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296
K.F. Binmoeller
Fig. 20.2 Transduodenal gallbladder drainage with a covered tubular SEMS (10 mm Wallstent, Boston Scienti fi c).
( a ) Endoscopic view of delivery catheter prior to stent
gallbladder in those patients likely to undergo
cholecystectomy later, based on the argument that
the gallbladder will be easier to remove when
adhesions form around the antrum compared to
the duodenum, where the cystic and common bile
ducts may be affected. The authors placed 5-F
nasocystic catheters in all patients and did not
witness any bile leakage. There were no immediate complications apart from one pneumoperitoneum, which did not adversely impact the clinical
course.
Use of a covered SEMS may seal the gap
between stent and fi stula tract to prevent bile
leakage (Fig. 20.2 ). Jang et al. reported on the use
of a modi fi ed covered SEMS with fl ared ends
(Bonastent, Standard Sci Tech, Seoul Korea) to
drain the gallbladder in 15 patients with acute
cholecystitis who were unsuitable for cholecystectomy, either through the stomach (n = 10) or
duodenum (n = 5) [
16 ] . Functional success was
achieved in all patients within 3 days after placement of the covered SEMS. Two patients experienced pneumoperitoneum and both responded to
conservative management. During a median follow-up of 145 days, no patient experienced recurrent cholecystitis.
The published experience with EUS-guided
cholecystenterostomy is small, and it is important
to note that only patients with acute cholecystitis
and likely adherence of the gallbladder to the
bowel wall have been treated. The gallbladder is
normally a mobile intraperitoneal organ, and
even transmural puncture of a normal gallbladder
deployment. ( b ) Gallbladder contents draining after stent
deployment. ( c ) Fluoroscopic view of stent after deploy-
ment. Arrow shows waist where stent straddles wall
with a 22-gauge FNA needle carries a substantial
risk of bile leakage. In a study of EUS-guided
puncture of the gallbladder to sample bile for
microlithiasis in patients with idiopathic pancreatitis, Jacobson et al. reported symptomatic bile
leakage in two of three patients, prompting the
authors to discontinue further recruitment for the
study [ 17 ] .
Drainage of a nonadherent gallbladder will
require initial securement of the gallbladder to the
enteric wall to reduce the risk of bile leakage. In
animal studies (porcine model), Fritscher-Ravens
et al. deployed T-anchors into the gallbladder
(n = 7) under real-time EUS guidance to af fi x the
gallbladder to the bowel wall to allow traction for
subsequent passage of 7-F catheters and plastic
stents [ 18 ] . Single sutures were held with a pin
and cylinder stitch locking mechanism.
Bile Duct Drainage (Bilioenterostomy)
Transpapillary stent placement by endoscopic retrograde cholangiopancreatography (ERCP) is the
established modality of choice for bile duct drainage in patients with obstruction due to malignant
biliary strictures. However, ERCP may not be
possible due to tumor in fi ltration of the duodenum, failed biliary cannulation, or an inaccessible
papilla. In such cases, percutaneous transhepatic
cholangiography and drainage (PTCD) is usually
performed as an alternative route to decompress
Fig. 20.3 Transgastric transhepatic bile duct drainage with a covered tubular SEMS (8 mm Wall fl ex, Boston Scienti fi c).
( a ) Endoscopic view of delivery catheter prior to stent deployment. ( b ) Bile duct contents draining after stent deployment
29720 Self-Expandable Metal Stents: Transluminal Stents
the bile duct and palliate obstructive symptoms.
However, PTCD has a complication rate of up to
32% that includes bilio-cutaneous fi stula formation, cholangitis, peritonitis, empyema, hematoma, and liver abscesses [ 19 ] . Additionally, the
quality of life in patients with PTCD is impaired
by the percutaneous drain that requires maintenance and, in some cases, exchanges.
EUS-guided transluminal drainage of the bile
duct has recently emerged as an alternative to
PTCD when transpapillary drainage is unsuccessful. In contrast to the retrograde approach of
ERCP, EUS-guided drainage is antegrade [ 20 ] .
The left hepatic bile duct can be accessed from
the stomach to perform a hepaticogastrostomy, or
the extrahepatic bile duct can be accessed from
the duodenum to perform a choledochoduodenostomy (Fig.
20.3 ). Transluminal drainage has a
number of theoretical advantages over PTCD.
Similar to transpapillary drainage by ERCP,
transluminal drainage is internal, which eliminates the drawbacks of external percutaneous
drainage, such as local skin pain, infection, drain
care, and bile loss. Transluminal drainage is not
limited by obesity and less limited by ascites than
PTCD. Transluminal access to the bile duct is
performed under color Doppler guidance, which
may be safer than standard fl uoroscopic guidance
of PTCD. A practical advantage of transluminal
drainage is the ability to perform this procedure
in the same session as a failed ERCP, potentially
by the same operator if they are skilled in both
ERCP and EUS [
21 ] .
Technical success rates for transluminal bile
duct drainage using plastic stents have been high;
however, bile leak has been a signi fi cant risk,
occurring in 19% of patients [ 22, 23 ] . The use of
a covered SEMS rather than a plastic stent has
been advocated to seal off the fi stula tract [ 23 ] .
However, the use of a covered SEMS may result
in stent migration. At least one fatality from covered SEMS migration has been reported [ 24 ] . In
a case series of hepaticogastrostomy, Bories et al.
reported two cases of upstream intraductal stent
migration, resulting in a biloma in one patient
and cholangitis in the other [ 25 ] . In a series of
eight patients undergoing transduodenal placement of a fully covered SEMS for palliative biliary drainage, one upstream stent migration 12 h
after implantation resulted in duodenal perforation that required surgery [ 23 ] .
SEMS with a modi fi ed design to prevent
migration have been reported for bilio-enterostomy. Park et al. [ 26 ] reported a prospective study
using a fully covered SEMS with fl ared ends
(Bonastent, Standard Sci Tech) to prevent distal
or proximal migration [ 26 ] . Fourteen patients
with malignant biliary obstruction underwent
hepaticogastrostomy (n = 9) or choledochoduodenostomy (n = 5). Stent placement was successful in all patients, but despite the anti-migration
design, downstream stent migration into the
298
bowel occurred in one patient. In a case report,
Ito et al. used a SEMS designed with a wavy
contour and uneven outer surface (Zeostent, Zeon
Medical Inc., Tokyo, Japan) to prevent stent
migration [
27 ] .
An advantage of using a SEMS is that it
creates a larger diameter fi stula that may allow
subsequent passage of an endoscope for cholangioscopy and various intraductal interventions such as biopsy and tumor ablation. This is
analogous to passing an endoscope across the
cystenterostomy for debridement of walled-off
pancreatic necroses. Eum et al. reported direct
endoscopic ablative treatments with photodynamic therapy and argon plasma coagulation in
three patients who had previously undergone
placement of a 10-mm SEMS [ 28 ] .
An alternative approach to create a choledochoduodenostomy is the use of mating magnets.
Jamidar et al. used a novel, hinged device
comprising a 7-F stent with a central ferrous
metallic component [ 29 ] . The metalloplastic
device was inserted into the bile duct of pigs
using a standard ERCP technique over a 0.035in. guidewire. A second magnet was then endoscopically positioned in the duodenum to mate
with the bile duct magnet and exert compressive
ischemic force. Anastomoses ranging from 5 to
10 mm were successfully accomplished in all
survival animals. What is unknown is whether a
transluminal stent will be required to maintain
drainage across the anastomosis. At the time of
this publication, no clinical experience using this
device has been reported.
There are theoretical advantages of transluminal drainage of the bile duct by hepaticogastrostomy or choledochoduodenostomy over
conventional transpapillary drainage by ERCP.
With transluminal drainage, the fi stula is upstream
from the obstructing stricture, and therefore, the
stent is not subject to tumor ingrowth or overgrowth, and the pancreas is avoided, eliminating
any risk of pancreatitis. Transluminal drainage
avoids the ampulla and accidental cannulation or
injection of the pancreatic duct. The problem of
dif fi cult bile duct cannulation and instrumenta-
tion across the stricture (wire passage, dilation,
and stenting) is also eliminated.
K.F. Binmoeller
Gastrojejunostomy: Gastric Bypass
Surgical gastrojejunostomy has long been the
standard palliative therapy for malignant gastric
outlet obstruction (GOO) caused by carcinoma of
the stomach, duodenum, or pancreas. More
recently, the growth in gastric bypass operations
for obesity has markedly increased the performance of gastrojejunostomies.
Endoscopic placement of an enteric (intraluminal) SEMS is an alternative treatment option
(see Chaps. 7 and 11 ). This endoscopic procedure
leads to resumption of oral intake in about 90%
of the patients; however, it may be complicated
by recurrent obstruction, caused by either stent
migration or tumor in fi ltration [ 30, 31 ] . A ran-
domized, controlled trial showed a signi fi cantly
higher incidence of recurrent obstructive
symptoms in patients treated with enteric stents
compared to surgery [ 32 ] .
The creation of a transluminal anastomosis
between the stomach and small bowel using an
expandable metal stent was fi rst reported in dog
studies by Cope et al. in 1999 [ 33 ] . The authors
used bare or partially covered fl ared 10-mm or
12-mm Z stents (Cook Medical). The gastroenteric anastomosis (GEA) was created by introducing rare earth magnets perorally into the
stomach and jejunum under endoscopic and
fl uoroscopic guidance and mating these across
the gastric and jejunal walls. The magnet pairs
were excreted in 5–7 days, and the partially
covered stents signi fi cantly extended the patency
rate of the GEA to 7 weeks or more. Use of a
fully covered “Yo-Yo” stent design (Cook
Medical) with 12-mm diameter and strongly
fl ared ends was reported in dogs and found to be
patent at 6 months in four of fi ve animals [ 34 ] .
Chopita et al. reported the fi rst clinical trial
using the Yo-Yo stent in 15 patients with malignant biliary and duodenal obstruction [ 35 ] .
Magnets were 12–14 mm in diameter with an
attractive force of 1,000 g. The success rate was
86.6% (13 of 15 patients). One perforation
occurred and was attributed to manipulation of
the recently formed fi stula. Three stents migrated
(two distal, one proximal) without further
29920 Self-Expandable Metal Stents: Transluminal Stents
complication. In a multicenter European study,
Van Hooft et al. evaluated the Yo-Yo stent in 18
patients with malignant obstruction [ 31 ] .
Migration of the Yo-Yo stent occurred in three of
seven patients (42.8%); subsequently, the authors
switched to a conventional 6-cm uncovered tubular duodenal stent design (duodenal Evolution
stent, Cook Medical). Subsequent stenting using
this design caused fatal perforation in one patient,
after which the study was terminated.
The use of endoscopic ultrasonography to gain
access to the jejunum for creation of a gastroenteric anastomosis was reported by Cope et al. in
dogs [
36 ] . The investigators fi lled the jejunum
with water to improve sonographic targeting of
the small bowel adjacent to the stomach. After
puncturing the jejunum from the gastric lumen
with a standard 22-G FNA needle, a 0.018-in.
wire was inserted into the jejunum and captured
with a previously inserted snare. A sheath was
railroaded over the wire to deploy double
T-anchors. The tract was dilated to 12 mm and
immediately bridged with a fully covered SEMS.
Fritscher-Ravens et al. described creation of a
compression gastroenterostomy wholly under
EUS guidance [ 18 ] . The jejunum was punctured
from the stomach with a modi fi ed 19-G FNA
needle that enabled placement of a T-tag anchor
to keep the jejunum in apposition with the stomach wall. A guidewire was then inserted through
the FNA needle for coaxial insertion of an anastomotic device formed from two 7-F catheter
segments. After removal of the guidewire, the
catheter segments formed a cross on the jejunal
side that was compressed against a spring plate
on the stomach side. In 4–7 days, an anastomosis
ranging from 3 to 9 mm was formed. The authors
were able to dilate the anastomoses for 10 Fr
stent placement and/or passage of an endoscope
into the duodenum.
Lumen Apposing Transluminal Stent
Tubular stents, conceived for lumen recanalization, have several limitations when applied to
transluminal drainage. First, they do not impart
lumen-to-lumen anchorage. This may result in
leakage of contents if there is physical separation
of lumens. Second, stent migration may occur,
due to the absence of a stricture to hold it in place.
Third, the length of tubular stents exceeds the
anatomical requirement of a short transluminal
anastomosis. The exposed stent ends may cause
tissue trauma, resulting in bleeding or perforation. Finally, the longer the stent length, the more
prone the stent is to clogging .
A lumen apposing, dual anchor stent (AXIOS,
Xlumena Inc., Mountain View, California USA)
was recently developed for transluminal drainage. The stent is designed to provide robust
anchorage across nonadherent luminal structures.
Made of braided wire, the self-expandable stent
has bilateral lumen apposing anchors to impart
luminal apposition (Fig. 20.4a ). Fully expanded,
the stent anchor diameter is approximately twice
that of the stent lumen. The stent anchors are
designed to distribute pressure evenly on the
luminal wall. The stent is fully covered to prevent
tissue ingrowth and tract leakage, as well as
enable removability.
The AXIOS stent is delivered through a 10.5-F
catheter and is 138 cm in working length.
A tapered “nose cone” at the catheter tip facilitates passage across tissue planes into the target
structure or lumen. Two radiopaque markers on
the catheter indicate each end of the preloaded
stent to enable fl uoroscopic control of stent position. An endoscopically visible marker identi fi es
the point at which the proximal stent anchor
should be released.
The handle of the AXIOS delivery system is
Luer-locked onto the echoendoscope instrumentation channel inlet port, analogous to a standard
FNA needle (Fig. 20.4b ). This gives the operator
full control of stent deployment with the right
hand, while the left hand holds the echoendoscope. The handle consists of a distal portion for
catheter control and a proximal portion for stent
control. The catheter portion positions and locks
the catheter in preparation for stent deployment.
Advancement of the “catheter control hub”
advances the catheter into the target lumen, and the
“catheter lock” retains the desired catheter position. The stent portion releases each stent anchor
independent of one another in two sequential
300
K.F. Binmoeller
Fig. 20.4 AXIOS stent and delivery system (Xlumena,
Mountain View, CA). ( a ) Fully covered nitinol braided
stent with bilateral fl anges consisting of handle and
catheter. ( b ) The handle Luer locks ( LL ) to the inlet port
of the working channel and has a distal portion for catheter
control and a proximal portion for stent control. The “catheter control hub” ( CCH ) advances and retracts the catheter.
The “stent deployment hub” ( SDH ) retracts the catheter
sheath to release each stent anchor independent of one
another in two sequential steps. CL = Catheter Lock
Fig. 20.5 Transluminal drainage using the AXIOS stent. ( a ) Endoscopic view. ( b ) Fluoroscopic view.
( c ) Endosonographic view. Arrow shows proximal and distal fl anges of stent
steps, with a full “stop” after the release of the
distal anchor to prevent premature deployment of
the proximal anchor. Retraction of the “stent
deployment hub” to the halfway mark retracts the
catheter sheath to deploy the distal anchor in
the target lumen. The “catheter lock” can then be
released to retract the “catheter control hub” to
engage the distal anchor against the wall of the
target lumen. Complete retraction of the “stent
deployment hub” deploys the proximal anchor in
the bowel lumen.
The AXIOS stent has been evaluated in animal
studies for various transluminal applications
(Fig.
20.5 ). A cholecystenterostomy was created
under EUS guidance in four survival pigs [
The stents retained their position without inducing pressure injury or a hyperplastic tissue reaction over a 1-month animal survival period.
Contrast injection after stent deployment showed
no leakage of contrast outside of the fi stula tract.
The stent covering prevented ingrowth through
the mesh, making removal easy using a snare
37 ] .
30120 Self-Expandable Metal Stents: Transluminal Stents
Fig. 20.6 Endoscopic view of AXIOS stent removal
using a snare
Fig. 20.8 Prototype all-in-one device (AXT, Xlumena) con-
sisting of needle ( N ), dilator ( D ), anchor ( A ), and stent ( S )
removal are possible. In the above animal studies,
the AXIOS stent lumen was found to be easily
intubated with the endoscope and to stabilize the
endoscope during manipulation, including
retro fl exion, without dislodgement.
Fig. 20.7 Transluminal passage of endoscope through
the AXIOS stent to access target lumen
tightened over the saddle portion. Necropsy
showed fusion of the gallbladder and stomach
walls at the site of the cholecystogastrostomy and
a leak-free fi stula tract. A gastrojejunostomy was
created in fi ve animals (one acute and four survival). The stents remained fully patent in all animals throughout the implantation period (up to
4.5 weeks) and were easily removed (Fig.
20.6 ).
A transluminal stent can facilitate passage of
an endoscope into the target lumen (Fig.
20.7 ).
This extends the gamut of potential endoluminal
interventions such as biopsy, tumor resection,
and tumor ablation. In the gallbladder, biliary
interventions for stone disease such as mechanical and electrohydraulic lithotripsy for stone
Exchange-Free Platform
for Transluminal Stenting
Future developments in transluminal stenting
include a catheter-based system that delivers multiple tools in a coaxial fashion without the need
for device exchange (Fig. 20.8 ). This will reduce
the risk of leak into the intermural space and
streamline the procedure. A prototype all-in-one
device (AXT, Xlumena) was evaluated in porcine
survival studies with technical success in creation
of a cholecystogastrostomy in three animals [ 38 ] .
The AXT device Luer locks to the echoendoscope
and is designed for single operator, single-hand
deployment. The exchange-free system is composed of a unique anchor needle that punctures
the walls of the GI tract and bile duct and maintains continuous apposition of the two lumens to
prevent leakage of contents during instrumentation. The AXIOS stent is then delivered and
deployed directly over the anchor needle.
302
K.F. Binmoeller
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Index
A
Achalasia , 211, 212
Aixstent , 118
Alimaxx-ES , 55, 74, 77, 82, 197
Antire fl ux stents (ARSs) , 63, 64, 81, 199–200
Axial force (AF) , 92, 241, 249
AXIOS stent , 299–301
B
Benign biliary diseases
biliary and pancreatic stents , 141–144
complications
fully covered , 254–255
pancreatitis and cholecystitis , 256
partially covered , 254
uncovered , 253–254
covered stents , 253
leaks , 251–253
principles , 249
strictures , 250–251
USEMS , 249
Benign biliary strictures (BBS) , 89, 142–143
Benign colorectal obstruction (BCRO) , 186–187
Benign esophageal disease , 131–132. See also
Esophageal stents
Benign esophageal stricture , 205–207
Benign strictures , 73, 270, 275–277
Bile duct cancer , 99
Bile duct drainage , 296–298
Bile duct stenting
biliary obstruction , 15, 16
complications and risks
cholangitis , 27, 28
external stimulation/energy , 26–27
microcolonies of rod-shaped bacteria , 25, 28
plastic polymers , 26
postpapillotomy bleeding and perforation , 25
yellowish sludge on stent , 25, 28
Cotton-Leung stent
Amsterdam endoprosthesis , 19
con fi guration changing effect , 19
cross section of plastic tubes , 19, 20
distal end position , 22
distal fl ap , 20
guidewire selection for placement , 23–24
length measurement , 22–23
length selection , 21–22
mean fl ow rates vs. caliber and con fi guration , 20
migration prevention , 20, 21
pigtail designs , 18
polyethylene , 21
proximal coaxial tapered tip design , 19
setup , 19
stent introducer system , 22, 23
endoscopic retrograde cholangiopancreatography
(ERCP) , 17–18
malignant obstructive jaundice , 15–16
migrated stent removal , 28
percutaneous transhepatic
cholangiography (PTC) , 16–17
plastic stents , 29
short-wire technology
fusion OASIS system , 25–27
guidewire maintenance , 25, 26
radiography , 25, 27
V-scope system , 24–25
wire locking device , 24
stent retrieval systems , 27
stent shaping , 29
Bile duct stones , 29, 144
Biliary fi stula/leak , 89
Biliary malignancy . See Distal biliary malignancy
Biliary self-expandable metal stents
advantages , 89
comparison , 99
covered
ComVi , 97, 98
vs. uncovered , 99
Hanarostent , 99
Niti-S , 98–99
Viabil , 97–98
Wallstent , 97
Zeostent , 98
mechanical properties , 89, 92
membrane , 92–93
structure and material , 92
types , 89–91
R. Kozarek et al. (eds.), Self-Expandable Stents in the Gastrointestinal Tract,
DOI 10.1007/978-1-4614-3746-8, © Springer Science+Business Media New York 2013
305
306
Index
Biliary self-expandable metal stents (cont.)
uncovered
Bonastent M-Hilar , 96
Flexxus , 96
Niti-S , 94, 95
Niti-S large cell D-type , 95
Sinus-Endoscopic , 97
WallFlex , 93–94
Wallstent , 93
X-Suit NIR Biliary Metallic , 96–97
Zilver , 94
Biliary stents
benign biliary diseases , 142–144
Gianturco Z-stent and Wallstent
animal experiments , 42
applications , 42
design , 42, 43
high expansile force , 42
photographs , 42
technical feasibility , 44
malignant biliary obstruction , 144–146
membrane-coated stents , 45
placement techniques
combined malignant biliary and duodenal
obstruction , 149–150
combined percutaneous and endoscopic
palliation , 149
delivery system , 146–147
endoscopic placement , 147
EUS-guided biliary stent placement , 150–151
malignant hilar obstruction drainage , 147–148
percutaneous placement , 149
radiopaque markers , 146
stent-in-stent placement , 148
rigid plastic stents , 41
SEMS , 141
tube-based nitinol stents , 44–45
wire-based nitinol stents , 44
Bilio-enterostomy , 296–298
Biodegradable self-expandable stents (BDSES) , 208–209
Biodegradable (BD) stents , 59–62, 83–84
Bismuth-Corlette classi fi cation , 218–220
Boerhaave’s syndrome , 209–210
Bonastent M-Hilar , 96
BONASTENT
®
pyloric/duodenal stent
covered , 113
M-duodenal , 113–114
uncovered , 110–112
Bowel obstruction , 277–279
Braided stents , 55–56, 58–60
C
Cholangitis , 27, 28, 242–243
Cholecystenterostomy , 295–296
Cholecystitis , 241–242, 256
Chronic pancreatitis (CP) , 250–251
Colonic obstruction , 275, 278
Colonic prostheses
delivery system , 121, 124
features , 121–123
Hanarostent , 126
Niti-S enteral , 125
uncovered/covered stent , 124–126
WallFlex enteral , 124
Colonic self-expandable metal stents
benign colorectal obstruction and fi stulae , 186–187
MCRO
OTW procedure , 182–183
outcomes , 183–186
patient preparation , 178
placement techniques , 180–183
rectosigmoid area without fl uoroscopy , 183, 184
selection , 178–180
surgical or endoscopic interventional
approach , 175–176
TTS procedure , 181–183
water-soluble contrast retrograde study , 177
Colonic stents
benign strictures , 275–277
bridge to surgery , 280–282
complications , 284–285
cost-effectiveness , 283–284
covered vs. uncovered SEMS , 282–283
extrinsic obstruction , 277–278
general principles , 275–276
palliation , 278–280
quality of life , 283
Colorectal neoplasia , 275
Colorectal obstruction , 122, 125
Colorectal stents
dual stent , 41
malignant colonic obstruction , 40
self-expandable metallic stent placement , 40
SEMS and SEPS , 41, 42
surgery , 40
Ultra fl ex , 41
uncovered self-expandable nitinol stents , 41
Wallstent , 41
ComVi stent , 41, 45, 97, 98, 108, 237
Conio stent , 74, 83
Cotton-Leung stent
Amsterdam endoprosthesis , 19
con fi guration changing effect , 19
cross section of plastic tubes , 19, 20
distal end position , 22
distal fl ap , 20
guidewire selection for placement , 23–24
length measurement , 22–23
length selection , 21–22
mean fl ow rates vs. caliber and con fi guration , 20
migration prevention , 20, 21
pigtail designs , 18
polyethylene , 21
proximal coaxial tapered tip design , 19
setup , 19
stent introducer system , 22, 23
Covered self-expandable metal stents
(CSEMSs) , 97, 99, 236–237
Cystenterostomy , 293–295