De Matthaeis M. Endoscopia Operativa Avanzata: quando e dove. ASMaD 2013

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  • * Refer to Most Current Version of the Instructions for Use Precautions
    PRECAUTIONS (Rev. D)
    Use of this device has not been studied in or may be more difficult, less effective, or less well-tolerated in patients with:
    Barrett’s esophagus length greater than 6 cm,
    age under 18 years,
    esophageal stricture preventing passage of endoscope with catheter;
    active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus;
    history or current diagnosis of malignancy of the esophagus;
    any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other);
    any previous endoscopic mucosal resection within the esophagus (recent studies have allowed 8 weeks after EMR prior to use of this device to allow complete healing);
    any previous surgery with staples present, as staples may interfere with the performance of this device and may lead to complications;
    an implantable pacing device unless permission is provided by the specialist responsible for the pacing device;
    nodularity of the esophageal mucosa.
  • To ensure safety and efficacy, we conducted trials on porcine specimens before humans
    During the dosimetry (dose-scaling) trial we figured out how deep we can go without causing damage to the submucosa
    Walk the physician through the layers from 5 joules to 20…... 20 joules being where strictures could happen.
    The results from the study indicated that the technology can ablate to a very specific depth without causing serious complications (strictures and buried glands) using
    10J/CM² & 12J/CM²,
  • De Matthaeis M. Endoscopia Operativa Avanzata: quando e dove. ASMaD 2013

    1. 1. HOT TOPICS IN GASTROENTEROLOGIA 2013: TEN TOPICS IN TEN MINUTES Endoscopia operativa avanzata Marina de Matthaeis Ospedale di Lavagna
    2. 2. Operative Endoscopic Procedures  Endoscopic mucosal resection EMR  Endoscopic mucosal dissection ESD  Radiofrequenty ablation RFA  Management of malignant obstrucions
    3. 3. Resection Modality according to tumor size size < 20 mm size >20 mm En-Bloc EMR Piecemeal EMR ESD
    4. 4. EMR “Strip biopsy” “Suck and ligate” “Duette”
    5. 5. Cestari 2010
    6. 6. EMR-C  Controlled suction  Submucosal injection Hydroxypropyl methylcellulose  Succinyl gel  Adrenaline (1:150.000)  Indigo carmine 
    7. 7. ESD
    8. 8. ESD DEVICE
    9. 9. HALO360 System • Balloon-based endoscopic ablation • Circumferential ablative therapy • Controlled depth • energy density, electrode geometry • Multiple trials for IM +/- dysplasia • Short and long segments studied
    10. 10. Circumferential Ablation Focal Ablation
    11. 11. Esophageal epithelium ~500µm Lamina Propria Muscularis Mucosae HALO System Ablation Depth ~1,000µm Submucosa Approximate EMR Depth Muscularis Propria Confidential 06-06-08 Confidential 06-06-08
    12. 12. Porcine Dosimetry Trial (n = 50) [J/cm2 = energy density = depth of ablation] G G 10 J/cm2 20 J/cm2 15 J/cm2 12 J/cm2 5 J/cm2 8 J/cm2
    13. 13. Histologic section
    14. 14. Incidence of lymph node metastases Infiltration IM esophagus Sm esophagus IM stomach Sm stomach IM colon Sm1 colon Lymp node (N) 1 - 3% 12% 2.2% 10 – 15% 0% 3.2% Colon depth>1mm RR 5.2 (95%CI 1.8-15.4) Bosch S. Endoscopy 2013;45:827-834
    15. 15. Stepwise radical endoscopic resection (4 referral centers – retrospective) 169 patients BE lenght ≤ 5 cm (3 cm; 2-5 cm) EMR every 4-8 weeks (50% circumf.) Technique EMR-C, Multi-Band-EMR, simple snare, ± APC (61%) N sessions 2-6 CE 97.6% (npl) 85.2% (SIM) Pouw RE, et al. Gut 2010
    16. 16. Complications Pouw RE, et al. Gut 2010
    17. 17. Post-EMR Esophageal Stenosis
    18. 18. One step circumferential endoscopic mucosal cap resection of Barrett’s esophagus with early neoplasia One_Step_Flowchart_Legend.doc Conio submitted to Clin Res Hepatol Gastroenterol 2013
    19. 19. Radiofrequency Complete Eradication IM or Dysplasia in BE At 2 years At 3 years CE-D CE-IM CE-D CE-IM Strictures 7,6% patients 101/106 99/106 patients 55/56 51/56 % 95% 93% % 98% 91% Shaheen NJ, et al Gastroenterology 2011
    20. 20. Durability of RFA in Barrett’s esophagus with dysplasia 119 106 patients Aims: Eradication of neoplasia (CEN) Eradication of BE (CEM) Durability of response Disease progression Adverse events Shaheen NJ et al., Gastroenterology 2011
    21. 21. AGA position statement • HGD: Endotherapy with RFA, PDT, EMR is recommended rather than surveillance review of the evolution of BE • LGD: RFA should be a therapeutic option for treatment of patients with confirmed LGD • NDBE: RFA with or without EMR should be a therapeutic option for select individuals with NDBE who are judged to be at increased risk for progression to HGD or cancer Gastroenterology 2011;140:1084-91
    22. 22. AGA position statement • “We recommend that endoscopic resection of nodular dysplastic BE be performed to determine the stage of dysplasia before considering other ablative endo-scopic therapy”.
    23. 23. • RFA recommened for HGD • RFA justified for LGD (diagnosis confirmed by a second pathologist) • Flat-type low risk of subsquamous glands • Non Flat-type induce squamous overgrowth of neoplastic lesions • Potent acid soppressor to optimize the results • Selected patients will do well with RFA, with a longer life expenctancy, higher risk of progression. Bergman J.J, Corley D.A. Gastroenterology 2012
    24. 24. 5 years overall mortality rate 7% after curative resection. Non patient died of gastric cancer Endoscopy 2013;45:703-707
    25. 25. Esophageal cervical stent Montgomery Life Europe
    26. 26. Esophageal Stent Niti-S Taewoong SX-Ella EllaCS Alimaxx-E Alveolus Polyflex Boston Scientific
    27. 27. Duodenal Stent Wallstent Hanaro Niti-S Ella Wallflex Life Europe
    28. 28. Complication
    29. 29. Esophageal Stent: Recommendations • SEMS and Plastic Stent to treat unresectable or advanced • • • • • • metastatic esophageal cancer. US FDA approved plastic stent for benign refractory strictures. Biodegradable SEMS for selected pz with refractory benign strictures Mediastinal tumor, tracheal compression SEMS covered treatment of choice in malignant tracheoesophageal fistula Reintervertion 10-50%: migration, tumor ingrowth, food obstruction Serious adverse event: 5,4% intra procedural
    30. 30. Biliary Stent Alimaxx-B Sx-Ella Boston Cook TaeWoong
    31. 31. Colon Stent Wallstent -Boston Z-stent Cook Life Europe Niti-S
    32. 32. Endoscopic stenting as “bridge to surgery” A meta-analysis 405 stent-471 emerg group • Migration 0-10.5% • Perforation 0-12.8% • Silent Perforation 0-26.6% • Stoma creation 0-51% SBTS and 0-96% Em.S • Protective stoma 0-30% SBTS and 0-31% Em.S • Primary anastomosis 44.7-100% SBTS and 13.8-100% Em.S • Anastomotic leakage 0-10.6% SBTS and 0-30.7% Em.S • Other morbidities 0-30% SBT and 11.4-48.2% of Em.S • Infection 0-22%og SBTS and 0-46.1% of Em.S • Mortality no significant differences 0-33% and 0-42.9% • Hospital stay 6-23 and 8-23 days De Ceglie et al Critical Reviews in Oncology/Hematology 2013
    33. 33. Endoscopic stenting as “bridge to surgery” • Clinical success 94.2% • Stent-related mortality was 0.58% “ SEMS were most effective in left-sided complete colonic obstrucion because they have a lower complication rate and higher success rate” • About the decision: • Consultation surgeon/endoscopist/radiologist De Ceglie et al Critical Reviews in Oncology/Hematology 2013
    34. 34. VIDEO ED EVENTUALI DIAPOSITIVE PER LA DISCUSSIONE
    35. 35. ESD BARRETT
    36. 36. DUETTE EMR
    37. 37. EMR CIECO
    38. 38. OTSC (over the scope clipping system)
    39. 39. Cervical esophageal stent

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