Impact of balloon inflation on the insertion of endoscopic ultrasound: a prospective, randomized controlled trial

Abstract

Background and study aims During endoscopic ultrasound (EUS), patients may experience severe discomfort. The radial echoendoscope has a balloon around its tip. Balloon inflation prior to insertion may reduce contact injury and pharyngeal pain. The purpose of this study was to investigate the effect of balloon inflation on pharyngeal pain during insertion.

Patients and methods Patients who underwent radial EUS for pancreatobiliary disease were randomized into standard insertion or balloon-inflated insertion. The primary outcome was the proportion of moderate-to-severe pharyngeal pain. Secondary outcomes were the degree of pharyngeal pain, risk factors for moderate pharyngeal pain, procedure-related adverse events, and pharyngeal pain depending on the experience of the endoscopist.

Results A total of 481 patients were randomized into two groups: standard insertion (238) and balloon inflation (243). No statistically significant differences in proportion of moderate-to-severe pain were found (26.5 % vs. 20.2 %, P = 0.107). Balloon inflation (HR 0.65; 95 % CI (0.42–0.98, P = 0.041) was a protective factor against moderate pain. Balloon inflation reduced the proportion of patients with moderate-to-severe pain when performed by physicians with less than 3months of experience with EUS (44.7 % vs. 25.3 %, P = 0.012).

Conclusion Balloon inflation did not reduce the absolute degree of post-procedural pain with EUS, but it reduced the number of patients with moderate-to-severe pain when performed by physicians with less than 3 months of experience.

Publikationsverlauf

Eingereicht: 11. Oktober 2019

Angenommen: 02. Dezember 2019

Artikel online veröffentlicht:
21. Februar 2020

• References

• 1 Ryozawa S, Fujita N, Irisawa A. et al. Current status of interventional endoscopic ultrasound. Dig Endosc 2017; 29: 559-566
• 2 Coban S, Basar O, Brugge WR. Future Directions for Endoscopic Ultrasound: Where Are We Heading?. Gastrointest Endosc Clin N Am 2017; 27: 759-772
• 3 Murad FM, Komanduri S, Abu Dayyeh BK. et al. Echoendoscopes. Gastrointest Endosc 2015; 82: 189-202
• 4 Zubarik R, Eisen G, Mastropietro C. et al. Prospective analysis of complications 30 days after outpatient upper endoscopy. Am J Gastroenterol 1999; 94: 1539-1545
• 5 Jeurnink SM, Steyerberg E, Kuipers E. et al. The burden of endoscopic retrograde cholangiopancreatography (ERCP) performed with the patient under conscious sedation. Surg Endosc 2012; 26: 2213-2219
• 6 Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain 2011; 152: 2399-2404
• 7 Hjermstad MJ, Fayers PM, Haugen DF. et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage 2011; 41: 1073-1093
• 8 Gerbershagen HJ, Rothaug J, Kalkman CJ. et al. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth 2011; 107: 619-626
• 9 Woo A, Lechner B, Fu T. et al. Cut points for mild, moderate, and severe pain among cancer and non-cancer patients: a literature review. Ann Palliat Med 2015; 4: 176-183
• 10 Ren J, Xie P, Lang IM. et al. Deterioration of the pharyngo-UES contractile reflex in the elderly. Laryngoscope 2000; 110: 1563-1566
• 11 Mentzelopoulos SD, Romana CN, Corolanoglou DS. et al. Balloon versus conventional laryngoscopy: a comparison of laryngoscopic findings and intubation difficulty. Anesth Analg 2000; 91: 1513-1519
• 12 Kawamura O, Easterling C, Aslam M. et al. Laryngo-upper esophageal sphincter contractile reflex in humans deteriorates with age. Gastroenterology 2004; 127: 57-64
• 13 Kim YS, Kim N. Sex-Gender Differences in Irritable Bowel Syndrome. J Neurogastroenterol Motil 2018; 24: 544-558
• 14 Labus JS, Gupta A, Coveleskie K. et al. Sex differences in emotion-related cognitive processes in irritable bowel syndrome and healthy control subjects. Pain 2013; 154: 2088-2099
• 15 Hong JY, Kilpatrick LA, Labus J. et al. Patients with chronic visceral pain show sex-related alterations in intrinsic oscillations of the resting brain. J Neurosci 2013; 33: 11994-12002
• 16 Meleine M, Matricon J. Gender-related differences in irritable bowel syndrome: potential mechanisms of sex hormones. World J Gastroenterol 2014; 20: 6725-6743
• 17 Wani S, Keswani RN, Han S. et al. Competence in endoscopic ultrasound and endoscopic retrograde cholangiopancreatography, from training through independent practice. Gastroenterology 2018; 155: 1483-1494.e1487
• 18 Shahidi N, Ou G, Lam E. et al. When trainees reach competency in performing endoscopic ultrasound: a systematic review. Endosc Int Open 2017; 5: E239-e243
• 19 Cho CM. Training in endoscopy: endoscopic ultrasound. Clin Endosc 2017; 50: 340-344