Tissue Characterisation by Endoscopic GI-elastography

NCT01360411 | Completed

• 1 other identifier: 17765
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Description of lesion elasticity

  2007- September 2011 (4 years)

• Value of Strain Ratio measurements

  2007 - September 2011 (4 years)

• Value of colour and pattern category

  2007 - September 2011 (4 years)

• Value of a Visual Analog Scale for strain image categorisation

  2007 - September 2011 (4 years)

Study Arms (3)

Pancreatic lesions

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

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

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Cystic pancreatic lesions
• Patients where the histology or cytology of the lesion in question is known at the time of examination

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital/University of Bergen

Bergen, 5021, Norway

Location

Related Publications (5)

• 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.

  PMID: 21040360 BACKGROUND

• 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.

  PMID: 18524458 BACKGROUND

• 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.

  PMID: 21437851 BACKGROUND

• 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.

  PMID: 21667433 BACKGROUND

• 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.

  PMID: 21963957 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples are stored as pathological slides in the diognostic biobank of Dep. of Pathology, Helse Bergen.

MeSH Terms

Conditions

Neoplasm Metastasis; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Birger Nesje, MD, PhD

  University of Bergen

  STUDY DIRECTOR

• Roald F. Havre, MD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 25, 2011
• Study Start: January 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

NO (1)