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

NCT02459041 | Completed DMC

• 1 other identifier: ADVEUS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Strain histogram and contrast enhancement during EUS in pancreatic masses and lymph nodes

  12 months

Study Arms (4)

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

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

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

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

Interventions

Elastography, contrast enhancement OTHER

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; Benign pancreatic masses; Malignant lymph nodes; Pancreatic cancer

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

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Medicine and Pharmacy Craiova: lead
• Institut Paoli-Calmettes: collaborator
• Caritas-Krankenhaus Bad Mergentheim: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• University of Santiago de Compostela: collaborator
• Shengjing Hospital: collaborator

Study Sites (1)

Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy

Craiova, Romania

Location

Related Publications (36)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreas and lymphnode samples (EUS-guided fine needle aspiration)

MeSH Terms

Conditions

Pancreatic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Saftoiu, Professor

  University of Medicine and Pharmacy Craiova

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

RO (1)