Tissue Characterisation by Endoscopic GI-elastography

Haukeland University Hospital

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01360411

17765

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

137 participants in 3 patient groups

Pancreatic lesions

Description:

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

Description:

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

Description:

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.