Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer

NCT01471249 | Terminated

• 1 other identifier: CE 11.039
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of a prospective clinical trial which aims to evaluate the impact of stent insertion for palliation of malignant dysphagia. The main goal being to examine the number of days required following stenting in order to have significant improvement in dysphagia and the length of time that this baseline is maintained. Approximately 100 patients will be prospectively enrolled in this study. Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertion will be prospectively enrolled into the study. Patients with esophageal obstruction or stricture due to other benign causes, tumors obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from the study. The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to improve malignant dysphagia as a main factor affecting the quality of life in these patients.

Conditions

Esophageal Cancer

Keywords

esophageal stenting; palliative; dysphagia

Outcome Measures

Primary Outcomes (1)

• improvement of dysphagia post stenting

  To assess the effectiveness of esophageal stenting in improving malignant dysphagia and assess the time period relating to this improvement

  3 months

Secondary Outcomes (1)

• Quality of life post stenting

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients referred to the thoracic clinic or in-patient

You may qualify if:

• All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions.

You may not qualify if:

• Inability to consent for the study.
• Patients less than 18 years old.
• Patients with other benign causes of dysphagia and esophageal obstruction or stenosis.
• Patients with malignant or benign airway - esophageal fistulas.
• Patients with cervical esophageal cancer

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Moishe Liberman, MD, PhD

  CHUM-Centre Universitaire de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: June 1, 2011
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

CA (1)