title: A pilot study assessing tolerance safety and feasibility of diagnostic transnasal esophagogastroduodenoscopy using an improved larger caliber endoscope and an adapted topical anesthesia.
abstract: BACKGROUND
  Transnasal esophagogastroduodenoscopy (TN-EGDS) is well tolerated by patients and the examination is perceived comfortable without the need of a sedative drug. Conversely, mainly in Western literature, some authors report limitations in illumination, image quality, and working channel as affecting TN-EGDS diffusion. To overcome these disadvantages, a new transnasal endoscope (TNE) was tested but, due to its larger diameter, we have no evidence of its clinical safety and tolerability. A new adapted nasal anesthesia could be useful to improve TNE tolerance. In an independent, not sponsored, pilot prospective study we enrolled, in a busy clinical hospital setting, 30 adult patients receiving nasal atomized Lidocaine and Xylometazoline (XAL) to undergo a diagnostic TN-EGDS with TNE to evaluate its tolerance, safety, and feasibility.
  
  
  METHODS
  Three physicians enrolled inpatients and outpatients with indication to diagnostic EGDS during a 6-month period. Main outcome measures were cardio-pulmonary monitoring data and patients' answers to an adapted questionnaire investigating pain, anxiety level, willingness to repeat the examination, operators' scores about endoscopy quality, examination conduction and anesthesia-related complications.
  
  
  RESULTS
  The examination was completed by the transnasal route in 100 % of the enrolled patients, endoscopy satisfaction and feasibility were scored to nearly the highest levels by the three different physicians. A total of 29/30 patients (96.6 %) declared the willingness to repeat the same examination if needed. The mean patients' score for overall pain was 3.7 ± 1 SD (range 1-10 by Visual Analog Scale). Mean endoscopy duration was 11.1 ± 2.6 min (range 5.0-19.0). In a total of 17/30 TN-EGDS that lasted more than 11 min, higher heart frequency variations and worse tolerance scores were found (p < 0.05).
  
  
  CONCLUSIONS
  Our pilot study demonstrates that TN-EGDS with TNE and NA is safe, well tolerated, and feasible. The best clinical tolerance is reached when TN-EGDS lasts <11 min.
authors.affiliation: Emergency and Operative Digestive Endoscopy Unit - Department of Medicine - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. valerio.balassone@gmail.com.|Department of General Surgery - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. valerio.balassone@gmail.com.
authors.forename: Valerio
authors.initials: V
authors.lastname: Balassone
authors.affiliation: Department of Emergency and Admission, Critical Care, Medicine Pain Medicine and Anesthetic Science - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Dauri
authors.affiliation: Emergency and Operative Digestive Endoscopy Unit - Department of Medicine - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cappuccio
authors.affiliation: Emergency and Operative Digestive Endoscopy Unit - Department of Medicine - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Di Camillo
authors.affiliation: Emergency and Operative Digestive Endoscopy Unit - Department of Medicine - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Benavoli
authors.affiliation: Department of General Surgery - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Oreste
authors.initials: O
authors.lastname: Buonomo
authors.affiliation: Department of General Surgery - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Petrella
authors.affiliation: Emergency and Operative Digestive Endoscopy Unit - Department of Medicine - Fondazione PTV, Policlinico Tor Vergata, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Italo
authors.initials: I
authors.lastname: Stroppa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage*; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage; D008012:Lidocaine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009296:Nasal Cavity; D009330:Nebulizers and Vaporizers; D017060:Patient Satisfaction; D010865:Pilot Projects; D011446:Prospective Studies; D064232:Visual Analog Scale
chemical_list: D000779:Anesthetics, Local; D007093:Imidazoles; D008012:Lidocaine; C009695:xylometazoline
keywords: Endoscopy; Feasibility; Nose; Patient compliance; Safety