Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

NCT04002778 | Completed DMC

• 1 other identifier: 45073415.3.0000.5257
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.

Conditions

Pancreatic Neoplasms

Keywords

EUS-FNA; pancreatic solid lesions; sample adequacy; cytopathology; endosonography

Outcome Measures

Primary Outcomes (1)

• Procedure duration

  Minutes

  Procedure

Secondary Outcomes (4)

• Specimen adequacy rate

  Through study completion, an average of 18 months

• Total number of passes

  Through study completion, an average of 18 months

• Number of adverse events

  Through study completion, an average of 18 months

• Diagnostic yield

  Through study completion, an average of 18 months

Study Arms (2)

ROSE by endosonographer

ACTIVE COMPARATOR

Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization

Diagnostic Test: Fine needle aspiration; Diagnostic Test: Rapid on-site evaluation

non-ROSE

OTHER

Submitted to fine-needle aspiration.

Diagnostic Test: Fine needle aspiration

Interventions

Fine needle aspiration DIAGNOSTIC_TEST

ROSE by endosonographer; non-ROSE

Rapid on-site evaluation DIAGNOSTIC_TEST

ROSE by endosonographer

Eligibility Criteria

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

You may qualify if:

• solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
• formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.

You may not qualify if:

• a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
• lesions previously punctured on past EUS-FNA procedures
• American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
• cases of surveillance of solid pancreatic lesions
• severe coagulation disorder (platelet count \< 50000 or International Normalized Ratio \> 2,0)
• impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
• patient unwillingness to participate

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Internal Medicine

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: July 1, 2019
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 1, 2019

Record last verified: 2019-06