Clinical Impact of EUS Elastography Mean Strain Histograms (SH) and Contrast Peak-enhancement in Focal Pancreatic Masses and Lymph Nodes

Summary

The study protocol is based on a multi-center semi-quantitative approach of EUS elastography data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration, as the ROIs are still manually selected by the user. The aim of the study is to establish an EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with negative or inconclusive cytopathology after EUS-FNA, based on previously published results and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph nodes, in the setting of patients with negative EUS-FNA results.

Conditions

• Pancreatic Cancer
• Secondary Malignant Neoplasm of Lymph Node
• Benign Neoplasm of Lymph Nodes
• Benign Pancreatic Tumors

Interventions

OTHER

Elastography, contrast enhancement

Elastography is an ultrasound method used for the reconstruction of tissue elasticity distribution in real-time. The main intended use is to differentiate between benign and malignant focal lesions based on the significantly smaller strain of the latter real time. Tissue elastography can be easily performed with conventional probes, including the linear EUS probes used for the examination of the pancreas and/or lymph nodes. Contrast-enhancement Ultrasound contrast agents in conjunction with contrast specific imaging techniques are increasingly accepted in clinical use for diagnostic imaging. Pancreatic adenocarcinomas are usually hypovascular tumors.

Sponsors & Collaborators

• Institut Paoli-Calmettes

  collaborator OTHER

• Caritas-Krankenhaus Bad Mergentheim

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Tel-Aviv Sourasky Medical Center

  collaborator OTHER_GOV

• University of Santiago de Compostela

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• University of Medicine and Pharmacy Craiova

  lead OTHER

Principal Investigators

• Adrian Saftoiu, Professor · University of Medicine and Pharmacy Craiova

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• Romania

Study Locations