Tissue Characterisation by Endoscopic GI-elastography
|ClinicalTrials.gov Identifier: NCT01360411|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : September 5, 2012
|Condition or disease|
|Disorder of Upper Gastrointestinal Tract Pancreatic Nodule Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes Secondary Malignant Neoplasm of Lymph Node|
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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||137 participants|
|Official Title:||Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
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
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.
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.
- Malignant or benign lesion [ Time Frame: 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.
- Description of lesion elasticity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360411
|Haukeland University Hospital/University of Bergen|
|Bergen, Norway, 5021|
|Study Director:||Lars Birger Nesje, MD, PhD||University of Bergen|
|Principal Investigator:||Roald F. Havre, MD||University of Bergen|