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NCT Number: NCT01360411

Tissue Characterisation by Endoscopic GI-elastography

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.

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Key information

Conditions

Disorder of Upper Gastrointestinal Tract Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pancreatic Nodule Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Malignant Neoplasm of Lymph Node Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital/University of Bergen

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
May 25, 2011
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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