Diagnostic Accuracy of FNA: is Aspiration- Related? (expect fna)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01717196
First received: October 22, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses. Different needle diameters and the use of stylet are not associated with differences in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and complications.

METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo; Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was performed by five experienced echo-endoscopist. The needle system was in all cases the 22 gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the slides, the material was fixed in formalin for cyto-histological evaluation. The cyto-pathologist was always blinded as to which aspiration was used for which specimen. After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up during the 30 days post-procedure in order to detect late complications.


Condition Intervention
PANCREATIC CANCER
Other: different volume aspiration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of FNA (Fine Needle Aspiration) on Solid Pancreatic Lesions: is Aspiration- Related?

Resource links provided by NLM:


Further study details as provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:

Primary Outcome Measures:
  • sample adequacy [ Time Frame: 20min ] [ Designated as safety issue: No ]
    Tissue samples was immediately smeared into slides after each puncture, fixed and all the prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site Evaluation). For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.


Secondary Outcome Measures:
  • diagnostic accuracy [ Time Frame: 5 days ] [ Designated as safety issue: No ]

    For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.

    The cases will be stratified into 4 diagnostic categories applied for ROSE and for histological evaluation:

    a) Positive for malignancy, b) Suspicious for malignancy, c) Negative for malignancy, d) Non diagnostic.



Other Outcome Measures:
  • complications [ Time Frame: up to 30 days after the procedure ] [ Designated as safety issue: Yes ]
    After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up with a scheduled protocol during the 30 days post-procedure in order to evaluate clinical status, blood chemistry, and to detect late complications. All patients were followed up for at least 1 month. All adverse events were evaluated and related or not to the procedure.


Estimated Enrollment: 100
Study Start Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DIFFERENT VOLUME ASPIRATION BIOPSY
The needle system was in all cases the 22 gauge EUS-FNA (Expect needle). After the puncture the stylet was removed, and we performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence of different volume aspiration Biopsy/ FNA (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system.
Other: different volume aspiration
comparison between diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed or suspected solid pancreatic lesions according to imaging (CT-scan or/and MRI);
  • no contraindications for FNA (see exclusion criteria).

Exclusion Criteria:

  • age < 18 years;
  • cystic pancreatic lesions;
  • history of previous gastrectomy;
  • patients hemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 60.000 cells/cubic millimetre [cmm3]);
  • patients unable to suspend anticoagulant therapy;
  • pregnancy;
  • inability to give informed consent;
  • refusal to participate to the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717196

Locations
Italy
ISMETT
Palermo, Italy, 90100
Sponsors and Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Investigators
Principal Investigator: Ilaria tarantino, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
  More Information

No publications provided

Responsible Party: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT01717196     History of Changes
Other Study ID Numbers: EX0001
Study First Received: October 22, 2012
Last Updated: October 26, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
sample adequacy
diagnostic accuracy
complications

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 August 20, 2014