Download The Spray Cryotherapy Liquid Nitrogen (LN2) System

RFA and Cyrotherapy for
Esophageal Disease
Daniel L. Miller MD
Chief, General Thoracic Surgery
WellStar Healthcare System/
Mayo Clinic Care Network
Clinical Professor of Surgery
Medical College of Georgia/
Georgia Regents University
Barrett’s Esophagus is Caused
by Chronic GERD
Chronic Injury
Endoscopic Image of a
Normal Esophagus
Cancer risk - 30 – 40 fold
increase
0.5 – 1.0% risk of
cancer per year
Barrett’s Esophagus
Barrett’s “Ideal” Treatment
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Endoscopic approach
Remove all intestinal metaplasia; circumferential
Uniform, reproducible, treatment depth
Target depth…muscularis mucosae
No injury to submucosa or deeper structures
Very low risk of complications
No buried glands
Quick and efficient; Re-treatment if required
Prevent Cancer development
Techniques for Mucosal Ablation
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Thermal
Argon plasma coagulation
 Lasers: Argon, Nd: YAG, KTP-YAG
 Radiofrequency Ablation (HALO 360)
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Chemical
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Photodynamic Therapy
New Technology
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CSA – CryoSpray Ablation
Ablation Technical Challenges
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Hand-held “Point and Shoot”
Technically demanding
Non-uniform ablation
Uncontrolled power delivery
Visual endpoint for completion
Anatomy of distal esophagus
not considered, its not round
Repeat therapy is the rule
Human Esophagus
Ablation Target
Muscularis mucosae
(Ablation Target Depth)
HGD
T1a
T1b
RFA Depth
Submucosa with
Submucosa
esophageal
glandswith
esophageal glands
EMR Depth
Muscularis
ularis propria
propria
CryoSpray Depth
Surgical Depth
How Ablation with the
HALO360 System Works
HALO360
Ablation Catheter
Balloon Based Bipolar Design
•Allows for 360 Degree Ablation of Targeted Tissue creating an even target 300 W (10 to 12 J/S2) – 300 msec
• Eliminates “Point and Shoot”;
• Energy Density and Ablation Depth Control of less than 1000 um prevent strictures or perforations
Radiofrequency Ablation
Complete Response after HALO360
Efficacy and Durability of RFA
for BE: Systematic Review and
Meta-analysis
Orman ES, Nan L, Shaheen NJ
Clinic Gastroeneterol Hepatol
2013:25;1 - 11
Results
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18 studies of 3802 patients reporting efficacy
6 studies of 540 patients reporting durability
Compete eradication after RFA
Intestinal metaplasia – 78% (70 - 86%) of patients
 Dysplasia – 91% (87 - 95%) of patients
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After eradication
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Intestinal metaplasia recurred – 13% (9 - 18%)
Progression to cancer
0.2% of patients during treatment
 0.7% of patients after CE-IM
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Esophageal stricture – 5% (3 - 7%) of patients
Pain – 3% (0 - 31%); Bleeding 1% (1 - 2%)
The Spray Cryotherapy
Liquid Nitrogen (LN2) System
Spray Cryotherapy: The CSA System
Energy Transfer
Extreme Cold (-196°C) Liquid Nitrogen
contacts tissue prior to phase shift
Rapid transfer of Thermal Energy
≈ 25W of energy delivered to treatment site
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Cryogen - LN2
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Continuous cryogen flow
Broad and focal coverage
Low pressure spray (< 5 psi at treatment site) of
non-toxic cryogen
No risk of fire
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Tissue Effect
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Treats over and through stents, mesh and
other appliances
Histological studies confirm preservation
of stromal components
Spray Cryotherapy: Procedure
Endoscope is introduced and
treatment area is mapped out
with team
Placement of the Cryo
Decompression Tube (CDT)
Spray Cryotherapy: Procedure
Insert and advance catheter through the biopsy channel of the endoscope
Spray Cryotherapy: Catheters
Spray Cryotherapy: Procedure Initiation
The Spray Cryotherapy
Liquid Nitrogen (LN2) System
Spray Cryotherapy: Procedure
Courtesy Dr. Fukami from the University of Colorado
LN2 Spray Cryotherapy
Depth of Injury
Controlled by Three Variables:
 Length of tissue freeze time
 Number of freeze–thaw cycles
 Amount of tissue targeted
Spray Cryotherapy for Barrett’s Dysplasia:
National CryoSpray Registry
96 patients (83% male); Two year follow-up (83%)
HGD – 67%, Long Segment BE – 65%
321 treatments (mean 3.3 per patient); q 2-3 mos till No BE
LGD – CE-D 91%; CE-IM 61%
HGD – CE-D 81%; CE-IM 65%
SSBE – CE-D 97%; CE-IM 77%
No perforations or deaths
Stricture 1%
Safe and effective modality for eradication of BE with LGD
and HGD, particularly SSBE
Ghorbani et al. Dis Esophagus 2015
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; 72% men
• Mean tumor length 3.7cm (T1= 60, T2 =16, T3 = 2, T4 =1)
• ~11 month average follow up
• Median of 3 Cryo Tx sessions
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Before
Adenocarcinoma
82 year-old T1sm
After
• Treatment complete for 44 patients
• CR- CA = 70.5%; CR-HGD = 68.2%, CR-D = 59.1%
Before
During
1 Year After
Squamous Carcinoma
BD Greenwald et al.: DDW 2009 (10 Centers)
Current Management of BE/HGD/CA
RFA/CryoSpray Summary
Individualize pt – ? Endoscopic Tx First line
 Multidisciplinary approach - Cost/Time/QOL
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GI Medicine
 Surgery
 Pathology
 Preventive Medicine
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Work-up
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EGD, EUS, Motility study, 24 hr ph study, Path review
Patient education – Long-term Follow-up
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GERD control; EGD surveillance; Risk factors for cancer