Role
Role of
of Endoscopy
Endoscopy
in
in Gastroesophageal
Gastroesophageal Reflux
Reflux Disease
Disease
Joachim Mössner
University of Leipzig
Berlin, May 4, 2006
Role
Role of
of Endoscopy
Endoscopy
in
in Gastroesophageal
Gastroesophageal Reflux
Reflux Disease
Disease
• In Diagnosis
– Magnifying endoscopy
– Chromoendoscopy
– NBI, narrow band imaging
• In Surveillance
• In Therapy
Barrett-Esophagus
Methylene Blue Staining
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Barrett-Esophagus
Staining with Acetic Acid 99%
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Confokal Laser Endomicroscopy
Normal Endoscopy
• ~ 30X
• No microscopic details
Zoom Endoscopy
• ~100X
• Crypts visible, but no details
Confocal Endoscopy
• ~1000X
• Cellular resolution of crypts
Kindly provided by R. Kiesslich/Mainz
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Barrett-Esophagus
• Kara et al: High-resolution endoscopy plus
chromoendoscopy or narrow-band imaging in Barrett's
esophagus: a prospective randomized crossover study.
Endoscopy 2005; 37: 929-36
• CONCLUSIONS: In most patients with highgrade dysplasia or early cancer in Barrett's
esophagus, subtle lesions can be identified with
high-resolution endoscopy. Indigo carmine
chromoendoscopy and narrow-band imaging
are comparable as adjuncts to high-resolution
endoscopy.
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Barrett-Esophagus
• Routine use of chromoendoscopy or
NBI:
• No proof of greater early detection
rate of neoplasia in addition to
magnifying endoscopy
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Gastroesophageal Reflux Disease
Heart Burn
• 7% dayly
• 14% weekly
• 44% once per month
Nebel et al, 1976
PPI:
successful therapy in 85-92%
relapse after stop of PPI´s: 80% within 6 months
⇒ Costs worldwide per year > 60 billion $
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Reflux Disease - “PPI - Gap”
• Allergic side effects
• Heart burn at night
• High volume reflux
• Extra esophageal manifestations
• Anxiety to take drugs
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Surgical Therapy
Laparoscopic Fundoplication
• Problems of surgery:
effective medical treatment available
• Indications:
persistant regurgitation, unwanted
side effects, denial to take drugs
continuously
• Precondition:
high volume, expert center,
manometry
• Complications:
vagus lesion, relapse, gas-bloat
syndrom
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
GERD-Therapy without Drugs
• Laparoscopic Fundoplication
• Endoscopic Therapies
Gastroplication
(EndoCinch, ESD,
Plicator)
Radiofrequency application
(Stretta, Curon Medical)
Injektion of an inert polymer
(Enteryx: no longer licensed,
Gatekeeper)
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
“Indications” for Endoscopic Antireflux Therapy
• Impairment of quality of life due to drug
therapy
• Alternative to continuous therapy with PPI
• Small axial hiatus hernia
• Important
Symptoms & proof of reflux: endoscopy & pH-metry
Manometry: exclusion of achalasia
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
EndoCinch – Endoscopic Sewing System BARD Co.
Several published studies
Medizinische Klinik & Poliklinik II
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JM May 2006
Patient: before EndoCinch
Medizinische Klinik & Poliklinik II
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JM May 2006
Endoscopic Fundoplication
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JM May 2006
Patient: 6 Weeks after EndoCinch
Medizinische Klinik & Poliklinik II
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Patient before EndoCinch
Pat. 6 weeks after EndoCinch
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EndoCinch II - Clipsystem
Medizinische Klinik & Poliklinik II
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JM May 2006
EndoCinch: US - Multi-Center-Study
•
Prospective, multi center
•
64 patients with symptomatic reflux disease
•
Post surveillance 1, 3, 6 months
Inclusion -
Exclusion Criteria
• GERD symptomatic
• Reflux esophagitis III/IV
> 2/weeks
• PPI/H2-Blocker con. therapy
positive response
• BMI > 40
• PPI refractory GERD
• Hiatal hernia > 2 cm
• pH <4 more than 4% of time
Filipi et al: Gastrointest Endosc 2001
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
EndoCinch: US - Multi-Center-Study
Heart burn symptom score (frequency x intensity) (N=64)
100
80
62.7
HBSS
60
p<.001
40
20.8
16.7
17.0
20
0
Pre
1 mo
3 mo
6 mo
Filipi et al: Gastrointest Endosc 2001
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
EndoCinch: US - Multi-Center-Study
Patients without Medication (< 4 Doses PPI/H2B /month)
62 %
80%
62 %
(N=64)
% Patients
60%
40%
20%
0%
0%
pre
3 mo
6 mo
Filipi et al: Gastrointest Endosc 2001
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
DeMeester Symptom Score (Leipzig)
100%
80%
21%
60%
40%
56%
20%
31%
36%
38%
27%
6 mo post-EndoCinch
(n=32)
12 mo Post-EndoCinch
(n=11)
0%
before EndoCinch (n=48)
Medizinische Klinik & Poliklinik II
7
6
5
4
3
2
1
0
Universität Leipzig
JM May 2006
% time pH < 4
24-hour pH-metry (Leipzig)
n=12
30
p<0,05
6
20
10
n=7
n=22
10,1
4,9
1
0
before EndoCinch
6 mo after EndoCinch
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Endocinch: Patients` Satisfaction
Would you do it again?
16%
84%
ja
nein
Would you recommend the procedure to
friends? N = 43
21%
yes
79%
ja
nein
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
EndoCinch - Effect on Symptoms
n=
(f/u)
Mean
F/U (mos)
HSS
RFS
Filipi (2001)
64(47)
6
yes
yes
Park (2001)
142
3
yes
yes
Patel (2001)
55
3.7
yes
yes
Mahmood (2001)
20(11)
3
yes
yes
Maple (2001)
23(21)
6.7
yes
yes
Abdu-Rebyeh (2002)
16(14)
<3
yes
----
Liu (2002)
19(17)
<6
yes
yes
Caca (2002)
54(43)
6
yes
yes
Chen (2002)
183(42)
12
yes
yes
Arts (2002)
20
3
yes
----
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Endocinch
• Schiefke I, Zabel-Langhennig A, Neumann S,
Feisthammel J, Moessner J, Caca K: Long term failure of
endoscopic gastroplication (EndoCinch). Gut 2005; 54:
752-8. Comment in: Gut. 2005; 54: 1820-1
• CONCLUSION: Endoscopic gastroplication
(EndoCinch) is a safe and minimally invasive
endoscopic treatment for GORD with
reasonable short term results. In contrast,
long term outcome is disappointing,
probably due to suture loss in the majority of
patients.
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Endocinch: predictors of outcome?
•
Schiefke I, Soeder H, Zabel-Langhennig A, Teich N, Neumann S,
Borte G, Mossner J, Caca K: Endoluminal gastroplication: what are
the predictors of outcome? Scand J Gastroenterol 2004; 39:1296303.
• Three variables were significantly predictive
for successful endoscopic anti-reflux
treatment at the multivariate level: presence
of typical symptoms (P=0.01), complete
symptom relief with acid suppressive therapy
(P=0.01), and normal lower esophageal
sphincter pressure (P = 0.04).
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
ESD: Flexible Endoscopic Sewing Device
Wilson-Cook Medical
¾No studies in GERD
¾Animal studies regarding sewing
technique
¾First trials in humans
¾FDA approval: „soft tissue
apposition“
¾In Europe not licensed
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
ESD: Flexible Endoscopic Sewing Device
Wilson-Cook
Medical
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
ESD
•
Schiefke I, Neumann S, Zabel-Langhennig A, Moessner J, Caca K.
Use of an endoscopic suturing device (the "ESD") to treat patients
with gastroesophageal reflux disease, after unsuccessful
EndoCinch endoluminal gastroplication: another failure.
Endoscopy 2005; 37: 700-5
• CONCLUSIONS: Endoluminal gastroplication
using the ESD is an easy and safe, but
unfortunately ineffective procedure for
endoscopic GERD treatment. Endoluminal
gastroplication techniques clearly need
refinements before these therapies can evolve
as a treatment option for GERD patients.
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
PLICATOR NDO Surgical
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
PLICATOR
Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G,
Pleskow D, Zaman M, Lembo A: A novel endoscopic fullthickness plicator for the treatment of GERD: A pilot study.
Gastrointest Endosc 2003; 58: 770-6
CONCLUSIONS: Endoscopic full-thickness
plication is feasible, safe and, in this pilot
study, appeared to reduce symptoms and
medication use associated with GERD.
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Stretta – Radiofrequency-Coagulation
12 published studies
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Stretta – Quality of Life: (GERD-HRQL)
N=94
Triadafilopoulos et al: Gastrointest Endosc 2002
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Stretta – Sham-Control-Study
Sham
(n=30)
Stretta
(n=34)
Heartburn
-0,6
- 1,6
p<0,01
GERD-HRQL
-3
- 13
p<0,05
SF-36
+1
+7
p<0,05
-29%
-46%
n.s.
6 Months
Stop of PPI
therapy
• 20 pats Cross-over: GERD-HRQL –2 → -11
• ∅ Change in pH-metry or manometry
but: pH-change in responder-subgroup
Corley et al: Gastroenterology 2003
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Injection of Biocompatible Polymers
EnteryxTM – Ethylene-Vinyl-Ethanol:
Enteric Medical / Boston Scientific
fatal complications
no longer in use
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Implantation of Polyacrylnitrol
Gatekeeper - Medtronic®
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Stretta
PPI
EndoCinch
X
Plicator
Laparoscopic
Fundoplication
Gatekeeper
?
ESD
X
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Peptic Esophageal Stenosis
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Peptic Esophageal Stenosis
after bouginage
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Endoscopic Antireflux Therapy
Summary
• Endoscopic anti reflux therapy at the beginning
of a new aerea
• Techniques at present only partially successful
• No clear cut long term results
• No prospective randomized comparative data
• Limited indications → detailled post
surveillance mandatory
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006
Summary
Barrett-Esophagus
• Routine use of chromoendoscopy or
NBI:
• No proof of greater early detection
rate of neoplasia in addition to
magnifying endoscopy
Medizinische Klinik & Poliklinik II
Universität Leipzig
JM May 2006