Trials / Completed

CompletedNCT01360411

Tissue Characterisation by Endoscopic GI-elastography

Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions

Status: Completed
Phase: —
Study type: Observational
Enrollment: 137 (actual)

Sponsor: Haukeland University Hospital · Academic / Other
Sex: All
Age: 18 Years – 90 Years
Healthy volunteers: Not accepted

Summary

In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.

Detailed description

The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based elastography to identify strain traits separating malignant from benign lesions. We are registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS + elastography with previous data on EUS alone. Inclusion criteria: * Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall discovered by endoscopy or other imaging modality. * Group 2: Pancreatic lesion discovered by other imaging modality. * Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging modality. Histology of lesions should not be known at the time of examination. EUS elastography findings are evaluated shortly after the examination and categorised by different methods; categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology results. Patients who do not undergo tissue sampling are followed up to discover disease progress.

Conditions

Timeline

Start date: 2007-01-01
Primary completion: 2012-06-01
Completion: 2012-07-01
First posted: 2011-05-25
Last updated: 2012-09-05

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01360411. Inclusion in this directory is not an endorsement.