Tissue Characterisation by Endoscopic GI-elastography

Secondary Malignant Neoplasm of Lymph Node Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360411
• Other study ID #: 17765
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: September 4, 2012
• Start date: January 2007
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disorder of Upper Gastrointestinal Tract
• Lymphoma
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Pancreatic Nodule
• Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes
• Secondary Malignant Neoplasm of Lymph Node

Locations

Country	Name	City	State
Norway	Haukeland University Hospital/University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Havre RF, Elde E, Gilja OH, Odegaard S, Eide GE, Matre K, Nesje LB. Freehand real-time elastography: impact of scanning parameters on image quality and in vitro intra- and interobserver validations. Ultrasound Med Biol. 2008 Oct;34(10):1638-50. doi: 10.1016/j.ultrasmedbio.2008.03.009. Epub 2008 Jun 4. — View Citation

Havre RF, Waage JR, Gilja OH, Odegaard S, Nesje LB. Real-Time Elastography: Strain Ratio Measurements Are Influenced by the Position of the Reference Area. Ultraschall Med. 2011 Jun 10. [Epub ahead of print] — View Citation

Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24. — View Citation

Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an ar — View Citation

Waage JE, Havre RF, Odegaard S, Leh S, Eide GE, Baatrup G. Endorectal elastography in the evaluation of rectal tumours. Colorectal Dis. 2011 Oct;13(10):1130-7. doi: 10.1111/j.1463-1318.2010.02440.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malignant or benign lesion	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.	Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)	No
Secondary	Description of lesion elasticity	To identify softer and harder areas within and adjacent to focal lesions which could identify smooth surface, necrotic centre, regional fibrosis or regional cacncer.	2007- September 2011 (4 years)	No
Secondary	Value of Strain Ratio measurements	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.	2007 - September 2011 (4 years)	No
Secondary	Value of colour and pattern category	Categorisation of images of lesions using a published categorising scheme and comparision to cytology, histology or follow up.	2007 - September 2011 (4 years)	No
Secondary	Value of a Visual Analog Scale for strain image categorisation	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.	2007 - September 2011 (4 years)	No