Evaluation of Polyflex Stenting in Esophageal Cancer Patients
NCT ID: NCT00727376
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2008-03-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation
Esophageal cancer patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide informed consent
* Willing to comply with follow-up requirements
* Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
* Indicated for chemotherapy and/or radiation therapy
* Ability to dilate stricture to 15mm diameter at extent of disease evaluation
* Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent
Exclusion Criteria
* Patients with prior esophageal stent placements
* Advance stage of disease, greater than T3 tumor or M1 disease
18 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Robert C. Martin
Professor
Principal Investigators
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Robert Martin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville
Louisville, Kentucky, United States
Countries
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References
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Martin RC 2nd, Cannon RM, Brown RE, Ellis SF, Williams S, Scoggins CR, Abbas AE. Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer. Oncologist. 2014 Mar;19(3):259-65. doi: 10.1634/theoncologist.2013-0344. Epub 2014 Feb 24.
Brown RE, Abbas AE, Ellis S, Williams S, Scoggins CR, McMasters KM, Martin RC 2nd. A prospective phase II evaluation of esophageal stenting for neoadjuvant therapy for esophageal cancer: optimal performance and surgical safety. J Am Coll Surg. 2011 Apr;212(4):582-8; discussion 588-9. doi: 10.1016/j.jamcollsurg.2010.12.026.
Other Identifiers
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08-0132
Identifier Type: -
Identifier Source: org_study_id
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