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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01033695
First received: December 15, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Bau Mortensen, Centre of Surgical Ultrasound
ClinicalTrials.gov Identifier: NCT01033695     History of Changes
Other Study ID Numbers: 12-2009
Study First Received: December 15, 2009
Last Updated: December 15, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 18, 2013