Evaluation of Polyflex Stenting in Esophageal Cancer Patients

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation

Time frame: 8 - 10 weeks

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Aug 4, 2008
Registry last updated: Aug 3, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed