Endoscopic Submucosal Dissection Regist… | Clinical Trial

Key information

Conditions

Gastrointestinal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients referred for endoscopic treatment of advanced gastrointestinal (colorectal, gastric, duodenal, esophagus) neoplasia, defined by any of the following procedures:

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Olympus

Registry information

Official study title

Establishment of Registry for Endoscopic Submucosal Dissection for Superficial Gastrointestinal Neoplasia

Acronym: ESD Registry

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 12, 2011
Registry last updated: Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed