Peter

R. Mueller,

M.D.

Metallic

T

Endoprostheses:

Boon

with

potential

from

occlusions

long-term

or Bust?’

complications

Both

the

et al (1) reand largest published study on the use of metallic biliary endoprostheses for the treatment of malignant bihiary disease. The question that this and other recently published reports (2-9) on metallic stents raises is,

the appropriately selected patient. Recently, radiologists have shown

sheaths.

tremendous est in the originally

small

Are

tallic

HE article ports

by

the

metallic

Lameris

newest

endoprostheses

really

bet-

deemed

enthusiasm use of metallic thought that

stents

would

acceptable

in

and

for and interstents. It was the use of me-

improve

long-term

results and reduce complications when compared with the use of conventional stents. Over the past few years, several

ter than conventional endoprostheses and should they replace them? Althouglt clinical trials (10-15) of various types of endoprostheses used as substitutes for internal-external catheters have been well documented, the search for the perfect stent resembles the surfer’s pursuit of the perfect wave. Initially, early reports of uncomplicated success with conventional endoprostheses were overly optimistic (16); however, after several years of experience, some authors advocated abandonment of these devices (17). In the past few years, the marginal benefits versus marginal costs have become understood, and a comfortable middleground approach has been reached,

artit’les

have

been

published

on the

Gianturco (Cook; Bloomington, Ind) (3,7) and Wallstent (Schneider [U.S.A.], Plymouth, Minn; and Pfizer, Minneapolis) (1,2,4,5) metallic endoprostheses, the two most commonly used metallic stents. Both sents are constructed

from

thin

stainless

steel

and

have

large

internal diameters (Table I). The Gianturco is zigzag; the Wallstertt has a meshlike structure. There are supporters and skeptics for both of these stents.. The major advantages and disadvantages of metallic stents are summarized herein.

Radiology

1991;

Small

179:603-605

local

minimal,

these

the

trauma

rather

analgesics

administered

and narcotics.

induced

is no

more

than that seen with a routine biliary drainage. This contrasts greatly with the 14-16-F transhepatic tract required for placement Similarly, the

of a conventional small introducer

stent. system

allows the option of placement tallic stent at a single-session the radiology department. Lameris et al (1) did not

nique,

of a mevisit to

Although

use this techet al (2) and Mueller et al

Adam

(18) noted that they placed metallic prostheses at the initial visit in up to 40% of patients. Even if this is not accomplished, the trauma of a second session is negligible, and the pain experienced by the patient is considerably less than the degree of discomfort that has been seen with placement of conventional endoprostheses.

Diameter

Perhaps

System

McLean and Burke pointed out in their state-of-the-art article on biliary endoprostheses that patients’ reactions to biliary intervention are paramount to its success and acceptance (14). The problems of multiple catheter manipulations and procedure-induced pain have contributed, as much as anything, to the reduction of radiologically controlled biliary interventions. One cannot overestimate the negative effects that multiple painful dilations of the transhepatic tract have on patients and clinical acceptance of the procedure.

‘From the Department of Radiology. Massachusetts General Hospital, 32 Fruit St. Boston, MA 02114. Received and accepted March 14, 1991. Address reprint requests to the author. ‘RSNA, 1991 See also the article by Lameris et al (pp 703707) in this issue.

Table

Introducer

tolerate

with

intravenously

Thus,

is often

patients

tracts

the Wallstent 7-10-F introducer

and

with

Dilatation

most

Large

ADVANTAGES Index terms: Bile ducts, interventional procedure, 768.1229 #{149} Bile ducts, neoplasms, 768.36 #{149} Bile ducts, stenosis or obstruction, 768.36 #{149} Editorials #{149} Gallbladder, neoplasms, 762.36S #{149} Interventional procedures, complications

Gianturco

can be inserted

the

most

significant

advan-

tage of the metallic stents over the conventional stents is their large internal diameter, which varies from I cm (Gianturco) to 1.2 cm (30 F) (Wallstent). In general, the largest external diame-

ter conventional stent F (7-8 mm). However,

inserted because

rather

external

thick

these

types

(2-3

mm)

of endoprostheses

is 12-14 of the wall,

have

a

relatively small (4-5 mm) internal diameter, which actually reduces the functional lumen. Experimental work by Rey et al has proved that patency is directly related to the stent diameter (19). The severalfold increase in diame-

I

Characteristics

of Metallic

Stents No. of Stents

Stent

Diameter (cm)

Length (cm)

Gianturco

1.2

1.5-3.0

Wallstent

1.0

6 or 10

Introducer Size (F)

Routinely Used

10

>2-3

9

1

Manufacturer

Cost(S)

Cook (Bloomington, Ind) Schneider (U.S.A.)

(Plymouth. Pfizer

700-1,200 1,000

Minn),

(Minneapolis)

603

ter of a metallic stent versus that of a conventional stent should increase patency.

Small

Surface

Area

et al

(1)

and

of Malignant

Obstruction

other

recent

articles

by Adam et al (2) and Gillams et al (5) seem to support this fact. Although they all reported a relatively high percentage of patients with recurrent jaundice, the rate of sepsis due to occlusion from debris was actually low.

Dooleyetal(1984)(11) Mueller et al (1985) (15) Lammer and Neumayer(1986)(13)

Dicketal

stent and of recurrent

(1), Adam

(1987) (10)

has

been jaundice

reported as a cause by Lameris et al

et al (2), and

Gillams

et al (5).

Consequently,

like conventional endoprostheses in which a problem of migration occurred, the metallic endoprosthesis should not be positioned so that it is the same length as the obstructing lesion. In a certain percentage of cases, particularly those with strictures longer than 3-4 cm, two or more stents are necessary. Whereas the Wallstent shortens s it expands, the Gianturco stent is simply shorter (1.5-3.0 cm in length). This necessitates placement of multiple stents. In fact, both Irving et a! (7) and Coons (3) reported the use of multiple stents in their patients; Coons used 87 metal-

lic Gianturco tients.

endoprostheses

in 31 pa-

the previously described adone should consider several disadvantages before declarmetallic stents are indeed more than conventional stents.

Treatment Because

of Occlusion both

the Gianturco and the Walistent are made of thin wire mesh that becomes incorporated into the bile duct mucosa and both exert natural pressure on the surface of the bile duct wall, they are not easily removed. In fact, Lameris et al noted complications in three of their patients because the wires eroded through the mucosa (1). Gillams et al also described a failed attempt at surgical removal (5). This is in contradistinction to the conventional endoprosthesis that can be removed by radiologic or endoscopic methods (22,23). However, this does not mean that occlusion cannot be treated. Re-

drainage, reinsertion and Fogarty balloon been tallic

used for stents.

of a new methods

treatment

stent, have

of clogged

all me-

Shortening Several

authors

report

a decrease

in

size of the Walistent of up to 40% of the original length within weeks of placement (2,9). due to the

604

This phenomenon mechanical properties

Radiology

#{149}

is simply of the

the

procedure.

proximately

The $1,000;

out,

the

use

the cost of

Wallstent

costs

ap-

a single

Gianturco

approximately $350. One often has to insert 3-4 Gianturco stents per patient; hence, if the stricture is longer than 1-2 cm, there is not a great difference in price between the two. Lameris et al (1) suggest that balloon dilation after placement of the metallic endoprosthesis may not be necessary, and stent,

not using

a balloon

dilation

catheter

might reduce the cost of the biliary procedure. However, other authors, notably Coons (3) and Adam et al (2), ar-

gue that dilation after placement mandatory. In summary, these penses contrast sharply low cost of a conventional varies between $60 and

is

exthe rather stent, which $160.

with

13 22

162 87

20 20

rence

of jaundice

patients

with

report lic

stated

stents

that

has

report

on

and/or

Early results of treatment of malignant obstruction with both Gianturcos and Walistents were not encouraging and were no better than results from major studies in patients with conventional stents (Tables 2, 3). Coons (3) reported that up to 21% of patients in his

study

experienced

late sequelae

that

42%

experienced

“.

cholangitis

the

.

.

of metalIn

Gillams

et al (5)

of

their

late

.

use

45

a

patients

complications

of

or jaundice.”

both Adam et al et al (1) demonstrated much better results. Adam et al reported long-term complications in only 7% of their patients. Importantly, Lameris et al (1) grouped their own patients Recently,

however,

(2) and

with

Lameris

long-term

ly into

complications

patients

common

who

bile

duct

separate-

had

disease

(2.4%)

and

in the those

hilar lesions (17%). As one rethe literature, particularly reports on patients with metallic stents, it is important to separate the results and with

views

related

analysis

of

use

to

the

disease

greater in

These cult

to

endoprostheses

with

of the

but

all

were of

combined

the

terestingly,

with

with

stent

most

recent

diffimany

and!

by

poor

stent,

shortening

stent

is placed.

and

Adam,

considerable

placement,

po-

possibly

natural

the

Lameris

diologists

lesions.

been

caused

the

after

were

hilar

of jaundice

metallic

with

occurs

a

likelihood

cases

cholangitis

that

always in

recurrent

sitioning

in

that

high

have

treat,

Carereports

of problems

patients lesions

location.

previous

indicates

percentage

seen

or

all

of metallic

malignant

In-

two

ra-

experience

have

publications

had and

best results. In general, reviewing the numerous published

the

have

had

the

doprosthesis

in

that

most

patients

long-term

of

long-term

It appears. experienced

who

complications

occlusion that

terms

the results in reports on en-

is difficult.

complications

to

had

problems

overgrowth (perhaps positioning and/or metallic stent) rather

from

needs

debris. be

This

studied

is an

further

beshortthan area be-

cause, if tumor overgrowth was indeed the cause of long-term complications, metallic

more

endoprostheses

encouraging

of

jaundice and/or cholangitis. Irving et al (7), in their summary of a multicenter European clinical trial, reported an approximately 50% rate of recur-

.

Their

disappointing.”

Walistents,

indicated

in

disease.

“.

been

with

cholangitis

malignant

due to tumor cause of poor ening of the

RESULTS

of Patients Complications

53 113

ful

As Lameris et al (1) point of metallic stents increases

Stents

Percentage Long-term

of the

DISADVANTAGES

Conventional

complications

Expense

Despite vantages, potential ing that beneficial

with

No. of Patients

Authors

Because the stents are constructed from extremely thin stainless steel wire, they have a low mass and small surface area. Theoretically, these decrease the possibility of infections. In studies of endoscopically placed endoprostheses, for example, it has been shown that the initiating event of infection occurs when bacteria adhere to the stent surface. This results in secondary deposition of protein and formation of a gelatin matrixlike material that promotes occlusion (14,19,20,21). Because the metallic endoprostheses present less surface area, such adherence would seem less likely to happen. Similarly, the wire mesh often becomes incorporated into the wall of the duct (1,3,5), which further reduces the surface area and decreases the likelihood of infection. In fact, the article by Lameris

Table 2 Results of Treatment

BENIGN The the lignant

use

previous of

metallic

disease,

may

have

a

future.

DISEASE commentary stents primarily

concerns strictly

in

because

June

mathe

1991

13.

Table 3 Results of Treatment

of Malignant

Obstruction

with

Metallic

Stents 14.

Stent

Authors

No. of Patients 16 41 41 69

Gianturco Wallstent Wallstent Wallstent

Coons (1989) (3) Gillams et al (1990) (5) Adam et al (1991) (2) Lameris et al(1991)(1)

Percentage Long-term

of Patients Complications

21 42 7 2 (common 18 (hilar)

with

15. duct) 16.

use

of stents-conventional or metalgenerally somewhat controversial in benign disease. The largest current study of the use of metallic stents in benign disease was reported by RosSi et al (9), who used Gianturco stents to

5.

lic-is

treat benign strictures in 17 patients. Even Rossi et al suggest that only selected patients should undergo this treatment, and only after other, more standard methods have failed. In summary, we are still in a discovery phase with metallic stents. The potential is still unproved and the results are still uncertain. U

6.

7.

8.

References 1.

2.

3.

4.

Lameris JS, Stoker J, Nijs HGT, et al. Malignant biliary obstruction: percutaneous use of self-expandable stents. Radiology 1991; 179:703-707. Adam A, Chetty N, Roddie M, Yeung E, Benjamin IS. Self-expandable stainless steel endoprostheses for treatment of malignant bile duct obstruction. AJR 1991; lS6:321-32S. Coons HG. Self-expanding stainless steel bihiary stents. Radiology 1989; 170:979983. Dick R, Gillams A, Dooley JS, Hobbs KEF. Stainless steel mesh stents for bihiary strictures. J Intervent Radiol 1989; 4:95-98.

Volume

179

Number

#{149}

3

9.

10.

11.

12.

Gillams A, Dick R, Dooley JS, Wallsten H, El-Din A. Self-expandable stainless steel braided endoprosthesis for biliary strictures. Radiology 1990; 174:137-140. Huibregtse K, Cheng J, Coene PPLO, Fockens P. Tytgat GNJ. Endoscopic placement of expandable metal stents for biliary strictures: a preliminary report on experience with 33 patients. Endoscopy 1989; 21:280-282. Irving JD, Adam A, Dick R, Dondelinger RF, Lunderquist A, Roche A. Gianturco expandable metallic biliary stents: results of a European clinical trial. Radiology 1989; 172:321-326. Roeren T, Brambs HJ, Richter GM, Kauffmann GW. Coated balloon-expandable stent for percutaneous treatment of mahignant biliary obstruction. Radiology 1990; l77(P):238-239. Rossi P, Bezzi M, Salvatori FM, Maccioni F, Porcaro ML. Recurrent benign biliary strictures: management with self-expanding metallic stents. Radiology 1990; 175: 661-665. Dick R, Platts A, Gilford J, Reddy K, Duncan-Irving J. The Carey-Coons percutaneous biliary endoprosthesis: a three-centre experience in 87 patients. Clin Radiol 1987; 38:175-178. Dooley JS, Dick R, George P, Kirk RM, Hobbs KEF, Sherlock S. Percutaneous transhepatic endoprosthesis for bile duct obstruction. Gastroenterology 1984; 86: 905-909. Gibson RN. Transhepatic biliary endoprostheses. J Intervent Radiol 1989; 4:712.

17.

18.

19.

20.

21.

22.

23.

Lammer J, Neumayer K. Bihiary drainage endoprostheses: experience with 201 placements. Radiology 1986; 159:625-629. McLean GK, Burke DR. Role of endoprostheses in the management of malignant biliary obstruction. Radiology 1989; 170:961-967. Mueller PR, Ferrucci JT Jr. Teplick 5K, et al. Biliary stent endoprosthesis: analysis of complications in 113 patients. Radiology 1985; 156:637-639. Coons HG, Cary PH. Large-bore, long biliary endoprostheses (bihiary stents) for improved drainage. Radiology 1983; 148: 89-94. Mendez G Jr, Russell E, LePage JR. Guerra JJ, Posniak RA, Trefler M. Abandonment of endoprosthetic drainage technique in malignant bihiary obstruction. AJR 1984; 143:617-622. Mueller PR, Tegtmeyer CJ, Saini 5, et al. Metallic biliary stents: early experience (abstr). Radiology 1990; l77(P):307. Rey JF, Marpetit D, Greff M. Experimental study of biliary endoprostheses efficiency. Endoscopy 1985; 17:145-148. Groen AK, Out 1, Huibregtse K, Delzenne B, Hoek FJ, Tytgat GNJ. Characterization of the content of occluded biliary endoprostheses. Endoscopy 1987; 19:57-59. Leung JWC, Ling TKW, Kung JLS, Vallance-Owen J. The role of bacteria in the blockage of biliary stents. Gastrointest Endosc 1988; 34:19-22. Jackson JE, Roddie ME, Yeung EYC, Benjamin IS, Adam A. Biliary endoprosthesis dysfunction in patients with malignant hilar tumors: successful treatment by percutaneous replacement of the stent. AJR 1990; 155:391-395. Lee MJ, Mueller PR, Saini 5, Morrison MC, Brink JA, Hahn PF. Occlusion of biliary endoprostheses: presentation and management. Radiology 1990; 176:531534.

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‘a’-

Metallic endoprostheses: boon or bust?

Peter R. Mueller, M.D. Metallic T Endoprostheses: Boon with potential from occlusions long-term or Bust?’ complications Both the et al...
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