Endobronchial Ultrasound (EBUS) for Nodal Staging in Esophageal Cancer

NCT01038544 | Completed

• 1 other identifier: CE 09.146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Mediastinal lymph nodes; Staging; EBUS; EUS; Endobronchial Ultrasound; Endoscopic Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months intervals

Secondary Outcomes (3)

• The safety of all diagnostic techniques will be evaluated and compared between techniques.

  6 months

• Procedure-related morbidity

  6 months

• Change in treatment plan based on EBUS

  Study termination

Interventions

Endoscopic Ultrasound (EUS) PROCEDURE

Minimally Invasive Echo-Endoscopic Lymph Node Evaluation and Biopsy

Also known as: minimally invasive mediastinal staging

Endobronchial Ultrasound (EBUS) PROCEDURE

Minimally Invasive Echo-Bronchoscopic Lymph Node Evaluation and Biopsy

Also known as: minimally invasive mediastinal staging

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patient on Coumadin (Warfarin) or Plavix (Clopidogrel) with inability to stop medication for 5 days prior to procedure
• Anatomy precluding EBUS
• Endobronchial tumor
• Pregnancy

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• C.E.T.O.C. - CHUM Endoscopic Tracheobronchial and Oesophageal Center: collaborator
• Marcel and Rolande Gosselin Chair in Thoracic Surgical Oncology: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 22, 2012

Record last verified: 2011-11

Locations

CA (1)