Clinical Trial: Tissue Characterisation by Endoscopic GI-elastography

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Haukeland University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Malignant or benign lesion [ Time Frame: Jan 2007 - September 2011 + 6 months( if no tissue sample) ]

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.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: April 26, 2010
Date Started: January 2007
Date Completion:
Last Updated: September 4, 2012
Last Verified: September 2012