Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

NCT02116322 | Terminated Results DMC

• 1 other identifier: NA_00090101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety

  30 days

Secondary Outcomes (1)

• Diagnostic Yield of the FNA Using Corkscrew Technique

  30 days

Study Arms (1)

Pancreatic mass

EXPERIMENTAL

Patients with pancreatic mass presenting for EUS-FNA

Procedure: EUS-FNA with Corkscrew technique; Device: Expect 19 G Flex needle

Interventions

EUS-FNA with Corkscrew technique PROCEDURE

Pancreatic mass

Expect 19 G Flex needle DEVICE

Also known as: Expect 19G Flex needle; Boston scientific

Pancreatic mass

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 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)

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
• Prior negative FNTA
• In situ metallic biliary stents
• Predominantly cystic lesions
• Inaccessible lesions to EUS

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

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

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 University

  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: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-05

Locations

US (1)