Comparison of a Novel 22-gauge Core Biopsy Needle

NCT01598194 | Completed Results DMC

• 1 other identifier: 2011-0907
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.

Conditions

Solid Pancreatic Mass Lesions; Malignant Neoplasm of Pancreas

Keywords

solid pancreatic mass lesions; 22-gauge core biopsy needle; reverse bevel design; endoscopic ultrasound; EUS; guided; fine needle aspiration; FNA

Outcome Measures

Primary Outcomes (2)

• Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.

  The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation.

  Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.

• Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle.

  The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count \> 500 cells) or 3 (estimated cell count \> 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score \< 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis.

  Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes

Secondary Outcomes (1)

• Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis

  Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes

Study Arms (1)

Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle

EXPERIMENTAL

The 22-gauge core biopsy needle with reverse bevel design (EchoTip® Procore™) will be compared prospectively to the standard straight hollow-core 22-gauge or 25-gauge FNA needle already used in our clinical practice for the diagnosis of solid pancreatic lesions.

Device: Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle

Interventions

Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle DEVICE

Two passes performed with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single lesion and from the same endoscopic location.

Novel 22-gauge Core Biopsy Needle Standard Biopsy Needle

Eligibility Criteria

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

You may qualify if:

• Patient age 18 years and older.
• All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions.

You may not qualify if:

• Unable to obtain informed consent.
• Unable to tolerate the procedure.
• Women with known pregnancy at time.
• Patient age less than 18 years of age.
• Bleeding diathesis
• Cystic pancreatic lesions
• Lesion not accessible by EUS guided FNA

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Weston BR, Ross WA, Bhutani MS, Lee JH, Pande M, Sholl AB, Krishnamurthy S. Prospective randomized comparison of a 22G core needle using standard versus capillary suction for EUS-guided sampling of solid pancreatic masses. Endosc Int Open. 2017 Jun;5(6):E505-E512. doi: 10.1055/s-0043-105492. Epub 2017 Jun 7.

  PMID: 28596983 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

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

Results Point of Contact

• Title: Weston,Brian,MD / Gastroenterology Hepatology & Nutrition
• Organization: UT MD Anderson Cancer Center

BWESTON@MDANDERSON.ORG

713-792-7734

Study Officials

• Brian Weston, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: January 30, 2012
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: December 27, 2018
• Results First Posted: December 27, 2018

Record last verified: 2018-12

Locations

US (1)