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Endoluminal Treatment of Barrett’s and Early Cancer. Brant K. Oelschlager, MD University of Washington. Paradigm Shifts in GI Diseases. Dilemma’s Associated with HGD/IM Cancer. Diagnostic Confidence in the diagnosis has an impact on treatment Malignant risk of the lesion
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Endoluminal Treatment of Barrett’s and Early Cancer Brant K. Oelschlager, MD University of Washington
Dilemma’s Associated with HGD/IM Cancer • Diagnostic • Confidence in the diagnosis has an impact on treatment • Malignant risk of the lesion • Is everyone’s risk the same? • Completeness of Resection/Ablation • How confident can we be? • Morbidity and Mortality of Treatment • Moving target and is provider specific • Eradication of Disease • Cancer, Dysplasia, Barrett’s, GERD
What we learned from surveillance? • With more accurate diagnosis • Better imaging • Better biopsies • Better pathologic recognition • The incidence of progression to cancer goes down • Fewer cancers go undetected
Prerequisites for Endoscopic Therapy • No Under-staging • Low failure rate • Accurate assessment of failures • Low complication rate • Excellent functional result • A method for dealing with the underlying disease • ? Consistency among practitioners
Prerequisites for Surgical Therapy • Low complication rate • Reasonable functional result • ? Consistency among practitioners
Risk Benefit Choice UNFAVORABLE FAVORABLE RISK Surgery circa 2000 Surgery 2010 Endo Tx circa 2000 Endo Tx 2010 BENEFIT
Problems with the Literature • Surgical Literature • All patients or those with unfavorable characteristics • Light on Quality of Life • Lack of consistent approach • Endoscopic Literature • Moving target • Lesions with favorable features • Short follow-up • All from the experts and innovators, none from the “community standard”
Post-Therapy Management • Post-Endoscopic Therapy • Monetary and emotional costs of surveillance • QOL of ongoing GERD • Anti-reflux Surgery • Post-Surgical Therapy • Few effective interventions for gastric emptying and dumping • Do they need surveillance as well • Can’t go back
Does One Shoe Fit All? • Young vs. Old • Long vs. Short Segment Barrett’s • Unifocal vs. Multifocal Disease • Well differentiated vs. Poorly differentiated • Nodular vs. Flat lesions • Symptomatic vs. Asymptomatic GERD
Initial Management of HGD/Early CA • Surveillance, Mapping biopsies • Diagnose Cancer • Length of Barrett’s • “Mapping” - Multi-focal disease • EUS • Depth of invasion – Submucosal involvement • Nodal Disease – Contraindication for Endoscopic Therapy • EMR • Diagnostic • Diagnosis of Cancer • Depth of Invasion • Therapeutic
Risk of Lymph Node Metastases • 15-25% for submucosal involvement • < 3% for intramucosal carcinoma • < 2cm in diameter, w/o ulcer/nodule <1% • Lower risk of metastases than mortality from surgery (0.36% vs. 0.5%)
Outcome of EMR for HGD/Early Cancer EMR Therapy alone – UC experience • 49 Complete EMR eradication • 33 HGD • 16 IMC • 22 patients (45%) – Stage changed • 18 (37%) developed stenosis Chennat J. Am J Gastro 2009
EMR +/- Ablation for Early Cancer • 178 patients with T1a AdenoCA • 132 Endoscopically Tx • Older • More Comorbidities • 46 Esophagectomy • Longer Segment BE • Mean f/u 64 mo • 12% recurrence rate in ENDO group • All successfully retreated Prasad GA. Gastroenterology 2009;137:815
EMR +/- Ablation for Early Cancer = Prasad GA. Gastroenterology 2009;137:815
Controlled ablation depth by: • Bipolar balloon based electrode • Fixed energy density • Fixed power • Automated RF delivery Magnified electrode Radiofrequency Energy Ablation
RFA Ablation for HGD • Multi-centered RCT • Treatment/Sham - 2/1 • LGD/HGD • Complications: • Hemorrhage - 1 Patient • Stricture – 5 Patients (6%) 77% 91% 81% n=43/84 n=22/42 n=21/42 Shaheen N. N Eng J Med. 2009;360:2277
Multi-Modality Therapy for Early Barrett’s Neoplasia: Endoscopic Resection Followed by Radiofrequency Energy Ablation
Ablation of Non-Dysplastic Barrett’s • 8 Centers – 70 Patients w/ IM (2-6cm) • f/u 1, 3, 6, 12, 30 mo • At 12 months • CR in 48/65 (69% ITT) • -Additional focal ablation- • At 30 months • CR in 60/61 (97% ITT) • No Strictures or buried glandular mucosa • No Serious Adverse Events Fleischer DE. Gastrointest Endosc 2008;68:867.
Spray Cryotherapy for Dysplastic Barrett’s Esophagus • 10 Sites - Retrospective case series for BE with HGD • N = 98 patients • 29.4% had prior EMR • Mean length of BE of cohort was 5.4 cm • Mean age was 64.1 years • Mean procedure time was 31.4 minutes • 10.5 month mean follow up • 1 progression to cancer • NO SAE’s, Stricture rate 3% patients and 1% of treatments • 96.7% with no, mild or moderate pain • Median of 4 tx sessions, Treatment complete for 61 patients • Efficacy results: • 97% complete eradication of HGD • 86% complete eradication of dysplasia Segment of BE Before (top) and During Spray Cryotherapy
Spray Cryotherapy for Esophageal Cancer • 10 Sites - Retrospective case series for Esophageal Cancer • N = 79 patients - All patients refused, failed, or were ineligible for conventional therapies! • Previous tx: EMR-27, PDT-11, XRT-7, Chemo/XRT-9, Chemo/XRT/Surgery-2, Concurrent XRT-12, Chemo-1, Stent-1, RFA-1, Concurrent EMR-9 • Mean age of 76 years • 3.7 cm mean tumor length (T1= 60, T2 =16, T3 = 2, T4 =1) • 10.8 month average follow up • Median of 3 tx sessions • Treatment complete for 44 patients • CR- CA = 70.5%; CR-HGD = 68.2%, CR-D = 69.1% Before Adenocarcinoma 82 year-old T1sm After Before During 1 Year After Squamous Carcinoma BD Greenwald et al.: DDW 2009 (10 Centers)
Submucosal Dissection • Major advantage: complete specimen for histopathologic analysis • Uses a electrocautery knife to acquire a single en bloc specimen (higher success rate vs EMR) • Technically difficult, prolonged procedure times • Scarred lesions more difficult • Higher complication rate vs EMR: bleeding, perforation • Limited data: only retrospective with majority performed in Japan studying gastric cancer, no comparative data
Treatment Algorithm Staging Endoscopy & EUS Multi-focal HGD/IM CA Good Risk Uni-focal HGD/IM CA Multi-focal HGD/IM CA Poor Risk EMR Positive Peripheral Margins Endoscopic Ablation Esophagectomy Negative Deep/Peripheral Margins Positive Deep margins or Lympho-vascular Invasion Frequent Surveillance