10. 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
20. 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
21. 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
22. 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
23. 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
24. 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”.
25. • 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
26. 5 years overall mortality
rate 7% after curative
resection. Non patient
died of gastric cancer
Endoscopy 2013;45:703-707
35. 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
36. 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
* 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,