Endoscopic Submucosal Dissection Registry

Gastric Cancer Clinical Trial

— ESD Registry  

Official title:

Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415609
• Other study ID #: 10-000160
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: November 7, 2012
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastric Cancer
• Gastrointestinal Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes