Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions

NCT03210948 | Unknown

• 1 other identifier: EUS01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound (EUS) fine needle aspiration (FNA). Aim of this randomized controlled trial (RCT) is to establish the diagnostic accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses. Eligible will be patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI). In the treatment arm, RTE assessment of pancreatic masses will be performed using a last generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded and stored in our database. A 25 G needle will be then inserted into the most suspicious part ("dark blue") of the lesion and immediately after the procedure the stylet will be removed. At the end of the procedure, the needle will be retracted and the samples will be prepared for cytological examination. Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample and safety It will be planned to enroll 142 patients (71 per arms) within 1 year. A minimum follow up of 6 months from the last patient unsuitable to surgery will be required.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Proportion of correctly classified subjects (true positives+true negatives) among all subjects (true positives+true negatives+false positives+false negatives)

  12 months

Secondary Outcomes (4)

• Diagnostic sensitivity

  12 months

• Diagnostic specificity

  12 months

• Number of passes needed to achieve an adequate sample

  1 day

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 week

Study Arms (2)

RTE-guided EUS-FNA

EXPERIMENTAL

The needle will be then inserted into the most suspicious part ("dark blue") of the lesion as assessed at real time elastography.

Device: RTE-guided EUS-FNA

Conventional EUS-FNA

ACTIVE COMPARATOR

A 25 G needle with a central stylet to protect the aspiration channel of the needle will be introduced though the endoscope's working channel.

Device: Conventional EUS-FNA

Interventions

RTE-guided EUS-FNA DEVICE

Fine needle aspiration with 25 gauge needle under RTE-guidance

RTE-guided EUS-FNA

Conventional EUS-FNA DEVICE

Fine needle aspiration with no RTE guidance

Conventional EUS-FNA

Eligibility Criteria

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

You may qualify if:

• Patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).

You may not qualify if:

• Age under 18 years
• Cystic pancreatic lesions
• Lesions \< 1 cm
• History of previous gastrectomy
• Patients with severe coagulopathy or under anticoagulant/antiaggregant therapy which could not be suspended
• Refusal to provide informed consent.

Sponsors & Collaborators

• Ospedali Riuniti di Foggia: lead

Study Sites (1)

Ospedali Riuniti Foggia

Foggia, 71122, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Antonio Facciorusso, MD

  Ospedali Riuniti di Foggia

  STUDY DIRECTOR

Central Study Contacts

Antonio Facciorusso, MD

CONTACT

+39 0881732015; antonio.facciorusso@virgilio.it

Nicola Muscatiello, MD

CONTACT

+39 0881733848; nicomuscatiello@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 7, 2017
• Study Start: January 23, 2019
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)