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NCT01033695 Clinical Trial

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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01033695
Other study ID # 12-2009
Secondary ID
Status Completed
Phase N/A
First received December 15, 2009
Last updated December 15, 2009
Start date January 2008
Est. completion date June 2009

Study information
Verified date August 2009
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Centre for Surgical Ultrasound Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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