Tissue Characterisation by Endoscopic GI-elastography

Completed

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

• Registration Number: NCT01360411
• Lead Sponsor: Haukeland University Hospital

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 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malignant or benign lesion	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

Name	Time	Method
Description of lesion elasticity	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 a Visual Analog Scale for strain image categorisation	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.
Value of Strain Ratio measurements	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	2007 - September 2011 (4 years)	Categorisation of images of lesions using a published categorising scheme and comparision to cytology, histology or follow up.

Trial Locations

Locations (1)

Haukeland University Hospital/University of Bergen; 🇳🇴 Bergen, Norway