Prospective evaluation of adverse events following lower gastrointestinal tract EUS FNA.
OBJECTIVE
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.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Michael J
MJ
Levy
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Barham K
BK
Abu Dayyeh
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Larissa L
LL
Fujii
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Lisa A
LA
Boardman
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Jonathan E
JE
Clain
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Prasad G
PG
Iyer
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Elizabeth
E
Rajan
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Mark D
MD
Topazian
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Kenneth K
KK
Wang
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Maurits J
MJ
Wiersema
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Ferga C
FC
Gleeson
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003106:Colon / Q000473:pathology*; D003108:Colonic Diseases / Q000453:epidemiology / Q000209:etiology; D003113:Colonoscopy; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D007022:Hypotension / Q000453:epidemiology / Q000209:etiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D012002:Rectal Diseases / Q000453:epidemiology / Q000209:etiology; D012007:Rectum / Q000473:pathology*; D012307:Risk Factors; D055815:Young Adult