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Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471249
First Posted: November 15, 2011
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
  Purpose

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.


Condition
Esophageal Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer (CT0023)

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • improvement of dysphagia post stenting [ Time Frame: 3 months ]
    To assess the effectiveness of esophageal stenting in improving malignant dysphagia and assess the time period relating to this improvement


Secondary Outcome Measures:
  • Quality of life post stenting [ Time Frame: 3 months ]
    To assess the effectiveness of esophageal stenting in improving quality of life and assess the time period relating to this improvement


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients referred to the thoracic clinic or in-patient
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471249


Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Moishe Liberman, MD, PhD CHUM-Centre Universitaire de Montreal
  More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01471249     History of Changes
Other Study ID Numbers: CE 11.039
First Submitted: November 10, 2011
First Posted: November 15, 2011
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
esophageal stenting
palliative
dysphagia

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