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Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01033695
Collaborator
(none)
74
Enrollment
1
Location
17
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.

The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Prospective
    Official Title:
    Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2009
    Actual Study Completion Date :
    Jun 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination
      Exclusion Criteria:
      • inadequate ES images were obtained by one of the observers

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Centre for Surgical Ultrasound Odense Denmark 5000

      Sponsors and Collaborators

      • Odense University Hospital

      Investigators

      • Principal Investigator: Michael H. Larsen, MD,

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01033695
      Other Study ID Numbers:
      • 12-2009
      First Posted:
      Dec 16, 2009
      Last Update Posted:
      Dec 16, 2009
      Last Verified:
      Aug 1, 2009
      Keywords provided by , ,
      Endoscopy
      Endoscopic Ultrasound
      Endoscopic Sonoelastography
      Cancer
      Interobserver agreement

      Study Results

      No Results Posted as of Dec 16, 2009