Minimally invasive percutaneous

BJUI BJU INTERNATIONAL

nephrolitholapaxy (PCNL) as an effective and
safe procedure for large renal stones
Mohamed F. Abdelhafez*†, Jens Bedke*, Bastian Amend*, Ehab ElGanainy†,
Hassan Aboulella†, Magdy Elakkad†, Udo Nagele‡, Arnulf Stenzl* and
David Schilling*
*Department of Urology, Tuebingen University, Tuebingen, Germany, and †Department of Urology, Assiut University
Hospital, Assiut, Egypt, ‡Department of Urology and Andrology, LKH Hall i. Tirol, Landeskrankenhaus Hall i.T., Austria
Accepted for publication 18 January 2012

Study Type – Therapy (case series)
Level of Evidence 4
OBJECTIVE
• To evaluate the safety and efficacy of
minimally invasive percutaneous
nephrolitholapaxy (MIP) in the
management of large and complex renal
calculi.
What’s known on the subject? and What does the study add?
The minimally invasive percutaneous nephrolitholapaxy (MIP) has shown high efficacy
and safety for the management of small renal stones. It was initially developed to
overcome a gap between the minimally invasive extracorporeal shockwave lithotripsy
and invasive conventional percutaneous nephrolitholapaxy (PCNL) in the management
of low stone burden but there is debate as to whether the MIP is also effective for
larger stones.
The present study shows the high efficacy and safety of MIP, which is comparable to
conventional PCNL in the treatment of stones of >20 mm, including complex staghorn
stones.

RESULTS • The only significant difference between

PATIENTS AND METHODS
• From January 2007 to March 2011, 73
patients with 83 renal units with large
renal stones (>20 mm in diameter) were
retrospectively evaluated.
• Stones were classified into simple
(isolated renal pelvis or isolated calyceal
stones) or complex (partial or complete
staghorn stones, renal pelvis stones with
accompanying calyceal stones).
• Stone-free rate, complications according
to the modified Clavien system, decrease in
haemoglobin, creatinine level, operative
duration and hospital stay were compared
for simple and complex renal calculi.
• The mean (SD) stone size was
36.7 (23.37) mm and mean operative
duration was 99.2 (48.3) min.
• In all, 65 cases (78.3%) were stone-free
after the first procedure and another 14
needed an auxiliary procedure (four
second-look percutaneous
nephrolitholapaxy, nine ureterorenoscopy,
and one extracorporeal shockwave
lithotripsy) to become stone-free, resulting
in a 95.2% stone-free rate.
• Complications occurred in 22 procedures
(26.5%), 17 of them were Clavien Grade 1
or 2 (20.5%), five were Grade 3 (6%). There
were no Grade 4 or 5 complications.
complex and simple stones was the
stone-free rate (96.9% vs 66.7%, P =
0.001).
CONCLUSION
• The MIP technique is effective and safe
for larger stones with low morbidity, good
success rate and reasonable operative
duration.
KEYWORDS
MIP, percutaneous nephrolitholapaxy
(PCNL), large stone, stone-free rate,
complication rate

INTRODUCTION
Miniaturized percutaneous
nephrolitholapaxy (miniPCNL) was first
introduced by Jackman et al. [1] as an
alternative treatment method compared
with conventional large bore (24–34 F) PCNL
in a paediatric population. Using a
miniaturized nephroscope and an 11 F
access sheath, they treated seven patients
with a median stone burden of 1.2 cm2. In
the subsequent years the technique was
adopted for adult patients and was initially
mainly used for smaller lower calyceal and
diverticular stones, filling the therapeutic
gap between extracorporeal shockwave
lithotripsy (ESWL), flexible ureterorenoscopy
(URS) and conventional PCNL [2]. Meanwhile
the technique has further been modified
towards a ‘minimally invasive PCNL’ (MIP),
characterised by the use of a 12 F
nephroscope and an 18 F access sheath, a
continuous low-pressure irrigation stream
allowing for quick stone clearance and
immediate closure of the access tract
without placing a nephrostomy tube [3].
Schilling et al. [4] 2010 reported that this

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technique had completely replaced
conventional PCNL in their department.
The efficacy and safety of MIP in treating
patients with a large stone burden and
complex staghorn stones has been
questioned, mainly due to the limited
diameter of the miniaturised access sheath,
putatively leading to reduced visibility,
prolonged operative duration and reduced
stone-free rate [5]. Not only stone size, but
also stone composition, distribution, renal
function, renal abnormalities as well as
associated UTI influence treatment success
[6]. In the present study stones were
classified as simple (isolated renal pelvis or
isolated calyceal stones) or complex (partial
or complete staghorn stones, renal pelvis
stones accompanying calyceal stones),
regardless of their size, as described by
Tefekli et al. [7] 2008.
The goal of this retrospective analysis was
to report our experience in treating patients
with complex large renal stones (>20 mm)
using the MIP technique, focusing on stone
clearance, complications and retreatment
rate.
PATIENTS AND METHOD
All patients treated for large renal stones
(greatest diameter on plain X-ray or CT
>20 mm) using MIP technique at the
Department of Urology of the University
Hospital Tuebingen from January 2007 to
March 2011 were included in the study.
All patients underwent MIP prone using the
modular miniature nephroscope system with
automatic pressure control by Nagele (Karl
Storz, Germany) as follows [8,9]. After
retrograde placement of a ureteric balloon
occlusion catheter proximal to the PUJ in
lithotomy position, patients were placed
prone with an inflatable cushion placed just
caudally to the xiphoid. Percutaneous access
was obtained under ultrasonographic and
fluoroscopic guidance. Single-step dilatation
with a 16 F metal dilator was applied and
then an 18 F metal Amplatz sheath was
introduced. Using the 12 F nephroscope,
stones were fragmented by pneumatic
ballistic lithotripsy (Swiss Lithoclast-EMS,
Switzerland) under vision and stone
fragments were evacuated under continuous
irrigation without additional pressure or
suction using the hydrodynamic effects of
© 2012 BJU INTERNATIONAL
MINIMALLY INVASIVE PCNL FOR LARGE RENAL STONES
the PCNL system. Only if fragments adhered
to the parenchyma, a 2.4-F tipless nitinol
basket (Zero Tip, Boston Scientific, USA) was
used for stone retrieval. At the end of the
procedure, the balloon occlusion catheter
was removed and a JJ stent was placed
antegradely. The Amplatz sheath was
withdrawn and usually the tract was closed
using a gelatine matrix haemostatic sealant
(GMHS; Baxter, Germany). The skin incisions
were closed with adhesive skin closures.
Generally renal access was gained through
the posterior lower calyx. If complete stone
clearance via this access was not achievable,
either flexible nephroscopy (Flex X2, Karl
Storz, Germany) and laser lithotripsy
through the 18 F sheath was performed or,
in case of a remaining large stone burden, a
second access using a 15 F Amplatz sheath
was placed under ultrasonographic and
fluoroscopic control in the middle or upper
calyx. In cases of remaining large fragments
at the end of the manoeuvre, the access
tract was not closed but a 12 F
nephrostomy tube was placed to allow for a
second-look PCNL 2–3 days later.
Patients were examined with plain X-ray (of
the kidneys, ureters and bladder) and
abdominal ultrasonography on the first
postoperative day. Haemoglobin level, serum
creatinine and electrolytes were monitored
pre- and postoperatively.
The clinical records were retrospectively
reviewed for the following clinical
parameters: stone complexity, operative
duration (defined as the time from puncture
to closure of the access tract), fluoroscopy
time, decrease in haemoglobin level, hospital
stay, stone-free rate and complications.
Stone complexity was recorded according to
the scoring system described by Tefekli et al.
[7] in 2008. Stones were classified as simple
(isolated renal pelvis or isolated calyceal
stones) or complex (partial or complete
staghorn stones, renal pelvis stones with
accompanying calyceal stones) regardless of
size. Patients were considered ‘stone-free’
in the absence of any detectable stone
fragment upon nephroscopy at the end of
the procedure and on postoperative X-ray
and ultrasonography. A ‘complication’
was defined as any adverse event
intraoperatively or ≤30 days after the
procedure. The grade of complication was
determined on the basis of the Clavien
classification and its modification for
percutaneous procedures [7].
Data are expressed as mean (SD) and P <
0.05 was considered to indicate statistical
significance.
RESULTS
Between January 2007 and March 2011, 73
patients (83 renal units) with renal stones of
>20 mm were treated with MIP in the
Department of Urology, University Hospital
Tübingen. The mean (SD, range) stone size
was 36.7 (23.37, 20–145) mm. In all, 51
stones (61.4%) were classified as complex
stones and 32 (38.6%) as simple stones.
In 73 cases (87.9%) a single tract procedure
was carried out. In eight cases (9.6%) two
tracts were used and in two cases (2.4%)
three access sheaths were inserted
simultaneously. Access was gained through
the posterior lower calyx in 82 cases
(98.8%). Puncture of the middle calyx was
performed in nine cases (10.8%) and of the
upper calyx in four cases (4.8%).
All punctures of the lower and the middle
calyx were subcostal; none of the punctures
was above the 11th intercostal space.
The mean (SD) operative duration for all 83
renal units was 99.2 (48.3) min and
fluoroscopy time 214 (147.4) s. The mean
(SD) operative duration in complex stones
was not significantly longer than in simple
stones, at 104.7 (51.6) vs 90.7 (42.1) min
(P = 0.2) and fluoroscopy time did not differ
significantly between the two groups, at
210 (137.8) vs 222.4 (163.4) s for complex
and simple stones, respectively (P = 0.4).
The mean (SD, range) decrease in
haemoglobin level was 1.7 (1.2, 0.1–5.3) g/
dL, with no significant difference between
the two groups, at 1.7 (1.3) vs 1.7 (1.1) g/dL
for complex and simple stones, respectively
(P = 0.5). Only one patient with complex
stones received blood transfusion after a
second-look PCNL.
In all, 65 of the 83 cases (78.3%) were
stone-free after the first procedure
(primarily stone-free). In 14 (16.9%) cases
auxiliary treatment methods rendered the
patients stone-free. Four patients (4.8%)
underwent a second-look MIP, nine (10.4%)
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ABDELHAFEZ ET AL.

flexible URS and one (1.2%) ESWL, thus the

TABLE 1 Univariate analysis of patients’ characteristics and treatment results for simple and complex
total stone-free rate with an auxiliary
stones
procedure was 79/83 renal units (95.2%).
Four patients (4.8%) required more than one
Variable Simple stones Complex stones P
auxiliary procedure to be stone-free. There
Total number 32 51
was a highly significant difference in the
Mean age, years 48 47.43 0.345
primary stone-free rate for complex stones
Gender, male: female, n 20:12 28:23 0.469
66.7% (34/51 renal units) vs 96.9% (31/32
Multiple access MIP, n 1 9 0.08
renal units) in simple stones (P = 0.001;
Mean OR-time, min 90.7 104.7 0.243
Table 1).
Mean fluoroscopy time, s 222.0 210.0 0.50
Mean decrease in haemoglobin, g/dL 1.7 1.7 0.594
In all, 22 complications occurred during 83
Stone free, n (%)
MIP procedures (26.5%, Table 2). In 17 cases
Primary 31 (96.9) 34 (66.7) 0.001*
(20.5%) complications were Clavien grade I
With second-look MIP – 4 (74.5) –
or II and were managed conservatively,
With any auxiliary procedure 32 (100) 47 (92.2) 0.9
five complications (6.0%) necessitated
Complications, n (%) 12 (37.5) 10 (19.6) 0.07
endoscopic intervention (Clavien grade IIIb).
There were no grade IV or V complications
*Statistically significant.
(Table 2). Grade I complications were more
likely to occur in simple stones (33.3% vs
5.8%, P < 0.01). However, grade IIIb
complications were more likely to occur in
complex stones (13.9% vs 3.1%, P < 0.6).
TABLE 2 Intra- and postoperative complications for simple and complex stones
Table 2 gives an overview of the
complications.
Clavien Simple Complex Total,
grade stone, n stone, n n
DISCUSSION
Transfusion II 0 1 1
Gross haematuria II 1 0 1
Percutaneous access to the renal collecting
Fever >38 °C I 8 3 11
system leads to a high stone-free rate and is
Bladder haematoma requiring cystoscopic evacuation IIIb 1 1 2
therefore recommended as the treatment of
Urinoma requiring JJ stent IIIb 0 1 1
choice for renal stones measuring >20 mm
Extravasation treated conservatively II 2 1 3
in diameter [10]. PCNL generally is
Obstruction requiring JJ stenting IIIb 0 2 2
considered a demanding procedure although
Perinephric haematoma II 0 1 1
safe and effective in experienced hands [11].
Total 12 10 22
Conventional PCNL is usually carried out
through a renal access with a diameter of
24–34 F and a semi-closed irrigating system.
Reducing the diameter of the renal access
sheath led to the implementation of the renal stones of <20 mm [3], the application Office of the Endourological Society
miniPCNL-technique [12]. Meanwhile, it has in patients with a larger stone burden has (CROES). In 5803 patients undergoing
been shown that miniPCNL can reduce been questioned. It has been argued that conventional PCNL the stone-free rate was
blood loss and transfusion rate compared the smaller access and putatively reduced 75.7% with a re-intervention rate of 15.5%
with conventional PCNL [13]. In an attempt irrigation flow leads to poorer visibility, [15]. However, the patient collective is very
to further reduce the morbidity of the difficulties in handling endoscopic graspers heterogeneous, including different surgical
procedure, the MIP has been established, and therefore reduced stone clearance techniques, e.g. prone and supine PCNL, as
characterized by a small-bore renal access [5,14]. The goal of this retrospective analysis well as small stones with a diameter of
(18 F), one-step dilatation technique, a was to determine the safety and efficiency <20 mm and complete staghorn stones.
continuous low-pressure irrigation allowing of the MIP concept in treating renal stones Several complicating factors besides stone
for rapid stone retrieval without the use of with a diameter >20 mm. size influence the success of the PCNL
stone forceps or baskets and finally the procedure: Tefekli et al. [7] suggested a
direct closure of the renal access without The primary stone-free rate for all MIP classification of simple and complex renal
the placement of a nephrostomy tube. The procedures in the present patient population calculi, with complex renal stones
safety, feasibility and efficacy in the was 78.3%, with a total stone-free rate of representing any stone with staghorn
treatment of small renal and lower calyceal 95.2% with an auxiliary procedure (need for formation or pelvic stones and
calculi has been shown earlier [3]. auxiliary manoeuvre: 16.9%). These results accompanying calyceal stones. In the
are similar to the stone-free rate in a large present study population, 61.4% cases had
Although the MIP concept leads to complete multi-institutional international prospective complex renal calculi. Not surprisingly the
stone clearance in 92.9% of patients with trial carried out by the Clinical Research primary stone-free rate in patients with

E1024 © 2012 BJU INTERNATIONAL


complex stones was significantly lower than
in patients with simple renal stones (66.7%
vs 96.9%, P = 0.001). This is also in
accordance with the aforementioned CROES
study in which the stone-free rate in
patients with staghorn stones was 56.9%;
conversely, when all patients with staghorn
stones were excluded from the analysis, the
stone-free rate increased to 82.5% [15]. To
meet the challenge of large stone burden or
complex stone disease, various treatment
approaches have been reported. In an
analysis of 127 consecutive patients with a
mean stone size of 23.8 mm undergoing
combined retrograde and percutaneous
stone treatment, Scoffone et al. [16]
achieved an 81.9% primary stone-free rate.
After a second-look PCNL using the same
renal access during the same hospital stay,
87.4% of their patients were rendered
stone-free. In comparison with
contemporary studies, the concept of MIP
shows comparable stone-free rates, even for
complex renal stones. Two comparative
studies between miniaturized and
conventional PCNL failed to show a
significant difference in stone-free rate
between the two methods [13,17].
Considering that the mean stone size in the
present analysis (36.7 mm) was higher than
in the aforementioned studies, it can be
assumed that stone clearance is not affected
by the smaller diameter of the access tract.
The stone retrieval using the ‘vacuum
cleaner effect’ of continuous low-pressure
irrigation [18] without the need for
endoscopic manipulation with stone
graspers might in fact contribute to an
effective stone clearance and accelerate the
procedure.
There is conflicting data as to whether
miniaturization of the access sheath
necessarily leads to longer operating time
(OR-time) for larger stones. A comparative
trial in 180 patients undergoing either
conventional or miniPCNL found
significantly longer OR-times for miniPCNL
in simple (89.4 vs 77.0 min), staghorn (134.3
vs 118.9 min) as well as multiple stones
(113.9 vs 101.2 min) [17]. In contrast, in a
prospective comparative study between
conventional and miniPCNL of 50
consecutive patients, Knoll et al. [13] noted
no significant difference in OR-time
between patients operated with an 18 F
access sheath than with a 26 F sheath
(miniPCNL 48 min vs PCNL 57 min).
However, the authors argue that this fact
© 2012 BJU INTERNATIONAL
MINIMALLY INVASIVE PCNL FOR LARGE RENAL STONES
might be attributed to differences in stone
burden between the two groups. The mean
operating duration in the present study was
99.2 min. Several aspects might lead to
decreased OR-time in MIP, namely the
one-step dilatation of the access tract and
the ‘vacuum cleaner effect’ allowing stone
retrieval without the need for stone
graspers. The so called ‘vacuum cleaner
effect’ is a hydrodynamic effect due to the
difference between the inner diameter of
the access sheath and the outer diameter of
the nephroscope. During continuous
irrigation a laminar low-pressure flow
occurs through the access sheath.
Turbulences occurring at the tip of the
nephroscope allow suction of stone
fragments from the renal collecting system.
One major concern in PCNL is significant
blood loss and the need for blood
transfusions. In the present investigation
only one of the patients had to receive
transfusions (transfusion rate 1.2%). This
patient underwent multiple accesses MIP for
a staghorn calculus. Contemporary studies
state transfusion rates of ≈4.5% and 9% for
non-staghorn and staghorn stones,
respectively [19]. A reason for the lower
transfusion rate in MIP might be the smaller
parenchymal trauma and the reduced risk of
injuring larger segmental renal vessels with
a small-bore dilator during establishment of
the access tract. The reduced transfusion
rate has also been reported previously [17].
Although blood loss seems to depend on
stone size and stone complexity, in the
present study there was no significant
increase in blood loss with increase in stone
size (P = 0.4) and no significant difference
between simple and complex stones
(P = 0.5).
During 83 MIP procedures, 22 complications
occurred (26.5%). Most of the complications
were modified Clavien grade I or II and
could be managed conservatively. Grade I
complications (mostly temperature >38.0 °C)
were significantly more frequent in simple
stones. However, there was a tendency to
higher grade complications in complex
stones. The incidence of urinoma and
haematoma was higher in complex stones
and these complications were frequently
associated with fever; however, these
complications were graded >grade I. This
might explain the statistical difference in
frequency of complications in these two
entities. The five grade III complications (6%)
could be managed endoscopically. Severe
complications (grade IV of V) did not occur
throughout the 83 procedures. The
complication rate reported here is in
accordance with published rates. Although
the overall complication rate in PCNL is
high, generally higher grade complications
(>grade II) are rare [11].
The present study investigated the feasibility
of MIP for treating large renal stones.
Although the data indicate that a minimally
invasive approach results in a similar
stone-free rate with an acceptable OR-time
and a low morbidity, the limitations of a
retrospective study without a comparative
control population have to be considered.
However, based on the relatively large
number of patients with a large stone
burden, a comparison with contemporary
publications can help to judge the
advantages and disadvantages of the
minimally invasive approach.
In conclusion, the present retrospective
analysis of 83 MIP procedures shows that
this approach is not only effective in small
stones but also in patients with a large
stone burden and complex stones. The
method has a stone-free rate comparable
with large bore conventional PCNL and is
similarly effective in complex renal calculi.
There is a tendency to a longer operative
duration; however, one major advantage is
the low blood loss and transfusion rate,
as well as the low rate of high grade
complications. The MIP may be equally
effective as conventional PCNL independent
of stone size. Further prospective, controlled,
randomised studies to properly evaluate the
method are recommended.
ACKNOWLEDGEMENTS
The authors thank Miriam Germann for
critically proof reading and correcting the
manuscript.
CONFLICT OF INTEREST
None declared.
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Correspondence: Mohamed F. Abdelhafez,
Department of Urology, Tuebingen
University, Konrad-Adenauer Street 48,
Tuebingen 72072, Germany.
e-mail: mohamedfarouk_2000@hotmail.
com
Abbreviations: (mini)PCNL, miniaturized
percutaneous nephrolitholapaxy; ESWL,
extracorporeal shockwave lithotripsy; URS,
ureterorenoscopy; MIP, minimally invasive
PCNL; CROES, Clinical Research Office of the
Endourological Society; OR-time, operating
time (time from puncture to closure of the
access tract).
© 2012 BJU INTERNATIONAL