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Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer

This study is currently recruiting participants.
Verified February 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01471249
First received: November 10, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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: Time Perspective: Prospective
Official Title: Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer (CT0023)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471249

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Vicky Thiffault, RN, CCRP     514-890-8000 ext 23432     vicky.thiffault.chum@ssss.gouv.qc.ca    
Principal Investigator: Moishe Liberman, MD, PhD            
Sub-Investigator: Pascal Ferraro, MD            
Sub-Investigator: André Duranceau, MD            
Sub-Investigator: Jocelyne Martin, MD            
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

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01471249     History of Changes
Other Study ID Numbers: CE 11.039
Study First Received: November 10, 2011
Last Updated: February 26, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 23, 2013