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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033695
First Posted: December 16, 2009
Last Update Posted: December 16, 2009
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:
Odense University Hospital
  Purpose

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
Lymph Nodes Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 74
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for EUS examination on the basis of a malignant indication.
Criteria

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
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): NCT01033695


Locations
Denmark
Centre for Surgical Ultrasound
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Michael H. Larsen, MD
  More Information

Responsible Party: Michael Bau Mortensen, Centre of Surgical Ultrasound
ClinicalTrials.gov Identifier: NCT01033695     History of Changes
Other Study ID Numbers: 12-2009
First Submitted: December 15, 2009
First Posted: December 16, 2009
Last Update Posted: December 16, 2009
Last Verified: August 2009

Keywords provided by Odense University Hospital:
Endoscopy
Endoscopic Ultrasound
Endoscopic Sonoelastography
Cancer
Interobserver agreement

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Liver Diseases