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,