european urology 50 (2006)

european urology 50 (2006) 1073 1078 available at www.sciencedirect.com journal homepage: www.europeanurology.com Reconstructive Urology Nephrovesical Subcutaneous Ureteric Bypass: Long-term Results in Patients with Advanced Metastatic Disease Improvement of Renal Function and Quality of Life Joerg Schmidbauer *, Christian Kratzik, Hans Christoph Klingler, Mesut Remzi, Jakob Lackner, Michael Marberger Department of Urology, Medical University of Vienna, Waehringer Guertel 18 20, A-1090 Vienna, Austria Article info Article history: Accepted February 8, 2006 Published online ahead of print on February 24, 2006 Keywords: End-stage malignancy Hydronephrosis Nephrovesical bypass Quality of life Ureteral obstruction Abstract Objective: Placing a percutaneous nephrostomy often is the only and final solution for patients with metastatic disease, where internal ureteral stenting proved to be impossible. Methods: Between August 1999 and June 2005, 31 nephrovesical ureteric bypasses were implanted in 28 patients with advanced metastatic disease. The ureteric bypass consists of two subcutaneously connected 12F polyurethane tubes, placed as a nephrostomy and cystostomy. Urinary culture, serum creatinine, quality of life score, and renal ultrasonography were evaluated at follow-up. Results: Mean follow-up was 11.9 mo (range, 2 54 mo). Preoperative hydronephrosis was eliminated in 27 cases (87.1%) and reduced in the remaining four kidneys (12.9%). Preoperative serum creatinine levels (5.9 3.2 mg%) decreased significantly postoperatively (1.4 0.9 mg%). Mean quality of life score was 3.4 1.4 preoperatively and 7.6 1.0 postoperatively. In five patients (17.9%) the system had to be replaced due to occlusion at a mean follow-up of 10.2 mo. Conclusion: This nephrovesical ureteric bypass is a simple, minimally invasive, and highly effective treatment for patients with hydronephrosis resulting from advanced oncologic disease. Patients gain a better quality of life due to increased independence and mobility during their final stages of life. # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Tel. +43 1 40 400/2616; Fax: +43 1 408 99 66. E-mail address: joerg.schmidbauer@aon.at (J. Schmidbauer). 0302-2838/$ see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2006.02.025

1074 european urology 50 (2006) 1073 1078 1. Introduction Managing extrinsic compression of the ureter by retrograde stenting is first-line therapy but involves a guarded decision because stent failure occurs in nearly half of the treated patients [1,2]. Therefore, placing a permanent percutaneous nephrostomy is still the method of choice whenever ureteral stenting fails, resulting in an impaired quality of life due to limited mobility and complications such as dislocation of the nephrostomy tube, infection, or obstruction [3]. Alternatively, to maintain an acceptable quality of life and to restore kidney function, we present our long-term results in patients with terminal malignancies and obstructed urinary systems due to tumour progression in whom an unilateral or bilateral nephrovesical subcutaneously passed ureteric bypass for complete ureteric prosthetic replacement was assembled. 2. Patients and materials 2.1. Operative technique A special ureteric subcutaneous bypass set composed of two 12F polyurethane J-tubes, a 58-cm percutaneous nephrostomy part and a 56-cm percutaneous cystostomy part, malleable tunnelers, and a metal connector for joining the two tubes, was developed (Rüsch, Kernen-Germany; Fig. 1). In the first six patients of our series, in those who had not received a percutaneous nephrostomy tube preoperatively, the patients were placed first in a prone position to have access to the kidney. Thereafter they were rotated to a supine position to access the bladder and place the distal part of the bypass. With further experience we changed our management and placed the subsequent patients in a 458 flank position that allowed access to the kidney and bladder without the need for rotation of the patient; this resulted in better hygienic conditions and reduced operating time. Fig. 1 Nephrovesical bypass. Fig. 2 CT-assisted 3D-reconstruction of the implanted bypass. Using ultrasound or fluoroscopic guidance (or both), the percutaneous nephrostomy is placed using a Seldinger technique. The skin incision for placing the tract is widened to about 2 cm and the distal part of the nephrostomy tube is subcutaneously brought to a secondary skin incision of about 2 cm in the lateral lower abdomen using the malleable metallic tunneler. A contrast agent is then applied to the tube to rule out buckling and to document proper stent placement. The stent is fixed subcutaneously and the skin incision in the region of the nephrostomy is closed. Via another small 2-cm skin incision 3 cm above the symphysis a cystostomy is established using needle puncture, guidewire, tract dilatation, and insertion of the cystostomy tube over a 14F split-sheath dilatator. The use of a split-sheath dilatator has proven to be more effective than other methods of bladder access in reducing postoperative extravasation. Using the malleable tunneler the proximal part of the cystosomy tube is then subcutaneously guided to the incision in the lateral lower abdomen. Again proper stent placement is monitored by injecting a contrast agent through the tube. After adequately shortening both tubes they are joined using a metal connector and are secured through additional sutures. Thereafter the bypass is channeled into the subcutis and the skin incisions are closed (Figs. 2 and 3). To avoid transient urinary extravasation,

european urology 50 (2006) 1073 1078 1075 2.3. Statistics To compare continous variables a two-paired Student t test was used, and a probability of 5% by chance was considered to be statistically significant (JMP, SAS, V.3.11). 3. Results which occurred in the first two patients, a 16F transurethral catheter is left in place for 48 h postoperatively. Antibiotic prophylaxis is initiated 24 h preoperatively for an overall period of 6 d. 2.2. Patients Fig. 3 Draft of the implanted bypass. Between August 1999 and June 2005, we implanted 31 ureteric bypasses in 28 patients diagnosed with unilateral or bilateral obstructed ureters due to progressive metastatic, end-stage malignancy (Table 1). Internal ureteral stenting had been found impossible or failed. The study group consisted of 15 women and 13 men with a mean age at thetimeofimplantationof62.2 9.8 yr (range, 38 88 yr). Mean follow-up was 11.9 mo (range, 2 54 mo). From the study group assembled seven patients had colonic cancer, six patients had prostate cancer, five had ovarian, five had breast, and three had cervical cancer. In three other patients transitional cell carcinoma of the ureter, gastric, and pancreatic malignancies were detected. One of those patients had coexistent cervical and colonic cancer. Three patients were known to have a solitary kidney. Cirrhosis of the contralateral, nonobstructed kidney was noticed in six patients (21.4%). In all patients urinalysis, serum creatinine, patients health-related quality of life (0 = very poor to 10 = excellent), and renal ultrasonography were determined preoperatively, 2 d postoperatively, and every 4 wk for follow-up. In those patients in whom obstruction of the bypass was suspected due to rising creatinine levels or recurrence of dilatation of the upper urinary tract, an additional reflux cystogram was performed. When obstruction was noticed, replacement of the system was carried out. Patients were followed-up until death resulting from their malignant disease. Except for four participants, all patients died during follow-up due to progressive metastatic disease. All patients had a unilateral or bilateral dilatated upper urinary tract and elevated creatinine levels. After placing the bypass, hydronephrosis was completely resolved in 27 kidneys (87.1%) and reduced in the remaining 4. Accordingly, serum creatinine levels decreased significantly from a mean 5.9 3.2 mg% (range, 2.3 12.8 mg%) to 1.4 0.9 mg% (range, 0.55 5.3 mg%; p < 0.0001). Mean quality of life score was 3.4 1.4 (range, 0 6) preoperatively and 7.6 1.0 (range, 5 9) postoperatively ( p < 0.0001). In five patients (17.9%), the system had to be replaced at a mean follow-up of 10.2 mo (range, 5 18 mo) due to occlusion and incrustation. In the first two patients extravasation occurred in the region of the bladder dome, where the bypass was inserted into the bladder. This complication was resolved in subsequent patients by leaving a 16F transurethral catheter in place for 48 h postoperatively. One bypass had to be removed and a conduit was conducted because, after external radiation for cervical cancer, a vesicovaginal fistula developed. After implantation of the subcutaneous ureteric bypass in another patient with a solitary kidney and ureteral transitional cell carcinoma preoperative hydronephrosis was eliminated but creatinine levels remained elevated due to chronically renal failure. Renal dialysis had to be initiated after 24 mo of follow-up. At that time the reflux cystogram had always shown a normal functioning, nonobstructed bypass system. Five patients (17.9%) reported transient but significant urgency postoperatively. After antibiotic treatment a single episode of urinary tract infection was resolved in five patients (17.9%). Two patients (7.1%) had recurrent urinary tract infections. 4. Discussion Progression of malignancies in the true pelvis or advanced metastatic, end-stage disease often results in unilateral or bilateral obstruction of the upper urinary tract. As a consequence, this condition may lead to uraemia and consequently to death of the patient if no adequate treatment is initiated.

1076 european urology 50 (2006) 1073 1078 Table 1 Preoperative and postoperative patient data Patient/ bypass no. Cancer type Crea preop, mg% Crea postop, mg% RS pre RS post Follow-up, mo Complications QoL pre/post (0 10) 1 a Colon 7.87 0.64 II b 0L 2 Single UTI 3/9 2 a Cervix 4.2 0.87 IIL 0L 31 Recurrent UTIs, 2/7 vesico-vaginal fistula 3 a Ovary 7.93 1.34 III b 0R 8 2/8 4 a Colon 2.42 1.08 IIIR 0R 16 2/9 5 c TCC 11.0 5.3 IIIL 0L 54 Replacement 4/9 6 a,c Ovary 10.4 1.5 IIIR 0R 2 0/6 7 a Rectum 6.67 1.32 IIIR 0R 21 Replacement twice, 4/8 single UTI, dysuria 8/9 a Prostate 2.86 1.95 III b 0 b 8 Single UTI 5/7 10 a Breast 5.37 1.06 III b 0R 6 4/7 11 a Gastric 4.27 1.02 III b 0L 4 5/8 12 a Ovary 3.27 1.3 IIIL 0L 7 Single UTI 3/7 13 a Prostate 4.23 1.02 IIIR 0R 11 5/8 14 a Ovary 3.5 1.71 III b 0R 6 3/7 15/16 a Colon, cervix 12.5 1.04 III b 0R IL 15 Single UTI, 2/8 replacement R 17 a Rectum 2.3 1.8 IIIL IIL 7 4/6 18 a Prostate 3.09 2.41 III b 0L 10 5/8 19 Breast 4.25 1.51 III b 0L 3 2/8 20 a Rectum 3.47 1.08 IIIL 0L 14 3/9 21 a Breast 5.97 0.55 III b 0R 10 Dysuria, replacement 3/6 22 a,c Pancreas 12.8 1.83 IIIR 0R 12 Recurrent UTIs 2/8 23 a Breast 8.31 1.3 III b 0L 8 3/8 24 a Prostate 3.1 1.92 II b IR 18 5/5 25 a Ovary 7.8 1.21 III b 0L 3 Single UTI 5/7 26 a Prostate 2.73 1.42 IIR 0R 12 6/8 27/28 a Cervix 7.3 0.72 III b 0 b 18 Dysuria, replacement L 3/9 29 a Breast 6.32 0.98 III b 0L 5 2/8 30 Prostate 3.01 2.04 IIIR IR 14 Dysuria 5/7 31 Colon 9.7 0.64 III b 0L 7 3/8 Crea = creatinine level; RS = renal ultrasound; QoL = quality of life; R = right kidney; L = left kidney; UTI = urinary tract infection. a Died due to progressive disease. b Both kidneys. c Solitary kidney. Retrograde stenting of the ureter may fail or be complicated by infection or obstruction. Overall in patients with extrinsic ureteral obstruction, on average 56% of internal ureteric stents are blocked within 3 mo, regardless of the stent diameter, resulting in a frequent need for exchange [2]. Alternatively, a permanent percutaneous nephrostomy can be placed requiring an external collection device and followed by a significant loss in quality of life [4]. External tube drainage is known to have a high success rate of up to 98% but a complication rate of >40% causes frequent rehospitalisation [5]. Besides urinary tract infections, catheter obstruction by debris, urinary leakage, and inflammation of the skin at the point of insertion, along with cracking, twisting, or accidental ripping out of the percutaneous tube may result in encumbering replacements. Alternatively, to minimize the complication rate of ureteral stents and percutaneous nephrostomies, different concepts of nephrovesical subcutaneous urinary diversions were developed starting before 1994 by Lingam and colleges [3]. During a 15-mo interval his extra-anatomic urinary diversion was successfully implanted in five patients using a onepiece 7F double-pigtail stent. The stent was changed at 4-mo intervals over a guidewire. In 1995, Desgrandchamps introduced a one-piece, selfretaining expanded polytetrafluoroethylene-silicone tube, which was successfully assembled as pyelovesical bypass in 19 patients with a mean follow-up of 7.2 mo [6]. None of the tubes were dislodged or obstructed due to incrustation or buckling. One drawback of this one-piece stent was its initially 70-cm length, which made surgical implantation complex, time-consuming, and cumbersome for the patient. Nakada et al. worked on a similar subcutaneous nephrovesical bypass at the same time [7]. Using the 8.5F prototype of the Lingam stent, they performed two stent placements successfully resulting in a marked immediate improvement in the quality of life. Nevertheless

european urology 50 (2006) 1073 1078 1077 stent obstruction recurred within 6 9 wk of followup. In addition, using these one-piece stents and applying a contrast agent to the tube during stent insertion is impractical to rule out buckling and to document a proper stent placement. Further technical advancement was achieved by Nissenkorn and Gdor who used two 14F 50-cm polyurethane J stents [4]. After stent placement was confirmed by injecting a contrast agent through the tube, these stents were intraoperatively shortened as needed and joined by a connector. The largest series of subcutaneous alloplastic ureteral replacement to date was published by Jabbour et al. in 2001 [8]. Using a composite prosthesis, consisting of two coaxial tubes, 35 prosthetic ureters were implanted in 27 patients including 5 patients in whom the nature of ureteral obstruction was benign. In additional publication of achievements were documented using similar stents as reported by Jabbour [9 11]. In our study we placed 31 subcutaneous stents in 28 patients and monitored these patients, all suffering from end-stage malignancies, to date (4 patients) or until death (24 patients). Depending on the performance status, age, and further intended therapies, patients underwent unilateral or bilateral bypass implantation. In patients suffering from endstage malignancies, preoperative normal bladder function was mandatory. This was achieved by reporting on subjective smooth micturition and having no significant residual volume documented by sonography. After placing the nephrovesical bypass, kidney function was restored in all of the patients except in one patient with a surgical single kidney where hydronephrosis was eliminated but creatinine nadir was insufficient for chemotherapy due to chronic renal failure. Creatinine levels decreased in all other patients significantly. Hydronephrosis was resolved in 27 kidneys (87.1%) and reduced in the remaining 4 (12.9%). Urinary tract infection was a minor problem. Transient urinary extravasation occurred in the first two patients at the level of the bladder dome and was successfully avoided in the subsequent patients by placing a 16F transurethral catheter for 48 h postoperatively. Secondary implantation of the bypass turned out to be a feasible option because in 13 of 28 patients the ureteric bypass was implanted by adapting a previously placed nephrostomy. After acute percutaneous drainage we always implanted the nephrovesical bypass within 48 h and additionally administered antibiotic prophylaxis. Urinary culture of the nephrostomy puncture was obligatory. In patients who had a long-lasting nephrostomy in situ, urinary culture results were awaited and concordant antibiotic treatment was applied before placing the bypass. Because patients with end-stage malignancies are known to have a short life expectancy, in our series 86% of the patients died during follow-up. Due to obstruction, the device had to be exchanged in five patients at a mean follow-up of 10.2 mo. Replacement of the bypass was easily performed using a guidewire. Three patients required only the distal part of the two-piece bypass to be exchanged. The polyurethane bypass we used had a diameter of 12F and was easily inserted. In the long term, our bypass device was well tolerated by the patients. Nissenkorn et al. [4] placed 10 polyurethane subcutaneous stents in eight men. These stents remained in place for 6 wk to 18 mo (mean, 5.5 mo). Five patients died and in three the stents had functioned well for 4 mo (2 patients) and 6 mo (1 patient). In comparison to the latest publications of Jabbour et al. [8] and Loertzer et al. [10], who used a composite implant consisting of an inner silicone-covered tube covered by a coiled expanded polytetrafluoroethylene tube with an external diameter of 28.5F, our device seems to be less invasive because Jabbour reported, difficulties occurred in placing the prosthesis in 5 of the 27 patients (19%). On the other hand, the rate of obstruction was low as Loertzer et al. [10] reported on one single obstruction due to encrustation in their 13 patients, which might be due the huge size of the tube. This composite prosthesis also was placed in patients, where the aetiology of ureteral obstruction was benign. Presumably, compared to our system, especially in men, a more extensive vesicoureteral reflux has to be taken into account. With respect to the short life expectancy of patients with advanced metastatic disease, in our minds the 12F polyurethane bypass used in our series is effective and therefore represents a feasible therapeutic option. The quality of life improved in all patients and was significantly influenced by preoperative uraemia in most of the patients. 5. Conclusion This nephrovesical subcutaneous ureteric bypass is minimally invasive, safe, and highly effective in bypassing ureteral obstruction in patients with endstage malignancies of the true pelvis. Patients, who otherwise would be in the need of permanent nephrostomy drainage, achieve a significantly better quality of life due to increased independence, flexibility, and mobility during their final period of life.

1078 european urology 50 (2006) 1073 1078 Acknowledgement The nephrovesical ureteric bypasses used in this study were provided by Willy Ruesch GmbH (Kernen, Germany). References [1] Chung SY, Stein RJ, Landsittel D, et al. 15-year experience with the management of extrinsic ureteral obstruction with indwelling ureteral stents. J Urol 2004;172:592 5. [2] Yossepowitch O, Lifshitz DA, Dekel Y, et al. Predicting the success of retrograde stenting for managing ureteral obstruction. J Urol 2001;166:1746 9. [3] Lingam K, Paterson PJ, Lingam MK, Buckley JF, Forrester A. Subcutaneous urinary diversion: an alternative to percutaneous nephrostomy. J Urol 1994;152:70 2. [4] Nissenkorn I, Gdor Y. Nephrovesical subcutaneous stent: an alternative to permanent nephrostomy. J Urol 2000; 163:528 30. [5] Radecka E, Magnusson A. Complications associated with percutaneous nephrostomies. A retrospective study. Acta Radiol 2004;45:184 8. [6] Desgrandchamps F, Cussenot O, Meria P, Cortesse A, Teillac P, Duc A. Subcutaneous urinary diversions for palliative treatment of pelvic malignancies. J Urol 1995; 154:367 70. [7] Nakada SY, Gerber AJ, Wolf JS, Hicks ME, Picus D, Clayman RV. Subcutaneous urinary diversion utilizing a nephrovesical stent: a superior alternative to long-term external drainage? Urology 1995;45:528 30. [8] Jabbour ME, Desgrandchamps F, Angelescu E, Teillac P, Le Duc A. Percutaneous implantation of subcutaneous prosthetic ureters: long-term outcome. J Endourol 2001; 15:611 4. [9] Bell DG, Fischer MA. Palliative subcutaneous tunnelled nephrostomy tube (PSTN): a simple and effective technique for the management of malignant extrinsic ureteral obstruction. Can J Urol 2002;9:1470 4. [10] Loertzer H, Jurczok A, Wagner S, Fornara P. Der künstliche pyelovesikale und pyelokutane Bypass. Urologe [A] 2003; 42:1053 9. [11] Jurczok A, Loertzer H, Wagner S, Fornara P. Subcutaneous nephrovesical and nephrocutaneous bypass. Gynecol Obstet Invest 2005;59:144 8. Editorial Comment Paul Méria paul.meria@sls.ap-hop-paris.fr Patients presenting advanced pelvic malignancies associated with upper urinary tract obstruction need ureteral stenting. Nevertheless, some of them will develop iterative obstruction despite the presence of reinforced stents. In such patients permanent percutaneous nephrostomy drainage is an alternative but it undoubtedly affects their quality of life and is associated with specific complications. The authors of this paper propose an alternative to permanent percutaneous nephrostomy by the means of a nephrovesical extra-anatomic bypass and describe a specific device. At present, such a device represents a reliable solution to improve quality of life in selected patients. As emphasized by the authors, before implantation of the device, bladder anatomy and function must be assessed and the absence of significant residual volume must be demonstrated since the absence of bladder fistula must be ascertained [1]. Former percutaneous nephrostomy tube increases the risk of postoperative infectious complications. For this reason, primary implantation of nephrovesical bypass seems preferable to an implantation following percutaneous nephrostomy drainage. For the device placement, a 458 flank position allows access both to kidney and bladder and avoids changing position. Kidney puncture is feasible even if the patient is not in the prone position, provided that hydronephrosis being pronounced. This important technical aspect reduces operating time and increases the procedure s safety. In certain patients with postoperative life duration longer than expected, device obstruction was observed and 18% of the patients required partial or complete replacement of the system in the present series. Such complication occurs less frequently when the device s diameter is larger, irrespective of its composition. In a recent paper, Andonian et al. estimated that a 17 F diameter is required to prevent encrustation in association with increased fluid intake [2]. Despite some weaknesses, subcutaneous ureteric bypass remains safe and effective for quality of life improvement in patients with neoplastic ureteric obstruction. References [1] Jabbour M, Desgrandchamps F, Angelescu E, Teillac P, Le Duc A. Percutaneous implantation of subcutaneous prosthetic ureters: long term outcome. J Endourol 2001; 15:611 4. [2] Andonian S, Zorn KC, Paraskevas S, Anidjar M. Artificial ureters in renal transplantation. Urology 2005;66:1109.