what’s new in the management of esophageal disease€¦ · what’s new in the management of...

6/2/2014

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What’s New in the Management of Esophageal Disease

Philip O. Katz, MD Chairman, Division of Gastroenterology

Einstein Medical Center Philadelphia Clinical Professor of Medicine

Jefferson Medical College Philadelphia, PA

Disclosure of Conflicts of Interest

• Philip O. Katz, MD, FACG, has affiliations with Takeda Pharmaceuticals (Honoraria); Ironwood Pharmaceuticals, Inc., Pfizer Consumer Health (Consultant).

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Comparative Effectiveness of Novel Techniques for Barrett’s Esophagus

Screening in the Community: A Prospective Randomized Trial

Gastrointest Endosc 2014; 79 (5S) [Abstract 160] AB113-114

Comparative Effectiveness of Novel Techniques for Barrett’s Esophagus Screening in the Community:

A Prospective Randomized Trial (cont’d)

• Screening for Barrett’s controversial

• Cost is major reason

• Transnasal EGD is less expensive (no sedation, etc.)

• Patients randomized to TNE or sedated EGD

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Comparative Effectiveness of Novel Techniques for Barrett’s Esophagus Screening in the Community:

A Prospective Randomized Trial (cont’d)

Results:

• Each completed at same rate

• Sedated better tolerated, shorter esophagus evaluation time

• Biopsy success better with sedated EGD

• Findings overall similar

Conclusion: TNE feasible for screening

A FISH Biomarker Panel for the Prediction of High-grade Dysplasia

and Adenocarcinoma in Non-Dysplastic Barrett’s Esophagus:

Results from a Long-term Prospective Cohort Study


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A FISH Biomarker Panel for the Prediction of High-grade Dysplasia and Adenocarcinoma in

Non-Dysplastic Barrett’s Esophagus: Results from a Long-term Prospective Cohort Study (cont’d)

• Stratifying risk for Barrett’s difficult

• Biomarkers are still under investigation

• Prospective study in 428 non-dysplastic patients

• P16, 53 Her-2/neu, 20 q and MYC aneuploidy

• -16, aneuploidy double risk for HGD/EAC

• Increase risk to 2%/year

Conclusion: Markers may be useful but still not mainstream

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Esophageal Brush Biopsy with Computer-assisted Tissue Analysis

Increases Detection of Barrett’s Esophagus and Dysplasia in a

Multi-site Community-based Setting

Gastrointest Endosc 2014; 79 (5S) [Abstract 371] AB294

Esophageal Brush Biopsy with Computer-assisted Tissue Analysis Increases Detection of

Barrett’s Esophagus and Dysplasia in a Multi-site Community-based Setting (cont’d)

• Standard biopsy protocol for Barrett’s maligned

• Wide area transepithelial sampling (WATS3D) can improve detection of dysphagia

• 2559 patients – EGD plus WATS3D

– GERD, possible or proven BE

• Overall – 377 cases of BE (15.1%)

• Dysplasia detection 10 cases of dysplasia and only EAC missed by biopsy

Conclusion: Adding WATS3D increases yield

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Inter-observer Agreement Among Pathologists Using Wide Area

Transepithelial Sampling of Barrett’s Esophagus with

Computer-assisted Analysis


Inter-observer Agreement Among Pathologists Using Wide Area Transepithelial Sampling of Barrett’s

Esophagus with Computer-assisted Analysis (cont’d)

Overall (95% CI) HGD/EAC (95% CI) IND/LGD (95% CI) NDBE (95% CI)

0.86 (0.75-0.97) 0.95 (0.88-0.99) 0.74 (0.61-0.85) 0.88 (90.81-0.94)

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Modifiable Risk Factors Predict Recurrence of Barrett’s Esophagus

After Successful Radiofrequency Ablation


Modifiable Risk Factors Predict Recurrence of Barrett’s Esophagus After Successful Radiofrequency Ablation (cont’d)

All (n=180) Recurrence (n=20) No Recurrence (n=160) p-value

Age mean years + SD 68 + 10 63 + 10 69 + 10 0.01

White n (%) 171 (98) 20 (100) 151 (98) 0.52

Male n (%) 132 (73) 13 (65) 119 (74) 0.37

BMI mean + SD 30 + 5.7 31 + 8.5 29 + 5.3 0.62

Current Alcohol n (%) 81 (45) 4 (20) 77 (48) 0.02

Current Tobacco n (%) 27 (15) 8 (40) 19 (12) 0.0009

Current NSAID n (%) 86 (48) 6 (30) 80 (50) 0.09

Anti-reflux Surgery n (%) 8 94) 0 (0) 8 (5) 0.31

Hiatal Hernia n (%) 161 (89) 18 (90) 143 (89) 0.93

Prague C mean cm + SD 1.2 + 2.3 1.7 + 2.8 1.1 + 2.2 0.36

Prague M mean cm + SD 4.4 + 3.0 5.5 + 2.9 4.2 + 2.9 0.051

Days Treatment mean + SD 171 + 166 170 + 131 171 + 170 0.58

Days Surveillance mean + SD 863 + 520 1032 + 608 842 + 506 0.17

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All (n=180) Recurrence (n=20) No Recurrence (n=160) p-value

Worst Treatment Histology

NDBE 5 (3) 1 (5) 4 (3)

LGD 56 (31) 6 (30) 50 (31)

HGD 102 (57) 12 (60) 90 (56)

EAC, non-invasive 17 (9) 1 (5) 16 (10)

Unadjusted OR [95% Cl] Adjusted * OR [95%CI]

Current Alcohol 0.26 [0.08, 0.85] 0.30 [0.09, 0.99]

Current Tobacco 5.02 [1.76, 14.30] 4.76 [1.49, 15.22]


Table 2: Odds Ratio from Logistic Regression Predicting Recurrence

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The Yield of Early Follow-up Endoscopy in Patients with Initial

Nondysplastic or Low-grade Dysplasia Barrett’s Esophagus


The Yield of Early Follow-up Endoscopy in Patients with Initial Nondysplastic or

Low-grade Dysplasia Barrett’s Esophagus (cont’d)

• Missed HGD or EAC in 2.2% (4 patients) on initial EGD

• Long segment

• All white men

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Surveillance Endoscopy is Associated with Improved Outcomes of

Esophageal Adenocarcinoma (EA) Detected in Patients with Barrett’s

Esophagus (BE)

Gastroenterology 2014; 146 (S1) [Abstract 709] S123

Surveillance Endoscopy is Associated with Improved Outcomes of Esophageal Adenocarcinoma (EA) Detected in Patients with Barrett’s Esophagus (BE) (cont’d)

• Surveillance for Barrett’s debated to efficacy

• VA database – 29,504 cases of BE, 433 EAC

• All men, 86% white, mean age 67

• 192 diagnosed on surveillance EGD/241 diagnostic

• Surveillance cases earlier stage (OR 2.94, 1.87-4.64)

• Surveillance decreased mortality (HR 0.51, 0.38-0.60)

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Prevalence and Characteristics of Esophagitis and Barrett’s

Esophagus in Population Subjects Without Gastroesophageal Reflux Symptoms: Results From a Large

Randomized Controlled Study

Gastroenterology 2014; 146 (S1) [Abstract 105] S28-29

Prevalence and Characteristics of Esophagitis and Barrett’s Esophagus in Population Subjects Without Gastroesophageal Reflux Symptoms: Results From a Large Randomized Controlled Study (cont’d)

Symptomatic GER Group (69)

Asymptomatic GER Group (140)

Comparison p value

Esophagitis Prevalence Grade A Grade B Grade C

22 (31.9%) 8 12 2 40 (28.5%) 21 17 2 0.78

BE Prevalence Mean (SD) length 6 (8.7%) 3.5 (2.4) I (1.4%)

11 (7.9%) 2.6 (1.4) 2 (1.4%)

0.49 0.62

Diaphragmatic hernia present (%) Mean (SD) size (cm)

44 (63.7%) 3.6 (2.1)

79 (56.4%) 2.6 (0.9) 026 0.001*

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Prevalence and Characteristics of Esophagitis and Barrett’s Esophagus in Population Subjects Without Gastroesophageal Reflux Symptoms: Results From a Large Randomized Controlled Study (cont’d)

Group 1: No Esophageal Injury + (142)

Group 2: Symptomatic GER Group with Esophageal Injury or Metaplasia + (23)

Group 3: Asymptomatic GER Group with Esophageal Injury or Metaplasia + (44)

Comparison of Group 1 vs. Group 2 & 3 p value

Comparison of Group 2 vs. Group 3 p value

Age (SD) 70 (9) 73 (9) 69 (9) 0.91 0.89

Male proportion (%)

55 (38.7%) 12 (52.2%) 29 (65.9%) 0.004* 0.15

WHR Mean (SD) 0.89 (0.1) 0.91 (0.09) 0.95 (0.09) 0.013* 0.15

BMI Mean (SD) 29.2 (10.7) 30.8 (6.0) 29.5 (5.1) 0.62 0.33

Smoker (>30 PY) (%)

20 (14.1%) 2 (13.1%) 6 (13.6%) 0.89 0.94

Excess Alcohol Use ‡ (%)

10 (8.7%) 3 (13.1%) 11 (25.0%) 0.014* 0.23

+ Esophageal injury includes presence of BE or esophagitis LA criteria Grade A, B, C

‡ Excess alcohol consumption classified as greater than 2 alcoholic beverages per day * p<0.05 considered significant

Gaviscon Double Action (Antacid + Alginate) Versus Equivalent Antacid

for Postprandial Acid Reflux: A Double-blind Crossover Study in

GERD Patients

Gastroenterology 2014; 146 (S1) [Abstract 103] S27-28

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Gaviscon Double Action (Antacid + Alginate) Versus Equivalent Antacid for Postprandial Acid Reflux: A

Double-blind Crossover Study in GERD Patients (cont’d)

Proximal extent of reflux

Reflux events, Gaviscon Reflux Events, Antacid

Acid, n=34* n (%)

Total, n=144 n (%)

Acid, n=78 n (%)

Total, n=169 n (%)

LES + 5 cm 5 (15%) 18 (13%) 7 (%) 19 (11%)

LES + 7 cm 9 (27%) 24 (17%) 13 (7%) 35 (21%)

LES + 9 cm 18* (53%) 76 (53%) 47 (60%) 85 (50%)

LES + 15 cm 1 (3%) 8 (6%) 4 (5%) 6 (4%)

LES + 17 cm 1* (3%) 18 (13%) 7 ((%) 24 (14%)

* P<0.05 vs antacid, Student’s T=test or Kruskal-Wallis

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Long-term Efficacy of PPI Therapy in Patients with PPI-responsive

Esophageal Eosinophilia: An International Multicenter Study


Long-term Efficacy of PPI Therapy in Patients with PPI-responsive Esophageal Eosinophilia: An International Multicenter Study (cont’d)

• 40 PPI-REE patients

• PPI equivalent to OME 20, 40/day or 40 BID to remission

• Taper based on symptoms

• EGD, biopsy @ 12 months (or more)

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Long-term Efficacy of PPI Therapy in Patients with PPI-responsive Esophageal Eosinophilia: An International Multicenter Study (cont’d)

• Initial dose – 18 (high) 22 (40)

• Maintenance – 19 (40 Ome) 22 (20 Ome)

• 26/40 remained in remission

• Most recurrence distal and resolved with increased dose

Two New Budesonide Formulations Are Highly Efficient for Treatment of

Active Eosinophilic Esophagitis: Results From a Randomized, Double-

blind, Double-dummy, Placebo-controlled Multicenter Trial


6/2/2014

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Two New Budesonide Formulations Are Highly Efficient for Treatment of Active Eosinophilic Esophagitis: Results From a Randomized, Double-blind, Double-dummy, Placebo-controlled Multicenter Trial (cont’d)

• Steroids are commonly used in EoE

• Optimal dose and delivery system are not known

• Budesonide effervescent tablet (2 x 1 mg/d) and viscous suspension (2 x 2 mg/d)

• Dysphagia improved in both groups

• Tolerated well

Presence of Basal Cell Hyperplasia and Dilation of Intercellular Spaces and Their Association with Baseline Impedance Values in Patients with

Positive Symptom Association Despite Normal Acid Exposure Further

Supports Their Role in Symptoms Generation In NERD


6/2/2014

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Presence of Basal Cell Hyperplasia and Dilation of Inter- cellular Spaces and Their Association with Baseline Impedance Values in Patients with Positive Symptom Association Despite Normal Acid Exposure Further Supports Their Role in Symptoms Generation In NERD (cont’d)

BCH PE DIS Neu/Eos

B1 at 3 cm

B1 at 5 cm

B1 at 3 cm

B1 at 5 cm

B1 at 3 cm

B1 at 5 cm

B1 at 3 cm

B1 at 5 cm

Grade 0-1

2300 (840-4225)

2100 (560-3300)

2415 (560-4225)

2282 (640-3300)

2930 (880-4225)

2850 (560-3540)

2200 (560-4225)

2080 (580-4060)

Per-oral Endoscopic Myotomy for Achalasia: Outcomes of a Large

Prospective Series


6/2/2014

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Per-oral Endoscopic Myotomy for Achalasia: Outcomes of a Large Prospective Series (cont’d)

• POEM is new treatment for achalasia

• Place not known as technique expertise, results evolving

• 119 patients underwent POEM; 81 classic 38 vigorous (Type III)

• Successful POEM in 95%, 6 aborted

• Follow up 12-24 months

• GERD 46%, EE 25%, 14 complained of heartburn

Conclusion: POEM feasible but NOT in all, successful mostly GERD common by tests

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