Evaluation of Polyflex Stenting in Esophageal Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00727376
First received: July 30, 2008
Last updated: August 4, 2011
Last verified: January 2010
  Purpose

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


Condition
Esophageal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation [ Time Frame: 8 - 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Esophageal cancer patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Esophageal cancer patients who have elected to have a stent placed.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727376

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Robert Martin, MD University of Louisville
  More Information

No publications provided by University of Louisville

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Martin, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00727376     History of Changes
Other Study ID Numbers: 08-0132
Study First Received: July 30, 2008
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
esophageal
stenting

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 14, 2014