HPB Surgery, 1997, Vol. 10, pp. 229-234
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Multidisciplinary Conservative
Treatment of Difficult Bile Duct
Stones" A Real Alternative to Surgery
E. MASCIa, L. FANTIa, A. MARIANIa, S. SPAGNOLOb, W. ZULIANIb,
M. CASTRUCCIc, P. A. TESTONId and A. TITTOBELLO
aDepartment of Gastroenterology, b
Department of Surgery, Department of Radiology, San Raffaele Hospital, University of
Milan, dDepartment ofInternal Medicine, University ofMilan
(Received 7 June 1996)
56 patients with large CBD or intrahepatic stones
underwent endoscopic and/or percutaneous treat-
ment followed by extracorporeal shock wave litho-
tripsy. Percutaneous access to the biliary tract was
chosen when an endoscopic approach was not
possible (hepaticojejunostomy in 5 patients, 1
juxtapapillary diverticulum and I inflammatory bile
duct stricture). Visualization of stones was achieved
radiologically in 32 patients and by ultrasound in 24.
The procedure was successful in 47 of 56 treated
patients (83.9%). Clearance of the biliary tract was
obtained in 25 cases (53%), whereas in 22 cases (47%)
complete clearing of biliary tract was obtained only
after endoscopic extraction of fragments (17 cases) or
percutaneous (5 cases). The median number of shock
waves in each session was 1725 (range 300-3166),
which were applied during one (n=30), two (n=22) or
three sessions (n=4). The only complications were 1
case of symptomatic hyperamylasemia and 3 cases of
macrohematuria. In conclusion, extracorporeal litho-
tripsy combined with endoscopic and/or percuta-
neous treatment is a real alternative to surgery for
difficult stones.
Keywords" Bile duct stones, endoscopic papillosphinctero-
tomy, extracorporeal shock-wave lithotripsy, percutaneous
transhepatic cholangiography
INTRODUCTION
Currently, the treatment of common bile duct
(CBD) stones as well as both multiple and
complex intrahepatic lithiasis, is no longer
exclusively surgical. Both endoscopic and trans-
hepatic percutaneous approaches, sometimes
combined, may offer successful treatment for
most cases [1-3]. However, when very large
stones have to be managed or anatomic condi-
tions interfere with their removal, the success
rates of nonsurgical methods are much lower [4].
On the other hand, in the elderly and in cases
with complicated stones, surgery is marked by
higher rates of morbidity and mortality, even
though the figure has dramatically dropped in
recent years [5-7]. Extracorporal lithotripsy has
been demonstrated to be useful for treatment of
large stones in the CBD and biliary intrahepatic
ducts. Several studies confirming its effective-
ness have been published [8-11]. We report here
Correspondence to: Enzo Masci MD Department of Gastroenterology San Raffaele Hospital via Olgettina 60 20132 Millan
(ITALY)
229
230 E. MASCI et al.
our experience with the conservative treatment
of large stones, both CBD and intrahepatic.
METHODS
From 1989 to 1994, 56 patients, 30 men and 26
women, aged from 27 to 92 years (median: 68
yr), underwent endoscopic and/or percutaneous
treatmentfollowedbyextracorporealshock-wave
lithotripsy the choice of non-surgical treatment
was based on the old age of patients, on
higher surgical risks factors and, for younger
patients, because of previous multiple surgical
intervention. 44 patients were treated because
of evidence for large CBD stones not amenable
to routine endoscopic measures (Dormia Basket
and mechanical lithotripsy). 12 patients had
intrahepatic lithiasis, 3 of them with associated
CBD stones. The maximum stone size of CBD
stones per patient ranged from 11.5 to 70 mm
(median: 25 mm) and of intrahepatic stones
from 10 to 35 mm (median: 17.5). In 3 of 56
patients, there was massive lithiasis of the
intra- and/or extrahepatic biliary tract.
For 7 patients, percutaneous access to the
biliary tract was chosen because endoscopic
access was not possible for anatomical rea-
sons (hepaticojejunostomy in 5 patients) or by
conditions that might limit endoscopic sphincter-
otomy (1 juxtapapillary diverticulum, 1 inflam-
matory bile duct stricture) in these cases the
maximum stone size per patient ranged from
6.5 to 10 mm (median: 10). Following endo-
scopic treatment and lithotripsy, 2 patients
underwent percutaneous extraction of intrahe-
patic fragments (Tab. I).
Stones and biliary system were visualized by
contrast medium injection through an endosco-
pically placed naso-biliary drainage catheter in
25 patients, or through transhepatically placed
catheters in 7 patients. All these patients were
treated with the first generation Dornier HM3
lithotripter, with the patient in the supine
position partially immersed in water. In 24 other
TABLE Procedures Employed before Extracorporeal
Lithotripsy and Biliary Stone Location
CBD ID CBD+ID
P T C (n=7) 7 0 0
Endoscopy (n=47) 37 9
Combined (n=2) 0 0 2
Total (n=56) 44 9 3
PTC: Percutaneous transhepatic ducts
CBD: Common bile duct
ID: Intrahepatic duct
patients the stones were visualized by ultra-
sound in 13 cases, before 1990, by the Wolf
Piezolith 2300 lithotripter (WP) and in 11
subsequent cases, by the MPL 9000 lithotripter.
During the treatment with Dornier HM3 (32
cases), patients underwent analgesia with Fen-
tanyl in doses varying from 0.05 to 0.15 mg,
combined with 5 to 10 mg of Diazepam when-
ever necessary, whereas in the remaining cases
no analgesia was needed. If at the end of the
session there was no evidence of fragmentation,
patients underwent an additional session. Frag-
mentation was verified the day after the litho-
tripsy was performed, after a series of washings
through the drain positioned in the biliary tract.
The choice between endoscopic removal of
fragments and percutaneous re-treatment was
made only after the extent of fragmentation
clearly indicated they could be removed and
there was no evidence of unassisted elimination.
Complications and side effects following both
endoscopic procedures and lithotripsy were
recorded in order to have an overall complica-
tion rate for the combined treatment.
RESULTS
56 patients underwent a total of 86 treatments
(average 1.5). Only a single session was required
in 30 cases (7 WP, 8 MPL, 15 Dornier), a second
session in 22 cases (3 WP, 2 MPL, 17 Dornier), a
third session in only 4 cases (1 MPL, 3 WP). The
median of the number of shock waves in each
session was 1725 (range: 300-3166). 3 obese
TREATMENT OF BILE DUCT STONES 231
patients, 2 others with CBD stones, and one with
intrahepatic stones were not treated because of
the impossibility of correctly positioning the
stones in the shock-wave focus, either radiologic
or ultrasonographic. Stones fragmentation was
achieved in 51/56 patients (91%). In 47 of 56
treated patients (83.9%), the procedure was
successful. Cholangiographic controls at the
end of treatment demonstrated un-assisted
clearance of the biliary tract in 28/47 cases
(59.5%), whereas in 19/47 cases (40.5%) com-
plete clearing of the biliary tract was obtained by
endoscopic extraction of fragments (17 cases) or
percutaneously (2 cases), with the Dormia
basket or balloon (Fig. 1). Among the 12 patients
treated for intrahepatic stones, either alone (9
cases) or combined with CBD stones (3 cases),
the methods failed for only one subject with a 20
mm stone, treated with Dornier HM3. The
reason for this failure was intolerance to the
procedure. In 2 of the remaining 8 patients with
CBD stones, failure was due to lack of fragmen-
tation. Both patients, in fact, had bulky CBD
stones (35 and 40 mm) and were treated with the
WP 2300 and the MPL 9000. 3 patients, two of
them treated with the Dornier HM3 and the
other with the MPL 9000, did have fragmenta-
RESULTS OF ESWL
56 PATIENTS 5 NOT FRAGMENTED
51 FRAGMENTED
47 CLEARED 4 NOT CLEARED
2 percutaneous extractions
28 spontaneously
17 endoscopic extractions
FIGURE
tion of the stones, but the massive lithiasis and
the overload of material prevented complete
clearing of the biliary tract. For another 3
subjects, the sessions were interrupted due to
intolerance to the procedure (2 Dornier HM3, 1
MPL 9000). The results after treatment with the
different lithotripters are summarized in Table II.
There were no serious complications with
either the endoscopic or the radiological proce-
dures. One case of symptomatic transitory
hyperamylasemia and three cases of macrohe-
maturia, that resolved spontaneously (1 MPL, 2
Dornier) were observed after treatment.
DISCUSSION
The surgical approach for biliary stones was the
standard method until about 10-15 years ago. Its
results have been excellent, with low rates of
both morbidity and mortality [12,7]. With the
advent of endoscopic sphincterotomy, surgical
exploration of the biliary tract has also lost its
place as priority treatment for young patients
without high surgical risks. The development of
laparoscopic cholecystectomy as one of the mini-
invasive surgical techniques, has additionally
stimulated the use of interventional endoscopy
for removal of stones from the biliary tract.
However, in about 10% of cases, endoscopic
treatment may fail due to the impossibility of
fragmentation and removal of bulky stones or
even of stones in the intrahepatic biliary tract. In
addition, some anatomic features may limit the
endoscopic removal of stones or even make endo-
scopic treatment difficult, if not impossible [4].
In cases in which the standard endoscopic
procedure is ineffective, several techniques have
been combined with it to improve the approach
to "difficult" stones of the biliary tract. In fact,
the use of chemical solvents has been intro-
duced, but this technique has been shown to be
inconvenient, time-consuming, and not totally
free of side-effects. In 40% of cases, in fact,
patients complained of nausea, vomiting and
232 E. MASCI et al.
TABLE II Number and Rate of Clearance, Fragmentation and Failure
after Treatment with Different Lithotripters
Clearance Fragment Failure
N (%) N (%) N (%)
TOTAL 47/56 (83,9) 51/56 (91,0) 9/56 (16,1)
WP 12/13 (92,3) 12/13 (92,3) 1/13 (7,6)
MPL 8/11 (72,7) 9/11 (81,8) 3/11 (27,2)
D 27/32 (84,3) 30/32 (93,7) 5/32 (15,6)
WP: Wolf Piezolith 2300 Extracorporeal Piezoelectric Lithotripter (EPL)
MPL: Dornier MPL 9000 Shock Wave Lithotripter
D: Dornier HM3 with Waterbath
diarrhea, so that the successful outcome was less
than 50% [13,14]. Mechanical lithotripsy may
also be ineffective if the stone is larger than 25
mm [4]. When the endoscopic approach to the
biliary tract was difficult or even impossible, a
multidisciplinary approach together with trans-
hepatic treatment combined with extracorporal
lithotripsy with shock-waves was, in our experi-
ence, of the utmost usefulness. In fact, in our
series we have observed stone fragmentation in
91% of our cases. Endoscopic and/or radiologic
treatment combined with extracorporeal litho-
tripsy enabled us to completly clear the biliary
tract in 83.9% of cases. The only 3 cases in which
it was impossible to focus the stone represent the
evident limitations of the first generation equip-
ment designed for the treatment of renal stones
that we employed. It is probable that updated
machines, supplied with a radiographic target-
ting system,would have enabled us to treat all the
patients in our series.
In any case, our results are in accordance with
data in the literature [10,15-17]. In our experi-
ence, in accord with a recent work of Lindstrom
et al. [16], the 32 patients treated with Dornier
HM3 lithotripter did not need any general
anesthesia and for all cases Diazepam plus
Fentanyl was effective. For two patients for
whom general anesthesia was not possible,
treatment had to be stopped. Although Sauer-
bruch et al. [15] reported the need for general
anesthesia in 75% of cases, in our series it was
not required and this not only simplifies the
procedure but also reduces the risks for older
patients while permitting good tolerance to the
procedure. The clearing rates of the biliary tract
achieved with the multidisciplinary approach to
difficult stones, are comparable to the results of
surgery, for which the rate of residual stones in
such cases is approximately 5 to 10% [18].
Recently, a prospective randomized trial [19]
comparing extracorporeal with intracorporeal
electrohydraulic lithotripsy (EHL) showed no
differences in stone-free rates between the two
therapies. The conclusion of the Investigators
however, was that large and multiple stones are
probably best treated with extracorporeal
lithotripsy. In these cases, in fact, for complete
duct clearance, up to three additional endoscopic
interventions may be necessary after EHL and
extracorporeal lithotripsy is better accepted by
the patient than an endoscopic session.
In our series, overall complications, spontane-
ously resolved in all cases, were 7.1%. There was
no case of cholangitis, particularly dangerous in
this kind of pathology, probably thanks to the
drainage placed in the biliary tract in almost all
cases and to antibiotic treatment during the
process of clearing. In our series, there was no
evidence of major complications, as has, in-
stead, been described by some other groups
[20-22]. Currently, through a combination of
endoscopy, radiologic intervention and extra-
corporeal shock-wave lithotripsy, we have a
real possibility of succesfully treating most of
the difficult stones of the biliary tract. Extra-
corporal lithotripsy also provides a real alter-
native to surgery for difficult stones.
TREATMENT OF BILE DUCT STONES 233
Even though the results of our study do not
enable us to say definitely whether conserva-
tive treatment is favorable in terms of cost-
benefit, the costs in our institution for extra-
corporeal lithotripsy, about 590 US S/session,
and for sphincterotomy, about 780 US $, are
comparable with the cost of surgical explora-
tion of CBD (1017 US $). Considering the low
rate of complication with conservative treat-
ment and the higher morbidity of surgery, and
the need sometimes for more complex inter-
ventions (bilio-digestive anastomosis, liver
resection), the cost of non-surgical treatment
is not very different than that of surgery and,
therefore, cost may not be, in our opinion, a
criterion of selection.
Inconclusion,the choicebetween surgical and
non-invasive removal of stones should in our
point of view be made individually for each
patient, taking into consideration the risk for
surgery for that patient but also, in patients
withoutsurgicalrisk,thefactthatfortheirbiliary
patology they had already been submitted to
previous multiple surgical interventions. The
presence of very large stones (>35 mm), the only
ones not cleared in ourexperience,couldmilitate
against non-surgical approach.
Acknowledgements
The Authors wish to thank Mr. Gaetano Lattar-
uolo for his collaboration in performing our
procedures.
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COMMENTARY J TOOULI
The management of common bile duct stones
has changed significantly in the last 10 to 15
years. Currently, there is little need to explore
the bile duct via an open approach in order to
treat stones in the duct. The impact of the newer
approaches has been reduced morbidity and
early recovery for patients. The newer non-
operative techniques have not always been
subjected to fair or valid comparative studies
with open surgery and they have been intro-
duced at a time when open surgery also has
become much safer. Then whilst there may be
little significant difference in mortality between
the open and minimally invasive techniques,
there undoubtedly is a better morbidity in
favour of the latter approach.
The success rate of the minimal access
techniques is high, however for patients with
very large stones or patients who have had
multiple operations in the upper abdomen, the
success rate is reduced. In this study the
treatment of 56 patients with difficult large bile
duct stones is reported. The authors have used
extracorporeal shock wave lithotripsy (ESWL) to
assist in their management of these patients via
endoscopic and percutaneous approaches. The
results clearly indicate the appropriateness and
success of this approach as most experienced
hepatobiliary surgeons would recognise that
these are the most difficult of patients with
choledocholithiasis to treat.
The only draw back of the technique de-
scribed in this paper is the requirement of access
to an extracorporeal lithotripsy device. These are
expensive devices which cannot be justified
economically on their management of bile duct
calculi alone. Hence, the approach described in
this report can only be used by clinicians who
might have access to ESWL that is generally
used for the treatment of renal calculi.
References
Seminars in Laparoscopic Surgery: Bile Duct Calculi Guest
Editor Toouli, J. Volume 2, Number 2, June 1995 WB
Saunders Company.
Prof. J Toouli
Head of Gastrointestinal Surgical Unit
Department of Surgery
Flinders Medical Centre.