Evaluation of Polyflex Stenting in Esophageal Cancer Patients

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT00727376
• Lead Sponsor: University of Louisville

Brief Summary

To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2018-03
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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 Criteria

• Patients contraindicated for endoscopy
• Patients with prior esophageal stent placements
• Advance stage of disease, greater than T3 tumor or M1 disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation	8 - 10 weeks

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States