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Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer (CT0003)

This study has been completed.
Sponsor:
Collaborators:
C.E.T.O.C. - CHUM Endoscopic Tracheobronchial and Oesophageal Center
Marcel and Rolande Gosselin Chair in Thoracic Surgical Oncology
Fonds de la Recherche en Santé du Québec
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01038544
First received: December 22, 2009
Last updated: June 20, 2012
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is determine if performing endobronchial ultrasound (EBUS) in addition to standard endoscopic ultrasound (EUS) can increase the precision and accuracy of staging esophageal cancer in comparison to EUS alone. The expectation is that EBUS can be used to biopsy lymph nodes that: (1) because of their position in the mediastinum would be inaccessible to EUS, or (2) would be inaccessible due to their position behind the esophageal tumor.


Condition Intervention
Esophageal Cancer
 Procedure: Endoscopic Ultrasound (EUS)
Procedure: Endobronchial Ultrasound (EBUS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer

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:
  • The primary outcome measure will be the accuracy of the combination of EUS and EBUS to correctly diagnose the presence or absence of mediastinal lymph node metastases compared to EUS alone. [ Time Frame: 6 months intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of all diagnostic techniques will be evaluated and compared between techniques. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Procedure-related morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change in treatment plan based on EBUS [ Time Frame: Study termination ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Endoscopic Ultrasound (EUS)
    Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy
    Other Name: minimally invasive mediastinal staging
    Procedure: Endobronchial Ultrasound (EBUS)
    Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy
    Other Name: minimally invasive mediastinal staging
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven esophageal cancer
  • Endoluminal esophageal mass without previous biopsy
  • Medical suitability for endoscopic procedure
  • Ability to consent

Exclusion Criteria:

  • Patient on Coumadin (Warfarin) or Plavix (Clopidogrel) with inability to stop medication for 5 days prior to procedure
  • Anatomy precluding EBUS
  • Endobronchial tumor
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038544

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)
C.E.T.O.C. - CHUM Endoscopic Tracheobronchial and Oesophageal Center
Marcel and Rolande Gosselin Chair in Thoracic Surgical Oncology
Fonds de la Recherche en Santé du Québec
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01038544     History of Changes
Other Study ID Numbers: CE 09.146
Study First Received: December 22, 2009
Last Updated: June 20, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Esophageal Cancer
Mediastinal lymph nodes
Staging
EBUS
 EUS
Endobronchial Ultrasound
Endoscopic Ultrasound

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

ClinicalTrials.gov processed this record on May 21, 2013