Devil’s Dean D. T. Maglinte, A. Cedric Johnson,

MD, Jr, MD

FACR #{149} James

Extracorporeal of Gallbladder

T

success of extracorporeal shock wave lithotripsy (ESWL) in the treatment of renal stones (1) spurred

the adaptation of ESWL to the treatment of gallstones. Almost 10 times as many Americans have gallstones as kidney stones (20 million vs 2.2 million), and more than a half million cholecystectomies are performed annually

potential,

invasive”

therefore,

alternative

elective hailed

as a major

treatment (3-5). Our institution

of a “non-

to surgery

treatment

in the

of gallstones advance

was

in gallstone

has gained

consider-

able experience with the clinical applications of ESWL since its introduction in North America (6,7). The Methodist Hospital of Indiana (MHI) installed the first ESWL device (Dornier HM3, Manetta, Ga) in the United States for the

treatment of renal stones in 1984 (1), and 4 years later it was one of 10 initial sites to receive a Dornier MPL 9000 for gallstone lithotnipsy to be performed according to the Dornier National Biliany Lithotnipsy Study (DNBLS) protocol approved by the U.S. Food and

Drug

Administration

Index

terms:

(FDA).

Gallbladder,

Gallbladder,

chemical

bladder, Gallbladder,

procedure,

surgery

Radiology

762.289.

762.1299

MD

#{149} Gall-

tion to standard cholecystectomy and ESWL (and oral bile acid dissolution therapy approved by the FDA in 1988) for the elective treatment of gallstones, our institution has conducted protocols for (or had access to) other new treat-

ment

modalities

for symptomatic

stones: percutaneous my (PCCL), direct lution with methyl

the

J.C.),

tomy. Both PCCL and laparoscopic cholecystectomy were also offered at IUMC. The newer treatments were publicized in the lay press and media, and all members of the state medical society received brochures in the mail from the different investigators that

detailed the pros ment alternatives.

and

the

Center

of Gastroenterology

pital otis,

of Indiana, IN 46206,

gy, Indiana Indianapolis

about therapy.

for our editorial.

2

1990;

See

the

DNBLS,

New

RSNA,

L.J.,

and

G.T.C.,

A.C.J.),

(D.D.T.M., and

the

Methodist

1701 N Senate the Department School G.T.C.).

Liver

AC.!.,

Blvd.

SecHos-

Indianapof Radioto-

of Medicine, Received

Au-

2. Address

re-

October

to D.D.T.M.

full

report England

323:1239-1245. ©

Gallbladder

(L.J.),

accepted

requests

1991

with 1 year

the role of ESWL From our vantage

pessimism

gallwith it is

for

are

the

subject

by

Schoenfield

Journal

of Medicine

op-

gallpoint

of this

TO

CONSIDER

1990;

impact

pniate in patients gallstones without bid disease (11).

The

risk of death from standard cho(open minilaparotomy) increases with age (12-17). In a prospective study of 17,000 patients who lecystectomy

cholecystectomy

STONES

times to 1.31% (12). The same increase was noted in women. Mortality is also dramatically affected by the timing of

the cholecystectomy (ie, whether it is performed emergently or electively). For an individual younger than 60 years, the mortality of emergent cholecystectomy is approximately 1%, or 20 times the risk of elective surgery in a similar age group. The risk of emergent cholecystectomy

in

than 70 years increase over

The

safety

of elective

cholecystectomy

ment.

Consequently,

since

first

must be compared of standard cholecys-

interven-

DORNIER BILIARY

NATIONAL

LITHOTRIPSY

We contributed tients

of which

FDA

(19).

in the were

In this

DNBLS2,

studies

poreat

is that

Drug Administration, sity Medical Center,

the removal of gallstones is not justified in asymptomatic patients and that elective removal of gallstones is appro-

of Indiana,

0CC taneous

=

wave

MTBE oral

to

presentation,

lithotripsy,

prospective

the rethe a total of

presented

DNBLS

of both

STUDY

104 of the 635 pa-

included

sults

subject in 1990

the

one in Berlin (18), cholecystectomy has been the standard treatment for gallstone disease. Any alternative interven-

shock

and

108 years

performed

Study,

consensus

and, treat-

in the

Langenbuch

Lithotripsy

The

a 20-fold rates.

is, therefore, well established, more important, it is definitive

Biliary

retrospective

older

individuals

is 18%-20% (18), elective mortality

Abbreviations:

the

at a large

number of institutions, the risk of death for a man younger than 50 years was 0.054%, whereas for a man older than 70 years the risk multiplied 25

stones

been

.

with symptomatic significant comor-

extent to which intervention interrupts the natural history of the disease. The morbidity and mortality of gallhave

FACR

View’

OF

of a therapeutic

MD,

IN

INTERVENTION

tion on a disease depends on (a) the natural history of the disease to be treated, (b) the inherent risks associated with the intervention itself, and (c) the

(8-10).

and

T. Chua,

tion for gallstones with the record tectomy.

THE

(R.G.,

University (D.D.T.M.,

17,

print

and

of the treat-

the other alternative modalities, now difficult to maintain our initial

FACTORS

of Radiology

Surgery

tion

gust

for R.G.,

Departments and

cons

After 2 years of experience stone ESWL and more than

timism stone

#{149} Gonzalo

underwent

#{149} Lithotripsy

(D.D.T.M.,

G.T.C.)

gall-

cholecystolithotostone-contact dissotert-butyl ether

(MTBE) (offered at the neighboring Indiana University Medical Center [IUMC]), and laparoscopic cholecystec-

The From

MD

Wave Lithotripsy A Pessimistic

GALLBLADDER 1

Jordan,

762.1299.

1991; 178:29-32

Diseases

#{149} Lee

as a referral and research center, we predict that ESWL will have a limited role, if any, in the future treatment of uncomplicated gallstones. The reasons

In addi-

calculi,

therapy,

interventional

Graffis, MD

Crossin,

Shock Stones:

HE

(2). The

#{149} Richard

Advocate

=

Dornier ESWL

=

National extracor-

FDA

IUMC MHI

Indiana Methodist

methyl

tert-butyl

cholecystography,

Food

PCCL

and

UniverHospital

=

ether, =

percu-

chotecystolithotomy.

29

Table

I

Experience

Indianapolis

with

Symptomatic

Gallstone

ESWL

Ursodeoxycholic (MHI

No. of patients Success Treatment

and

treated

Alternative

and

acid IUMC)

MTBE PCCL

(MHI)

140 70 asia

Mortality Average hospitalization Complications

Local anesthesia

Biliarycolic Bile leakage Bleeding (all mild) Severe Additional

pancreatitis procedures

An additional

61% had minimal

residual

surgery

INDIANAPOLIS EXPERIENCE

The first gallstone lithotripsy ment in our community was July 1988, contact dissolution 30

#{149} Radiology

0

0

0

1

2

3

treatdone in with

5, surgical tectomy

(33%)

0 3 1 0 1, percutaneous drainage of bibma; 3, surgical cholecystectomy; 1, laparoscopic

6 mo)(8 3, pancre-

(Mm)

stone debris and were

467 patients were considered evaluable for efficacy and safety purposes. Of 242 patients randomized to receive ESWL plus ursodeoxycholic acid, 22.3% were free of stones in 6 months, compared with 8% in the group that underwent ESWL and received placebo. In a subset of patients with a single radiolucent gallstone (diameter,

Extracorporeal shock wave lithotripsy of gallbladder stones: a pessimistic view.

Devil’s Dean D. T. Maglinte, A. Cedric Johnson, MD, Jr, MD FACR #{149} James Extracorporeal of Gallbladder T success of extracorporeal shock wave...
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