Autoimmune Pancreatitis, Gastrointestinal Stromal Tumors, Neuroendocrine Tumors
Conditions
Keywords
Endoscopic ultrasound, Pathological diagnosis, Fine needle aspiration, Fine needle biopsy
Brief summary
Endoscopic ultrasound (EUS)-guided fine needles with side fenestrations are used to collect aspirates for cytology analysis and biopsy samples for histologic analysis. The investigators conducted a large, multicenter study to compare the accuracy of diagnosis via specimens collected with fine-needle biopsy (FNB) versus fine-needle aspiration (FNA) for patients with lesions requiring immunohistochemistry (IHC) pathological diagnosis.
Detailed description
Current guidelines recommend FNA and FNB needles equally for pancreatic and other deep-seated lesions. However, some studies indicate that the sample adequacy for histologic evaluation is higher when using FNB compared with FNA needles. The diagnosis of neuroendocrine tumor (NET), autoimmune pancreatitis (AIP), and other gastrointestinal stromal tumors require high-quality tissue sampling for IHC diagnosis. Whether FNB is superior to FNA in these IHC-required lesions remains unclear. The investigators performed this at 2 tertiary care centers in China. The study prospectively collected patients undergoing EUS for a solid mass (\>1 cm) in the pancreas, abdomen, mediastinum, or pelvic cavity from December 2014 diagnosed with AIP, NET, mesenchymal tumors, and Lymphoma. Patients accepted FNB or FNA according to doctors' and patients' willingness in a real-world setting. All procedures were performed by experienced endosonographers; cytologists and pathologists were blinded to the sample collection method. Patients were followed for at least 48 weeks, and final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion. The primary aim was to compare diagnostic yields of EUS-FNA with EUS-FNB for all solid masses, then separately as AIP, NET, mesenchymal tumors, and lymphoma. The secondary endpoint was the quality of the histologic specimen.
Interventions
DEVICEFNB group
Fine-needle-biopsy (Echotip ProCore Needle)
DEVICEFNA group
Fine-needle-aspiration (Echotip Needle)
Sponsors
Peking Union Medical College
Huazhong University of Science and Technology
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years; * presence of a solid mass lesion was confirmed by at least 1 imaging modality and it was located within pancreas, abdomen, mediastinum, or pelvic cavity; * mass size \>1 cm; * final diagnoses were obtained after surgery, imaging analysis, or resolution of the lesion, including AIP, NET, mesenchymal tumors, and lymphoma.
Exclusion criteria
* coagulopathy (international normalized ratio, 1.5); * thrombocytopenia (platelet count \<50,000/mm3); * acute pancreatitis within the previous 2 weeks; * inability to safely perform EUS-TA (eg, cardiorespiratory dysfunction, mental diseases, or drug addiction); * refusal or inability to provide an informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yields of EUS-FNA with EUS-FNB for solid masses | From admission until the date of pathological diagnosis obtained or follow-up up to 24 months | Overall dignostic yields of all solid lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of histologic specimen | From admission until specimen evaluted by two independent pathologists, assessed up to 4 weeks | Specimen adequacy - whether adequate for IHC staining |
Countries
China
Outcome results
None listed