Original Paper

Urologia Internationalis

Received: August 29, 2014 Accepted after revision: October 20, 2014 Published online: February 7, 2015

Urol Int DOI: 10.1159/000369216

Ultrasonographic versus Fluoroscopic Access for Percutaneous Nephrolithotomy: A Meta-Analysis Kun Wang Peijin Zhang Xianlin Xu Min Fan Department of Surgical Urology, The Third Affiliated Hospital of Soochow University, Jiangsu Changzhou, Department of Public Health, Xuzhou Medical College, Jiangsu Xuzhou, China

Abstract Objective: To assess the safety and efficacy of ultrasonographic vs. fluoroscopic access for percutaneous nephrolithotomy (PCNL). Methods: Medline (PubMed), Embase, Ovid, Cochrane, and the Chinese Biomedical Literature databases were searched to identify clinically controlled trials (CCTs) and randomized controlled trials (RCTs) that compared ultrasonographic access with fluoroscopic access for PCNL. RevMan 5.1 software and Stat Manager V4.1 software were used for the meta-analysis. Results: Five RCTs and nine CCTs were included in our study, which contained a total of 3,019 patients. Of these, 1,574 (52%) had undergone ultrasonographic access, and 1,445 (48%) had undergone fluoroscopic access. The pooled results revealed that the ultrasonographic access patients had shorter duration of access (min) by 2.56 min (weighted mean difference (WMD) = −2.56, 95% confidence interval (CI): −4.40 to −0.72, p = 0.006). There was a higher stone-free rate in the ultrasonographic access group (odds ratio (OR) = 1.26, 95% CI: 1.02–1.55, p = 0.03), as well as a lower rate of operative complications (OR = 0.72, 95% CI: 0.56–0.93, p = 0.01), reduced intraoperative blood

© 2015 S. Karger AG, Basel 0042–1138/15/0000–0000$39.50/0 E-Mail [email protected] www.karger.com/uin

loss (ml) (WMD  = −14.55 ml, 95% CI: −27.65 to −1.46, p  = 0.03), and a lower rate of blood transfusion requirement (OR  = 0.39, 95% CI: 0.24–0.63, p  = 0.0001). Sensitivity and subgroup analyses were also performed. Conclusion: Except for no radiation exposure, our meta-analysis revealed that ultrasonographic access had many advantages, such as a shorter access time, reduced intraoperative blood loss, a lower rate of operative complications, a lower rate of blood transfusion, and a higher stone-free rate. Because of these significant advantages, we recommend the use of ultrasonographic access for PCNL. © 2015 S. Karger AG, Basel

Introduction

According to clinical epidemiological investigations, urolithiasis accounts for a large proportion of cases of the urinary system disease [1, 2]. However, the localization and size of the urinary stones differ among patients, leading to a variety of treatment options [3–6]. PCNL plays a very important role in the treatment of nephrolithiasis, and was first applied in the late 1970s [7]. Due to the fact that it has lowered the incidence of complications, PCNL is now a primary and safe surgical option for treatment of urolithiasis [8, 9]. Xianlin Xu Department of Surgical Urology The Third Affiliated Hospital of Soochow University Jiangsu Changzhou 213003 (China) E-Mail xuxianlin2014 @ sina.com

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Key Words Fluoroscopic · Nephrolithotomy · Percutaneous · PCNL · Ultrasonographic

Methods Inclusion Criteria Studies included in this analysis had to fulfill the following requirements: (1) comparisons between ultrasonography-guided and fluoroscopy-guided renal access in PCNL; (2) the documentation of adult patients suitable for PCNL; (3) matched baseline characteristics of patients in the two groups; (4) the study evaluated at least two of the following outcomes: duration of access, stone-free rate, duration of hospital stay, intraoperative blood loss, blood transfusion rate, or operative complications; (5) the patients were in the flank or prone position during PCNL; and (6) the articles were published in English or Chinese in open-access journals. When multiple trials were from the same authors and/or institute, only the latest publication, or publication of highest quality, was included in the study. Exclusion Criteria Trials were excluded for the following reasons: (1) case reports, reviews, editorials, abstracts, expert opinions, letters, and noncomparative studies; (2) studies reporting on computed tomography guidance; (3) studies comparing PCNL with open surgery; (4) repeated reports from authors, centers, or patient populations; (5) considerable overlap between a cohort evaluated previously. Study Selection Medline (PubMed), Embase, Ovid, Cochrane, and the Chinese Biomedical Literature databases were searched for studies performed between 2000 and 2014 that compared ultrasonographic with fluoroscopic access. The following Mesh search headings were used: ‘fluoroscopic,’ ‘ultrasonographic,’ ‘percutaneous,’ ‘nephrolithotomy,’ and ‘PCNL’. And their combinations were also searched. The function of ‘related articles’ was applied to enlarge

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Urol Int DOI: 10.1159/000369216

the search. The references of each included study were also seriously reviewed, and the last study date for the search was July 9, 2013. To ensure that any relevant studies were not missed, many scholars in the field of endourological surgery were consulted. This analysis only included comparative clinical full-text studies, and the final articles included in the study were agreed upon by all authors on this manuscript. Data Extraction The following data were independently extracted by two reviewers (ZPJ and WK) from each study: year of publication, first author, characteristics of targeted population, research design, interventions, and outcomes of interest. In order to avoid missing the related study data, two reviewers made great efforts to contact the authors where information was lacking or unclear. Conflicts about the outcomes of interest between investigators were subsequently reviewed and the agreements were reached on the final interpretation of the data. Outcomes of Interest and Definitions The following outcomes were used to compare the ultrasonographic access with the fluoroscopic access: (1) duration of access (min), and intraoperative blood loss (ml); (2) stone-free rate (the stone-free rate at one session); (3) duration of hospital stay (days) and blood transfusion rate (intraoperative and postoperative); (4) operative complications: wound infections, vascular, pulmonary, extravasation, chronic wound pain, fever, urological complications, and death. Statistical Analysis This meta-analysis followed the Quality of Reporting of Metaanalyses guideline and the recommendations of the Cochrane Collaboration [14, 15]. Stat Manager Version 4.1 software and Review Manager V5.1 software were used. The weighted mean difference (WMD) was used to analyze continuous variables, and dichotomous variables were analyzed by using odds ratios (ORs) [16]. Fourteen studies were found to be within 95% confidence intervals (CIs). ORs represented the occurrence odds of an event in the group of ultrasonographic access patients compared with fluoroscopic access, and the numerical differences between the two groups were summarized by WMDs for continuous variables. If the p value was less than 0.05 and the 95% CI did not include the value one; the OR and WMD were considered statistically significant. When continuous data were presented as ranges and means, we used statistical algorithms and ‘bootstrap’ resampling techniques to calculate and verify the standard deviations (SD) [17]. To evaluate the quality of the studies we used the NewcastleOttawa Scale; with minimal modifications this scale matched for the requirements of this study [18]. The quality of the studies was assessed according to the following criteria: selection of patients, comparability between the two groups, and outcome assessment. Except for the RCTs, each study was assessed by scoring 0 to 9 (as stars). The maximum number of stars in the selection, comparability, and outcome categories was 3, 4, and 2, respectively. The studies in which six or more stars were allocated to and the RCTs were believed to be of high quality. The Higgins χ2 test was performed to evaluate the heterogeneity. Statistical heterogeneity was evaluated by the p value and I2 value. If an I2 value was 0.1, the hetero-

Wang/Zhang/Xu/Fan

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The key to PCNL is entrance into the collecting system [5], for which fluoroscopic-guided renal access is routinely performed. This procedure has several advantages, including the ease of learning ability and operation [10, 11]. But one disadvantage is the exposure of the staff to X-ray irradiation when fluoroscopy is used for entering into the collecting system and subsequent dilation [12]. To reduce the risk of the operating room staff being exposed to radiation, alternative techniques such as ultrasonographyguided renal access [13] have been suggested. Nevertheless, there is no significant clinical evidence to suggest that the operative effects of ultrasonography-guided renal access are better than fluoroscopy-guided access. Although a few clinical-controlled studies have compared ultrasonographic with fluoroscopic access, most of the related trials have a small sample number of patients and varying results. Therefore, we believe that a meta-analysis from the relevant published trials is required to better elucidate the operative effects of the two different access routes.

Studies identified (Medline/Pubmed) (n = 111)

Additional studies identified through other sources (n = 122)

Studies after duplicate exclusion (n = 112)

Studies screened (n = 112)

Studies excluded based on title and abstract screening (n = 94)

Studies assessed for eligibility (n = 18)

The data were incomplete, containing only averages (n = 2) Only contain the control group (n = 1) The data were confused (n = 1)

lection process according to PRISMA guidelines.

geneity was considered to be within an appropriate range and data were pooled using a fixed-effects model. When significant heterogeneity was present (I2 >50%, p < 0.1), the random-effects model was applied. In order to interpret significant heterogeneity, we performed subgroup analyses. The influence of the low-quality studies on the overall effect was detected using sensitivity analysis. We performed Egger’s tests and Begg’s funnel plots to evaluate the publication bias of studies in all comparison models.

ed: the data of two studies were incomplete and contained only averages, one study did not contain a control group, and the data from another study were unclear and confusing. The following 14 studies were included: five RCTs (randomized controlled trials) and nine CCTs (clinically controlled trials). The flow diagram outlining the process of study selection is shown in figure 1.

Eligible Studies The identified studies selected for this analysis successfully matched the selection criteria and were published between 2000 and 2014. The search strategy generated 233 relevant clinical studies, of which 18 full-text articles were investigated further. Of these 18, four studies were exclud-

Study Characteristics (table 1) The characteristics of 14 studies that fulfilled the inclusion criteria are summarized in table 1. From these studies, a total of 3,019 patients were included. Of these, 1,574 (52%) had undergone ultrasonographic access, and 1,445 (48%) had undergone fluoroscopic access. Five studies were RCTs, including 608 patients. Nine studies were CCTs, including 2,411 patients. Six studies were recorded in English, including 1,410 patients, and eight studies

Ultrasonography versus Fluoroscopy in PCNL

Urol Int DOI: 10.1159/000369216

Results

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Fig. 1. Flow diagram outlining the study se-

Studies included in final analysis (n = 14, 6 was in Medline/Pubmed and 8 was in CBM) Randomized controlled trial (n = 5) Clinically controlled trial (n = 9)

Table 1. The basic characteristic of included studies

Study

Study design

Country

Group

Sample size

Duration of access, min

Stone-free rate, %

Agarwal M, 2011

RCT

India

UG FG

112 112

1.8±0.7 3.2±1.2

100 100

Basiri A, 2008

RCT

Iran

UG FG

50 50

11±3.5 5.5±1.7

90 96

Falahatkar S, 2010

CCT

Iran

UG FG

14 14

NA NA

Andonian S, 2013

CCT

Canada

UG FG

453 453

Karami H, 2010

RCT

Iran

UG FG

Barasi A, 2013

RCT

Iran

Wu JP, 2013

RCT

Liang XL, 2012

Outcomes measures

Study quality (stars rating)

1, 2, 3, 4



10 8

1, 2, 3, 4



78.6 71.4

21.4 28.6

2, 3

****

NA NA

79.8 73.5

18.5 21.7

2, 3, 4, 5

******

30 30

14.5±2.6 9.4±2.3

86.7 90

6.7 3.3

1, 2, 3, 4, 5



UG FG

46 46

NA NA

79 65.2

2.3 15.2

1, 2, 3, 4



China

UG FG

74 58

10.6±6.2 30.2±14.6

55.4 64

4.1 14.3

1, 2, 3



CCT

Chian

UG FG

40 35

8.3±3.4 7.8±2.8

5 8.6

1, 3, 7

******

Yang XM, 2009

CCT

Chian

UG FG

30 30

13±3 22±4

96.7 93.3

0 0

1, 2, 3

****

Xing R, 2011

CCT

China

UG FG

30 30

8.5±5.2 13.2±4.4

90 86.7

6.7 10

1, 2, 3, 5, 6

*****

Zhu ZP, 2013

CCT

China

UG FG

260 256

NA NA

88.7 81

3.1 7.4

2, 3, 5, 6

******

Liu L, 2011

CCT

China

UG FG

60 60

NA NA

88.3 73.3

NA NA

3, 5, 6

******

Wu XH, 2008

CCT

China

UG FG

52 62

29.6±14.4 32.1±15.2

88.5 93.5

NA NA

1, 2, 6

******

Kan HM, 2013

CCT

China

UG FG

323 209

4.3±0.4 7.9±0.6

92.6 93.1

3.4 3.4

1, 2, 3, 6

******

NA NA

Complication rate, % 1.8 1.8

were in Chinese, including 1,609 patients. Operative complications were reported in 279 cases (9.2%) in 11 studies. From four studies it was learned that eighty-five cases (2.8%) needed blood transfusion. Meta-Analysis of Ultrasonographic Access vs. Fluoroscopic Access (table 2; fig. 2) Duration of Access (min). Nine studies reported the duration of access: four RCTs and five CCTs. The pooled results indicated that no significant differences were re4

Urol Int DOI: 10.1159/000369216

vealed between the two groups, with a pooled WMD value of −2.56 (95% CI: −4.40 to −0.72; p = 0.006). Stone-Free Rate. Thirteen studies reported the stonefree rate, and all five RCTs provided available data for pooling. And the pooled results revealed that the stonefree rate in the ultrasonographic access and fluoroscopic access groups was 86.2 and 81.9%, respectively; the difference was significant (OR: 1.26; 95% CI: 1.02–1.55; p  = 0.03). This suggests that the group of ultrasonographic access had a higher stone-free rate in PCNL. Wang/Zhang/Xu/Fan

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Continuous variables are presented as means, SD. SD = Standard deviation; RCT = randomized controlled trial; CCT = clinically controlled trial; UG = ultrasonographic guidance; FG = fluoroscopic guidance; NA = not available. 1 = duration of access; 2 = stonefree rate; 3 = operative complications rate; 4 = blood transfusion rate; 5 = hospital day; 6 =intraoperative blood loss.

Table 2. Meta-analysis of the ultrasonographic versus fluoroscopic access

Outcome of interest

Studies, n

Patients, n

OR/ WMD

95% CI

p value

Heterogeneity, p value

I 2, %

Duration of access, min Stone-free rate Operative complications rate Blood transfusion rate Hospital stay, days Intraoperative blood loss, ml

9 13 12 5 6 6

1,357 2,934 2,785 1,382 1,754 1,417

–2.56 1.26 0.72 0.39 –0.69 –14.55

–4.40, –0.72 1.02, 1.55 0.56, 0.93 0.24, 0.63 –2.51, 1.14 –27.65, –1.46

0.006 0.03 0.01 0.0001 0.46 0.03

Ultrasonographic versus Fluoroscopic Access for Percutaneous Nephrolithotomy: A Meta-Analysis.

To assess the safety and efficacy of ultrasonographic vs. fluoroscopic access for percutaneous nephrolithotomy (PCNL)...
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