Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy

NCT03016637 | Completed Phase 1

• 1 other identifier: MBM-71
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may improve the diagnostic yield during biopsies of pancreatic lesions

Conditions

Pancreatic Cancer

Keywords

endoscopic ultrasonography; EUS-FNA

Outcome Measures

Primary Outcomes (1)

• Number of conclusive biopsies

  minimum 6 moths after biopsy

Secondary Outcomes (2)

• Complications

  2 weeks after biopsy

• Quality test of biopsies

  2 weeks after biopsy

Study Arms (1)

EUS biopsy

EXPERIMENTAL

EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy

Device: SharkCore (TM) FNB Exchange System

Interventions

SharkCore (TM) FNB Exchange System DEVICE

Also known as: 25 Gauge or 22 Gauge SharkCore needle

EUS biopsy

Eligibility Criteria

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

You may qualify if:

• Pancreatic lesion suspected of malignancy and EUS biopsy indicated

You may not qualify if:

• Resectable pancreatic lesions

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Odense, 5000, Denmark

Location

Related Publications (5)

• Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.

  PMID: 22248600 BACKGROUND

• Bardales RH, Stelow EB, Mallery S, Lai R, Stanley MW. Review of endoscopic ultrasound-guided fine-needle aspiration cytology. Diagn Cytopathol. 2006 Feb;34(2):140-75. doi: 10.1002/dc.20300.

  PMID: 16511852 BACKGROUND

• Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.

  PMID: 21420083 BACKGROUND

• Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.

  PMID: 22658389 BACKGROUND

• Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. doi: 10.1055/s-2005-861142.

  PMID: 15692930 BACKGROUND

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

• Michael B Mortensen, Professor

  Odense University Hospital, University of Southern denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 10, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)