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PWE-008 Multicentre randomised trial comparing eus guided fine needle aspiration cytology (fnac) with fine needle aspiration biopsy (fna b) in sampling solid pancreatic mass lesions: preliminary results from the procore trial
  1. J Ortiz-Fernández-Sordo1,
  2. K Ragunath1,
  3. M Wireko1,
  4. M James1,
  5. P Kaye1,
  6. K Oppong2,
  7. M Nayar2,
  8. A Darne3,
  9. B Mahon4,
  10. C Forde4,
  11. P Tarniere4,
  12. G Aithal1
  1. 1Nottingham University Hospitals NHS Trust, Nottingham
  2. 2Freeman Hospital
  3. 3Royal Victoria Infirmary, Newcastle-Upon-Tyne
  4. 4Queen Elizabeth University Hospital Birmingham NHS Trust, Birmingham, UK

Abstract

Introduction EUS-guided FNA is the standard of care for tissue sampling of pancreatic lesions. The new Echo Tip ProCore biopsy needle (Cook Medical) was developed to obtain core tissue specimens for histological analysis improving the diagnostic yield and potentially obviating the need for onsite cytopathologist. Our aim was to compare the standard Echo tip ultra FNAC needle with the new Echo Tip Ultra ProCore FNAB needle in the sampling of solid pancreatic lesions.

Method Randomised multicenter trial (REC Ref 12/EM/0189). All patients referred for EUS-guided tissue sampling of a solid pancreatic mass were invited to participate. Linear EUS (Aloka-Olympus/Hitachi-Pentax) was performed and patients were randomised to either FNAC or FNAB. Due to the nature of the study the endoscopist could not be blinded. A 22G needle was used when sampling from the stomach and a 25G from the duodenum. A maximum of 5 passes were allowed. Sampling time from first insertion of the needle into the lesion to the time the last tissue sample is transferred into the histology pot, number of passes and adequacy for diagnosis were recorded and included for analysis. Immediate and delayed complications were also recorded.

Results 266 patients were recruited (median age 67 years, 52% men); 142 randomised to the FNAC group and 124 to the FNAB group. Two patients were excluded after randomization; no mass lesion was seen in 1 patient randomised to FNAC and the needle failed in 1 patient in the FNAB group and FNAC was performed. 264 patients were analysed, 141 in the FNAC group (22G=83 and 25G=58. Median max diameter of the lesion 34 mm, range 10–87 mm) and 123 in the FNAB group (22G=53 and 25G=71. Median max diameter 33 mm, range 8–85 mm). There was no statistical significant difference between groups in number of passes (median 4, range 1–5 in the FNAC group vs. median 3, range 1–5 in the FNAB group, p = 0.12), sampling time (median 13 min, range 1–32 min vs. median 13 min, range 2–42 min, p = 0.63) and adequacy of the specimen for diagnosis (90.8% vs. 87%, p = 0.33). Three technical failures were observed in the FNAB group and none in the FNAC cohort (1.6% vs. 0%, p = 0.99). No complications reported in either group.

Conclusion FNAC and FNAB needles were comparable in terms of sampling time, number of passes, sample adequacy for diagnosis and safety. Technical failure was higher in the FNAB arm but not statistically significant.

Disclosure of interest None Declared.

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