Status:
COMPLETED
Evaluation of Polyflex Stenting in Esophageal Cancer Patients
Lead Sponsor:
University of Louisville
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
Eligibility Criteria
Inclusion
- 18 years of age and older
- 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
- Patients contraindicated for endoscopy
- Patients with prior esophageal stent placements
- Advance stage of disease, greater than T3 tumor or M1 disease
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00727376
Start Date
March 1 2008
End Date
February 1 2011
Last Update
August 3 2020
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202