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Tissue Characterisation by Endoscopic GI-elastography

This study has been completed.
University of Bergen
Information provided by (Responsible Party):
Roald Flesland Havre, Haukeland University Hospital Identifier:
First received: April 26, 2010
Last updated: September 4, 2012
Last verified: September 2012
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions

Resource links provided by NLM:

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
Tissue samples are stored as pathological slides in the diognostic biobank of Dep. of Pathology, Helse Bergen.

Enrollment: 137
Study Start Date: January 2007
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Pancreatic lesions

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.
Lymph nodes
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.

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients referred to EUS examination or relevant surgery at Haukeland University Hospital, bergen, Norway within the inclusion period (2007- January 2011).

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01360411

Haukeland University Hospital/University of Bergen
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Study Director: Lars Birger Nesje, MD, PhD University of Bergen
Principal Investigator: Roald F. Havre, MD University of Bergen
  More Information


Responsible Party: Roald Flesland Havre, MD, Haukeland University Hospital Identifier: NCT01360411     History of Changes
Other Study ID Numbers: 17765
Study First Received: April 26, 2010
Last Updated: September 4, 2012

Keywords provided by Haukeland University Hospital:
strain ratio
GI wall lesions
lymph nodes

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on April 28, 2017