Diagnostic Accuracy of FNA: is Aspiration- Related?

NCT01717196 | Unknown DMC

• 1 other identifier: EX0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PANCREATIC CANCER

Keywords

sample adequacy; diagnostic accuracy; complications

Outcome Measures

Primary Outcomes (1)

• sample adequacy

  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.

  20min

Secondary Outcomes (1)

• diagnostic accuracy

  5 days

Other Outcomes (1)

• complications

  up to 30 days after the procedure

Study Arms (1)

DIFFERENT VOLUME ASPIRATION BIOPSY

EXPERIMENTAL

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

Interventions

different volume aspiration OTHER

comparison between diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.

DIFFERENT VOLUME ASPIRATION BIOPSY

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed or suspected solid pancreatic lesions according to imaging (CT-scan or/and MRI);

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: lead

Study Sites (1)

ISMETT

Palermo, 90100, Italy

Location

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

• Ilaria tarantino, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

IT (1)