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A Randomised Prospective Analysis of Effectivness of ESWL vs PCNL in Renal Stone Size 1-2 cm and Review of Literature

Introduction: Majority of renal stones diagnosed today are below 2 cm. The preferred treatment of <1cm stone is extracorporeal shockwave lithotripsy (ESWL) while standard of care for renal stone >2 cm is percutaneous nephrolithotomy (PCNL). The procedure of choice for 1-2 cm renal stones is still a subject of debate. This study was undertaken to formulate a better understanding of management of renal stones of size 1-2cm in this patient population Material and methods: A prospective study was carried out to evaluate clearance of ESWL vs PCNL in patients with renal stones of size 1-2 cm. Complete follow up data were available for 281 patients 140 in PCNL and 141 in ESWL group, 12 patients were lost to follow up. Results: Both the groups were well matched with regards to age and sex distribution. 141 patients underwent ESWL and 103/141(73%) patients had stone clearance in 1-3 months. 140 patients underwent PCNL out of which 133 (95%) patients had stone clearance. Complications were mostly minor and found in 9.7% in patients undergoing ESWL while same were seen in 30% of those undergoing PCNL. Conclusion: The primary objective in stone management is total stone clearance. Considering this as priority PCNL has proved superior to ESWL in our study for renal stones 1-2 cm in size. It has also got lower auxiliary and retreatment rates but has its own share of complications and longer hospital stay are other important factors in PCNL.


INTRODUCTION
Urolithiasis is a problem that has confronted clinicians since vedic period of Sushruta and times of Hippocrates. At present urinary stone prevalence is estimated at 3% in general population and lifetime risk of developing kidney stones is around twelve percent.Even after treatment of first renal stone the recurrence rate of 50% has been observed in ten years. The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey 2012-10.6% of men and 7.1% of women in the United States are affected by renal stone disease, compared to just 6.3% of men and 4.1% of women in 1996.In India incidence shows wide regional variation with high number of cases reported from west and north compared to south Majority of renal stones diagnosed today are below 2 cmperhaps due to easy and early accessibility to X -ray and ultrasonography. The preferred treatment of <1cm stone is extracorporeal shockwave lithotripsy (ESWL) while standard of care for renal stone >2 cm is percutaneous nephro-lithotomy (PCNL). The procedure of choice for 1-2 cm renal stones is still a subject of debate. Controversy exists with regard to optimum management of these stones by PCNL and ESWL with reference to stone clearance, hospital stay and complications This study was undertaken to formulate a better understanding of management of renal stones of size 1-2 cm in this patient population.

MATERIAL AND METHODS
A prospective study was carried out to evaluate clearance of ESWL vs PCNL in patients with renal stones of size 1-2 cm. The protocol of the study was approved by the ethical committee of institute. A randomisation table was used, Patients in group A were allocated for PCNL while Group B included patients who underwent ESWL. The treatment options were then discussed with patient and his/her relatives with a detailed explanation of the involved procedure and complication as well as the available other alternative. Informed written consent was obtained from all subjects enrolled in the study. The patients were subjected to clinical history, physical examination, radiological studies (Plain X-ray film, USG, Intra Venous Urogram (IVU) and Non contrast CT (NCCT), haematology, biochemical and urine tests, to determine the site and size. The data were recorded as per study Performa. Patients were divided into subgroups based on their stone location, composition, size for better subgroup analysis. The treatment outcomes were recorded and analysed as per study Performa. An auxiliary procedure was considered as any additional procedure (s) to render patient stone free. For failed ESWL the auxiliary procedures were ureteroscopy /PCNL. For failed PCNL ESWL / ureteroscopy were used as auxiliary procedures. The patients were followed up at one and three months by routine postoperative x-ray and ultrasound if required.

PCNL study technique
All PCNL procedures were done by standard technique in general anaesthesia in prone position. Percutaneous access was obtained using C-armed fluoroscopy and retrograde contrast pyelogram. X-ray KUB and routine blood examination was performed on 3rd postoperative day. PCNL procedure success was defined as no residual stone visible on X-ray KUB. Success included stone-free, i.e., complete stone clearance, or clinically insignificant residual fragments (CIRF) ≤ 4 mm at three months. Complications were classified according to modified Clavien grading system.

ESWL study technique
Patient of solitary renal calculus of 1-2 cm were evaluated similar to PCNL. All patients underwent ESWL using The Siemens. The fragmentation of the calculus during the therapy was monitored by fluoroscopy. Post procedural plain X-ray was done to document fragmentation and clearance at the end of one and three months. Success included stone-free, i.e., complete stone clearance, or CIRF with no symptoms at 3 months after ESWL. Failure was defined as residual stone fragments, i.e., clinically significant residual fragments> 4 mm after three sessions of ESWL. Before ESWL all patients had NCCT with 3 mm contiguous sections, A TOSHIBA ACQUILLION, high-speed CT scanner was used at 120 -135 kV, 81 mAs, and 1.4:1 pitch. Patients were followed up at 1 month after ESWL with a plain abdominal film. If there were fragments of significant size a second session of ESWL was planned. In between two sessions minimum 30 days gap was maintained. However, if there were only insignificant fragments the patients were re-evaluated after 1 month. The final results were considered after 3 months from the first ESWL session.

STATISTICAL ANALYSIS
The data was subjected to statistical analysis with SPSS version 17 statistical software and Microsoft excel. The p-value <0.05 was considered significant. Results were analysed using Student's t -test and chi-square test, Fischer exact test multivariate analysis and one-way ANOVA. The need for Auxiliary procedurewas 7(17.07%) in ESWL and 2(5%)with p value =0.1691 by Chi square test.

Hospital Stay
The mean hospital stay in the two groups was 0.2 ± 0.89 days(range 0-3 days) and 5.725 ±1.78 days(range 4-11 days) with a p value =0.0001 (95% CI 4.90 to 6.14) in ESWL and PCNL respectively.

Emergency Admission
The emergency admission rate was 10(7.3%) and 3(2.5%) in ESWL and PCNL groups respectively, p value = 0.6259. Gradually ESWL due to its non-invasive nature gained popularity and widespread acceptability by patients but this initial enthusiasm of ESWL in every size of stone was met with poor outcomes in many patients. PCNL being invasive has its own limitations but due to its better one time clearance in bigger stones its use has increased in last twenty years. As experience with these two modality increased researchers tried to define the place of ESWL and PCNL in the management of renal calculi of various size, location and composition.

Hospital Stay
The mean hospital stay in the two groups was 0.2 ± 0.89 days (range 0-3 days) and 5.725 ±1.78 days (range 4-11 days) with a p value =0.0001 (95% CI 4.90 to 6.14) in ESWL and PCNL respectively.

Complications
Complications were mostly minor in our study -in 9.7% patients undergoing ESWL but in 30% of patients treated by PCNL. The two-tailed P value equals 0.0446. The blood transfusion was 18(12.5%) in PCNL group, while none in ESWL (P =0.01) Grade 1 complications were seen in 13(7.3%) and 17 (12.19%), Grade II complications were seen in 3(2.4%) and 17 (12.19%), Grade III complications seen in 0 and 7(5%) of ESWL and PCNL respectively. These complications rate as per modified Clavien grade are similar to those observed in contemporary series. In Okan Bas et al 16 study Grade 1 complications were seen in 4% and 4%, Grade II complications were seen in 1.3% and 4%, Grade III complications seen in 1.3% and 4% of ESWL and PCNL respectively. In the study of Anup et al. 17 Grade 1 complications were seen in 2% and 8%, Grade II complications in 1% and 2% in ESWL and PCNL respectively. No Grade III complications were seen.

CONCLUSION
The primary objective in stone management is total stone clearance. Considering this as priority PCNL has proved superior to ESWL in our study for renal stones 1-2 cm in size. It has also got lower auxiliary and retreatment rates but has its own share of complications and longer hospital stay are other important factors in PCNL.