Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions

NCT01936467 | Completed Phase 3 Results DMC

• 1 other identifier: NA_00079301
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure. There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.

Conditions

Pancreatic Solid Lesions; Pancreatic Mass

Keywords

Pancreatic solid lesions; Pancreatic mass; Pancreatic cancer; Endoscopic Ultrasound; EUS; Fine needle aspiration; FNA; EUS-FNA

Outcome Measures

Primary Outcomes (5)

• Diagnostic Yield of Capillary Technique

  Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

  up to 6 months

• Diagnostic Yield of Standard Technique

  Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.

  up to 6 months

• Sensitivity of EUS-FNA With Capillary Technique

  Sensitivity of the EUS-FNA with Capillary technique

  6 months

• Sensitivity of EUS-FNA With StandardTechnique

  Sensitivity of the EUS-FNA with Capillary technique

  6 months

• Sensitivity of EUS-FNA

  Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions

  6 months

Secondary Outcomes (3)

• First Pass Diagnostic Rate

  immediate

• Acquisition of Core Tissue

  immediate

• Diagnostic Accuracy of EUS-FNA

  6 months

Study Arms (2)

Standard suction

EXPERIMENTAL

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Device: Standard technique EUS-FNA

Capillary suction

EXPERIMENTAL

These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.

Device: Capillary suction technique for EUS FNA

Interventions

Standard technique EUS-FNA DEVICE

Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.

Standard suction

Capillary suction technique for EUS FNA DEVICE

Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously

Capillary suction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA

You may not qualify if:

• Uncorrectable coagulopathy (INR \> 1.5)
• Uncorrectable thrombocytopenia (platelet \< 50,000)
• Uncooperative patients
• Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
• Refusal to consent form
• Cystic lesions
• Inaccessible lesions to EUS

Sponsors & Collaborators

• Johns Hopkins University: lead
• Boston Scientific Corporation: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

Related Publications (1)

• Saxena P, El Zein M, Stevens T, Abdelgelil A, Besharati S, Messallam A, Kumbhari V, Azola A, Brainard J, Shin EJ, Lennon AM, Canto MI, Singh VK, Khashab MA. Stylet slow-pull versus standard suction for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic lesions: a multicenter randomized trial. Endoscopy. 2018 May;50(5):497-504. doi: 10.1055/s-0043-122381. Epub 2017 Dec 22.

  PMID: 29272906 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

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, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Limitations and Caveats

The endosonographers were not blinded to the procedure technique. A small possibility that cytotechnicians may have witnessed the technique. Cellularity of the specimens were not quantified. A 6 months follow-up may not detect all false negatives

Results Point of Contact

• Title: Dr. Mouen Khashab
• Organization: Johns Hopkins Hospital

mkhasha1@jhmi.edu

443-287-1960

Study Officials

• Mouen A Khashab, MD

  Johns Hopkins Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Director of Therapeutic Endoscopy

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 6, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (2)