2. Extreme Pediatric Aerodigestive Medicine and Unsedated In Office Endoscopy: Monitoring Pediatric Esophagitis and Gastritis Using Unsedated Gastroscopy and Esophagoscopy
Joel Friedlander
Assistant Professor of Pediatrics
Digestive Health Institute
Aerodigestive Program

3. Disclosure/COI
This talk will discuss off-label use of medical and surgical devices that are authorized by the FDA
I currently hold a patent on a currently-not available endoscope device.
No other conflicts of interest

4. The Aerodigestive Conundrum
The pursuit of more efficient,
higher quality, less expensive care

5. The Aerodigestive Conundrum
The pursuit of more efficient,
higher quality, less expensive care
Multiple procedural specialties
Need for multiple procedures

6. The Aerodigestive/GI Conundrum
The pursuit of more efficient,
higher quality, less expensive care
What Role Does Reflux Play?
Multiple procedural specialties
Need for multiple procedures

7. The Aerodigestive/GI Conundrum
The pursuit of more efficient,
higher quality, less expensive care
How do we follow it up?
What Role Does Reflux Play?
Multiple procedural specialties
Need for multiple procedures

8. The GI Background
Eosinophilic Esophagitis (EoE) and Reflux Esophagitis are increasingly common chronic inflammatory diseases that need to be addressed by the pediatric gastroenterologist and found in Aerodigestive clinics (often incidentally)
Assessment of esophageal mucosa is needed during diagnosis and subsequent therapeutic monitoring
Currently sedated endoscopy is the most common procedure used for evaluation of the esophagus and gastric mucosa
Dellon ES, Gonsalves N, Hirano I, et al. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). Am J Gastroenterol 2013;108:679-92; quiz
Greenhawt M, Aceves SS, Spergel JM, et al. The management of eosinophilic esophagitis. J Allergy Clin Immunol Pract 2013;1:332-40; quiz
Papadopoulou A, Koletzko S, Heuschkel R, et al. Management guidelines of eosinophilic esophagitis in childhood. J Pediatr Gastroenterol Nutr 2014;58:
Liacouras CA, Furuta GT, Hirano I, et al. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol 2011;128:3-20 e6; quiz 21-2

9. The GI Background Endoscopy is expensive
Sedation requires monitoring and has risks
There is increased literature regarding potential risk of anesthesia in young children
Aerodigestive clinics desire assessment of the presence of reflux and improved lower cost care
Children with EoE need frequent endoscopy for targeting therapies and follow up
Gleich SJ, Flick R, Hu D, et al. Neurodevelopment of children exposed to anesthesia: Design of the Mayo Anesthesia Safety in Kids (MASK) study. Contemp Clin Trials 2014;41C:45-54.
Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood) 2008;27:

10. The GI Background
Unsedated endoscopy has been reported often in adults and minimally in pediatrics
Unsedated transnasal endoscopy (laryngoscopy) is performed routinely in pediatric otolaryngology and pulmonology clinics and by ENT/Pulmonary in Aerodigestive
Unsedated endoscopy is less expensive and potentially less risky than sedated endoscopy in a pediatric population
Committee AT, Rodriguez SA, Banerjee S, et al. Ultrathin endoscopes. Gastrointest Endosc 2010;71:893-8.
Bishop PR, Nowicki MJ, May WL, et al. Unsedated upper endoscopy in children. Gastrointest Endosc 2002;55:
Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr 2008;20:266-71

11. The GI Background
Unsedated endoscopy has been reported often in adults and minimally in pediatrics
Unsedated transnasal endoscopy (laryngoscopy) is performed routinely in pediatric otolaryngology and pulmonology clinics and by ENT/Pulmonary in Aerodigestive
Unsedated endoscopy is less expensive and potentially less risky than sedated endoscopy in a pediatric population
Committee AT, Rodriguez SA, Banerjee S, et al. Ultrathin endoscopes. Gastrointest Endosc 2010;71:893-8.
Bishop PR, Nowicki MJ, May WL, et al. Unsedated upper endoscopy in children. Gastrointest Endosc 2002;55:
Wood RE. Evaluation of the upper airway in children. Curr Opin Pediatr 2008;20:266-71

12. The Original Hypothesis
Transnasal Esophagoscopy (TNE) is a safe and effective
tool to monitor the mucosa of children with Eosinophilic
Esophagitis

13. The Original Hypothesis
Transnasal Esophagoscopy (TNE) is a safe and effective
tool to monitor the mucosa of children with Eosinophilic
Esophagitis (And Perhaps Reflux Esophagitis/Gastritis)

14. The Specific Aim of Original Study
Evaluate the performance of TNE with biopsies using
ultra-slim flexible endoscopes in assessing the esophageal
mucosa of pediatric subjects with EoE.
a. Assess parental and subject satisfaction
b. Assess adequacy of biopsy samples
c. Monitor for adverse events
d. Assess duration and charges of procedure

15. How it got started? Aerodigestive Medicine=ENT, Pulm, GI
We are Similar Yet Different Specialties

16. How it got started? Peds Bronchoscopes 2.8 mm (1.2 mm channel)
Peds Gastroscopes
mm (2 mm channel)
8.6 mm-9.2mm (2.8 mm channel)

17. How it got started? Our Scopes are Very Similar Peds Bronchoscopes
2.8 mm (1.2 mm channel)
4 mm (2.8 mm channel)
Peds Gastroscopes
mm (2 mm channel)
8.6 mm-9.2mm (2.8 mm channel)
Our Scopes are Very Similar

18. The Feasibility?

19. Standard Pediatric Forceps (2 mm)
The Feasibility?
Standard Forceps (2.8 mm)
Standard Pediatric Forceps (2 mm)
Micro Forceps (1.2 mm)

20. Study Design and Flow

21. The Project Began Flow of TNE (NPO 2 hours prior)
Patient arrival and consent performed
Patient brought to clinic room
Movie goggles put on, lights dimmed
4% lidocaine administered 2 sprays left nostril, 4 sprays right nostril
Assure topical anesthesia achieved and procedural time out
ENT/Pulmonary performs nasal laryngoscopy with esophageal insertion
GI performs esophagoscopy/gastroscopy with biopsies
Patient discharged and asked to remain NPO until throat sensation returns to normal and/or 1 hour elapses from lidocaine administration.
9. Patient returns to regular activities.

22. Cohort Gender (n) Age in Years Ethnicity (n)
Average Number of Previous Endoscopies
Male 13
13 Years
Caucasian 19
2.19
Female 9
STD 2.7
Hispanic 2
STD 2.12
Native American 1

23. Efficiency and Cost of Procedure
Speed of Procedure Improved with Endoscopist Experience and Scope Size
Duration of TNE
Total Subjects (n)
TNE Subject Number
5-10 minutes 10
10, 13, 14, 15, 16, 17, 18, 19, 20, 21
10-15 minutes 8
2, 3, 4, 5 , 8, 9, 11, 12
>15 minutes 3
1, 6, 7
Average Charge Reduction per Subject for TNE was 60.1% less than their previous EGD
11 EGD’s Met Criteria for Comparison
(Isolated EGD without other procedures)
Average Charge EGD (SD )
vs.
Average Charge TNE (SD $254.42)

24. Efficiency of Procedure
Speed of Procedure Improved with Endoscopist Experience and Scope Size
Duration of TNE
Total Subjects (n)
TNE Subject Number
5-10 minutes 10
10, 13, 14, 15, 16, 17, 18, 19, 20, 21
10-15 minutes 8
2, 3, 4, 5 , 8, 9, 11, 12
>15 minutes 3
1, 6, 7
Average Duration of Time In Hospital:
45-60 minutes with follow up
90 minutes with research
180 minutes for sedated EGD at CHCO

25. Efficiency of Procedure
Speed of Procedure Improved with Endoscopist Experience and Scope Size
Duration of TNE
Total Subjects (n)
TNE Subject Number
5-10 minutes 10
10, 13, 14, 15, 16, 17, 18, 19, 20, 21
10-15 minutes 8
2, 3, 4, 5 , 8, 9, 11, 12
>15 minutes 3
1, 6, 7
Average Duration of Time In Hospital:
60 minutes with Follow up
90 minutes with Research
180 minutes for EGD at CHCO
Scope Size Subject 2-12: 2.8 mm
Scope Size Subject 1, 13-21: 4mm

26. Self Reported Symptoms
Total Subject #
Nausea 4
Choking/Gagging 12
Sore Throat 10
Vomiting 2
Chest Pain
Abdominal Pain 1
Other
No Significant Symptoms 7
No Significant Adverse Events
(1 subject had 1 drop blood as epistaxis)

27. Satisfaction with Procedure
Instrument/Question
Instrument Score
mGHAA-9 Score (Max 45 Points)
43.19 (SD 2.6)
Qualitative Satisfaction Instrument
Total Subject of 21 total(n)
Child: Satisfaction with TNE
17 (81%)
Parent: Satisfaction with TNE
19 (90.5%)
Parent/Child Satisfied with Sedated EGD
Parent Child Concerned about Sedated EGD
13 (61.9%)
Child: Willing to Repeat TNE
16 (76%)
Parent: Willing to Repeat TNE
21 (100%)
Child: Prefer to repeat TNE
11 (52.4%)-4 prefer neither EGD or TNE
Parent: Prefer to repeat TNE
18 (85.7%)-1 prefer neither EGD or TNE

28. What did we find? Visual Findings Total Specimens (n) Normal 10
Slight Furrowing 3
Furrowing 8
Biopsy Results
Total Specimens (n)
Normal Specimen 13
Eosinophils >15 hpf 5
Eosinophils <15 hpf 3

29. What did we find? p value between comparing both 2.8 mm groups 0.146
Biopsy Forceps
Sample Size
Average Epithelial Surface Area (mm2)
P value
Matched Paired Biopsy Sample
2.8 mm standard biopsy forceps
n=11
0.38 (SD 0.14)
P=0.308
TNE Sample
1.2 mm mini biopsy forceps
0.33 (SD 0.09)
n=9
0.52 (SD 0.19)
P=0.496
2.0 mm pediatric biopsy forceps
0.50 (SD 0.15)
p value between comparing both 2.8 mm groups 0.146

30. What did we find?
Biopsy with Active EoE using 2.8 mm forceps (Subject 2)
Surface Area 0.10 mm2
Biopsy from same patient with Active EoE using 1.2 mm forceps (Subject 2)
Surface Area 0.12 mm2

31. What did we find? Biopsy using 1.2 mm can also obtain lamina propria.
(Utility of Lamina Propria in EoE…ongoing debate)

32. Family Feedback
It did not require anesthesia, it took less time and it was not painful.
2. It was quick and he didn’t need to be under anesthesia.
3. Short duration of procedure. No anesthesia. Not Scary. Did have sore throat for 24 hours after.
4. She did not have to go under anesthesia
5. A lot less discomfort and time with endoscopies (TNE)
6. She was uncomfortable and in a lot of pain during and shortly after. Took to long
7. He did not have to be put to sleep which was great.
8. Minimally invasive

33. Conclusion and Future Conclusion:
Unsedated TNE is an effective, preferred, lower cost procedure
for monitoring the esophageal mucosal of children with EoE

34. What has happened since?
Demographics: 5 years of age to 21 years of age
Total # of TNE: 143
(March 2014-October 2016, 122 Since January 2015)
Adverse Events: None significant (3 scant epistaxis, 7 emesis)
Specimen Evaluation: all adequate
Being used for follow up of Barrett’s esophagus, Reflux Esophagitis, EoE,
Gasrtitis, and TEF monitoring.
Ongoing follow up study of specimen adequacy and use in other conditions ongoing

35. What has happened since?
Refinements:
New distraction techniques
New topical anesthesia methods
Newer scope technologies
Disposable Micro Forceps
Improving work flow
Training of others
Expansion and modification of in office procedures to other areas

36. TNE for TEF-EA 10 year old male with TEF/EA Symptoms: Dysphagia, GERD
Special Consideration:
family requested evaluation
Without anesthesia or radiology
Anastomosis
Mid Esophagus
LES

37. Transgastrostomy Esophagoscopy (TGE)
Permission by family given

38. Transgastrostomy Esophagoscopy (TGE)
Demographics: 9 children (10 TGE)
Age: 16 mos-21 years of age
Co-Morbidities: aspiration, metabolic disorder, heart transplant, liver transplant,
developmental delay and psychiatric disorders
Adverse Events: None Significant (gagging, stomach discomfort)
Biopsy Adequacy: All Adequate
Findings: 1 EoE, 4 Esophagitis, 5 normal (1 reactive gastropathy, 1 gastritis,
1 PPI effect)
Average Time in office: Around 60 minutes

39. Thank You and Questions
Aerodigestive Team
GEDP Team
Ben Corbett
Emily Deboer
Jacklyn Deck
Robin Deterding
Sparrow Helland
Jenny Maybee
Krystal Mesenbrink
Jeremy Prager
Bethany Thomas
Todd Wine
Nora Janosy
Melissa Brooks
Clint Smith
Dan Atkins
David Fleischer
Glenn Furuta
Calies Menard-Katcher
DHI Team
David Brumbaugh
Robert Kramer
Ron Sokol
Ed Hoffenberg