Clinical trial NCT01360411: Tissue Characterisation by Endoscopic GI-elastography
Official title: Tissue Characterisation Using Ultrasound Based Strain Imaging(Elastography)Examining Lesions in the Gastrointestinal Wall, Adjacent Lymph Nodes and Pancreatic Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Upper Gastrointestinal Tract
Pancreatic Nodule
Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes
Secondary Malignant Neoplasm of Lymph Node
Keywords: elastography
strain ratio
pancreas
GI wall lesions
lymph nodes
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2011-05-25
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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

Primary outcomes:
measure: Malignant or benign lesion
timeFrame: Jan 2007 - September 2011 + 6 months( if no tissue sample)(4 years)
Secondary outcomes:
measure: Description of lesion elasticity
timeFrame: 2007- September 2011 (4 years)
measure: Value of Strain Ratio measurements
timeFrame: 2007 - September 2011 (4 years)
measure: Value of colour and pattern category
timeFrame: 2007 - September 2011 (4 years)
measure: Value of a Visual Analog Scale for strain image categorisation
timeFrame: 2007 - September 2011 (4 years)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital/University of Bergen
Study officials:
affiliation: University of Bergen
name: Lars Birger Nesje, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen
name: Roald F. Havre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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. 2012 Dec;33(6):559-568. doi: 10.1055/s-0031-1273247. Epub 2011 Jun 10.
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 artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.