Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions
18 Years
90 Years
Both
Disorder of Upper Gastrointestinal Tract, Pancreatic Nodule, Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes, Secondary Malignant Neoplasm of Lymph Node
Trial Information
Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Malignant or benign lesion
Outcome Description:
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.
Outcome Time Frame:
Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)
Safety Issue:
No
Principal Investigator
Lars Birger Nesje, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
University of Bergen
Authority:
Norway: Norwegian Social Science Data Services
Study ID:
17765
NCT ID:
NCT01360411
Start Date:
January 2007
Completion Date:
July 2012
Related Keywords:
- Disorder of Upper Gastrointestinal Tract
- Pancreatic Nodule
- Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes
- Secondary Malignant Neoplasm of Lymph Node
- elastography
- strain ratio
- pancreas
- GI wall lesions
- lymph nodes
- Neoplasms
- Neoplasms, Second Primary
- Pancreatic Neoplasms
- Lymphoma
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