Gastroenterology Grand Rounds February 20, 2014 Fellow: David Tang, M.D. Faculty: Marcelo Vela, M.D.
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Transcript of Gastroenterology Grand Rounds February 20, 2014 Fellow: David Tang, M.D. Faculty: Marcelo Vela, M.D.
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Gastroenterology Grand Rounds
February 20, 2014Fellow: David Tang, M.D.
Faculty: Marcelo Vela, M.D.
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Case Presentation
• 36 year old White man• Heartburn x 10 years• Intermittent dysphagia and chest pressure x 2
years• EGD in 2011– Long segment Barrett’s Esophagus, Prague C10M10,
without dysplasia– Eosinophilic esophagitis
• Symptoms resolved with twice daily Nexium
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EGD 2013
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EGD 2013
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Case Presentation
• Histology
– Esophagus at 34 cm to 28 cm Intestinal metaplasia with low grade dysplasia at multiple levels
– Esophagus at 25 cm Squamous mucosa with > 40 intraepithelial eosinophils per high power field
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Diagnosis
Eosinophilic EsophagitisAnd
Barrett’s Esophagus with Low Grade Dysplasia
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Clinical Questions
• What is the difference in recommendations for RFA in patients with LGD vs HGD?
• What is the efficacy and durability of RFA for Barrett’s Esophagus with LGD?
• Should RFA be performed for Barrett’s Esophagus with LGD?
• What is the relationship between Barrett’s Esophagus and Eosinophilic Esophagitis?
• How safe is RFA of dysplastic Barrett’s in Eosinophilic Esophagitis?
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Carcinogenesis in BE
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Incidence of EAC in BE
• Non dysplastic BE EAC – 0.12% - 0.50% per year
• LGD EAC– 1.7% per year
• HGD EAC– 6.6% per year
Sikkema Am J Gastroenterol 2011Hvid-jensen NEJM 2011
Wani Am J Gastroenterol 2009
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Inter-observer Variability in LGD
• 147 patients with a community diagnosis of LGD during BE surveillance– 15% with LGD confirmation by two other expert
pathologists– 85 % down-staged to non dysplastic BE
• Incidence rate of progression to HGD/EAC– 13.4% in patients with confirmed LGD– 0.49% in patients down-staged to NDBE
Curvers Am J Gastroenterol 2010
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2011 AGA Guidelines
• “We recommend endoscopic eradication therapy with radiofrequency ablation (RFA) … rather than surveillance for treatment of patients with confirmed high-grade dysplasia”
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2011 AGA Guidelines
• “Endoscopic eradication therapy with RFA should also be a therapeutic option for treatment of patients with confirmed low-grade dysplasia in Barrett’s esophagus.”
• “In the absence of long-term studies showing efficacy, it is not clear that the potential benefit of ablation in reducing cancer risk for patients who have Barrett’s esophagus with low-grade dysplasia warrants the risks and substantial expense of the ablative procedures.”
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AIM Dysplasia Trial
• Multicenter RCT of RFA vs Sham procedure in dysplastic Barrett’s Esophagus
• N = 127– randomized in 2:1 ratio
• Primary outcomes– Complete eradication of LGD @ 12 mos– Complete eradication of HGD @ 12 mos– Complete eradication of IM @ 12 mos
Shaheen NEJM 2009
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AIM Dysplasia Trial
Intention to Treat Per Protocol0%
10%20%30%40%50%60%70%80%90%
100%81%
90%
19% 20%
RFASham
Eradication of HGD (N=43) @ 12 mos
Shaheen NEJM 2009
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AIM Dysplasia Trial
Intention to Treat Per Protocol0%
10%20%30%40%50%60%70%80%90%
100% 90% 95%
23% 26%
RFASham
Eradication of LGD (N=58) @ 12 mos
Shaheen NEJM 2009
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AIM Dysplasia Trial
LGD to HGD LGD to CA HGD to CA0%2%4%6%8%
10%12%14%16%18%20%
5%
0%2%
14%
0%
19%
RFASham
Progression of Dysplasia
Shaheen NEJM 2009
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AIM Dysplasia Extension
Shaheen Gastro 2011
LGD HGD68%
73%
78%
83%
88%
93%
98%98%
93%93%89%
CE-DCE-IM
Eradication @ 24 mos
Allowed for 1 session of “touch up” RFA @ 15 mos
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AIM Dysplasia Extension
Shaheen Gastro 2011
Durability of CE-D
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AIM Dysplasia Extension
Shaheen Gastro 2011Wani Am J Gastroenterol 2009
Incidence of Progression to EAC [per year]
LGD HGD
0.51% 0.60%
1.7%
6.6%
Post RFA
Natural History
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RFA Meta-analysis
Shaheen Gastroenterology 2011 Shaheen Gastrointest Endosc 2012
Orman Clin Gastroenterol Hepatol 2013
LGD HGD
93% 89%
68%56%
72% 68%AIM DysplasiaCommunity RegistryMeta-analysis
Eradication of Dysplasia
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RFA Meta-analysis
Adverse Events
Stricture Pain Bleeding
7.6%
2.5%
0.8%
5%
3%
1%
AIM Dysplasia
Meta-analysis
Shaheen Gastroenterology 2011 Orman Clin Gastroenterol Hepatol 2013
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AIM Dysplasia Extension
Shaheen Gastro 2011Orman Clin Gastroenterol Hepatol 2013
Wani Am J Gastroenterol 2009
Incidence of Progression to EAC
LGD HGD
0.51% 0.60%0.20% 0.40%
1.7%
6.6%
RFA - AIMRFA - Meta-analysisNatural History
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SURF Trial
Phoa Gastroenterology 2013
• European multicenter RCT of RFA vs Surveillance in LGD
• N = 136 randomized in 1:1• Primary outcome– Neoplastic progression (HGD or EAC) at 3 years
after randomization• Interim results at median 21 mos follow up
presented at DDW 2013
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SURF Trial
Phoa Gastroenterology 2013
CE-D CE-IM
98% 98%
37%
0%
RFASurveillance
Efficacy of RFA @ 12 mos
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SURF Trial
Phoa Gastroenterology 2013
Incidence Rate of Progression to ECA
LGD
0.9%
4%
1.7%
RFASurveillanceNatural History
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
• Computer model RFA and surveillance strategies of 50 year old “patients” followed until age 80 or death.
• Possible causes of death– Age related all cause mortality– RFA complications– Surgical esophagectomy mortality– Esophageal adenocarcinoma
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
• LGD cohort– Confirmed assume no initial diagnostic error– Stable LGD found on more than one EGD at least
6 months apart• Management– Endoscopic surveillance q 6 months x 1 year, then
yearly– RFA at 0, 2, 4, 9 mos, then “touch up” RFA as
needed
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
• RFA Outcomes– Residual dysplasia– CE-D– CE-IM– Recurrence of IM– Sub squamous intestinal metaplasia
• Incremental cost effective ratio (ICER)• Willingness to pay (WTP) set at
$100,000/QALY
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
Surgery
RFA
RFA
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
Willingness to Pay < $ 100,000 per QALY
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Barrett’s Esophagus and EoE
Ravi Am J Gastroenterol 2011
• Cross sectional study of 200 patients with BE
• 14 of 200 patients with BE (7%) found to have > 15 eosinophils/hpf on squamous biopsy
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Post RFA Esophageal Eosinophilia
Villa Dis Esophagus 2013
• Retrospective review of 148 patients with pre and post RFA esophageal biopsies
• 4 of 148 patients (2.7%) developed esophageal eosinophilia at 12 months– All four had LGD– None had clinical or endoscopic findings
suggestive of EoE– No pre RFA biopsies of squamous epithelium– Adverse events not reported
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Safety of Esophageal Dilation in EoE
Jung GIE 2011Cohen Clin Gastroenterol Hepatol 2007
• Retrospective single center study• N = 293 dilations in 161 patients– 9.2% mucosal tear– 0.3% major bleeding– 1% immediate perforation• All treated without surgery
• Prior study of 36 patients with complication rate of 31% and perforation rate of 8%
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Thank you
Dr. Marcelo VelaDr. Nicolas Villa
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Prasad G, Talley N, Romero Y, et al. Prevalence and predictive factors of eosinophilic esophagitis in patients presenting with dysphagia: a prospective study. The American journal of gastroenterology 2007;102:2627-2632.
Wolfsen H, Hemminger L, Achem S. Eosinophilic esophagitis and Barrett's esophagus with dysplasia. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2007;5.
Rodrigo S, Abboud G, Oh D, et al. High intraepithelial eosinophil counts in esophageal squamous epithelium are not specific for eosinophilic esophagitis in adults. The American journal of gastroenterology 2008;103:435-442.
Shaheen N, Sharma P, Overholt B, et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. The New England journal of medicine 2009;360:2277-2288.
Wani S, Puli S, Shaheen N, et al. Esophageal adenocarcinoma in Barrett's esophagus after endoscopic ablative therapy: a meta-analysis and systematic review. The American journal of gastroenterology 2009;104:502-513.
Jacobs J, Spechler S. A systematic review of the risk of perforation during esophageal dilation for patients with eosinophilic esophagitis. Digestive diseases and sciences 2010;55:1512-1515.
American Gastroenterological A, Spechler S, Sharma P, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology 2011;140:1084-1091.
Hvid-Jensen F, Pedersen L, Drewes A, et al. Incidence of adenocarcinoma among patients with Barrett's esophagus. The New England journal of medicine 2011;365:1375-1383.
Ravi K, Katzka D, Smyrk T, et al. Prevalence of esophageal eosinophils in patients with Barrett's esophagus. The American journal of gastroenterology 2011;106:851-857.
References
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Shaheen N, Overholt B, Sampliner R, et al. Durability of radiofrequency ablation in Barrett's esophagus with dysplasia. Gastroenterology 2011;141:460-468.
Spechler S, Sharma P, Souza R, et al. American Gastroenterological Association technical review on the management of Barrett's esophagus. Gastroenterology 2011;140.
Hur C, Choi S, Rubenstein J, et al. The cost effectiveness of radiofrequency ablation for Barrett's esophagus. Gastroenterology 2012;143:567-575.
Dellon E, Gonsalves N, Hirano I, et al. ACG clinical guideline: Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE). The American journal of
gastroenterology 2013;108:679.
Orman E, Li N, Shaheen N. Efficacy and durability of radiofrequency ablation for Barrett's Esophagus: systematic review and meta-analysis. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2013;11:1245-1255.
Villa N, El-Serag H, Younes M, et al. Esophageal eosinophilia after radiofrequency ablation for Barrett's esophagus. Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus / I.S.D.E 2013;26:674-677.
Falk G. Update on ablation for Barrett's esophagus. Current gastroenterology reports 2014;16:368.Fitzgerald R, di Pietro M, Ragunath K, et al. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus. Gut 2014;63:7-42.
References
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AIM Dysplasia Trial
Intention to Treat Per Protocol0%
10%20%30%40%50%60%70%80%90%
77%83%
2% 3%
RFASham
Eradication of IM @ 12 mos
Shaheen NEJM 2009
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AIM Dysplasia Extension
Shaheen Gastro 2011
• 2 year extension of AIM Dysplasia• Original control arm offered cross over to RFA• N = 119– 106 patients completed 2nd year of follow up• 100 eligible for extension through year 5
– 56 completed 3rd year of follow up at time of publication
• Durability of eradication of both dysplasia and metaplasia assessed at 2nd and 3rd year
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AIM Dysplasia Extension
Shaheen Gastro 2011
Durability of CE-IM
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AIM Dysplasia Extension
Shaheen Gastro 2011
Progression of Dysplasia
• 5 of 119 (4.3%) with progression of any type• 3 LGD HGD
– 2 with eventual CE-IM– 1 with EMR of focal HGD and withdrew from study
• 1 LGD to EAC– Initially randomized to Sham arm x 12 mos– RFA x 3 after crossing over– Eventual EMR of focal EAC
• 1 HGD to EAC– EMR of focal EAC– Eventual CE-IM at 3 years
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RFA Meta-analysis
• Efficacy of RFA– 3802 patients• 2135 patients in RFA registry from 148 community and
academic practices
• Durability of RFA– 540 patients
Orman Clin Gastroenterol Hepatol 2013
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RFA Meta-analysis
Orman Clin Gastroenterol Hepatol 2013
IM Recurrence
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Cost Effectiveness of RFA
Hur Gastroenterology 2012
• Assumptions– NDBE EAC 0.12%, 0.33%, 0.50%– LGD EAC 0.19%, 0.5%, 0.75%
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Eosinophilic Esophagitis
• Symptoms– Dysphagia, Food impaction– Reflux– Dyspepsia
• Associated with atopy • Requires > 15 eos per HPF on biopsy
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Overlap of EoE and GERD
Attwood Am J Gastroenterol 1993
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Overlap of EoE and GERD
Rodrigo Am J Gastroenterol 2008
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Diagnosis of EoE
Dellon Am J Gastroenterol 2013