title: Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography.
abstract: OBJECTIVE
  Prospective data are lacking on the safety of endoscopic ultrasonography (EUS) and on patient satisfaction with the procedure. We prospectively recorded complications related to EUS in order to establish morbidity and mortality. In addition the levels of patient satisfaction were evaluated, with regard to the tolerability of the procedure (pain, discomfort, and anxiety levels) and the provision of information.
  
  
  METHODS
  3324 consecutive patients who underwent EUS were studied with regard to complications. During the study period 300 patients were interviewed and followed up in detail as part of the evaluation of patient satisfaction.
  
  
  RESULTS
  Ten patients (0.3 %) suffered from a complication related to the EUS procedure, and two patients died (0.06 %). There were no significant differences between the complication rates for EUS-guided fine-needle aspiration (EUS-FNA) and for EUS, but both fatal cases related to EUS-FNA/EUS-guided intervention. Nine of the ten patients with complications (90 %) had a diagnosis of malignancy, and esophageal perforation accounted for half of all complications. Although the majority of patients with nonlethal complications were managed well on conservative regimens, only one case, of self-limiting acute pancreatitis, could be classified as a mild complication. With regard to patient tolerability, only minor incidents occurred during the EUS procedure (tracheal suction 5 %, vomiting 0.3 %, aspiration 0.3 %) and no intervention was necessary. During the procedure, 80 % of the patients had no or only slight pain and more than 95 % experienced only slight or no anxiety, whereas more than half of the patients experienced moderate to severe discomfort. More than 90 % of the patients were satisfied or very satisfied with the information provided to them before and after the EUS, and the same number of patients were ready without hesitation to undergo an additional EUS examination if necessary.
  
  
  CONCLUSIONS
  EUS, EUS-FNA and EUS-guided intervention are safe techniques, but severe and lethal complications do occur. The EUS procedures can be performed with a high level of patient satisfaction and with low levels of pain, discomfort and anxiety.
authors.affiliation: Department of Surgical Gastroenterology, Odense University Hospital, Odense, Denmark. m.bau@dadlnet.dk
authors.forename: M B
authors.initials: MB
authors.lastname: Mortensen
authors.forename: C
authors.initials: C
authors.lastname: Fristrup
authors.forename: F S
authors.initials: FS
authors.lastname: Holm
authors.forename: T
authors.initials: T
authors.lastname: Pless
authors.forename: J
authors.initials: J
authors.lastname: Durup
authors.forename: A P
authors.initials: AP
authors.lastname: Ainsworth
authors.forename: H O
authors.initials: HO
authors.lastname: Nielsen
authors.forename: C
authors.initials: C
authors.lastname: Hovendal
mesh_terms: D018784:Abdominal Abscess / Q000628:therapy; D000208:Acute Disease; D044963:Biopsy, Fine-Needle / Q000009:adverse effects; D019160:Endosonography / Q000009:adverse effects* / Q000401:mortality; D004938:Esophageal Neoplasms / Q000628:therapy; D004939:Esophageal Perforation / Q000209:etiology*; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology; D010190:Pancreatic Neoplasms / Q000628:therapy; D010195:Pancreatitis / Q000628:therapy; D017060:Patient Satisfaction; D011446:Prospective Studies; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome