Kalli Don Is 2016

Journal of Endourology
Page 1 of 22 © Mary Ann Liebert, Inc.

DOI: 10.1089/end.2016.0571
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PAPILLARY VERSUS NON PAPILLARY PUNCTURE IN PERCUTANEOUS NEPHROLITHOTOMY: A PROSPECTIVE RANDOMIZED TRIAL. (doi: 10.1089/end.2016.0571)
and proof correction. The final published version may differ from this proof.
PAPILLARY VERSUS NON PAPILLARY PUNCTURE IN PERCUTANEOUS
NEPHROLITHOTOMY: A PROSPECTIVE RANDOMIZED TRIAL.

This paper has been peer-reviewed and accepted for publication, but has yet to undergo copyediting and proof correction. The final published version may differ from this proof.
Panagiotis Kallidonis1, Iason Kyriazis1, Dimitrios Kotsiris1, Adamantia Koutava1,
Wissam Kamal1, Evangelos Liatsikos1
1
Department of Urology, University of Patras, Greece
Keywords: percutaneous, nephrolithotomy, papillary, infundibular, randomized
Word count text: 2135
Word count abstract: 265

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This article has been peer-reviewed and accepted for publication, but has yet to undergo
Corresponding Author:
Evangelos N. Liatsikos M.D PhD, Associate Professor
Department of Urology, University of Patras Medical School,
Rion, 26 505, Patras, Greece
e-mail: liatsikos@yahoo.com
Tel: +30 2610 999386,
Fax: +30 2610 993981

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ABSTRACT
Introduction: Literature suggests that the percutaneous punctures for PCNL must be
performed at the papilla of the renal calyx and a puncture at the infundibulum or the
direction of the pelvis is not advisable due to increased hemorrhagic risk. A
prospective randomized study was conducted to investigate the safety in terms of
blood loss of the infundibular approach for PCNL.
Materials and methods: Patients with renal stones with a accumulative size of at
least 2cm were randomly assigned to one of two parallel groups to undergo PCNL
with either papillary (Group 1) or infundibular (Group 2) renal access. The primary
outcome measures were the hemoglobin drop on 1st postoperative day and the need
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for transfusion during the first postoperative month. Secondary endpoints included the
copyediting
operative and fluoroscopy time, number of accesses performed, overall complication

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rate, hospitalization time, complications up to 3 months.
Results: Totally, 27 and 28 patients were enrolled in Group 1 and 2, respectively.
Patient age, BMI and stone size were similar among the groups (p=0.672, 0.256 and
0.889, respectively). Hemoglobin drop and transfusion rate did not differ among
Groups 1 and 2 (p=0.916, p=1.0, respectively). Operative time was higher in the case
of Group 1 (p=0.027). The overall complications rate was 7.4% for Group 1 and
7.14% for Group 2. Hospitalization time was not significantly different in the study
groups (p=0.724).
Conclusions: The infundibular approach for PCNL to the posterior middle renal
calyces is not associated with higher blood loss or transfusion rate in comparison to
the respective approach to the fornix of the papilla when the currently described
technique is performed.
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INTRODUCTION
Percutaneous nephrolithotomy (PCNL) constitutes the primary method of treating
large renal calculi. The percutaneous access is achieved by puncturing the
pelvicalyceal system (PCS) under guidance and dilation of the access route. Literature
suggests that the punctures must be conducted at the papilla of the renal calyx and a
puncture at the infundibulum or the direction of the pelvis is not advisable due to
increased hemorrhagic risk, intra- and postoperatively (1-3). The data were obtained
from studies which described the anatomic relations of the intrarenal vessels to the
PCS and evaluated the risk of vascular injuries of needle puncture in cadaveric
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kidneys (3-5). Nevertheless, the risk of vascular injury of the tract due to the tract
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dilation and the anatomic relations of the kidney to the surrounding tissue were not
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investigated. The latter issue still remains unanswered in the literature as the risk of
injuring the intra-renal vessels during tract dilation has never been evaluated. In
addition, the individual anatomy of the patients and the diversity of the stones may
not allow the papillary puncture and a “more aggressive” access to the infundibulum
or even the renal pelvis may be necessary in some cases (6). The infundibular
approach for PCNL is frequently practiced at our institution without any increase in
the morbidity and our retrospective experience was recently reported (7). The
approach is associated with the increased range of motion of the nephroscope which
allows more effortless movement to better assess the PCS. Thus, the number of
necessary accesses to the PCS can be reduced in comparison with the papillary
approach. In an attempt to establish a high level of evidence concerning the safety
profile of the infundibular approach during PCNL, a prospective randomized study
was conducted.
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MATERIALS AND METHODS
Inclusion- exclusion criteria, Study groups and Randomization process
The study and the surgical intervention took place at the University Hospital of Patras.
The details of the study have been registered in a public database (ISRCTN serial
number 11393/16-6-2015). The reporting of the investigation was done according to
the PRISMA statement.
Patients were randomly assigned to one of two parallel groups to undergo PCNL with
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either infundibular or papillary renal access. The randomization method employed

copyediting
was that of Sequentially Numbered Opaque Sealed Envelopes. The envelope was
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opened prior to the anesthesia of the patient in the operative room. Eligible
participants were all patients with renal stones of a cumulative stone size of at least
2cm and indication for PCNL. The Inclusion and exclusion criteria are presented in
detail in Table 1. Group 1 underwent PCNL with access and tract dilation to the
papilla of the desired calyx (control) whereas Group 2 underwent PCNL with access
to the infundibulum of the calyx.
Surgical technique
The technique for PCNL and perioperative care protocols have been previously
described in detail (7). The technical details are presented in Table 2.
All cases were performed by specialist surgeons.

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Outcome measures, Perioperative care and Follow-up

The patients were discharged on the 2nd-4thpostoperative day based on the presence of
clear urine in the Malecot tube. The primary outcome measures were the hemoglobin
drop till the discharge day and the need for transfusion during the first postoperative
month. The outcomes of the study and the recorded parameters are presented in Table
1 and Table 3, respectively. The complications were classified according to Dindo and
Clavien (8). The physicians evaluating the patients were blinded regarding the
approach. The statistical analysis methods are presented in Table 1.
RESULTS
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Patient population
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The patient recruitment process is described in Figure 1. Totally, 27 and 28 patients
were enrolled in Group 1 and 2, respectively. Patient age, BMI and stone size were
similar among the groups (p=0.672, 0.256 and 0.889, respectively) (Table 4).
Primary endpoints
Hemoglobin drop between the pre-operative and the discharge day values was similar
among the groups of the study (p=0.916). The Hemoglobin drop had an average value
of 1.54±1.29 and 1.35±0.79, respectively (Table 5). Transfusion rate was similar
(p=1.0) and only one case of Group 2 required transfusions. Thus, the bleeding was
not higher in any of the evaluated approaches.
Secondary endpoints
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The cases required an average time of 51.97±16.1 and 43.21±12.38 min in Group 1
and Group 2, respectively. Operative time was higher in the case of Group 1
(p=0.027). The number of multiple accesses was higher in the case of Group 1 with 4
cases of multiple accesses instead of none in Group 2. This trend did not prove to be
significant (p=0.051). The middle infundibular punctures represented 85.7% of the
overall cases of Group 2 (26/28). The overall complications rate was 7.4% and 7.14%,
respectively. No statistical significance was noted (p=1). All complications were
observed within the first four weeks of follow-up. Hospitalization time was not
significantly different in the study groups (p=0.724). The average length was
5.57±1.70 and 5.80±2.56 days for Group 1 and 2, respectively. Tables 4,5,6
summarize the data and statistical analysis of the investigation.

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DISCUSSION
The fornix of the papilla is the preferred site for a puncture to the collecting system
and the principle behind this approach relies on the anatomical distribution of the
blood vessels within the kidney (1, 6). Anatomical studies showed that the puncture to
the upper infundibulum was related to arterial injury in 67% of the cases. The access
through the mid- and lower calyceal infundibula was associated with an arterial lesion
in 23% and 13% of the studied kidneys (1, 5). The endourologists have embraced the
concept that the minimum damage in the domains with ample vascular supply should
result in minimum hemorrhagic complications, and a papillary access would be the
most appropriate approach.
The above anatomical studies are not associated with clinical evidence confirming the
clinical advantage of the papillary access over other approaches. The only recent
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study using the modern equipment and instrument for the performance of infundibular
approach to the PCS for PCNL has been recently reported by our group (7). This
retrospective study showed similar results regarding complications and blood loss to
the current literature and provided the first clinical evidence that a non-calyceal
puncture could be routinely performed with safety. Since the retrospective nature of
the study was related to limitations, a prospective randomized trial was designed to
provide more substantial evidence on the risk of bleeding of the infundibular in
comparison to the papillary access.
The current study showed that there is not any difference in blood loss between the
infundibular and the papillary approach since both the hemoglobin drop (p=0.916)
and the transfusion rates were similar (p=0.49). These results show that the feared
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bleeding related to the “more aggressive” puncture to the renal infundibulum may not
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be justified. In fact, the anatomical studies available are based on the evaluation of
vascular injuries induced by the puncture of different access sites but have never
considered the damage caused by the tract dilation process. A dilation of the tract to
30Fr represents an entirely different degree of invasiveness to the renal tissue in
comparison to the needle puncture. Structures such as vessels are avoided during
puncturing and could be easily injured with tract dilation process. Moreover, the
anatomical orientation of the kidney and the any effect of the surrounding tissue were
not considered in the available anatomical studies since the kidneys were removed
from the cadavers (3-5). Another issue not addressed by the studies mentioned above,
is the possible impact of the dilation of the PCS to its anatomical relations to the
intrarenal vessels. Since the majority of the stone patients have dilated collecting
systems, the currently available evidence on the probability of vascular injury could
not describe with accuracy these systems. The above considerations question the
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acceptance of the papillary puncture, due to its safety regarding bleeding, and the
concept of performing only papillary punctures should probably be revisited.

Access to the infundibulum of the posterior middle calyx was performed in the
majority of the cases of Group 2 (24/28 cases) as it is the standard practice for
performing infundibular access at our institution (Figure 2) (7). The access to the
infundibulum provides a higher degree of movement for the nephroscope. The lower
and middle calyces, as well as the renal pelvis, can be approached. Stones in the upper
calyces are also possible to treat through an infundibular middle calyceal access in
some cases (i.e. dilated PCSs). The need for multiple tract dilations was diminished in
Group 1 as none of the patients required additional tract dilations. The stone size and
the location of stones were similar among the groups and may not have biased the
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selection of the site of access to the PCS (Table 4). The middle calyceal approach is
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also advocated as a favorable access site by other investigators and may possess
advantages over the other infundibular punctures (9, 10). Specifically, the posterior
segmental artery is in close relationship to the upper infundibulum or the junction of
the pelvis with the upper infundibulum in 57% of the cases (5). The upper
infundibulum is practically encircled by the ventral and dorsal branches and probably
prone to bleeding complications (11). On the other hand, the lower infundibular
access is related to an incidence of arterial injury in 13% of the cases (1, 5).
Nevertheless, the accuracy of the above evidence was not adequately addressed by the
current study since the accesses to the upper or lower infundibulum were limited in
number. Still, the cases treated by these approaches were not associated with any
complication. Considering the above evidence, the access to the infundibulum of the
posterior middle calyx represents a safe method for reaching the majority of the
collecting system at least with PCNL technique proposed by the authors.

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The lower operative time for Group 2 in comparison to Group 1 presented an
additional advantage of the approach (p=0.027). This benefit could be related to the
need for establishing additional access tracts in Group 1 (4 multiple access tracts
cases). It could also be proposed that the higher degree of movement of the instrument
in the infundibular approach may additionally facilitate the removal of the stones.
Specifically, a higher number of cases required the use of flexible nephroscope for the
removal of stones in Group 1 in comparison to Group 2 while the fluoroscopy time
was similar (Table 4, p=0.389). Thus, the additional time could be attributed to the
establishment of a second tract and to the endoscopic manipulations.
The duration of the hospitalization was similar between the groups (p=0.724).
Nevertheless, the average hospital stay times of 5.53±1.64 and 5.82±2.48 days do not
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compare favorable to the literature (12-14). This observation is related to the public
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health system of the country. The cases are admitted the day before surgery and the
hospitalization time is increased for at least one day. Complications were encountered
in 7.4% and 7.14% of the cases of Group 1 and 2, respectively (p=1). The
complications of Group 1 had a higher Clavien grade and their management required
interventions. This observation is probably a random phenomenon related to a sample
calculated to elucidate differences in blood loss and is probably not related to the
approach.
A limitation of the current study is the number of the included patients which may not
allow for reliable results in parameters other than those considered in the sample size
calculation. Nonetheless, the current population showed clear results regarding the
blood loss and interesting results on several qualitative and quantitative parameters.
Stone-free status did not represent a primary endpoint of the study and was not
reported in the current study. Further evaluation would elucidate the efficacy of the
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infundibular approach in the stone management of the renal stones. An additional
limitation is the lack of a follow-up extending over several weeks or even months.
The current population represents cases referred to our high volume urolithiasis
center, and the patients are referred to their treating physicians after the procedure.
The incidence of long-term complications such as the incidence of infundibular
stenosis was not investigated and the study could not provide any evidence on the
issue. Nevertheless, a potential infundibular stenosis would produce symptoms due to
calyceal dilation, and all symptomtic cases were followed by radiographic evaluation
during the follow up period. No case of symptomatic infundibular stenosis was
observed in the entire cohort. Given the great variation of PCNL access techniques,
further evaluation is required in order to ensure that our favorable outcomes in central
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punctures are replicated by the other access techniques (i.e. ultrasound access) before
establishing the non-papillary access as a safe approach.

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CONCLUSION
The infundibular approach for PCNL to the posterior middle renal calyces is not
associated with higher blood loss or transfusion rate in comparison to the respective
approach to the fornix of the papilla when the described technique is performed.
References
1. Sampaio FJ. Renal anatomy. Endourologic considerations. The Urologic clinics of

North America. 2000 Nov;27(4):585-607, vii. PubMed PMID: 11098758. Epub 2000/12/01.
eng.
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2. Sampaio FJ. Renal collecting system anatomy: its possible role in the effectiveness of
renal stone treatment. Current opinion in urology. 2001 Jul;11(4):359-66. PubMed PMID:
11429494. Epub 2001/06/29. eng.
3. Sampaio FJ, Aragao AH. Anatomical relationship between the intrarenal arteries and
the kidney collecting system. The Journal of urology. 1990 Apr;143(4):679-81. PubMed
PMID: 2313791. Epub 1990/04/01. eng.
4. Sampaio FJ, Passos MA. Renal arteries: anatomic study for surgical and radiological
practice. Surgical and radiologic anatomy : SRA. 1992;14(2):113-7. PubMed PMID: 1641734.
Epub 1992/01/01. eng.
5. Sampaio FJ, Zanier JF, Aragao AH, Favorito LA. Intrarenal access: 3-dimensional
anatomical study. The Journal of urology. 1992 Dec;148(6):1769-73. PubMed PMID:
1433604.
6. Miller NL, Matlaga BR, Lingeman JE. Techniques for Fluoroscopic Percutaneous Renal
Access. The Journal of urology. 2007 7//;178(1):15-23.
7. Kyriazis I, Kallidonis P, Vasilas M, Panagopoulos V, Kamal W, Liatsikos E. Challenging
the wisdom of puncture at the calyceal fornix in percutaneous nephrolithotripsy: feasibility
and safety study with 137 patients operated via a non-calyceal percutaneous track. World
journal of urology. 2016 Aug 10. PubMed PMID: 27510761. Epub 2016/08/12. Eng.
8. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new
proposal with evaluation in a cohort of 6336 patients and results of a survey. Annals of
surgery. 2004 Aug;240(2):205-13. PubMed PMID: 15273542. Pubmed Central PMCID:
PMC1360123. Epub 2004/07/27. eng.
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9. Song Y, Jin W, Hua S, Fei X. Middle calyx access is better for single renal pelvic stone
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in ultrasound-guided percutaneous nephrolithotomy. Urolithiasis. 2016 Mar 14. PubMed

PMID: 26973333. Epub 2016/03/15. Eng.
10. Falahatkar S, Kazemnezhad E, Moghaddam KG, Kazemzadeh M, Asadollahzade A,
Journal
Farzan A, et al. Middle calyx access in complete supine percutaneous nephrolithotomy.

Canadian Urological Association journal = Journal de l'Association des urologues du Canada.

2013 May-Jun;7(5-6):E306-10. PubMed PMID: 23766832. Pubmed Central PMCID:
PMC3668405. Epub 2013/06/15. eng.
11. Sampaio FJ. Anatomical background for nephron-sparing surgery in renal cell
carcinoma. The Journal of urology. 1992 Apr;147(4):999-1005. PubMed PMID: 1552622.
Epub 1992/04/01. eng.
12. De S, Autorino R, Kim FJ, Zargar H, Laydner H, Balsamo R, et al. Percutaneous
nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-
analysis. Eur Urol. 2015 Jan;67(1):125-37. PubMed PMID: 25064687. Epub 2014/07/30. eng.
13. Yuan D, Liu Y, Rao H, Cheng T, Sun Z, Wang Y, et al. Supine Versus Prone Position in
Percutaneous Nephrolithotomy for Kidney Calculi: A Meta-Analysis. Journal of endourology /
Endourological Society. 2016 Jul;30(7):754-63. PubMed PMID: 27072075. Epub 2016/04/14.
eng.
14. Zhang W, Zhou T, Wu T, Gao X, Peng Y, Xu C, et al. Retrograde Intrarenal Surgery
Versus Percutaneous Nephrolithotomy Versus Extracorporeal Shockwave Lithotripsy for
Treatment of Lower Pole Renal Stones: A Meta-Analysis and Systematic Review. Journal of
endourology / Endourological Society. 2015 Jul;29(7):745-59. PubMed PMID: 25531986.
Epub 2014/12/23. eng.
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This article has been peer-reviewed and accepted for publication, but has yet to undergo of Endourology
copyediting and proof correction. The final published version may differ from this proof.
LEGENDS TO FIGURES
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Figure 1: Flow diagram of the recruitment process

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ureter.
Abbreviations
punctured.
SFR= Stone free rate

PCS= Pelvicalyceal system
fluoroscopy is oriented at 0°.
PCNL= Percutaneous nephrolithotomy

Figure 2: Intraoperative images during the puncture process
instrument to show the infundibulum of the middle calyx which is going to be

perpendicular to the long axis of the patient. The surgeon is using an
puncture has been done in the pelvis and the guidewire has been inserted in the
C) A case that a puncture to the fornix of the papilla is performed. The

B) The same case with figure 1A with the fluoroscopy oriented at 0°. The
A) The site of the puncture is selected with the fluoroscopy oriented at 30°
14
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RF= Residual fragment

15
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Table 1: Study design

INCLUSION AND EXCLUSION CRITERIA
Inclusion: Patients with calculi of accumulative diameter of at least 2cm in the kidney
Patient’s exclusion criteria:
1. Single kidney
2. Concurrent ureteral lithiasis in the ipsilateral system
3. Lithiasis of diverticulum
4. Concurrent inflammation of the urinary tract
5. Congenital anatomic abnormalities of the urinary tract
6. Patients with skeletal abnormalities (kyphosis, scoliosis, lumbar spine trauma)
PRIMARY AND SECONDARY ENDPOINTS

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Primary and secondary endpoints
1. Hemoglobin drop (pre-op to discharge)

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2. Need for transfusion (during the 1st month)
Secondary outcome measures
1. Operative time
2. Number of accesses performed
3. Overall complication rate
4. Hospitalization time
5. Complications up to 3 months
OUTCOME DEFINITIONS
1. Operative time: measured from the initiation of the puncture to the

insertion of all nephrostomy tubes.
2. Fever: temperature ≥38.5°C
3. Hemorrhage: any bleeding significantly altering the postoperative course
and requiring additional measures such as hospitalization, transfusion.
STATISTICAL ANALYSIS
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operatively.
Armonk, NY, USA).

analysis of the data. Statistical significance was set at p<0.05.
Statistical analysis was performed with the IBM SPSS version 20 (IBM Corp.,
Sample size: A sample size of 26 subjects per group was necessary to achieve a power
Statistical tests: Mann-Whitney, t-test and Fischer’s exact test were used for the
of 80% and to detect a difference of 50% in the values of hemoglobin pre- and post-
17
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Table 2: Technical details of the PCNL
Steps of the PCNL procedure

1:The patient was anesthetized, and a ureteral catheter was inserted in the ipsilateral
collecting system with the patient in the lithotomy position.
2: A C-arm fluroroscopic equipment was set at 30°perpendicular to the long axis of

the patient and the puncture site was selected. The puncture was advanced parallel to
the C-arm axis according to the so called “bull’s eye” technique. The depth of needle
insertion was assessed with the fluoroscopy device set at 0°.
3: In Group 1, the fornix-papilla of the calyx was punctured. In the case of Group 2,
the infundibulum was accessed.
4: An appropriate guidewire was inserted in the ureter (if possible). Additional

accesses were prepared if necessary.
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5: The rest of the procedure was performed by dilating the tract to the pelvicalyceal
system at a diameter of 30Fr with the use of Amplatz dilators. A rigid nephroscope
was inserted.
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6: After the successful puncture The calculi were removed with the use of a clamp or
ultrasound lithotripter (Lithoclast Master, EMS, Switzerland).
7: The flexible nephroscope was used to remove stones inaccessible to the rigid scope
and to confirm the stone-free status. The stone-free status was also confirmed with
intraoperative fluoroscopy.
8: At the end of the procedure, a Malecot re-entry tube was left in place.
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procedure
Table 3: Recorded parameters
7. Days of hospitalization
3. Instruments and material used
5. Operative and fluoroscopy time

4. Number and location of accesses
2. Positions and dimensions of the calculi
1. Demographic characteristics (age, weight, height)
Blood analysis – Biochemical analysis including renal function tests.
8. Peri-operative complications and complications up to 3 months after the

6. Complete pre- and postoperative laboratory results (1st postoperative day)-
19
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Table 4: Patient demographics and operative data

Group 1 Group 2 p value

– papillary puncture –infundibular puncture
n=27 n=28
PATIENT
DEMOGRAPHICS
Age, years 58.11±12.72 53.68±14.29 0.23
Gender, M/F, no. 19/8 11/17
BMI, kg/m2 25.83±2.89 26.07±2.63 0.567
Stone size – maximal 14.25±5.82 14.86±6.6 0.788
diameter, mm
Number of stones treated 50 44
Side, R/L, no. 15/12 7/21

Stone location-extension:
Upper calyx 5 2
Middle calyx 4 6
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Lower calyx 20 15
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Pelvis 21 21
OPERATIVE DATA
Operative time, min 51.97±16.1 43.21±12.38 0.027
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Fluroscopy time, sec 131.3±43.55 122.6±29.23 0.389

Single/Multiple access 0.051
(percentage of multiple
access cases) 23/4 (14.8%) 28/0 (0%)
Puncture site:
Upper calyx 3 1
Middle calyx 16 26
Lower calyx 12 1
Use of flexible 10 4 0.068
nephroscopy for stone
removal
Malecot tube (24Fr) 27 28
Nephrostomy tube (16Fr) 4 0
Use of Hemostatics 6 6
Numerical values are presented as mean values±standard deviation. M=male,
F=female, BMI=body mass index, R=right, L=left
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g/L
days
lithotripsy
Creatinine
Hospital stay,
change, mg/dL
Hemoglobin loss,
Group 1
5.57±1.70
1.54±1.29
– papillary
-0.04±0.23
Table 5: Postoperative outcome
puncture n=27
Group 2
5.80±2.56
0.04±0.25
1.35±0.79
–infundibular
puncture n=28
0.793
0.887
0.916
p value
Numerical values are presented as mean values±standard deviation. KUB=kidney-

ureter-bladder x-ray, CT= computized tomography nonenhanced. SWL=shock wave
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Fever
Hematuria
Transfusion
Hemothorax
(percentage)
Complication
Pseudoaneurysm
Overall complications
No/Treatment/Grading
Table 6: Complications
-
-
puncture
2/27 (7.4%)
1/27 (3.4%)
collection/IIIa
1/Angiographic
embolization/IIIa
1/Drainage of the
Group 1 – papillary
-
-
puncture
0/28 (0%)
1/ resolved
antibiotics/II
1/ Prolonged
2/28 (7.14%)
conservatively/II
Group 2 –infundibular
1
0.49
p value
22
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Journal of Endourology

Page 1 of 22 © Mary Ann Liebert, Inc.

PAPILLARY VERSUS NON PAPILLARY PUNCTURE IN PERCUTANEOUS

NEPHROLITHOTOMY: A PROSPECTIVE RANDOMIZED TRIAL.

Panagiotis Kallidonis1, Iason Kyriazis1, Dimitrios Kotsiris1, Adamantia Koutava1,

Wissam Kamal1, Evangelos Liatsikos1

Keywords: percutaneous, nephrolithotomy, papillary, infundibular, randomized

Word count text: 2135

Word count abstract: 265

Evangelos N. Liatsikos M.D PhD, Associate Professor

Department of Urology, University of Patras Medical School,

Rion, 26 505, Patras, Greece

Tel: +30 2610 999386,

Fax: +30 2610 993981

direction of the pelvis is not advisable due to increased hemorrhagic risk. A

prospective randomized study was conducted to investigate the safety in terms of

blood loss of the infundibular approach for PCNL.

operative and fluoroscopy time, number of accesses performed, overall complication

rate, hospitalization time, complications up to 3 months.

Results: Totally, 27 and 28 patients were enrolled in Group 1 and 2, respectively.

Percutaneous nephrolithotomy (PCNL) constitutes the primary method of treating

large renal calculi. The percutaneous access is achieved by puncturing the

approach. In an attempt to establish a high level of evidence concerning the safety

profile of the infundibular approach during PCNL, a prospective randomized study

MATERIALS AND METHODS

Inclusion- exclusion criteria, Study groups and Randomization process

number 11393/16-6-2015). The reporting of the investigation was done according to

the PRISMA statement.

either infundibular or papillary renal access. The randomization method employed

to the infundibulum of the calyx.

described in detail (7). The technical details are presented in Table 2.

All cases were performed by specialist surgeons.

Outcome measures, Perioperative care and Follow-up

approach. The statistical analysis methods are presented in Table 1.

The patient recruitment process is described in Figure 1. Totally, 27 and 28 patients

not higher in any of the evaluated approaches.

significant (p=0.051). The middle infundibular punctures represented 85.7% of the

respectively. No statistical significance was noted (p=1). All complications were

summarize the data and statistical analysis of the investigation.

result in minimum hemorrhagic complications, and a papillary access would be the

most appropriate approach.

provide more substantial evidence on the risk of bleeding of the infundibular in

comparison to the papillary access.

30Fr represents an entirely different degree of invasiveness to the renal tissue in

concept of performing only papillary punctures should probably be revisited.

segmental artery is in close relationship to the upper infundibulum or the junction of

collecting system at least with PCNL technique proposed by the authors.

The lower operative time for Group 2 in comparison to Group 1 presented an

removal of stones in Group 1 in comparison to Group 2 while the fluoroscopy time

establishment of a second tract and to the endoscopic manipulations.

interventions. This observation is probably a random phenomenon related to a sample

infundibular approach in the stone management of the renal stones. An additional

The incidence of long-term complications such as the incidence of infundibular

issue. Nevertheless, a potential infundibular stenosis would produce symptoms due to

during the follow up period. No case of symptomatic infundibular stenosis was

establishing the non-papillary access as a safe approach.

1. Sampaio FJ. Renal anatomy. Endourologic considerations. The Urologic clinics of

in ultrasound-guided percutaneous nephrolithotomy. Urolithiasis. 2016 Mar 14. PubMed

Farzan A, et al. Middle calyx access in complete supine percutaneous nephrolithotomy.

Canadian Urological Association journal = Journal de l'Association des urologues du Canada.

Figure 1: Flow diagram of the recruitment process

SFR= Stone free rate

PCNL= Percutaneous nephrolithotomy