Tissue Characterisation by Endoscopic GI-elastography

Study Overview
=================
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.

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

Conditions
-----------------
Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes, Secondary Malignant Neoplasm of Lymph Node

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic lesions<br>Any patient with a solid pancreatic lesion of unknown histology may be recruited. Cystic lesions are not included. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. | |
| Intramural upper GI-lesions<br>Patients with intramural lesions discovered by endoscopy or other imaging modalities are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. | |
| Lymph nodes<br>Patients with visible mediastinal lymph nodes or retroperitoneal lymph nodes in patients with inflammatory or malignant diseases are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malignant or benign lesion | 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. | Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of lesion elasticity | To identify softer and harder areas within and adjacent to focal lesions which could identify smooth surface, necrotic centre, regional fibrosis or regional cacncer. | 2007- September 2011 (4 years) | 
| Value of Strain Ratio measurements | 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. | 2007 - September 2011 (4 years) | 
| Value of colour and pattern category | Categorisation of images of lesions using a published categorising scheme and comparision to cytology, histology or follow up. | 2007 - September 2011 (4 years) | 
| Value of a Visual Analog Scale for strain image categorisation | 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. | 2007 - September 2011 (4 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elastography, strain ratio, pancreas, GI wall lesions, lymph nodes