Interventional Plinio Rossi, MD Francesca Maccioni,
#{149} Mario
MD
Bezzi, #{149} Mario
MD #{149} Filippo M. Salvatori, L. Porcaro, MD
Recurrent Benign Management with Metallic Stents’ Self-expanding metallic stents of a modified Gianturco design were used to treat benign strictures of the biliary tree in 17 patients. Thirteen patients had undergone several unsuccessful
surgical
repairs,
and
four
had not undergone surgery because of their clinical status. All patients had already undergone multiple percutaneous balloon dilations without success. Stents were placed percutaneously, through a transhepatic approach, without complications. Adequate caliber of the strictured segment, stable relief of symptoms, and normalization of liver function tests were achieved in 14 patients (82.4%). Partial primary success was obtained in one patient; initial success was achieved in two patients, but strictures recurred after 5 months. The average follow-up period was 8 months. Results suggest that placement of these stents might represent a permanent therapeutic solution for intractable recurrences. Extended follow-up and cxperimental studies to clarify longterm patency and biotolerance are needed.
MD
Biliary Strictures: Self-expanding
B
ENIGN
biliary
strictures
represent
PATIENTS
a distinct therapeutic problem due to the high frequency of recurnence after treatment. When performed by an experienced surgeon, surgical repair of these strictures has a success nate of 78%-88% at the first attempt (1-3). Recurrences develop in
i5%-25%
of cases
and
may
necessi-
tate repeat surgery, but the success rate decreases as the number of surgical attempts increases. Satisfactory results
have
been
reported
in less
than
6i% of cases after the third operation (i,3). Percutaneous balloon dilation has become a viable alternative to the surgical treatment of benign biliary strictures and has a reported success nate ranging from 70% to 83% (4-6). This rate can be considered more than satisfactory if one keeps in mind that most patients undergoing such a procedure have already undergone at least one on two unsuccessful surgical repairs. Recurrences also occur after percutaneous balloon dilation and usually result from chronic inflammation
on possibly
compliance of an elastic
from
low
stricture
because of the presence component in the scan
tissue.
In recurrent cases, after several balloon dilations and short-term stent placement have been performed, there
Index
terms:
Bile
ducts,
interventional
proce-
dune, 76.1229 #{149} Bile ducts, prostheses, 76.459. Bile ducts, stenosis or obstruction, 76.289 Radiology
1990; 175:661-665
From the tal Radiology, I
Department University
of General of Milan,
and the Department of Radiology, tedna, University of Rome (MB., M.L.P.).
requested February
Received
January 1; accepted
Seconda CatF.M.S., F.M.,
2, 1989;
3, 1990; revision February
1990
revision
received re44, 00197
19. Address
to P.R., Via Bertoloni
print requests Rome, Italy. RSNA,
November
and DenItaly (P.R.)
Radiology
are
limited
therapeutic
options,
including repeat surgical repair, often refused by the patient, or additional dilation and long-term stent placement. Both options offer no guarantee of permanent patency. In these cases, self-expanding metallic stents may represent a permanent solution because patency of the bile duct lumen is mechanically maintained; thus, elastic recoil and recurrent stenosis are prevented (7,8). sults
panding with
balloon
We report the of the application
metallic strictures
dilations.
preliminary of self-ex-
stents recurring
re-
after
several
METHODS
Patients From
October
tients
with
1988
to June
recurrent
benign
1989,
17 pa-
biliary
stric-
hires were treated with self-expanding metallic stents. Ten were men and seven were women, ranging in age from 22 to 76 years (average age, 60 years). The patients were selected from a group of 67 patients treated with percutaneous balloon dilation in our institution in the past 5 years (9).
Twelve site
patients
had strictures
of a bilioentenic
anastomosis,
had strictures of the ten cholecystectomy,
common and one
notic
the
at the four
bile had
duct afa ste-
choledochocholedochostomy.
two patients anastomosis, origin
angitis initial
In
with a stenotic bilioentenic the stricture also involved of the
main
hepatic
two patients, multiple rowings from secondary were present. percutaneous
ducts.
In
intrahepatic sclerosing At the treatment,
nanchol-
time all
of the pa-
tients had jaundice and symptoms of recurrent cholangitis. In 13 of the 17 patients, multiple surgical attempts to repair the strictures had been performed, with an average of two attempts in each patient. The other four patients had not undergone previous sungical repair of the postcholecystectomy stricture and were referred directly to us by the surgeons because of old age or high surgical risk. An average of 4.5 balloon dilations
were
performed
in each
patient,
with
bal-
loon size ranging from 8 to 20 mm and large-bore catheter stent placement of several months duration (average, 10 months in each patient). Self-expanding metallic stents were then employed because the dilations were not stable and because jaundice and cholangitis recurred in some patients. Informed consent for
new
this
each
procedure
was obtained
from
patient.
Methods The stainless
in 17 patients
AND
stents
are constructed
steel
wire
(Cook,
of either Bloomington,
md) or laser-cut stainless steel plate giomed, Kanisruhe, Federal Republic Germany).
Both
stents
are
(Anof
of a modified
661
Gianturco design (10,11), with the wines arranged in a zigzag pattern and tied with a nylon suture that passes through an eyelet at the end of each bend to form
a cylindric
structure
When
(Fig 1).
completely
are 8-10
expanded,
mm in diameter
the
and
stents
1-2 cm
long. Two or three stents of different lengths can be linked together head to tail (double on triple stents) to dilate long segments with greater flexibility than that provided by a single longer stent. No stents with “skirts” (11) on “barbs” were employed. Twenty-six stents (18 single and eight double) were placed in the 17
patients. High doses of broad-spectrum antibiotics were given intravenously to all patients, preferably 24 hours before the pro-
cedure. Cefota.xime (2 g three times a day) was used alone or with amikacin sulfate
a.
(500
ducer
mg twice
a day)
vere sepsis. The technique
in patients
with
se-
of insertion
catheter, and a guide to position a 10-12-F
is similar
Once
ex-
truded from the delivery system, the metallic endoprosthesis spontaneously expands to its original diameter within 1236 hours (Figs 2, 3). If possible, any ma-
to fully expand the stent by of a balloon catheter or to traverse
the stent should be avoided time to prevent dislodgment tioning. After the stent is released,
during this or malposia straight
catheter is advanced oven the guide above the stent to allow for flushing fluoroscopic
expand, ensure rteous
control.
the guide an access maneuvers.
If the
stent
5-F
wire and
does
not it to percuta-
wine is left within route Once
for future neexpansion
is
considered satisfactory, the catheter and guide wine are definitively removed. Follow-up studies included ultrasound (US) and liver enzyme and bilirubin assays in all patients, preferably performed at 1, 3, 6, and 9 months after the procedure. Computed tomography was performed in two patients to assess the patency of the stent lumen.
RESULTS Placement
of metallic
stents
was
technically adequate and satisfactory in all patients. In one patient, two separate stents dislodged in the duo662
Radiology
#{149}
(bottom).
steel
Ruler
in a double
stent
indicates
zigzag
expanded
(top)
centimeters.
(b)
and
partially
Laser-cut
compressed
stent
with
into
a double
the intro-
set
of struts
an-
pattern.
to
wire is left in place Teflon sheath be-
end of the stenosis.
(a) Stainless
2). The a balloon
yond the distal end of the lesion. The stent then is introduced over the wire into the sheath; advanced to the sheath tip by an obturator; and released by slowly withdrawing the sheath, with the obturaton kept stable. An essential point in the technique is the localization of the ideal level for stent release. The landmarks are obtained by placing metallic needles on the patient’s skin and injecting a minimal amount of contrast mediurn through a small catheter placed alongside the sheath, to visualize the
neuver means
1.
ranged
that described by Coons (7) (Fig stricture is initially dilated with
proximal
b.
Figure
denum at the duodenostomy pass a catheter
level of a choledochoduring maneuvers to through a stent that
was not fully expanded. The were removed endoscopically, double stent was adequately
stents and posi-
but
mally fourth
immediately
slid
placed.
Both
patients
like strictures bility.
After
that
had caused
short, stent
a
webinsta-
placement,
14 of the
17
still
elevated
5-6
the procedure (alkaline levels were 393, 430, normal values, 87-220 ings reflecting chronic after other
longstanding 1 1 patients,
were
normal.
months
after
phosphatase and 370 IU/L; lU/L), findliver damage
obstruction. the enzyme
In the levels
In one patient (5.9%) with Hodgkin disease and sclerosing cholangitis secondary to a stenotic bilioen-
tenic
anastomosis,
stent
through
other
the
two
temporary
was
metallic
and
cholangitis
was
suggestive
patients
relief
obtained.
The
(11.8%),
of the
onset
The at a
disease
of jaundice
5 months
thereafter
of a recurrent
stnic-
tune. In one patient, percutaneous cholangiography revealed multiple filling defects within the stent. This could have been due to mucosal hyperplasia (12), fungal proliferation (7), or neoplasm. No tissue specimens
were
stent
patients (82.4%) were clinically stable, with remission of jaundice and cholangitis. Bilirubin levels returned to or stayed normal in the 14 patients. In three patients, levels of serum alkaline phosphatase and ‘y-glutamyl transpeptidase decreased considerably after the procedure but
were
In the only
proxi-
and distally to the lesion; double stent was eventually
in place
stent to drain the biliary system. metallic stent remained patent follow-up period of 9 months.
a
tioned 1 month later. In another patient with a postcholecystectomy stricture of the common bile duct, three separate stents were initially
placed
left
obtained
because
the
patient
fused to undergo additional ventional procedures.
In all patients, od
ranged
age,
the
from
re-
inter-
follow-up
pen-
4 to 12 months
(aver-
8 months).
No
major
served, Minor
complications
and there complications
were
were
sea and epigastnic pain, similar those occurring during other taneous transhepatic procedures.
One
patient,
who
ob-
no deaths. included nau-
had
to pencu-
advanced
biliary cirrhosis and a long-standing obstruction caused by a recurrent stricture, presented with bleeding vanices 2 months after stent placement. A portal thrombosis was discovered at angiognaphy.
DISCUSSION
placement
and expansion at the level of the main stricture were satisfactory, but symptoms were not relieved because of multiple intrahepatic narrowings. We suggested that other stents be
The initial treatment of choice for uncomplicated postsungical benign biliary strictures is surgical repair. It
placed at the area, but this
formed. However, alternative treatment may be beneficial in patients at high surgical risk and in whom mul-
ferning
level of each stenotic was refused by the ne-
physicians.
A catheter
was
has
fewer
a success
than
rate
three
of 78%-88%
operations
(1-3)
if
are per-
June
1990
a.
b.
C.
Figure
2. (a) Image of a 71-year-old woman with a postcholecystectomy stricture of the common bile duct (arrow) after three balloon dilations and a total of 5 months of stent placement. (b) Insertion of a double stent (black arrows) through a 10-F sheath. A 5-F angiognaphic catheter (white arrow) placed below the bifurcation of the hepatic ducts allows for injection of contrast mediurn
and
visualization
proper
stent
ly after
of the
placement.
stricture
for
(c) Stent
immediate-
deployment,
with the sheath withtip of sheath). (d) Complete stent expansion 24 hours after placement. (e) Image obtained 5 days after placement
drawn
(arrow
=
shows optimal downflow of contrast al and restoration of adequate caliber common bile duct.
procedure is completed in 2-5 days, and the patient is discharged without a drainage catheter. Another potential advantage is the relatively lange inner diameter of these stents, which ensunes a decreased rate of occlusion, compared with that achieved with currently available plastic endopros-
e.
d.
mateniof the
theses.
This
because
the
is particularly
life
important,
expectancy
of pa-
tiple surgical repairs have failed. Such therapeutic options, which mainly consist of percutaneous balloon dilation, are necessary due to the progressive and possibly malignant evolution of this benign disease toward biliary cirrhosis and secondary sclerosing cholangitis, tragic events if one considers that the majority of these strictures (3) are iatrogenic and therefore preventable. The success rate of percutaneous balloon dilation in iatrogenic nonanastomotic strictures is 76%-88% (4,6), while that for anastomotic strictures
to the around
and prevent elastic recoil of the lumen and possible repeat stenosis. In addition, the reduced surface area of the struts may lower the risk of chol-
validity has not been proved. As with any small series of cases, definitive data must be regarded with caution
is slightly
angitis
because
Volume
lower,
175
67%-73%
Number
#{149}
3
(4,6),
due
considerable the stricture
fibrotic reaction (4). In recurrent
stenoses, successive repeat dilation is possible, but the patient would be subjected to increased discomfort due to a long-term indwelling catheter and all of its potential complications. Self-expanding stainless steel stents may represent a solution for recurrences because they provide structural
support
(7).
Most
of the
important,
bile
duct
the
entire
tients much
with benign longer than
with malignant Unfortunately, tency stents
stenoses. the long-term
rate and effects on the bile duct
been ies
biliary strictures that of patients
documented. (7,8)
longest than might
and
in the
21 months; be feasible,
they
pa-
of metallic wall have
In previous
follow-up
are
present
period thus, but
is
not
studstudy,
was
the
less
the procedure its long-term
extremely
sensitive
Radiology
663
#{149}
to change few
with
the
addition
of only
a
cases.
The action of the metallic structure of the stents on the biliary wall is unknown. We do not know if a mucosal lining will cover the steel wire on if the stents act as a chronic source of irritation perplasia
the
to the mucosa, causing and growth of tissue
lumen,
rent
with
stenosis.
subsequent
Alvanado
hyinto
recuret al (i2)
showed mucosal hyperplasia to be relevant in a canine model, but it is not clear whether the findings are applicable in humans in the same percentage and within the same time frame. Thus, the issue of biotolenance remains a major concern in the manufacture and experimental development of metallic stents in the futune. An auspicious refinement, which would decrease the potential risks of a permanent foreign body inside the biliary tree, would be the development of retrievable metallic stents that could be removed once patency is ensured.
However,
we
do
a.
b.
not
know if the stents could really be retrieved after several months of permanence within the biliary tree. Percutaneous cholangioscopy might offer this information. We currently believe that metallic biliary
stents
should
be
used
in the
treatment of benign biliary strictures in only selected cases after several trials of balloon dilation, until the questions concerning long-term outcome
are resolved.
The most important technical aspect in the placement of self-expanding metallic stents is the precise localization of the site for stent deployment. An important refinement of the technique is the placement of a small angiognaphic catheter alongside the sheath and above the stnictune for opacification of the biliary tree while the stent delivery system is already
in place
(Fig
in one
patient.
Figure
A double
stent,
sure
row),
to
with
would be the use of hourstents, which would en-
greaten
tunes,
stability
although
stents
same
expansile
and
the
664
#{149}
Radiology
in such with
stnicthis
strength
shape
are
(a) Cholangiogram
although
of a 35-year-old
shows dilatation the jejunum. (b)
into
partial
stainless steel stent. stent is protruding
the midpontion placed at the narrowest point of the stricture, might help prevent such dislodgment. Another possibility glass-shaped
3.
hepaticojejunostomy material passing
2). Stent
length is crucial in assuring connect positioning and preventing dislodgment. Because postoperative stnictunes of the common bile duct tend be short and bandlike, single stents tend to become displaced, either proximally on distally, by the elastic force of the stricture, as we observed
d.
C.
has been
Adequate patency the jejunum.
of the
transition
where
there
from
ben lumen.
a small-
Again,
double
an-
is an abrupt to large-cali-
stents
are
recommended because of more effective adhesion to a longer segment of duct wall (Fig 3). Stents with barbs or hooks have been proposed for such cases, but we do not have experience with them. When multiple stents are necessary, they should be placed in a netno-
grade
manner,
with
the
more
distal
a stricture
and only dilations,
obtained.
placed
because wine and
the
placed guide
first.
should
be entered first.
This
when a guide
caus-
stenoses, stents
are
all to be
with
a
is crucial
cause a stent placed within duct may occlude the origin ducts fore,
is im-
stent without or malpositioning.
in which
wire
of the
This
in multiple
ducts
of a double
A portion
it is difficult to pass a sheath through a
previously placed ing dislodgment
Moreover,
of contrast persists (an-
expansion
anastomosis.
being
portant guide
at the site of a high
a small amount the stricture
(c) Complete
bilioenteric
ones
difficult to make. Another site of possible dislodgment is at the level of bilioenteric
astomoses,
with
of the biliary tree After three balloon
decompression
(d) into
woman
be-
a major of other
it expands fully. Therewine in each branch
would guarantee expansion of the
an access first stent.
route
June
after
1990
a
Preliminary
results
are
encourag-
ing, despite the unresolved questions about biocompatibility and the need for technical refinements that will improve the technique. In 14 of our patients (82.4%), the procedure was completely successful and ended the discomfort of multiple dilations and long-term stent placement. However, the follow-up period in this study, as well as in other series published in the literature (7,8), has been relatively short, and the findings of late necurrence
after
surgical
repair
show that a 3-5-year follow-up od is necessary to evaluate the rence
(i)
perirecur-
rate.
In one patient with intrahepatic strictures from sclerosing cholangitis, only partial success was obtained because only the main stricture could be dilated with a metallic stent, without significant clinical improvement. In patients with primary or secondany scierosing cholangitis, the only method to obtain satisfactory, although palliative, results is the placement of a metallic stent in all intraand extrahepatic strictures (7), which is best accomplished through a T tube or a superficially fixed Roux loop (13) for easy insertion of multiple guide wires. In such cases, it is hoped that percutaneous techniques (ie, initial percutaneous balloon dilation, and later placement of metallic stents), if applied precociously, may arrest the obliterative inflammatory course of the disease and its progression to chronic
liven damage.
Finally, ed deaths in the
other
vorably
of procedure-relatin our series and
reports
(7,8)
compares
2.
fa-
with the 7.7% mortality rate to surgery (14). However, is even more favorable if one
attributed
the
the lack observed
rate
considers
that
the
candidates
for
me-
tallic stent placement had already been considered to be at high surgical risk because of previous surgery, old age, on chronic liver damage. In conclusion, self-expanding stainless steel stents are still experimental devices but may provide a solution to the therapeutic problem of recurrent benign biliary strictures. However, we are in accordance with other authors (7,8) that percutaneous balloon dilation should be the first therapeutic choice for treating recurrent benign biliary strictures, because it will be curative in a large percentage of cases. Self-expanding metallic stents should be reserved for intractable cases. Further clinical trials and technical developments will possibly extend the range of indications in the future. U ADDENDUM
ondary
died sclerosing
of liver
failure
from
4.
T, Parapatis
kins RK, Longmire WP. ing outcome in patients
tive biliary
strictures.
5K, Tomp-
Mountain
KW,
5.
6.
7.
8.
RA,
Thomas
Clin
North JC,
of strictures
Sung
Mueller center
Clin
North
MJ.
review
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Midell
Al.
of the Am 1971;
PR, vanSonnenberg Biliary
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E, Ferrucci dilatation:
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multiin
73 patients. Radiology 1986; 160:17-22. Moore AV Jr. Illescas FF, Mills SR. et al. Percutaneous dilation of benign strictures. Radiology 1987; 163:625-628. Williams HJ Jr. Bender CE, May GR. Benign postoperative biliary strictures: dilation with fluoroscopic guidance. Radiology 1987; 163:629-634.
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Irving
JD,
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1989; 173:321-326. Rossi P, Salvatori FM, Bezzi M, et al. Percutaneous management of benign biliary strictures. Cardiovasc Intervent Radiol (in press). Carrasco CH, Wallace 5, Charnsangavej C, et al. Expandable biliary endoprosthesis: an experimental study. AJR 1985; 145: 1279-1281. Uchida BT, Putnam JS, Rosch J. Modifications of Gianturco expandable wire stents. AJR 1988; 150:1185-1187. Alvarado R, Palmaz JC, Garcia OJ, Tio FO,
Rees CR.
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Evaluation
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balloon-expandable stents in bile ducts. Radiology 1989; 170:979-984. Russell E, Yrizarny JM, Huber JS, et al. Percutaneous
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Volume
175
#{149} Number
3
Radiology
665
#{149}