Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer (EMUNE-07)

December 18, 2015 updated by: University of Chicago

EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer

The aim of this study is to evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer allows an earlier preliminary cytological diagnosis of neoplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized controlled trial which will recruit patients referred for suspicion of pancreatic mass and indication of EUS-FNA as part of standard of care in the Interventional Endoscopy Unit at the University Of Chicago Medical Center. Basic demographic data will be recorded for each patient. If a pancreatic mass is confirmed in EUS evaluation the patient will be randomized in a 1:1 ratio to either Control group (Single needle) or Investigational group (Multiple Needle). There will be an expert cytopathologist in the exploration room (blinded to the group assignment). Samples obtained through FNA will be prepared onsite either for cytological evaluation by the cytopathologist: each fine needle sample will be expressed by using a 10mL air-filled syringe onto a separate glass slide, and a direct smear will be made by an on-site cytopathologist. Each slide will be air-dried and/or alcohol fixed (95% ethanol), and direct smears will be prepared for immediate interpretation by staining with Diff-quick staining system.

Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

A cytopathologist (#1) will be present during each EUS-FNA procedure to prepare the slides and determine whether each specimen was adequately cellular. After the procedure, all the cytological samples will be sent to the Pathology department in order to complete the study. A cytopathologist (#2) not present during the procedure will study all the sampling specimens obtained during the EUS-FNA procedure and produce the final and definitive cytopathological diagnosis.

Criteria for pancreatic cancer and benign pancreatic lesions will be defined. Follow-up of all patients to assess early and late complications will be carried out for 30 days after the procedure.

Endpoints:

  1. Primary endpoint: Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia. We hypothesized that the number of passes needed using the multiple needles will be significantly less than that using the single needle.

  2. Secondary endpoints:

    • Rate of complications related with EUS-FNA
    • Influence of different factors in obtaining a positive cytological result (histological differentiation)

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspicion of pancreatic mass due to previous exam/s (CT, MR, ERCP, US, …) that requires EUS-FNA in order to complete diagnosis
  • Age ≥ 18 y/o
  • Formal informed consent
  • No previous chemotherapy or radiotherapy
  • No previous pancreatic surgery

Exclusion Criteria:

  • Any patient unable to understand the procedure, nature of the current study, or sign a consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Patients assigned to simple needle group (SN) will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
Procedure: Single needle
Patients will be sampled for a total of 6 consecutive FNA passes with a single EUS-FNA needle (only replaced if the needle has a reduced performance). After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
Experimental: B
Patients assigned to multiple needle group (MN) will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.
Procedure: Multiple needle
Patients will be sampled for a total of 6 consecutive FNA passes, replacing the needle after every 2 passes. After completing the 6th pass the endoscopist will be informed by the onsite cytopathologist about the preliminary cytological diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate if the early change of needle during EUS-FNA for suspected pancreatic cancer can reduce the number of passes needed to obtain a preliminary cytological diagnosis of neoplasia.
Time Frame: October 2007- September 2008
October 2007- September 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of complications related with EUS-FNA
Time Frame: October 2007- September 2008
October 2007- September 2008
Influence of different factors in obtaining a positive cytological result
Time Frame: October 2007- September 2008
October 2007- September 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Cook Group Incorporated

Investigators

  • Principal Investigator: Irving Waxman, MD, Department of Medicine, University of Chicago Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 23, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 18, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15497A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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