Tissue Characterisation by Endoscopic GI-elastography

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Roald Flesland Havre, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01360411
First received: April 26, 2010
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition
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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360411

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

Publications:

Responsible Party: Roald Flesland Havre, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01360411     History of Changes
Other Study ID Numbers: 17765
Study First Received: April 26, 2010
Last Updated: September 4, 2012
Health Authority: Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014