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

NCT01033695 | Completed

• 1 other identifier: 12-2009
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymph Nodes; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer

Keywords

Endoscopy; Endoscopic Ultrasound; Endoscopic Sonoelastography; Cancer; Interobserver agreement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for EUS examination on the basis of a malignant indication.

You may qualify if:

• the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination

You may not qualify if:

• inadequate ES images were obtained by one of the observers

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Centre for Surgical Ultrasound

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases

Study Officials

• Michael H. Larsen, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 16, 2009

Record last verified: 2009-08

Locations

DK (1)