One balloon or two? - Pennsylvania Society of Gastroenterology

PSG Annual Scientific Meeting
Small bowel bleeding:
g One balloon or two?
David L. Jaffe, M.D.
Division of Gastroenterology
University of Pennsylvania School of Medicine
September 25th, 2010
Small Bowel Imaging:
• Traditionally:
– not endoscopically easily accessible
– relatively few pathologic entities
• Recently:
– capsule
p
endoscopy
py p
provided new impetus
p
– new technologies allow for diagnosis and therapy of
small bowel disease:
• Single balloon enteroscopy
• Double balloon enteroscopy
• Spiral enteroscopy
Small bowel imaging:
P i generation
Prior
i
• Pediatric colonoscope
• Push enteroscope (with or without
overtube)
• Sonde enteroscopy
• Intra-operative
Intra operative enteroscopy
• V
Various
i
lilimitations:
it ti
iimage quality,
lit d
depth
th off
penetration, looping, invasiveness, inability
to perform therapeutics,
therapeutics time consumption.
consumption
Video Capsule endoscopy
(VCE)
• Non
Non-invasive
invasive
• Superior diagnostic yield compared to
radiological
di l i l studies
t di and
d push
h enteroscopy
t
• Continuing overt bleeding (92%), previous
overt bleeding (12.9%) and guaiac positive
(44.2%)
• Can miss lesions in the proximal small
bowel
• Pennazio et al. Gastroenterology 2004;126-643-53
From mouth to colon
Teeth
Wall of right colon
Epiglottis
Multiple telangiectasia
on a gastric fold
Ileocecal valve
Small Intestine
Push Enteroscopy
•
•
•
•
Endoscopic therapy
60-125 cm beyond the LOT
Di
Diagnostic
ti yield
i ld - 41%
64% within the reach of a standard
endoscope
• Zaman A,
A Katon RM
RM. GIE1998;47:372-76
GIE1998;47:372 76
Capsule Endoscopy
Triester et al, Am J Gastro 2005:100:2407-18
Intraoperative Enteroscopy
• Intraoperative
Enteroscopy
– Diagnostic yield 5858100%
– Invasive
– Technically difficult
– Prolonged
postoperative ileus
– Perforation/
Lacerations and
deaths
Issues for accomplishing deep
enteroscopy
t
• Length of small intestine ( 400-600 cm)
• Active contractions
• Suitability for hooking / retraction /
pleating
• Loop formation
– Gastric
– Small bowel distension/ stretching of the
mesentery
– Diminish transmission of force to tip of the
endoscope
Balloon-assisted enteroscopy
(BAE)
Double Balloon Enteroscopy
• Described in 2001 (Fujinon, Yamamoto)
• First U.S.
U S cases in 2004
• Capable of ‘to
to-and-fro
and fro’ movement and
standard interventions
– Biopsy, thermal ablation, balloon dilation, injection, polypectomy
• DBE can potentially visualize the entire 400400
600 cm of the adult small bowel
DBE
Balloon Controller
•Maintenance pressure: 5.6 kPa (42 mmHg)
Double Balloon Enteroscopy
Fluoroscopic Results
Anterograde route
Retrograde route
Yamamoto Experience
123 patients
Sept 2000-2004
178 DBE procedures
p
89 ante grade (oral)
89 retrograde (anal)
•Max distance: Beyond
y
ICV ((2))
•Max distance: Beyond
y
Lig
g of Treitz ((1))
•Average distance: 1/2 - 2/3 of SB
•Average distance: 1/2 - 2/3 of SB
2 complications: perforation in a SB
lymphoma/chemo pt, microperforation in a Crohn’s pt
Yamamoto H et al. Clin Gastro Hep, 2004; 2: 1010-16
Ability to Achieve Total Small Bowel
Visualization
• 86% success rate
– Comparable to reports of capsule
endoscopy
– 100% in pts without prior laparotomy
– 70% in p
pts with prior
p
laparotomy
p
y
– Median time for “complete” enteroscopy:
123 min
i ((range 80
80-180
180 min)
i )
Yamamoto H et al. Clin Gastro Hep, 2004; 2: 1010-16
DBE vs PE
• German Study: Compared conventional
push-enteroscopy to DBE (n=50; 38 pts
had GIB)
• Diagnostic yield: 78% Vs 42% (p<0.001)
• Average SB intubation: 210 cm Vs 80 cm
(p<0.001)
(p<0
001)
– May A et al. GIE. July 2005, 62(1): 62-70
Diagnostic Yield and Impact on
T t
Treatment
t Decisions
D i i
• New diagnosis (34%)
• Confirmed a diagnosis
(30%)
• Determined extent of a
known diagnosis (12%)
• Excluded previous
di
diagnosis
i (10%)
• No p
pathologic
g findings
g
(20%)
May A et al. GIE. July 2005, 62(1): 62-70
• DBE impacted
treatment decisions in
76% (104/137)
– Endoscopic (41.5%)
– Medical (new/change)
(17%)
– Surgical (17.5%)
• N
No R
Rx iimplications
li ti
iin
24%
Early experience in 6 U
U.S.
S Centers
188 patients (237 procedures)
149 (63%) ante grade
77 Retrograde (33%)
Mean duration 109±44.6 min in first 10 cases
92.4±37.6 min in subsequent cases (p=0.005)
Failure to intubate TI in 31%
Diagnostic yield 43%
Diagnostic and therapeutic maneuvers in 64%
Significant agreement between DBE and CE
1 perforation
DBE -Procedure Time
US M
U.S.
Multi-Center
liC
S
Study
d
U S Single Center Study
U.S.
• 200 Procedures over 17 months(115 Ante grade and 85
R t
Retrograde)
d )
• Mean Procedure duration
– 101±35 min ((oral)) and 96±33 ((anal))
• Length of small bowel examined
– 220±80 cm (oral) and 124±60 cm (anal)
• Clinical impact of DBE
– 58% in the first 50 to 86% last 50-200
• Total enteroscopy
– 8% iin th
the fifirstt 50 procedures
d
tto 63% iin llastt 50
50-200
200
– Gross SA and Stark ME, GIE 2008;67:6:800-97.
DBE: Yield in Obscure GI
Bleeding
100
76
80
73
51
60
40
20
0
Yamamoto (2004, Japan)
Heine 2006 (Amsterdam)
Yield (%)
Mehdizadeh 2006 (US Multicenter)
DBE Complications
• Multi center survey -10 centers in 4 countries
• Overall complications - 0.8%
• Major complications - 1.7%
– Diagnostic 0.8% and Therapeutic 4.3%
– Perforation – 0.3% (0.1 and 0.8%)
– Bleeding -0.8% (0.1 and 3%)
– Pancreatitis – 0.3%
0 3%
• Minor Complications
– Abdominal pain -20%
– Ileus
– Aspiration
– Mensink PBF et al. Endoscopy 2007;39:613-615
DBE Complications
p
• 2478 DBE examinations performed from 2004 to 2008.
• Major complications: 0.9% including perforation in 0.4%,
pancreatitis in 0.2%, and bleeding in 0.2%. One of 6
cases of pancreatitis occurred post retrograde DBE
DBE.
• Perforations occurred in 0.2% of anterograde
g
exams and
1.1% retrograde DBEs (P = .004).
• In surgically altered anatomy
anatomy, perforations occurred in
3%, (0.6% anterograde DBE, and 10% retrograde) and
20% peristomal DBE examinations (P < .005 compared
with patients without surgically altered anatomy)
anatomy).
Gerson et al. CGH, Nov. 2009
DBE vs.
vs Capsule Endoscopy
• MetaMeta analysis of 11 studies
• Pooled overall diagnostic yield for suspected
small bowel disease 60%
% for CE ((n-397)) and
57% for DBE (n=360)
g -24%
• Vascular findings
• Inflammatory findings 18% (CE) and 16% (DBE)
o yps a
and
d tu
tumors
o s 11%
%
• Polyps
– Pasha et al., CGH 2008;6:671-6
Cost effectiveness
M
Management
strategies
i ffor OGIB
• Cost effectiveness analysis
y
comparing
p
g no therapy
py to 5
competing modalities for obscure overt GI bleeding
• PE, IOE, Angiography, Initial ante grade followed by
retrograde DBE, CE with DBE directed by CE findings
• Initial DBE most cost effective approach with 86%
bleeding cessation rate
• Gerson L, Kamal A. GIE 2008;68:5:920-936
DBE Problems
DBE-Problems
• Long procedure times
• Cost of capital investment
• Technical skills
Single balloon Enteroscopy
(SBE) Olympus
SBE Procedure
Single Balloon Enteroscopy
•
27 patients and 37 exams
•
3 physicians
h i i
-no prior
i experience
i
with
i h DBE
•
Time required for total SB exam 125 min.
•
Mean Duration (Antegrade) 83±38 min (Retrograde) 90±32 min
•
Eval of entire small bowel 12.5%
Eval.
12 5% (c/w 86% reported with DBE)
•
Diagnostic yield 40.7% (11/27 patients)
•
1 Perforation
• Kawamura et al., GIE 2008;68:6:1112-6.
Single balloon Enteroscopy
(SBE)
•
•
•
•
•
•
Simpler design -?shorter
?shorter learning curve
Potentially lower capital investment
Less preparation time (5 min vs 15 min for DBE)
No latex balloons
Ability to perform therapy
Disadvantages
– Depth of small bowel intubation inferior to that of DBE
• Kawamura et al., GIE 2008;68:6:1112-6.
DBE vs. SBE.
• Prospective
P
ti randomized
d i d study
t d 100 patients
ti t ((mean age 55)
• Indications: SB bleeding (majority), Crohn's disease, smallb
bowel
l masses, chronic
h i di
diarrhea
h or abdominal
bd i l pain
i
• Results: Instrument prep time was faster with SBE
• Complete enteroscopy achieved with the DBE in 66%,
either with the PO route alone or with combined routes
compared with 22% with the SBE technique
technique, (P<0
(P<0.0001;
0001;
only with combined).
• The complete enteroscopy rate: 3x higher with DBE than
with SBE.
May et al. AJG. 2010
105(3):575-81
DBE vs. SBE (May study)
• Investigators compared techniques, but did not
compare devices
• Investigators had more prior experience with
DBE and operator experience is known to
DBE,
influence success rates
• Complete enteroscopy may not be the most
important endpoint
• “Diagnostic yield” not statistically different in the
two groups
Spiral (Overtube) Enteroscopy
DSB; Spirus Medical Inc, Stoughton, Mass
Working length 118 cm
Internal diameter 9.8 mm
External diameter 14.5 mm
Spirals 5.5 mm – distal 22 cm
Spiral Enteroscopy
• 27 patients with obscure GI bleeding
• Successful in 25 patients
• Pediatric colonoscope with Endo
Endo-Ease
Ease
discovery SB (DSB;Spirus Medical Inc, Stoughton, Mass)
• Average depth of SB intubation -176
176 cm
(80-340 cm) from LOT
• Average procedure time -37 min (19-65 m)
• Minor complications in 11 patients
» Akerman et al.,
al GIE:2009;69:2:327
GIE:2009;69:2:327-32
32
Spiral Enteroscopy vs. DBE for
Ob
Obscure
GI bleeding
bl di
• Small retrospective single center nonnon
randomized study of 34 patients
• Comparable diagnostic yield-70% with DBE and
65% with spiral
p
enteroscopy
py
• Mean
ea p
procedure
ocedu e ttime
e longer
o ge with
t DBE 77 min
vs. 59 min (not statistically significant)
– Schembre D and Ross AS. Yield of DBE vs. Spiral enteroscopy
for obscure GI bleeding GIE:2009;69:AB193
Summary
• Balloon assisted enteroscopy and Spiral enteroscopy
facilitate endoscopic evaluation of the small bowel in
patients with obscure GI bleeding
• Diagnostic and therapeutic DBE and SBE can be
performed safely in the majority of patients
patients, but risks are
greater than for conventional endoscopy
• Experience with Spiral enteroscopy suggests great
promise with shorter procedure times
• E
Experience
perience and improvements
impro ements in design will
ill decrease the
procedure times and may improve safety
• Wh
What’s
t’ next?
t? St
Steerable
bl capsules
l with
ith th
therapeutic
ti
potential !
Fujinon
EN450P5
Fujinon
EN450T5
Fujinon
EC450B15
Olympus
PCFQ180AL
Working Length (cm)
200
200
152
168
Total Length (cm)
230
230
External Diameter (mm):
Body
Distal end
8.5
8.5
9.3
9.4
9.3
9.4
11.5
11.3
Accessory Channel Diameter
(mm)
22
2.2
28
2.8
28
2.8
32
3.2
Field of View (degrees)
120
140
140
140
12.2
13.2
10
10 8
10.8
Distal End Diameter (mm)
8.7
9.8
Total Length (cm)
145
145
ENDOSCOPE:
OVERTUBE:
External Diameter (mm)
I
Inner
Diameter
Di
t (mm)
(
)
200.5
Longterm
g
outcomes in DBE for OGIB
• Retrospective cohort study, DBE performed in 200
consecutive patients with OGIB.
• DBE detected bleeding sources in 155 of 200 patients
(77.5%). The most frequent source detected was small
intestine ulcers/erosions. Patients who underwent DBE
within 1 month after the last episode of bleeding had a
better yield 84% vs 57%, P = .002).
• The overall rate of control of OGIB was 64%. Vascular
lesions of the small intestine had a lower rate of control
than those with other small intestine lesions ((40% vs
74%, P = .001).
g large
g
• Increased likelihood of overt rebleeding:
transfusion requirement before DBE, multiple lesions,
and suspicious (not definite) lesions in patients with
vascular small bowel lesions.
Shinozaki et. al CGH, Feb 2010

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