classification)
• Ulcerated lesion \< 2cm (Paris type lll) staged as T1N0 on endoscopic ultrasound
• 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.

You may not qualify if:

• 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.
• Patients who refuse or who are unable to consent.
• Suboptimal colon prep, or solid gastric residual that precludes safe lesion resection at the time of endoscopy.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Olympus: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Michael B Wallace, MD,MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

US (1)