Evaluation of Polyflex Stenting in Esophageal Cancer Patients

University of Louisville (UOFL)

Status: Completed

Conditions: Esophageal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00727376

08-0132

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

26 participants in 1 patient group

Observation

Description:

Esophageal cancer patients