Prospective evaluation of adverse events following lower gastrointestinal tract EUS FNA.

Objectives: There are virtually no data concerning the risk of adverse events (AEs) following lower gastrointestinal (LGI) endoscopic ultrasound (EUS). Our aim was to determine the incidence and factors associated with AEs following LGI EUS fine needle aspiration (FNA).

Methods: We conducted a prospective cohort study at a tertiary referral center. Five hundred and sixty-three patients underwent LGI EUS FNA between 1 January 2004 and 1 January 2012. We analyzed the 502 patients who had complete follow-up. AE severity was graded (1-5) utilizing Common Terminology Criteria or Visual Analog Scale. AEs were assessed during the procedures, in clinical follow-up, during phone interviews conducted at 7-14 days, and final clinical and/or phone interviews at 2-4 months.

Results: AEs developed in 103 (20.5%) patients and were classified as grade 1, 2, 3, or 4 in 34 (6.8%), 41 (8.2%), 23 (4.6%), and 5 (1.0%) patients, respectively. Bleeding and pain were the commonest AEs. No deaths occurred. On multivariate analysis, AEs were associated with prior pain (odds ratio (OR): 3.83, 95% confidence interval (CI): 2.35-6.25), FNA from a site other than a lymph node (LN) or gut wall (OR: 2.26, 95% CI: 1.10-4.70), and malignant FNA cytology (OR: 1.80, 95% CI: 1.10-2.97); serious (grade 3-4) AEs were associated with prior pain (OR: 15.21, 95% CI: 5.04-45.85) and FNA from a site other than a LN or gut wall (OR: 3.25, 95% CI: 1.15-9.20).

Conclusions: LGI EUS FNA is associated with a high rate of serious grades 3-4 AEs. This may reflect the total number of associated interventions and the frequency of underlying pathology and symptoms.