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

stricture

1981;

Midell

Al.

of the Am 1971;

PR, vanSonnenberg Biliary

Bili-

Am

biliary 51:711-

E, Ferrucci dilatation:

of clinical

management

JT

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.

Coons

HG.

biliary 983.

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Irving

JD,

Self-expanding

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R, Dondelinger

RF, Lunderquist A, Roche A. Gianturco expandable metallic biliary stents: results of a European clinical trial. Radiology 9.

10.

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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.

13.

Evaluation

of polymer-coated

balloon-expandable stents in bile ducts. Radiology 1989; 170:979-984. Russell E, Yrizarny JM, Huber JS, et al. Percutaneous

transjejunal

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Pitt HA, Miyamoto

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Volume

175

#{149} Number

3

Radiology

665

#{149}

Recurrent benign biliary strictures: management with self-expanding 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 patien...
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