Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes, Secondary Malignant Neoplasm of Lymph Node
Conditions
Keywords
elastography, strain ratio, pancreas, GI wall lesions, lymph nodes
Brief 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.
Interventions
None listed
Sponsors
University of Bergen
Haukeland University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Solid focal lesions in pancreas or pancreatitis * Intramural lesions in esophagus, ventricle or duodenum * Lymph nodes or tumour \> 1 cm in mediastinum or retroperitoneum accessible by EUS
Exclusion criteria
* Cystic pancreatic lesions * Patients where the histology or cytology of the lesion in question is known at the time of examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malignant or benign lesion | Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years) | Imaged lesions are sampled, surgically removed or followed up \> 6 months to conclude on their nature. Images are evaluated, measured and categorised shortly after examination and compared to histological, cytological or follow up result. Elastography results do not interfere with surgical or oncological treatment planning in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of lesion elasticity | 2007- September 2011 (4 years) | To identify softer and harder areas within and adjacent to focal lesions which could identify smooth surface, necrotic centre, regional fibrosis or regional cacncer. |
| Value of Strain Ratio measurements | 2007 - September 2011 (4 years) | Strain ratio provides opportunity to compare strain in user selected areas of the elastogram. This is a semi-quantification of strain differences and may be useful for a better distinction between malignant ond non-malignant lesions. |
| Value of colour and pattern category | 2007 - September 2011 (4 years) | Categorisation of images of lesions using a published categorising scheme and comparision to cytology, histology or follow up. |
| Value of a Visual Analog Scale for strain image categorisation | 2007 - September 2011 (4 years) | Evaluation of the use of a simple 100 mm Visual analog scale to classify if lesion appears softer, equal to or harder than the surrounding tissue is useful for creating semiquantitative cut-off levels between malignant and benign lesions. |
Countries
Norway
Outcome results
None listed