Evaluation of Polyflex Stenting in Esophageal Cancer Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00727376

Enrollment

Registered

2008-08-04

Start date

2008-03-31

Completion date

2011-02-28

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

esophageal, stenting

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results