Date post: | 25-May-2015 |
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Health & Medicine |
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Where do we stand today around the
world?
Ductal indications
S. Ian Gan MD FRCPCVirginia Mason Medical Center
Digestive Disease InstituteSeattle, USA
Ductal indications
1. What are the current guidelines for the characterization of indeterminate pancreatico-biliary strictures?
2. Are they effective? 3. How should pCLE be integrated into the approach to
indeterminant PB strx?4. What further is required for pCLE to become standard
of care? How do we make evidence robust enough to WARRANT guidelines?
5. Can we define an ideal consensus guidelines for pCLE use in pancreaticobiliary strictures?
Ideal pCLE guidelines
• Defined patient populations• Defined indications:
• Indeterminant strictures• Potential change in management – how?
• Methods• Guidelines for learning and competency
Disruptive innovation
Disruptive technology
“Disruptive Technology” - first coined in 1997 by Clayton Christensen
A new technological innovation, product or service that eventually overturns the existing dominant technology or product in the market
Radical disruptive innovations
1. Build on existing patterns of consumer behaviour
2. Attract early adopters and create loyal followers
3. Outperform dominant market or create new market
4. Reduce complexity; simpler in design and easier to use
5. Overcomes initial barriers to acceptance
• New market• Effective• Relatively low
costs• Easy to use, learn• Wide indications
Dr. Gavriel D. Meron
Radical disruptive innovations
1. Build on existing patterns of consumer behaviour
2. Attract early adopters and create loyal followers
3. Outperform dominant market or create new market
4. Reduce complexity; simpler in design and easier to use
5. Overcomes initial barriers to acceptance
Defining the problem
Indeterminant stricturesBenign vs. malignant
3000 CCA/ year USA
ddx biliary stenosis
Malignant• Cholangiocarcinoma• Pancreatic CA, GB cancer, metastasisBenign• Ischemia• Mirizzi’s• Radiation• Primary sclerosing cholangitis• Autoimmune pancreatitis/cholangiopathy• AIDS cholangiopathy• Parasites
Current guidelines for dx of CCA
AGA, ACG, ESGE – no guidelinesGIE (ASGE) 2003
The role of endoscopy in the evaluation and treatment of patients with pancreaticobiliary malignancy
Gut 2002 – Khan et.al.Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document
Tumor markers: Ca 19-9, CEA, Ca 125CTMRIMRCP, ERCP, PTCHistology
Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus documentKhan Gut 2002
• Serum tumor markers – Evidence level 2b• CA 19-9 > 100U/L – 75% Sn 80% Sp
• Imaging• CT and US – Evidence level 4 – useful to confirm biliary
obstruction, may identify mass• MRI – Evidence 2b and 3a – OPTIMAL investigation for
suspected CCA giving extent of tumor, mets, vascular involvement
• ERCP• Brushings 30% yield• Brushing PLUS bx – yield 40-70%
Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus documentKhan Gut 2002
Biliary drainage (recommendation grade A).• Routine biliary drainage before assessing resectability,
or preoperatively, should be avoided except for certain clinical situations such as acute cholangitis
Confirmatory histology (evidence level 5)• Although positive histology and cytology are often
difficult to obtain at ERCP, they are recommended for confirmation of a diagnosis of cholangiocarcinoma. Histology is also important for planning clinical trials....
Treatment options
• Surgery – Whipple, Trisegmentectomy• Radiation • Chemotherapy• Photodynamic therapy• RFA
Complications of missed diagnosisDelayed treatmentNo treatmentRepeated diagnostic procedures
Before pCLE…..
Ca19-9
Brush
ing
BiopsyERCP
Cholangio
scopy
FISH
PET EUS
0
20
40
60
80
100
120
SensitivitySpecificityAccuracy
Radical disruptive innovations
1. Build on existing patterns of consumer behaviour
2. Attract early adopters and create loyal followers
3. Outperform dominant market or create new market
4. Reduce complexity; simpler in design and easier to use
5. Overcomes initial barriers to acceptance
Where does pCLE stand now?
• ~200 hospitals worldwide• 30 in USA;
Current guidelines for PB pCLE
N. America• ASGE
• The role of endoscopy in the evaluation and treatment of patients with pancreaticobiliary malignancy, 2003
❯ No mention
• Confocal laser microscopy - Technology guidelines, 2009❯ Cholangioflex probe mentioned❯ Use in pancreaticobiliary strictures not acknowledged
• AGA - • ACG - • CAG -
EUROPE• ESGE -
Current agreed indications for pancreaticobiliary pCLE
• Indeterminant strictures• De novo• Eluding diagnosis despite standard tissue
sampling
Miami classification
Miami validation Meining Endoscopy 2012
Part I• Consensus meeting x 2 with 5 investigators• 47 consecutive patients, 112 pCLE videos• Blinded and randomized
Part II• 42 videos previously unreviewed• Evaluated for Miami criteria
Miami classification
73%
36%
27%
27%
Inter-observer agreement
kThin dark bands (BENIGN) 0.49
Thick dark bands with flow (MALIGNANT) 0.47
Thin white bands (MALIGNANT) 0.43
Visualization of epithelium (MALIGNANT) 0.56
Dark clumps NS
Radical disruptive innovations
1. Build on existing patterns of consumer behaviour
2. Attract early adopters and create loyal followers
3. Outperform dominant market or create new market
4. Reduce complexity; simpler in design and easier to use
5. Overcomes initial barriers to acceptance
Standard of care…. The Holy Grail
• Safety and feasible• Effective• Proven clinical impact• Cost-effective• Accessible
Brush cyto Biopsy pCLE0
10
20
30
40
50
60
70
80
90
SensitivitySpecificityAccuracy
Giovannini Surg Endos 2011
Meining GIE 2011
SN SP PPV NPV ACC0
20
40
60
80
100
120
Std pathpCLE
Radical disruptive innovations
1. Build on existing patterns of consumer behaviour
2. Attract early adopters and create loyal followers
3. Outperform dominant market or create new market
4. Reduce complexity; simpler in design and easier to use
5. Overcomes initial barriers to acceptance
Barriers to expanded use
• Cost• Reimbursement• Learning curve• Evidence for change in
management• Limited patient
population• Expansion of indications• Increase awareness
Cost
pCLE
Capital costs CellvizioProbe CPT code reimbursement?
Improved accuracy• Add vs. supplant• avoid repeat studies?• better outcomes?• Reduced delay in diagnosis
Cytology brushing
$30/brushProfessional fee $186$152 cytopath interpretation
Learning curve (Meining GIE 2011)
Cohort 1 Cohort 20
0.10.20.30.40.50.60.70.80.9
1
SensitivitySpecificityAccuracy
Learning curve (Meining GIE 2011)
Cohort 1 Cohort 202468
101214161820
Time required
Time required
Competency
• The minimum level of skill, knowledge, and/or expertise derived through training and experience, required to safely and proficiently perform a task or procedure.
• Eg. EUS: For comprehensive competence in all
aspects of EUS, a minimum of 150 supervised cases, of which 75 should be pancreaticobiliary and 50 EUS-guided FNA, is recommended.
Clinical impact
Broadening indications
Inflammatory criteria
Questions > Answers
• Can the criteria be made more definitive to improve interobserver agreement?
• Stratification of criteria? • Fitting pCLE into the algorithm…
• Add to vs supplant tissue acquisition?
• Where will molecular imaging fit?• How do we ensure learning and competency? • Can pCLE perform well outside of high-volume
centers?
Possible consensus
• Indications• Any de novo indeterminant pancreaticobiliary stricture
without evidence of associated mass• Pre-or post stenting• Dominant strictures in PSC
• Consensus criteria• “Miami PLUS” (inclusive of new inflammatory criteria)
• Competency: • X number of formal review of benign, inflammatory and
malignant video series• Testing score - > 80% accuracy
Summary
• Current indications for pCLE in pancreaticobiliary system reserved for indeterminant strictures
• Further required areas of research and development• Special patient populations – PSC, AIP, pancreatic stx• Effect of stenting• Clinical impact• Cost analysis• Formal MD education, learning curves, assessment