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

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ClinicalTrials.gov Identifier: NCT02459041
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Institut Paoli-Calmettes
Caritas-Krankenhaus Bad Mergentheim
San Raffaele University Hospital, Italy
Tel-Aviv Sourasky Medical Center
University of Santiago de Compostela
Shengjing Hospital
Information provided by (Responsible Party):
University of Medicine and Pharmacy Craiova

Brief 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Secondary Malignant Neoplasm of Lymph Node Benign Neoplasm of Lymph Nodes Benign Pancreatic Tumors Other: Elastography, contrast enhancement

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreatic cancer

Consecutively admitted patients with pancreatic cancer confirmed by EUS-guided FNA.

EG-EUS and CE-EUS will be applied in all patients.

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.


Benign pancreatic masses

Consecutively admitted patients with benign pancreatic masses with negative EUS-guided FNA.

EG-EUS and CE-EUS will be applied in all patients.

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.


Malignant lymph nodes

Consecutively admitted patients with malignant lymphnodes confirmed by EUS-guided FNA.

EG-EUS will be applied in all patients.

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.


Benign lymph nodes

Consecutively admitted patients with benign lymphnodes with negative EUS-guided FNA.

EG-EUS will be applied in all patients.

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.





Primary Outcome Measures :
  1. Strain histogram and contrast enhancement during EUS in pancreatic masses and lymph nodes [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Pancreas and lymphnode samples (EUS-guided fine needle aspiration)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with a suspicion of pancreatic masses or lymph nodes should undergo EUS, with sequential EG-EUS and CE-EUS. Personal data (name, surname, age, admission date, SSN, diagnosis at admission) will be registered in the study.

EUS and EUS-guided fine needle aspiration are methods used for pancreatic masses and lymphnodes assessment in daily clinical practice. Contrast enhanced-EUS (CE-EUS) is aproved in european countries, and this mehode has been accepted for EUS procedures in daily practice, as well as elastography (EG-EUS). Anyway, signed informed consent for EG-EUS, CE-EUS and FNA biopsy is required for participation in the study.

Criteria

Inclusion Criteria:

  • Patients diagnosed with solid pancreatic tumor masses, with cytological / histo-logical confirmation
  • Patients with or without suspected lymph node involvement are eligible
  • Age 18 to 90 years old, men or women
  • Signed informed consent for EG-EUS, CE-EUS and FNA biopsy

Exclusion Criteria:

  • Prior surgical treatment with curative intent or chemo-radiotherapy
  • Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459041


Locations
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Romania
Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy
Craiova, Romania
Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
Institut Paoli-Calmettes
Caritas-Krankenhaus Bad Mergentheim
San Raffaele University Hospital, Italy
Tel-Aviv Sourasky Medical Center
University of Santiago de Compostela
Shengjing Hospital
Investigators
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Study Chair: Adrian Saftoiu, Professor University of Medicine and Pharmacy Craiova

Publications:
Havre RF, Waage JER, Gilja OH, Ødegaard S, Nesje LB. Semi-quantification of elastic contrasts by strain ratio in elastography - possibilities and pitfalls. Euroson 2010, Copenhagen August 22 - 25th

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Responsible Party: University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT02459041    
Other Study ID Numbers: ADVEUS
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases