PANCREATIC CANCER Clinical Trial
— expect fnaOfficial title:
Diagnostic Accuracy of FNA (Fine Needle Aspiration) on Solid Pancreatic Lesions: is Aspiration- Related?
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | ISMETT | Palermo |
Lead Sponsor | Collaborator |
---|---|
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | complications | 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. | up to 30 days after the procedure | Yes |
Primary | 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 | No |
Secondary | diagnostic accuracy | 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. |
5 days | No |
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