CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Elastography, contrast enhancementother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02459041
NCT02459041N/ACompleted
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Real-time Semi-quantification of Endoscopic Ultrasound Elastography and Contrast-enhancement Using Strain Histograms (SH) and Contrast-enhancement (CE) for the Differentiation of Focal Pancreatic Masses and the Assessment of Lymph Node Involvement

University of Medicine and Pharmacy Craiova·observational·Posted Jun 1, 2015·Updated Jan 17, 2018

In Brief

An observational study evaluating Elastography, contrast enhancement for Pancreatic Cancer and 3 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer, Secondary Malignant Neoplasm of Lymph Node, Benign Neoplasm of Lymph Nodes, Benign Pancreatic Tumors
CountriesRomania
CollaboratorsInstitut Paoli-Calmettes, Caritas-Krankenhaus Bad Mergentheim, San Raffaele University Hospital, Italy, Tel-Aviv Sourasky Medical Center, University of Santiago de Compostela, Shengjing Hospital

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 1, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.1 years ago

Interventions

Elastography, contrast enhancementother

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.