Urolithiasis DOI 10.1007/s00240-014-0644-5

Original Paper

Comparison of the safety and efficacy of one‑shot and telescopic metal dilatation in percutaneous nephrolithotomy: a randomized controlled trial Shahriar Amirhassani · Seyed Habibollah Mousavi‑Bahar · Abdolmajid Iloon Kashkouli · Saadat Torabian 

Received: 28 October 2013 / Accepted: 22 January 2014 © Springer-Verlag Berlin Heidelberg 2014

Abstract  Minimizing X-ray exposure during percutaneous nephrolithotomy (PCNL) is challenging. Using the single semirigid dilator, also called “one-shot” or “one-stage” is a good alternative to routine telescopic metal dilators to reduce X-ray exposure. Our aim was to compare the single semirigid one-shot dilator with a telescopic metal dilator in PCNL. The intraoperative status was evaluated in 100 consecutive patients randomly assigned to two equal groups undergoing PCNL either with the one-shot (group A) or telescopic technique (group B). No significant difference in stone burden and location existed between the groups (P > 0.05). The mean age of group A and group B was 44.8  ± 15 and 45.6 ± 14 years, respectively (P  = 0.78). The mean operation time was 51.14 ± 40.85 min in group A and 57.00 ± 38.85 min in group B (P = 0.46). The mean X-ray exposure time was 41.2 ± 17 and 48.4 ± 15 s in group A and group B, respectively (P = 0.03). The stonefree rate was 94 % (n = 47) in group A and 84 % (n = 42) in group B (P  = 0.10). The mean hemoglobin drop was 1.26 ± 0.09 and 1.44 ± 0.11 g/dl in group A and group B, respectively (P = 0.09). The one-shot technique is feasible, safe, and well tolerated in patients undergoing PCNL. In

S. Amirhassani · S. H. Mousavi‑Bahar · A. Iloon Kashkouli  Urology and Nephrology Research Center, Hamadan University of Medical Sciences, Hamadan, Iran S. Amirhassani · S. H. Mousavi‑Bahar · A. Iloon Kashkouli (*) · S. Torabian  Urology and Nephrology Research Center, Beheshti Hospital, Eram Blvd, 6516783871 Hamadan, Iran e-mail: [email protected] S. Torabian  Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran

addition to lack of complications, the method also provides less radiation exposure for urologists and nursing teams. Keywords Renal calculi · Dilatation · Kidney stone · Nephrolithotomy · Percutaneous

Introduction Since its original description by Fernström and Johansson in 1976 [1], percutaneous nephrolithotomy (PCNL) has been a common and well-tolerated minimally invasive procedure for the treatment of renal stones. It is currently the first line treatment for removal of kidney calculi greater than 2–3 cm diameter, multiple kidney calculi and staghorn, and also for cases who fail extracorporeal shockwave lithotripsy (SWL) [2–4]. Because minimizing X-ray exposure is a challenge during PCNL, several attempts have been made in recent years to reduce X-ray exposure as a hazardous factor [5]. One method is the use of the one-shot (one-stage) technique for tract dilatation. However, there are few published studies [5–8] on the use of this technique. Our study included a large number of patients and compared the one-shot technique with telescopic dilatation in PCNL.

Materials and methods This randomized controlled trial was approved by the Urology and Nephrology Research Center, Hamadan University of Medical Sciences, Hamadan, Iran, and by the Chancellor of Research and Technology of Hamadan University of Medical Sciences, and met the criteria of the Helsinki Declaration of 1975 (as revised in 2008). The

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study was conducted at Shahid Beheshti and Booali Hospital from December 2012 to October 2013. One hundred patients with renal stones who required PCNL surgery were enrolled in the study without selection by involving a single surgeon. The population included patients ≥18 years of age with any size of stones, American Society of Anesthesiology physical status 1 or 2, randomly assigned by a blinded nurse based on a random block of 4 in the ward, to the one-shot technique (group A = 50 patients) or telescopic metal dilatation (group B = 50 patients). After randomization, the surgeon explained the one-shot technique and obtained written informed consent. If a patient from group A refused the procedure, they were excluded from the study. Exclusion criteria for patient selection were: any contraindication for PCNL such as uncorrectable bleeding tendency and acute infection; any co-morbidity such as severe cardiopulmonary disease, for which PCNL is not advised by other specialists; and patients who refused the procedure. After full preoperative evaluations and workups including history, general physical, and laboratory examinations including complete blood count, fasting blood sugar, blood urea nitrogen, creatinine, sodium, potassium, urinalysis, urine culture, and diagnostic studies such as ultrasonography (US), kidney ureters bladder, intravenous urogram, isotope scan or computed tomography scan, and anesthesiologist visit for PCNL in prone position fitness, patients were admitted to the hospital the day before the procedure. Demographic characteristics (stone burden and location, degree of hydronephrosis, number of tracts, intraoperative problems, and previous intervention due to renal calculi), mean operation time, mean X-ray exposure time, stone-free rate, hemoglobin, and blood transfusion rate were compared among the groups. Statistical analysis Results are reported as mean ± standard deviation for the quantitative variables and percentages for the categorical variables. The groups were compared using the independent t test for quantitative parameters and Chi square test for other parameters. We used SPSS software version 17.0 for windows (SPSS Inc., Chicago, IL) for all statistical analyses. p values of ≤0.05 were considered statistically significant. Surgical procedure First, the fluoroscope was set at 76 kV and 30 mAs as mentioned as optimum parameters for radiography of the abdomen plus kidney in www.wikiradiography.com [9] in all cases. After preprocedural antimicrobial prophylaxis, anesthesia induction, and placing the patient in the lithotomy

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position, cystoscopy and ureteral and urethral catheterizations were performed. All cases underwent surgery in the prone position. Track dilation was performed by the oneshot technique in group A and with the telescopic technique in group B to accept a 28–30-Fr Amplatz sheath. In the one-shot technique, after incision of the skin over the puncture site, an 18-gauge coaxial needle was introduced into the fornix of the targeted calyx and after efflux of urine or injected fluid from the urethral catheter through the needle, a working guidewire was passed through the needle into the collecting system. The nephrostomy tract was then dilated using an 8-Fr polyurethane dilator. The dilator was removed and the Alken guide was replaced and a single funnel-shaped tip 28–30 Fr semirigid plastic (polyurethane) dilator was passed very gradually along the Alken guide, on which an Amplatz sheath was introduced into the renal collecting system. All steps of tract dilation and sheath placement were under fluoroscopic control. After the correct position of the Amplatz sheath was ensured, the complex of dilator and Alken guide was removed, and the Amplatz sheath and working guidewire were left in place. In the telescopic technique, rigid progressively enlarging coaxial stainless steel rods over a guidewire were used for dilation and similar procedures followed as in group A. Blind puncture or stone guide technique was used only when there was complete ureteral obstruction and US was not available; thereafter, contrast injection and routine dilation were performed gradually and with a high level of caution under fluoroscopy, after urine efflux. All the next steps were performed under fluoroscopic control. A 24-Fr Wolf nephroscopy and pneumatic lithoclast (EMS Swiss, Nyon, Switzerland) were used for stone fragmentation and second and third tracks were made if necessary. With multiple tracks, additional surgical caution was necessary and in a few selected cases continued dilatation with a medium sized semirigid dilatator (14–18 Fr) was needed. The best calices were selected to have the best access to the entire or most parts of the calculi. We did not hesitate to create intercostal access if mandatory; nevertheless, the pathway was kept far from the upper rib and slightly closer to the lower rib (away from subcostal vessels) to minimize vessel injury and subsequent bleeding, as possible. All attempts were made to remove the stone and all cases were monitored by fluoroscopy thereafter. Nephrostomy tubes were fixed in the majority of cases, especially those with residual stone, single kidney, or pyelocaliceal system injury, and based on surgeon’s preference, double J stents were fixed in selected cases such as with significant perforation of the collecting system, suspected ureteral obstruction due to edema, stone fragment migration into the ureter, and cases with supracostal access and retained for up to 30 days or lesser if problem developed. All patients were transferred back to the ward after surgery and all were evaluated by KUB or

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US, and chest X-ray in the cases with intercostal access, the day after surgery. Repeat PCNL was performed through the same tracks or new ones, if there were significant residual particles identified with KUB or US. Laboratory values were rechecked 24 h after operation, the nephrostomy tube was removed, and patients were discharged on the second or third day after the surgery. If operation-related complications developed, patients were referred to the emergency room and managed immediately. All patients were visited 1 week and 1 month after discharge and evaluated with US and KUB (in the presence of opaque stones) and if hydronephrosis or residual stones were detected, intravenous urogram or CT was performed. Because of the high cost and limited availability of CT in our center, the authors could not perform CT routinely but, if deemed essential, CT was performed in certain patients. We attempted to use as little X-ray exposure as possible.

Results We evaluated the characteristics of all 100 patients. No mortality occurred and no patients requested open surgery. The authors did not experience incomplete dilatation or loss of tract. A small number of kinked guidewires was seen in both groups. If kinking occurred during the procedure, guidewires were changed, if possible. The rates of parenchymal injury, over-dilatation and collecting system perforation were 2 % in group A and 6 % in group B, without significant statistical difference. No significant difference in stone burden and location, degree of hydronephrosis, number of tracts, and previous intervention due to renal calculi existed in the two groups (P > 0.05). The mean age of the group A and group B patients was 44.8 ± 15 years (range 41–86 years) and 45.6 ± 14 years (range 38– 81 years), respectively (P  = 0.78); of which 28 (56 %) and 27 (54 %) cases in group A and B, respectively, were men and the remainder were women. Staghorn or complex stones of >2.5 cm diameter were seen in 31 (62 %) and 33 (66 %) of group A and B patients, respectively (P = 0.41). Intercostal puncture was necessary in 5 (10 %) and 4 (8 %) patients, blind puncture in 1 (2 %) and 2 (4 %), and multiple tracks in 4 (8 %) and 7 (14 %) patients in group A and B, respectively, to complete stone removal (P > 0.05). Pneumothorax occurred in one patient with intercostal access in each group (P > 0.05). The mean operation time from the beginning of renal puncture to termination of the surgery was 51.14 ± 40.85 and 57.00 ± 38.85 min (P = 0.46), the mean X-ray exposure time was 41.20 ± 17 and 48.40 ± 15 s (P  = 0.03), the stone-free rate was 94 % (n  = 47) and 84 % (n = 42) (P = 0.10), and the mean hemoglobin drop was 1.26  ± 0.09 and 1.44 ± 0.11 g/dl (P  = 0.09) in group A

and B, respectively. Repeat PCNL (second-look nephroscopy) was done in 4 % (n  = 2) of the group B patients because of incomplete success and stone size >4 mm. The demographic characteristics of the patients are outlined in Table 1 and the findings in Table 2.

Discussion PCNL has changed a major open surgery to a minimally invasive operation with minimal patient discomfort and fewer complications as well as shorter hospitalization. Its effect on people’s quality of life, family budget, and insurance costs is even more noticeable considering the fact that renal calculi is a recurrent disease in adults and involves both genders in their most active decades. Even with advances in surgical techniques, patients suffered from the actual operation and related complications. Urologists and related nursing teams have dealt with long operation times and greater X-ray exposure. To address these issues, we now have a shorter and safer procedure with the oneshot dilatation for PCNL. Previous studies have discussed the possibility of PCNL with the one-shot technique, but adequate data are lacking. Attempts have also been made previously to improve PCNL tolerability and simplify the track dilatation with good results. Falahatkar and colleagues reported 215 patients who underwent percutaneous renal surgery with the one-shot technique compared with telescopic dilatation to reduce X-ray exposure time (P  = 0.003), without significant differences in success rate, operation time, and hemoglobin drop (P > 0.05) [5]. Amjadi and colleagues also reported PCNL in 90 patients. They compared the safety of the one-shot and telescopic dilatation techniques and found no significant differences in early and late complications (P > 0.05) [6]. Ziaee and colleagues compared 46 patients with a history of previous open nephrolithotomy and 54 patients without a history of previous open nephrolithotomy, who then underwent PCNL for management of kidney stone disease with the one-shot technique. There was no significant difference between the two groups in terms of access time, radiation exposure time during access, postoperative hemoglobin drop, and bleeding complications (P > 0.05) [7]. Frattini and colleagues reported their results in evaluating the one-shot technique, balloon, and telescopic dilatation in patients who underwent percutaneous renal surgery. Their results showed equal morbidity with all three techniques with the smallest X-ray exposure and cost with the one-shot procedure [8]. In our study, one-shot and telescopic metal dilatation techniques were compared for the most critical parameters during PCNL including stone-free rate, surgical complications, operation time, X-ray exposure time, and values such as Hb drop. Although the presence of dense perirenal

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Urolithiasis Table 1  Demographic characteristics of 100 patients who undergo PCNL with oneshot versus telescopic dilatation

SD standard deviation, ASA American Society of Anesthesiology, kg/m2 kilogram/meter2, PCNL percutaneous lithotripsy, SWL shockwave lithotripsy, TUL transurethral lithotripsy

Variable

One-shot technique (n = 50)

Telescopic technique (n = 50)

p value

BMI (kg/m  ± SD) Mean age (year ± SD) Male gender Female gender ASA physical status 1 ASA physical status 2 Previous PCNL Previous nephrolithotomy Previous SWL Previous TUL Sever hydronephrosis Moderate hydronephrosis Mild hydronephrosis No hydronephrosis Upper calyces stone Middle calyces stone Lower calyces stone Renal pelvis stone Proximal ureters stone Staghorn or complex stones Access by one track

26.2 ± 7.3 44.8 ± 15 28 (56 %) 27 (54 %) 41 (82 %) 9 (18 %) 3 (6 %) 0 10 (20 %) 2 (4 %) 8 (16 %) 16 (32 %) 24 (48 %) 2 (4 %) 2 (4 %) 2 (4 %) 3 (6 %) 9 (18 %) 3 (6 %) 31 (62 %) 46 (92 %)

25.4 ± 6.8 45.6 ± 14 22 (44 %) 23 (46 %) 39 (78 %) 11 (22 %) 5 (10 %) 0 10 (20 %) 5 (10 %) 9 (18 %) 18 (36 %) 17 (34 %) 6 (12 %) 3 (6 %) 1 (2 %) 4 (8 %) 7 (14 %) 2 (4 %) 33 (66 %) 43 (86 %)

0.57 0.78 0.84 0.84 0.40 0.40 0.35 – – 0.21 0.33 0.33 0.33 0.33 0.87 0.87 0.87 0.39 0.50 0.41 0.26

Access by two or more tracks

4 (8 %)

7 (14 %)

0.26

2

Table 2  Important findings of 100 patients who undergo PCNL with one-shot versus telescopic dilatation Variable

One-shot technique (n = 50)

Telescopic technique (n = 50)

p value

Mean operation time (min ± SD) Mean X-ray exposure time (s ± SD)

51.14 ± 40.85 41.2 ± 17

57 ± 38.85 48.4 ± 15

0.46 0.03

Stone-free rate Mean preoperative hemoglobin (g/dl ± SD) Mean postoperative hemoglobin (g/dl ± SD) Mean hemoglobin drop (g/dl ± SD) Blood transfusion rate Intraoperative bleeding

47 (94 %) 14.85 ± 1.8 13.54 ± 1.7 1.26 ± 0.09 1 (2 %) 2 (4 %)

42 (84 %) 14.34 ± 2.16 12.90 ± 2.07 1.44 ± 0.11 1 (2 %) 5 (10 %)

0.10 0.20 0.09 0.09 0.99 0.24

Kidney and pelvis injury

1 (2 %)

3 (6 %)

0.30

SD standard deviation, g/dl gram/deciliter

scarring from prior procedures is a good indication for using a rigid metal dilator, we were able to use our technique by choosing another pathway to the renal system, as possible. The rate of multiple tracts was low and not significant between groups (P > 0.05) and did not affect outcomes. Although differences between the mean operation time (approximately 7 min) in the two groups were not statistically significant and not clinically important (P = 0.46), the time of  0.05). The mean Hb drop in our study was 1.26 ± 0.09 and 1.44 ± 0.11 g/dl in group A and B, respectively, and significantly less than in previous studies [14, 15]. Only 4 % of the patients required blood transfusion. Because of significant differences between our study and previous studies [10, 16], the blood transfusion protocol in our center will be reevaluated. Study limitations The limitations of this study deserve mention. Obviously, enrolling more patients in the two groups would enhance the power of the study. Although we randomized the patients before the operation, to eliminate possible confounding factors, our exclusion criteria were based mainly on perioperative conditions. Although we followed the patients for at least 1 month, long-term follow up studies of adverse effects such as renal parenchymal damage after PCNL with telescopic versus one-shot tract dilation are needed. Finally, because CT was not performed to look for residual stones, the need for second-look nephroscopy may have been underestimated.

Conclusion The one-shot technique is feasible, safe, and well tolerated in the management of patients undergoing PCNL for renal stone treatment. The technique has fewer complications and provides less radiation exposure for urologists and nursing teams. Acknowledgments  We thank the staff of the Shahid Beheshti and Booali Hospitals, Urology and Nephrology Research Center, and the Chancellor of Research and Technology of Hamadan University of Medical Sciences, Hamadan, Iran for their help during the study, and also Davood Yarmohammad Tooski (MD) and Abbas Moradi (Community Medicine Specialist) for primary analysis and interpretation of the data. Sources of financial support All authors are employees of Hamadan University of Medical Sciences. This study was approved and supported financially by the Chancellor of Research and Technology of Hamadan University of Medical Sciences and Urology & Nephrology Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflict of interest  The authors declare that they have no conflict of interest.

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Comparison of the safety and efficacy of one-shot and telescopic metal dilatation in percutaneous nephrolithotomy: a randomized controlled trial.

Minimizing X-ray exposure during percutaneous nephrolithotomy (PCNL) is challenging. Using the single semirigid dilator, also called "one-shot" or "on...
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