Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer - Full Text View

Purpose

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.

Condition	Intervention
Pancreatic Cancer	Procedure: Single needle Procedure: Multiple needle

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic
Official Title:	EMUNE-07 Evaluation of Multiple Needle Use in EUS-FNA for Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of complications related with EUS-FNA [ Time Frame: October 2007- September 2008 ] [ Designated as safety issue: Yes ]
Influence of different factors in obtaining a positive cytological result [ Time Frame: October 2007- September 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548626

Contacts

Contact: Alberto Herreros de Tejada, MD	7737025891	aherrero@medicine.bsd.uchicago.edu
Contact: Jennifer Chennat, MD	7738340152	jennifer.chennat@uchospitals.edu

Locations

United States, Illinois
University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Alberto Herreros de Tejada 773-702-5891 aherrero@medicine.bsd.uchicago.edu
Contact: Talonda Franklin, MD 773-702-5588 tfrankli@medicine.bsd.uchicago.edu
Principal Investigator: Irving Waxman, MD
Sub-Investigator: Alberto Herreros de Tejada, MD
Sub-Investigator: Jennifer Chennat, MD
Sub-Investigator: Shang Li, MD
Sub-Investigator: Tiffany Chang, MD
Sub-Investigator: Charles Dye, MD

Sponsors and Collaborators

University of Chicago

Cook

Investigators

Principal Investigator:

Irving Waxman, MD

Department of Medicine, University of Chicago Medical Center

More Information

Publications:

LeBlanc JK, Ciaccia D, Al-Assi MT, McGrath K, Imperiale T, Tao LC, Vallery S, DeWitt J, Sherman S, Collins E. Optimal number of EUS-guided fine needle passes needed to obtain a correct diagnosis. Gastrointest Endosc. 2004 Apr;59(4):475-81.

Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7.

Eloubeidi MA, Tamhane A, Varadarajulu S, Wilcox CM. Frequency of major complications after EUS-guided FNA of solid pancreatic masses: a prospective evaluation. Gastrointest Endosc. 2006 Apr;63(4):622-9.

Eloubeidi MA, Gress FG, Savides TJ, Wiersema MJ, Kochman ML, Ahmad NA, Ginsberg GG, Erickson RA, Dewitt J, Van Dam J, Nickl NJ, Levy MJ, Clain JE, Chak A, Sivak MV Jr, Wong R, Isenberg G, Scheiman JM, Bounds B, Kimmey MB, Saunders MD, Chang KJ, Sharma A, Nguyen P, Lee JG, Edmundowicz SA, Early D, Azar R, Etemad B, Chen YK, Waxman I, Shami V, Catalano MF, Wilcox CM. Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States. Gastrointest Endosc. 2004 Sep;60(3):385-9.

Harewood GC, Wiersema MJ. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses. Am J Gastroenterol. 2002 Jun;97(6):1386-91.

Eloubeidi MA, Jhala D, Chhieng DC, Chen VK, Eltoum I, Vickers S, Mel Wilcox C, Jhala N. Yield of endoscopic ultrasound-guided fine-needle aspiration biopsy in patients with suspected pancreatic carcinoma. Cancer. 2003 Oct 25;99(5):285-92.

O'Toole D, Palazzo L, Arotcarena R, Dancour A, Aubert A, Hammel P, Amaris J, Ruszniewski P. Assessment of complications of EUS-guided fine-needle aspiration. Gastrointest Endosc. 2001 Apr;53(4):470-4.

Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95.

Niederhuber JE, Brennan MF, Menck HR. The National Cancer Data Base report on pancreatic cancer. Cancer. 1995 Nov 1;76(9):1671-7.

Binmoeller KF, Thul R, Rathod V, Henke P, Brand B, Jabusch HC, Soehendra N. Endoscopic ultrasound-guided, 18-gauge, fine needle aspiration biopsy of the pancreas using a 2.8 mm channel convex array echoendoscope. Gastrointest Endosc. 1998 Feb;47(2):121-7.

Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. Review.

Mortensen MB, Pless T, Durup J, Ainsworth AP, Plagborg GJ, Hovendal C. Clinical impact of endoscopic ultrasound-guided fine needle aspiration biopsy in patients with upper gastrointestinal tract malignancies. A prospective study. Endoscopy. 2001 Jun;33(6):478-83.

Responsible Party:	Irving Waxman, Department of Medicine. University of Chicago Medical Center
ClinicalTrials.gov Identifier:	NCT00548626 History of Changes
Other Study ID Numbers:	15497A
Study First Received:	October 22, 2007
Last Updated:	June 6, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Pancreatic Cancer
Endoscopic Ultrasonography
Fine-Needle Aspiration
Cytopathology

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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