Prospective Evaluation of Patient Tolerability, Satisfaction with Patient Information, and Complications in Endoscopic Ultrasonography

Background and Study Aims: 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.
Patients and 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.

References

• 1 Nickl N, Hofmann B, Hawes R. et al . Clinical outcomes of endoscopic ultrasound (EUS): the American Endosonography Club study [abstract].  Gastrointest Endosc. 1995;  41 310
• 2 Rösch T, Dittler H J, Fockens P. et al . Major complications of endoscopic ultrasonography: results of a survey of 42 105 cases [abstract].  Gastrointest Endosc. 1993;  39 341
• 3 Harewood G C, Wiersema M J. Endosonography-guided fine needle aspiration biopsy in the evaluation of pancreatic masses.  Am J Gastroenterol. 2002;  97 1386-1391
• 4 Gress F, Michael H, Gelrud D. et al . EUS-guided fine-needle aspiration of the pancreas: evaluation of pancreatitis as a complication.  Gastrointest Endosc. 2002;  56 864-867
• 5 Williams D B, Sahai A V, Aabakken L. et al . Endoscopic ultrasound guided fine needle aspiration biopsy: a large single centre experience.  Gut. 1999;  44 720-726
• 6 Catalano M F, Rosenblatt M L, Chak A. et al . Endoscopic ultrasound-guided fine needle aspiration in the diagnosis of mediastinal masses of unknown origin.  Am J Gastroenterol. 2002;  97 2559-2565
• 7 Hollerbach S, Klamann A, Topalidis T, Schmiegel W H. Endoscopic ultrasonography (EUS) and fine-needle aspiration (FNA) cytology for diagnosis of chronic pancreatitis.  Endoscopy. 2001;  33 824-831
• 8 Gunaratnam N T, Sarma A V, Norton I D, Wiersema M J. A prospective study of EUS-guided celiac plexus neurolysis for pancreatic cancer pain.  Gastrointest Endosc. 2001;  54 316-324
• 9 Nguyen P, Feng J C, Chang K J. Endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration (FNA) of liver lesions.  Gastrointest Endosc. 1999;  50 357-361
• 10 Masci E, Toti G, Mariani A. et al . Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.  Am J Gastroenterol. 2001;  96 417-423
• 11 Viiala C H, Zimmerman M, Cullen D J, Hoffman N E. Complication rates of colonoscopy in an Australian teaching hospital environment.  Intern Med J. 2003;  33 355-359
• 12 O’Toole D, Palazzo L, Arotcarena R. et al . Assessment of complications of EUS-guided fine-needle aspiration.  Gastrointest Endosc. 2001;  53 470-474
• 13 Raut C P, Grau A M, Staerkel G A. et al . Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration in patients with presumed pancreatic cancer.  J Gastrointest Surg. 2003;  7 118-126
• 14 Fritscher-Ravens A, Brand L, Knofel W T. et al . Comparison of endoscopic ultrasound-guided fine needle aspiration for focal pancreatic lesions in patients with normal parenchyma and chronic pancreatitis.  Am J Gastroenterol. 2002;  97 2768-2775
• 15 Jacobson B C, Pitman M B, Brugge W R. EUS-guided FNA for the diagnosis of gallbladder masses.  Gastrointest Endosc. 2003;  57 251-254
• 16 Lai R, Stanley M W, Bardales R. et al . Endoscopic ultrasound-guided pancreatic duct aspiration: diagnostic yield and safety.  Endoscopy. 2002;  34 715-720
• 17 Catalano M F, Nayar R, Gress F. et al . EUS-guided fine needle aspiration in mediastinal lymphadenopathy of unknown etiology.  Gastrointest Endosc. 2002;  55 863-869
• 18 DeWitt J, Leblanc J, McHenry L. et al . Endoscopic ultrasound-guided fine needle aspiration cytology of solid liver lesions: a large single-center experience.  Am J Gastroenterol. 2003;  98 1976-1981
• 19 Affi A, Vazquez-Sequeiros E, Norton I D. et al . Acute extraluminal hemorrhage associated with EUS-guided fine needle aspiration: frequency and clinical significance.  Gastrointest Endosc. 2001;  53 221-225
• 20 Levy M J, Jondal M L, Clain J, Wiersema M J. Preliminary experience with an EUS-guided trucut biopsy needle compared with EUS-guided FNA.  Gastrointest Endosc. 2003;  57 101-106
• 21 Barawi M, Gottlieb K, Cunha B. et al . A prospective evaluation of the incidence of bacteremia associated with EUS-guided fine-needle aspiration.  Gastrointest Endosc. 2001;  53 189-192
• 22 Levy M J, Norton I D, Wiersema M J. et al . Prospective risk assessment of bacteremia and other infectious complications in patients undergoing EUS-guided FNA.  Gastrointest Endosc. 2003;  57 672-678
• 23 Pfau P R, Ginsberg G G, Lew R J. et al . Esophageal dilation for endosonographic evaluation of malignant esophageal strictures is safe and effective.  Am J Gastroenterol. 2000;  95 2813-2815
• 24 Wallace M B, Hawes R H, Sahai A V. et al . Dilation of malignant esophageal stenosis to allow EUS guided fine-needle aspiration: safety and effect on patient management.  Gastrointest Endosc. 2000;  51 309-313
• 25 Tonnesen H, Puggaard L, Braagaard J. et al . Stress response to endoscopy.  Scand J Gastroenterol. 1999;  34 629-631
• 26 Abuksis G, Mor M, Segal N. et al . A patient education program is cost-effective for preventing failure of endoscopic procedures in a gastroenterology department.  Am J Gastroenterol. 2001;  96 1786-1790
• 27 Mahajan R J, Johnson J C, Marshall J B. Predictors of patient cooperation during gastrointestinal endoscopy.  J Clin Gastroenterol. 1997;  24 220-223
• 28 Mahajan L, Wyllie R, Steffen R. et al . The effects of a psychological preparation program on anxiety in children and adolescents undergoing gastrointestinal endoscopy.  J Pediatr Gastroenterol Nutr. 1998;  27 161-165
• 29 Aabakken L, Baasland I, Lygren I, Osnes M. Development and evaluation of written patient information for endoscopic procedures.  Endoscopy. 1997;  29 23-26
• 30 Preiss C, Charton J P, Schumacher B, Neuhaus H. A randomized trial of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) versus peroral small-caliber EGD versus conventional EGD.  Endoscopy. 2003;  35 641-646