http://informahealthcare.com/sju ISSN: 2168-1805 (print), 2168-1813 (electronic) Scand J Urol, 2015; Early Onlne: 1–7 DOI: 10.3109/21681805.2015.1040451
ORIGINAL ARTICLE
The “I-Pouch”: Results of a new ileal neobladder technique Georgios Gakis1, Mohamed F Abdelhafez1,2 & Arnulf Stenzl1 Department of Urology, University Hospital Tu€bingen, Tu€bingen, Germany, and 2Department of Urology, Assiut University Hospital, Assiut, Egypt
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1
Abstract
Key Words:
Objective. The aim of this study was to investigate perioperative, oncological and functional outcomes of the “I-Pouch” neobladder. Materials and methods. From 2002 to 2011, 97 patients (72 men, 25 women, median age 65, range 42-84 years) underwent radical cystectomy with I-Pouch neobladder reconstruction. Complications were graded according to the Clavien-Dindo classification. Oncological and functional outcomes were assessed. The median oncological and functional follow-up was 41 months (range 3-107 months) and 18 months (3-111 months), respectively. Results. In the total cohort, the 5 year cancer-specific survival was 67.9%. The major 30 and 90 day complication rates were 14.4% and 17.5%, respectively. Open reimplantation for ureterointestinal stricture was necessary in two (2.1%). Of the 95 functionally evaluable patients postoperatively, 93 urinated spontaneously (97.9%) and two patients (2.1%) required clean intermittent catheterization to empty their neobladder. The median postvoid residual urine volume (PVR) was 0 ml (range 0-200 ml). One patient had postoperative reflux (1%), as evidenced by voiding cystography. The median number of urinary tract infections per year was 0 (range 0-2) and showed no association with increased PVR (p = 0.18). Conclusions. The perioperative, oncological and functional outcomes of the I-Pouch are comparable to those of other types of ileal neobladder. An advantage of the I-Pouch is that the implantation of the ureters lies on the neobladder floor, which facilitates later instrumentation of the upper tract.
Functional, ileal, I-Pouch, neobladder, oncological, orthotopic bladder substitution, perioperative, upper urinary tract
Introduction Radical cystectomy (RC) is the mainstay of treatment for muscle-invasive bladder cancer [1]. As oncological outcomes have evolved in the past few decades, urinary diversion has increasingly gained the attention of clinicians and patients alike [2], with orthotopic bladder substitution (OBS) being established for the majority of patients in academic centers of expertise [2]. The goal is to store urine at low pressure while providing a voiding pattern similar to that of the native bladder [3]. Various types of ileal neobladder currently used for OBS have shown satisfactory functional and oncological outcomes [4,5]. Relevant considerations in neobladder reconstruction are the propensity for postoperative complications [3] and oncological and functional issues that may affect long-term results. In this regard, an important oncological aspect is the necessity for easy access to the upper tract for monitoring [3]. In terms of functional outcomes, the length of ileum used most frequently to form a neobladder reservoir is approximately 40 cm [6]. Although long-term preservation of renal function is of paramount importance, uncertainty persists about the superiority of an antirefluxive over a refluxive ureteral implantation technique [7].
History Received 23 October 2014 Accepted 2 April 2015
It was hypothesized that a neobladder made of 40 cm of ileal length with an antirefluxive implantation technique and easily accessible ureterointestinal anastomosis would address these important oncological and functional issues. This study presents perioperative, oncological and functional data on the “I-Pouch” neobladder.
Materials and methods Patient selection In this cross-sectional study, which was approved by the local ethics committee (63/2012BO2), a patient search was performed in February 2012 via a prospectively maintained cystectomy database. From 2002 to 2011, a total of 331 patients underwent RC for bladder cancer. Ileal neobladder reconstruction was performed in 171 patients. Of these, 97 received an I-Pouch neobladder. The median age at cystectomy was 65 years (range 42-84 years). In total, 73 patients were alive and 24 patients had died before initiation of this retrospective analysis. Functional and oncological follow-up data were available for all patients. Indications for I-Pouch neobladder reconstruction were stage cT2-T4a N0-2 bladder cancer or high-risk non-muscle-
Correspondence: Georgios Gakis MD, Associate Professor, Department of Urology, Eberhard-Karls University, University Hospital Tu€bingen, HoppeSeyler Street 3, D-72076 Tu €bingen, Germany. Tel: +49 7071 2985092. Fax: +49 7071 295092. E-mail: [email protected] 2015 Informa Healthcare.
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Scand J Urol, 2015; Early Online: 1–7
invasive bladder cancer after failure of bladder-preserving treatment and American Society of Anesthesiologists (ASA) scores 1-3. Exclusion criteria were uncontrolled coagulation disorders, intraoperative cT4b or cN3 disease, stress urinary incontinence, preoperative glomerular filtration rate less than 60 ml/min, azotemia, severely impaired liver function, chronic intestinal disease, impaired dexterity and intellectual capacity. Renal function was evaluated preoperatively and postoperatively in all patients scheduled for I-Pouch surgery with serum creatinine clearance as measured by the Modification of Diet in Renal Disease (MDRD) formula. In any patient with borderline renal function preoperatively or postoperatively (defined as 50–60 ml/min), [51Cr]EDTA clearance or creatinine clearance measured by 24 h urine collection was used for exact evaluation of renal function. Only patients with creatinine clearance greater than 60 ml/min were considered for OBS. Preoperative evaluation Preoperative evaluation consisted of a detailed history and physical examination, estimation of body mass index and routine laboratory work-up with urine analysis and culture. Preoperative imaging studies included contrast-enhanced computed tomography (CT) scans or magnetic resonance imaging (MRI). Bone scintigraphy was done in cases of elevated serum alkaline phosphatase or equivocal findings on cross-sectional imaging. Positron emission tomography/ computed tomography (PET/CT) was done in some cases with nodal involvement, and renal nuclear scanning when parenchymal damage was considered possible. Cystectomy technique All patients received mechanical bowel preparation the day before surgery. All were site-marked for a cutaneous stoma and intensively instructed in the care of a cutaneous diversion and proper catheterization techniques if retention occurred postoperatively. A vertical midline incision was made from the pubic symphysis to the umbilicus. Bilateral pelvic lymphnode dissection was performed. In men, RC included the removal of the tumor-bearing bladder, prostate and seminal vesicles, and in women the tumor-bearing bladder, uterus, adnexes and anterior vaginal wall.
Figure 1. After isolation of an ileal segment of 40 cm about 15– 20 cm proximal to the ileocaecal valve and restoration of bowel continuity, approximately 8 cm of the paramesenteric borders are sutured together to form the posterior wall of the ureteric trough.
widely spatulated and conjoined ureters (with 5-0 Vicryl according to a modified Wallace technique) are placed into the trough, sutured to the intestinal mucosa with a 5-0 PDS running suture (Figure 3a) and stented with single-J stents (Figure 3b). Then, the seromuscular layers of both loops are sutured together over the ureters, thereby completing the trough (Figure 4). The reservoir is then cross-folded and the upper and lower edges of the intestinal loops are joined together, forming the spherical configuration of the pouch according to Goodwin’s principle (Figure 5) [3]. The single-J stents are externalized through two separate openings in the mesentery. Then, the edges are sutured together, leaving the dependent part of the pouch to be connected to the urethra in
I-Pouch technique For the I-Pouch (so called because of the vertical implantation of the ureters into the pouch) an ileal segment of 40 cm is isolated about 20 cm proximal to the ileocaecal valve, with each limb having a length of 20 cm. Bowel continuity is restored via end-to-end anastomosis with 4-0 PDS running suture. Approximately 8 cm of the paramesenteric borders are sutured together to form the basis of the subserosal trough (Figure 1). Both ileal loops are opened by scissors at their antimesenteric borders 2 cm from the beginning of the loops to the site of future ureteric implantation (circa 8 cm), going medially to become paramesenteric at this point and then completing the opening at the antimesenteric border (Figure 2). After this, a U-shaped ileal plate is formed. The
Figure 2. The ileal loops are opened by scissors at the antimesenteric borders 2 cm from the beginning of the loops to the site of ureteric implantation (8 cm), going medially to become paramesenteric at that point and then completing the opening at the antimesenteric border.
The “I-Pouch” neobladder
DOI: 10.3109/21681805.2015.1040451
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A
3
B
Figure 3. The two ureters are spatulated and joined together with 5-0 Vicryl according to the modified Wallace technique (a) and stented with single-J stents (b).
men; in women, all the edges of the pouch are closed and an opening at the lower-most dependent part of the pouch is created and finally sutured to the urethra. After removal of the indwelling mono-J stents on the 9th and 10th postoperative day, voiding cystography was performed in all patients on the 14th postoperative day. Any patients with dilatation of the upper tract during follow-up were also investigated with voiding cystography for exclusion of reflux. Figures 6 and 7 both intraoperative and endoscopic views, respectively, of the close proximity of the neobladder outlet and ureters. Oncological and perioperative outcomes
assessment was performed in a single pathology department according to the 2002 tumor, node, metastasis (TNM) classification [9]. Postoperative follow-up visits included cross-sectional imaging at regular intervals for detection of recurrence. All patients with positive ureteral or urethral margins underwent strict surveillance with serial investigations including urethroscopy, urinary cytology/urine-based markers (fluorescence in situ hybridization, immunocytology, NMP22) and upper tract imaging and, in case of suspicious findings, were examined with endoscopy and biopsy [10,11]. Patients generally were seen at least every 3-4 months for the first year, semiannually for the second and third years, and annually thereafter. The median oncological follow-up in the 95 patients was 41 months (range 3-107 months).
Hospital charts and physician records were reviewed to determine demographic characteristics and clinical outcomes. Complications (30 and 90 day) were graded according to the modified Clavien-Dindo classification [8]. The histological
Figure 4. The ureters are sutured with the intestinal mucosa with a 5-0 running suture; the seromuscular layers of both loops are then sutured over the ureters, thereby completing the trough.
Figure 5. The upper and lower edges of the intestinal loops are joined together, forming the configuration of the pouch according to Goodwin’s principle. The single-J stents are externalized through two separate openings in the mesentery.
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Scand J Urol, 2015; Early Online: 1–7
Table 1. Early (30 day) and late (90 day) postoperative complications in 97 patients with the I-Pouch. Complication
Fever > 38.5 C Hypokalemia Delayed intestinal motility Prolonged vomiting Blood transfusion Paralytic ileus Lymphocele, conservative treatment Scrotal swelling Wound infection Lymphocele, percutaneous drainage Obstruction, endoscopic antegrade JJ Intestinal obstruction, resection/reanastomosis Rectal injury, repair Burst abdomen, closure Umbilical hernia, repair Hemiparesis Lung emboli Septic shock Fulminant pulmonary embolism Peritonitis due to intestinal leakage Total
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o
Figure 6. Intraoperative illustration of the close connection of the urethra (U) and ureter in relation to the I-Pouch reservoir.
Functional follow-up Functional assessment was based on retrospective hospital charts, including on postvoid residual urine volume (PVR), micturition volume, presence of vesicoureteral reflux, postoperative serum creatinine level and rate of urinary tract infections (UTIs), defined as any UTI (either symptomatic or asymptomatic) requiring antibiotic treatment. Functional data are given at specific time-points during follow-up. The median functional follow-up was 18 months (range 3-111 months).
a
Statistical analysis For univariable analysis, the chi-squared/Fisher’s exact test was used for nominal data and Student’s t test for scaled data. p Values are two sided, with p less than 0.05 considered significant. Kaplan-Meier analysis with log-rank testing was used to estimate cancer-specific survival. Statistical analysis was performed with JMP 11.0. Values are given as mean ± SD for all normally distributed variables or as median (range) for non-normally distributed variables.
Results Oncological outcomes In total, 97 patients (72 men, 25 women) underwent RC with I-Pouch neobladder reconstruction. None of the patients underwent neoadjuvant chemotherapy. In the total cohort, the 5 year cancer-specific survival was 67.9%. No patient A
B
Patients
Early
Late
(n)
(n)
(n)
Gradea
4 3 2 1 4 3 2
4 3 2 1 4 3 2
0 0 0 0 0 0 0
I I I I II II II
1 1 3
1 1 2
0 0 1
II II IIIA
4
3
1
IIIB
2
2
0
IIIB
1 1 1 1 1 1 1
1 1 0 1 1 1 1
0 0 1 0 0 0 0
IIIB IIIB IIIB IVA IVA IVB V
1
1
0
V
38
35
3
Clavien-Dindo classification.
exhibited pT4b or pN3 disease at surgery. Five patients had undergone radical prostatectomy with pelvic lymph-node dissection for localized prostate cancer in their history before the diagnosis of bladder cancer, and were therefore staged pNX at RC. Only four patients had positive final urethral margins (4.1%); three were positive on frozen section, but all of them had refused non-orthotopic diversion a priori. All of them showed carcinoma in situ (CIS) without invasive components on final histological examination. Ureteral margins were positive on frozen section analysis in five patients (right in two and left in three). Eight patients showed positive results in the final specimen (three right, five left), with all displaying CIS. Urethral and upper tract recurrence arose in one patient each (1% and 1%, respectively). Perioperative outcomes Thirty-five patients (36.1%) experienced complications (Table 1) in the 30 day postoperative period, with an additional three patients experiencing late complications from the 31st to the 90th day (total rate 39.2%). Major complications occurred in 17 patients (17.5%). In the two patients who died, the cause was pulmonary embolism in one and intestinal leakage with consequent peritonitis in the other.
Figure 7. (a,b) Endoscopic view of the anatomical proximity of the neobladder outlet (NB) to the Wallace plate (WP), with indwelling guidewire (GW), in a woman with an I-Pouch neobladder undergoing ureterorenoscopy during follow-up.
Functional outcomes in the early postoperative period Of the 95 functionally evaluable patients postoperatively (after the 30th day postoperatively), 93 urinated spontaneously
The “I-Pouch” neobladder
DOI: 10.3109/21681805.2015.1040451
Table 2. Functional characteristics in the 95 patients with I-Pouch neobladder according to defined times during follow-up.
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Time-point (during follow-up)
No. of patients
No of patients on CIC (No vs Yes) at 3 months 31 vs 0 at 6 months 8 vs 0 at 12 months 12 vs 0 at 24 months 13 vs 0 at 36 months 9 vs 0 at 48 months 8 vs 0 at 60 months or later 12 vs 2 PVR £ 50 ml vs > 50 ml at 3 months 41 vs 0 at 6 months 8 vs 3 at 12 months 9 vs 3 at 24 months 6 vs 1 at 36 months 5 vs 0 at 48 months 4 vs 3 at 60 months or later 10 vs 2 No of UTIs/year (0 vs ‡ 1 UTI) at 3 months 39 vs 5 at 6 months 4 vs 7 at 12 months 8 vs 3 at 24 months 3 vs 5 at 36 months 3 vs 2 at 48 months 3 vs 3 at 60 months or later 8 vs 2 Serum creatinine level (£ 13 vs > 13 mg/dl) at 3 months 42 vs 2 at 6 months 10 vs 1 at 12 months 10 vs 2 at 24 months 5 vs 3 at 36 months 3 vs 2 at 48 months 5 vs 1 at 60 months or later 7 vs 5 Micturition volume (> 150 ml vs £150 ml) at 3 months 45 vs 4 at 6 months 10 vs 1 at 12 months 10 vs 1 at 24 months 7 vs 0 at 36 months 5 vs 0 at 48 months 5 vs 1 at 60 months or later 7 vs 0
(%) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (86 vs 14) (100 vs 0) (73 vs 27) (75 vs 25) (86 vs 14) (100 vs 0) (57 vs 43) (83 vs 17) (89 (36 (73 (38 (60 (50 (80
vs 11) vs 64) vs 27) vs 62) vs 40) vs 50) vs 20)
(96 (91 (83 (63 (60 (83 (58
vs 4) vs 9) vs 17) vs 37) vs 40) vs 17) vs 42)
(92 vs 8) (91 vs 9) (91 vs 9) (100 vs 0) (100 vs 0) (83 vs 17) (100 vs 0)
CIC = clean intermittent catheterization; PVR = postvoid residual urine volume; UTI = urinary tract infection.
(97.9%) with only two patients requiring clean intermittent catheterization (CIC) to empty the neobladder. The median number of UTIs per year was 0 (range 0-2). The median PVR was 0 ml (range 0–200 ml). No significant association was found between the rate of UTIs (0 vs ‡ 1) and PVR (£ 50 ml vs > 50 ml; p = 0.18). No significant association was found between changes in serum creatinine level (both continuously coded and dichotomously; £ 1.3 mg/dl vs > 1.3 mg/dl) with increasing follow-up time (p = 0.16). The median micturition volume was 250 ml (interquartile range 160–280 ml). Data on the rate of CIC, PVR, UTIs, micturition volumes and serum creatinine levels according to defined times during follow-up are given in Table 2. One patient had direct postoperative reflux (1%), evidenced by voiding cystography. Sixteen patients developed some degree of hydronephrosis in the early postoperative period (16.5%). This resolved spontaneously in nine (9.3%), but seven patients required intervention (7.2%): temporary percutaneous nephrostomy with antegrade double-J stenting in four (4.1%), temporary retrograde double-
5
J stenting in one (1.0%) and open ureteric reimplantation in two (2.1%).
Discussion This study presents a new technique of ileal neobladder reconstruction, termed the I-Pouch. The 5 year cancerspecific survival was 67.9%, comparable to that of a larger single-center series [12]. Six of the 97 patients were staged pT4a at RC. In this regard, all patients underwent frozen section analysis of the distal urethral margin before neobladder reconstruction. In the authors’ centers, prostatic loop biopsies are not routinely performed before neobladder reconstruction, as several studies have shown that the degree of correlation between transurethral loop biopsy of the prostatic urethra and final analysis of RC specimen is relatively low [13–15]. In the present series, patients with positive ureteral or urethral margins underwent primarily strict surveillance with serial investigations including urethroscopy, urinary cytology or urine-based markers as well as upper tract imaging and, in case of persistent suspicious findings, were examined with endoscopy and biopsy. Urethral and upper tract recurrence arose only in one patient each. The authors acknowledge that the length of ureters may have an impact on the rate of positive margins and carry a higher risk of upper tract recurrence when arising from the remaining distal ureteral segments. However, some authors think that even when malignancy is found at the distal ureteral margin, a resection of more proximal portions of the ureter does not decrease the risk of upper tract recurrence, as “skip lesions” can be present in the proximal ureter and pelvicocalyceal system [16]. The overall 90 day complication rate in the 97 patients was approximately 39% and the rate of major complications was 17.5%. Although the latter accords well with that in previous series reporting a 13–22% risk of major complications (grade III-V) after various neobladder procedures [17,18], the mortality rates in the literature range widely, from 0.8% to 8.3% [19]. In the present series, two patients died (2.1%) within 90 days, which is comparable to 90 day mortality rates reported in high-volume single-center series [18]. Nonetheless, comparisons among RC series with different types of diversion must be viewed with caution, as patient characteristics may differ significantly. In a recent study comparing four different types of OBS, the authors found that overall complication rates of neobladder reconstruction were 38% and 42%, respectively (similar to the approximately 40% overall rate in this study), while the 90 day complication rate was 51% [20]. For determining grade I and II complications, the authors relied on patient charts, which were available for all 97 patients. Any medication given orally, subcutaneously or intravenously was counted as grade I or II complication, as determined by the Clavien-Dindo classification. Nonetheless, it should be kept in mind that retrospective chart analysis may not allow for a complete and adequate compilation of all grade I and II complications. In this series, only two patients (2.1%) required definitive open ureteral reimplantation. This seems to be comparable to prior series [17–19] in which rates of ureteroileal stenosis of 2.7-10% were found for other types of ileal neobladders [21–23].
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6 G. Gakis et al. Anastomosis of the ureter to the posterior wall of the I-Pouch neobladder gives the advantage of placing the ureters in an easily accessible place for possible later endoscopy (Figure). In four out of five patients with postoperative hydronephrosis, the upper tract was primarily desobstructed via nephrostomy to avoid manipulation of the ureterointestinal anastomosis (in the early postoperative phase), which resolved finally in all cases. In this series, only one patient (1%) had postoperative reflux evidenced by retrograde cystography. This patient underwent strict follow-up of renal function and has not experienced any renal impairment thus far. Altogether, these results are comparable to those of other techniques with refluxive or antirefluxive anastomoses, reportedly between 3% and 10% [21,23]. In this regard, the authors agree that current evidence does not provide enough evidence for the necessity of an antirefluxive implantation technique for protection of the upper tracts in neobladder patients. However, a recent randomized study comparing directly refluxing and antirefluxive implantation techniques (using serous-lined extramural troughs) did not find a significant difference between the techniques in terms of postoperative changes in renal function, as measured by [99m]Tc-MAG3-scintigraphy [24]. Therefore, not only the type of ureteral implantation technique but also the careful preparation of ureters during a cystectomy procedure may play a key role in the development of stricture formation during follow-up. The authors acknowledge several limitations of this study. The study includes a relatively moderate sample size, lack of data on continence status and short follow-up time for functional outcomes. As this study is retrospective, functional outcomes cannot be addressed on a longitudinal time basis. For this reason, the number of patients investigated at specific time-points during follow-up was provided (Table 2). As approximately one-third of the patients had a maximum functional follow-up of 3 months (and continued later on with follow-up examinations on an outpatient basis), missing examinations at later follow-up visits may have left possible additional upper or lower tract obstructions undetected. An attempt was made to adjust for this possible effect by analyzing for changes in serum creatinine level with increasing follow-up time, but no significant effect was found. Nonetheless, in the authors’ opinion, the data presented herein suggest that the outcomes of the I-Pouch neobladder are comparable to those of other neobladder techniques. Acknowledgement We thank Hannes Schramm (University Hospital Tu €bingen, Germany) for Figures 1,2,3,4,5. Declaration of interest: All authors have no conflicts of interest.
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DOI: 10.3109/21681805.2015.1040451
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ORIGINAL ARTICLE
The “I-Pouch”: Results of a new ileal neobladder technique Georgios Gakis1, Mohamed F Abdelhafez1,2 & Arnulf Stenzl1 Department of Urology, University Hospital Tu€bingen, Tu€bingen, Germany, and 2Department of Urology, Assiut University Hospital, Assiut, Egypt
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1
Abstract
Key Words:
Objective. The aim of this study was to investigate perioperative, oncological and functional outcomes of the “I-Pouch” neobladder. Materials and methods. From 2002 to 2011, 97 patients (72 men, 25 women, median age 65, range 42-84 years) underwent radical cystectomy with I-Pouch neobladder reconstruction. Complications were graded according to the Clavien-Dindo classification. Oncological and functional outcomes were assessed. The median oncological and functional follow-up was 41 months (range 3-107 months) and 18 months (3-111 months), respectively. Results. In the total cohort, the 5 year cancer-specific survival was 67.9%. The major 30 and 90 day complication rates were 14.4% and 17.5%, respectively. Open reimplantation for ureterointestinal stricture was necessary in two (2.1%). Of the 95 functionally evaluable patients postoperatively, 93 urinated spontaneously (97.9%) and two patients (2.1%) required clean intermittent catheterization to empty their neobladder. The median postvoid residual urine volume (PVR) was 0 ml (range 0-200 ml). One patient had postoperative reflux (1%), as evidenced by voiding cystography. The median number of urinary tract infections per year was 0 (range 0-2) and showed no association with increased PVR (p = 0.18). Conclusions. The perioperative, oncological and functional outcomes of the I-Pouch are comparable to those of other types of ileal neobladder. An advantage of the I-Pouch is that the implantation of the ureters lies on the neobladder floor, which facilitates later instrumentation of the upper tract.
Functional, ileal, I-Pouch, neobladder, oncological, orthotopic bladder substitution, perioperative, upper urinary tract
Introduction Radical cystectomy (RC) is the mainstay of treatment for muscle-invasive bladder cancer [1]. As oncological outcomes have evolved in the past few decades, urinary diversion has increasingly gained the attention of clinicians and patients alike [2], with orthotopic bladder substitution (OBS) being established for the majority of patients in academic centers of expertise [2]. The goal is to store urine at low pressure while providing a voiding pattern similar to that of the native bladder [3]. Various types of ileal neobladder currently used for OBS have shown satisfactory functional and oncological outcomes [4,5]. Relevant considerations in neobladder reconstruction are the propensity for postoperative complications [3] and oncological and functional issues that may affect long-term results. In this regard, an important oncological aspect is the necessity for easy access to the upper tract for monitoring [3]. In terms of functional outcomes, the length of ileum used most frequently to form a neobladder reservoir is approximately 40 cm [6]. Although long-term preservation of renal function is of paramount importance, uncertainty persists about the superiority of an antirefluxive over a refluxive ureteral implantation technique [7].
History Received 23 October 2014 Accepted 2 April 2015
It was hypothesized that a neobladder made of 40 cm of ileal length with an antirefluxive implantation technique and easily accessible ureterointestinal anastomosis would address these important oncological and functional issues. This study presents perioperative, oncological and functional data on the “I-Pouch” neobladder.
Materials and methods Patient selection In this cross-sectional study, which was approved by the local ethics committee (63/2012BO2), a patient search was performed in February 2012 via a prospectively maintained cystectomy database. From 2002 to 2011, a total of 331 patients underwent RC for bladder cancer. Ileal neobladder reconstruction was performed in 171 patients. Of these, 97 received an I-Pouch neobladder. The median age at cystectomy was 65 years (range 42-84 years). In total, 73 patients were alive and 24 patients had died before initiation of this retrospective analysis. Functional and oncological follow-up data were available for all patients. Indications for I-Pouch neobladder reconstruction were stage cT2-T4a N0-2 bladder cancer or high-risk non-muscle-
Correspondence: Georgios Gakis MD, Associate Professor, Department of Urology, Eberhard-Karls University, University Hospital Tu€bingen, HoppeSeyler Street 3, D-72076 Tu €bingen, Germany. Tel: +49 7071 2985092. Fax: +49 7071 295092. E-mail: [email protected] 2015 Informa Healthcare.
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invasive bladder cancer after failure of bladder-preserving treatment and American Society of Anesthesiologists (ASA) scores 1-3. Exclusion criteria were uncontrolled coagulation disorders, intraoperative cT4b or cN3 disease, stress urinary incontinence, preoperative glomerular filtration rate less than 60 ml/min, azotemia, severely impaired liver function, chronic intestinal disease, impaired dexterity and intellectual capacity. Renal function was evaluated preoperatively and postoperatively in all patients scheduled for I-Pouch surgery with serum creatinine clearance as measured by the Modification of Diet in Renal Disease (MDRD) formula. In any patient with borderline renal function preoperatively or postoperatively (defined as 50–60 ml/min), [51Cr]EDTA clearance or creatinine clearance measured by 24 h urine collection was used for exact evaluation of renal function. Only patients with creatinine clearance greater than 60 ml/min were considered for OBS. Preoperative evaluation Preoperative evaluation consisted of a detailed history and physical examination, estimation of body mass index and routine laboratory work-up with urine analysis and culture. Preoperative imaging studies included contrast-enhanced computed tomography (CT) scans or magnetic resonance imaging (MRI). Bone scintigraphy was done in cases of elevated serum alkaline phosphatase or equivocal findings on cross-sectional imaging. Positron emission tomography/ computed tomography (PET/CT) was done in some cases with nodal involvement, and renal nuclear scanning when parenchymal damage was considered possible. Cystectomy technique All patients received mechanical bowel preparation the day before surgery. All were site-marked for a cutaneous stoma and intensively instructed in the care of a cutaneous diversion and proper catheterization techniques if retention occurred postoperatively. A vertical midline incision was made from the pubic symphysis to the umbilicus. Bilateral pelvic lymphnode dissection was performed. In men, RC included the removal of the tumor-bearing bladder, prostate and seminal vesicles, and in women the tumor-bearing bladder, uterus, adnexes and anterior vaginal wall.
Figure 1. After isolation of an ileal segment of 40 cm about 15– 20 cm proximal to the ileocaecal valve and restoration of bowel continuity, approximately 8 cm of the paramesenteric borders are sutured together to form the posterior wall of the ureteric trough.
widely spatulated and conjoined ureters (with 5-0 Vicryl according to a modified Wallace technique) are placed into the trough, sutured to the intestinal mucosa with a 5-0 PDS running suture (Figure 3a) and stented with single-J stents (Figure 3b). Then, the seromuscular layers of both loops are sutured together over the ureters, thereby completing the trough (Figure 4). The reservoir is then cross-folded and the upper and lower edges of the intestinal loops are joined together, forming the spherical configuration of the pouch according to Goodwin’s principle (Figure 5) [3]. The single-J stents are externalized through two separate openings in the mesentery. Then, the edges are sutured together, leaving the dependent part of the pouch to be connected to the urethra in
I-Pouch technique For the I-Pouch (so called because of the vertical implantation of the ureters into the pouch) an ileal segment of 40 cm is isolated about 20 cm proximal to the ileocaecal valve, with each limb having a length of 20 cm. Bowel continuity is restored via end-to-end anastomosis with 4-0 PDS running suture. Approximately 8 cm of the paramesenteric borders are sutured together to form the basis of the subserosal trough (Figure 1). Both ileal loops are opened by scissors at their antimesenteric borders 2 cm from the beginning of the loops to the site of future ureteric implantation (circa 8 cm), going medially to become paramesenteric at this point and then completing the opening at the antimesenteric border (Figure 2). After this, a U-shaped ileal plate is formed. The
Figure 2. The ileal loops are opened by scissors at the antimesenteric borders 2 cm from the beginning of the loops to the site of ureteric implantation (8 cm), going medially to become paramesenteric at that point and then completing the opening at the antimesenteric border.
The “I-Pouch” neobladder
DOI: 10.3109/21681805.2015.1040451
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A
3
B
Figure 3. The two ureters are spatulated and joined together with 5-0 Vicryl according to the modified Wallace technique (a) and stented with single-J stents (b).
men; in women, all the edges of the pouch are closed and an opening at the lower-most dependent part of the pouch is created and finally sutured to the urethra. After removal of the indwelling mono-J stents on the 9th and 10th postoperative day, voiding cystography was performed in all patients on the 14th postoperative day. Any patients with dilatation of the upper tract during follow-up were also investigated with voiding cystography for exclusion of reflux. Figures 6 and 7 both intraoperative and endoscopic views, respectively, of the close proximity of the neobladder outlet and ureters. Oncological and perioperative outcomes
assessment was performed in a single pathology department according to the 2002 tumor, node, metastasis (TNM) classification [9]. Postoperative follow-up visits included cross-sectional imaging at regular intervals for detection of recurrence. All patients with positive ureteral or urethral margins underwent strict surveillance with serial investigations including urethroscopy, urinary cytology/urine-based markers (fluorescence in situ hybridization, immunocytology, NMP22) and upper tract imaging and, in case of suspicious findings, were examined with endoscopy and biopsy [10,11]. Patients generally were seen at least every 3-4 months for the first year, semiannually for the second and third years, and annually thereafter. The median oncological follow-up in the 95 patients was 41 months (range 3-107 months).
Hospital charts and physician records were reviewed to determine demographic characteristics and clinical outcomes. Complications (30 and 90 day) were graded according to the modified Clavien-Dindo classification [8]. The histological
Figure 4. The ureters are sutured with the intestinal mucosa with a 5-0 running suture; the seromuscular layers of both loops are then sutured over the ureters, thereby completing the trough.
Figure 5. The upper and lower edges of the intestinal loops are joined together, forming the configuration of the pouch according to Goodwin’s principle. The single-J stents are externalized through two separate openings in the mesentery.
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Table 1. Early (30 day) and late (90 day) postoperative complications in 97 patients with the I-Pouch. Complication
Fever > 38.5 C Hypokalemia Delayed intestinal motility Prolonged vomiting Blood transfusion Paralytic ileus Lymphocele, conservative treatment Scrotal swelling Wound infection Lymphocele, percutaneous drainage Obstruction, endoscopic antegrade JJ Intestinal obstruction, resection/reanastomosis Rectal injury, repair Burst abdomen, closure Umbilical hernia, repair Hemiparesis Lung emboli Septic shock Fulminant pulmonary embolism Peritonitis due to intestinal leakage Total
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o
Figure 6. Intraoperative illustration of the close connection of the urethra (U) and ureter in relation to the I-Pouch reservoir.
Functional follow-up Functional assessment was based on retrospective hospital charts, including on postvoid residual urine volume (PVR), micturition volume, presence of vesicoureteral reflux, postoperative serum creatinine level and rate of urinary tract infections (UTIs), defined as any UTI (either symptomatic or asymptomatic) requiring antibiotic treatment. Functional data are given at specific time-points during follow-up. The median functional follow-up was 18 months (range 3-111 months).
a
Statistical analysis For univariable analysis, the chi-squared/Fisher’s exact test was used for nominal data and Student’s t test for scaled data. p Values are two sided, with p less than 0.05 considered significant. Kaplan-Meier analysis with log-rank testing was used to estimate cancer-specific survival. Statistical analysis was performed with JMP 11.0. Values are given as mean ± SD for all normally distributed variables or as median (range) for non-normally distributed variables.
Results Oncological outcomes In total, 97 patients (72 men, 25 women) underwent RC with I-Pouch neobladder reconstruction. None of the patients underwent neoadjuvant chemotherapy. In the total cohort, the 5 year cancer-specific survival was 67.9%. No patient A
B
Patients
Early
Late
(n)
(n)
(n)
Gradea
4 3 2 1 4 3 2
4 3 2 1 4 3 2
0 0 0 0 0 0 0
I I I I II II II
1 1 3
1 1 2
0 0 1
II II IIIA
4
3
1
IIIB
2
2
0
IIIB
1 1 1 1 1 1 1
1 1 0 1 1 1 1
0 0 1 0 0 0 0
IIIB IIIB IIIB IVA IVA IVB V
1
1
0
V
38
35
3
Clavien-Dindo classification.
exhibited pT4b or pN3 disease at surgery. Five patients had undergone radical prostatectomy with pelvic lymph-node dissection for localized prostate cancer in their history before the diagnosis of bladder cancer, and were therefore staged pNX at RC. Only four patients had positive final urethral margins (4.1%); three were positive on frozen section, but all of them had refused non-orthotopic diversion a priori. All of them showed carcinoma in situ (CIS) without invasive components on final histological examination. Ureteral margins were positive on frozen section analysis in five patients (right in two and left in three). Eight patients showed positive results in the final specimen (three right, five left), with all displaying CIS. Urethral and upper tract recurrence arose in one patient each (1% and 1%, respectively). Perioperative outcomes Thirty-five patients (36.1%) experienced complications (Table 1) in the 30 day postoperative period, with an additional three patients experiencing late complications from the 31st to the 90th day (total rate 39.2%). Major complications occurred in 17 patients (17.5%). In the two patients who died, the cause was pulmonary embolism in one and intestinal leakage with consequent peritonitis in the other.
Figure 7. (a,b) Endoscopic view of the anatomical proximity of the neobladder outlet (NB) to the Wallace plate (WP), with indwelling guidewire (GW), in a woman with an I-Pouch neobladder undergoing ureterorenoscopy during follow-up.
Functional outcomes in the early postoperative period Of the 95 functionally evaluable patients postoperatively (after the 30th day postoperatively), 93 urinated spontaneously
The “I-Pouch” neobladder
DOI: 10.3109/21681805.2015.1040451
Table 2. Functional characteristics in the 95 patients with I-Pouch neobladder according to defined times during follow-up.
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Time-point (during follow-up)
No. of patients
No of patients on CIC (No vs Yes) at 3 months 31 vs 0 at 6 months 8 vs 0 at 12 months 12 vs 0 at 24 months 13 vs 0 at 36 months 9 vs 0 at 48 months 8 vs 0 at 60 months or later 12 vs 2 PVR £ 50 ml vs > 50 ml at 3 months 41 vs 0 at 6 months 8 vs 3 at 12 months 9 vs 3 at 24 months 6 vs 1 at 36 months 5 vs 0 at 48 months 4 vs 3 at 60 months or later 10 vs 2 No of UTIs/year (0 vs ‡ 1 UTI) at 3 months 39 vs 5 at 6 months 4 vs 7 at 12 months 8 vs 3 at 24 months 3 vs 5 at 36 months 3 vs 2 at 48 months 3 vs 3 at 60 months or later 8 vs 2 Serum creatinine level (£ 13 vs > 13 mg/dl) at 3 months 42 vs 2 at 6 months 10 vs 1 at 12 months 10 vs 2 at 24 months 5 vs 3 at 36 months 3 vs 2 at 48 months 5 vs 1 at 60 months or later 7 vs 5 Micturition volume (> 150 ml vs £150 ml) at 3 months 45 vs 4 at 6 months 10 vs 1 at 12 months 10 vs 1 at 24 months 7 vs 0 at 36 months 5 vs 0 at 48 months 5 vs 1 at 60 months or later 7 vs 0
(%) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (100 vs 0) (86 vs 14) (100 vs 0) (73 vs 27) (75 vs 25) (86 vs 14) (100 vs 0) (57 vs 43) (83 vs 17) (89 (36 (73 (38 (60 (50 (80
vs 11) vs 64) vs 27) vs 62) vs 40) vs 50) vs 20)
(96 (91 (83 (63 (60 (83 (58
vs 4) vs 9) vs 17) vs 37) vs 40) vs 17) vs 42)
(92 vs 8) (91 vs 9) (91 vs 9) (100 vs 0) (100 vs 0) (83 vs 17) (100 vs 0)
CIC = clean intermittent catheterization; PVR = postvoid residual urine volume; UTI = urinary tract infection.
(97.9%) with only two patients requiring clean intermittent catheterization (CIC) to empty the neobladder. The median number of UTIs per year was 0 (range 0-2). The median PVR was 0 ml (range 0–200 ml). No significant association was found between the rate of UTIs (0 vs ‡ 1) and PVR (£ 50 ml vs > 50 ml; p = 0.18). No significant association was found between changes in serum creatinine level (both continuously coded and dichotomously; £ 1.3 mg/dl vs > 1.3 mg/dl) with increasing follow-up time (p = 0.16). The median micturition volume was 250 ml (interquartile range 160–280 ml). Data on the rate of CIC, PVR, UTIs, micturition volumes and serum creatinine levels according to defined times during follow-up are given in Table 2. One patient had direct postoperative reflux (1%), evidenced by voiding cystography. Sixteen patients developed some degree of hydronephrosis in the early postoperative period (16.5%). This resolved spontaneously in nine (9.3%), but seven patients required intervention (7.2%): temporary percutaneous nephrostomy with antegrade double-J stenting in four (4.1%), temporary retrograde double-
5
J stenting in one (1.0%) and open ureteric reimplantation in two (2.1%).
Discussion This study presents a new technique of ileal neobladder reconstruction, termed the I-Pouch. The 5 year cancerspecific survival was 67.9%, comparable to that of a larger single-center series [12]. Six of the 97 patients were staged pT4a at RC. In this regard, all patients underwent frozen section analysis of the distal urethral margin before neobladder reconstruction. In the authors’ centers, prostatic loop biopsies are not routinely performed before neobladder reconstruction, as several studies have shown that the degree of correlation between transurethral loop biopsy of the prostatic urethra and final analysis of RC specimen is relatively low [13–15]. In the present series, patients with positive ureteral or urethral margins underwent primarily strict surveillance with serial investigations including urethroscopy, urinary cytology or urine-based markers as well as upper tract imaging and, in case of persistent suspicious findings, were examined with endoscopy and biopsy. Urethral and upper tract recurrence arose only in one patient each. The authors acknowledge that the length of ureters may have an impact on the rate of positive margins and carry a higher risk of upper tract recurrence when arising from the remaining distal ureteral segments. However, some authors think that even when malignancy is found at the distal ureteral margin, a resection of more proximal portions of the ureter does not decrease the risk of upper tract recurrence, as “skip lesions” can be present in the proximal ureter and pelvicocalyceal system [16]. The overall 90 day complication rate in the 97 patients was approximately 39% and the rate of major complications was 17.5%. Although the latter accords well with that in previous series reporting a 13–22% risk of major complications (grade III-V) after various neobladder procedures [17,18], the mortality rates in the literature range widely, from 0.8% to 8.3% [19]. In the present series, two patients died (2.1%) within 90 days, which is comparable to 90 day mortality rates reported in high-volume single-center series [18]. Nonetheless, comparisons among RC series with different types of diversion must be viewed with caution, as patient characteristics may differ significantly. In a recent study comparing four different types of OBS, the authors found that overall complication rates of neobladder reconstruction were 38% and 42%, respectively (similar to the approximately 40% overall rate in this study), while the 90 day complication rate was 51% [20]. For determining grade I and II complications, the authors relied on patient charts, which were available for all 97 patients. Any medication given orally, subcutaneously or intravenously was counted as grade I or II complication, as determined by the Clavien-Dindo classification. Nonetheless, it should be kept in mind that retrospective chart analysis may not allow for a complete and adequate compilation of all grade I and II complications. In this series, only two patients (2.1%) required definitive open ureteral reimplantation. This seems to be comparable to prior series [17–19] in which rates of ureteroileal stenosis of 2.7-10% were found for other types of ileal neobladders [21–23].
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6 G. Gakis et al. Anastomosis of the ureter to the posterior wall of the I-Pouch neobladder gives the advantage of placing the ureters in an easily accessible place for possible later endoscopy (Figure). In four out of five patients with postoperative hydronephrosis, the upper tract was primarily desobstructed via nephrostomy to avoid manipulation of the ureterointestinal anastomosis (in the early postoperative phase), which resolved finally in all cases. In this series, only one patient (1%) had postoperative reflux evidenced by retrograde cystography. This patient underwent strict follow-up of renal function and has not experienced any renal impairment thus far. Altogether, these results are comparable to those of other techniques with refluxive or antirefluxive anastomoses, reportedly between 3% and 10% [21,23]. In this regard, the authors agree that current evidence does not provide enough evidence for the necessity of an antirefluxive implantation technique for protection of the upper tracts in neobladder patients. However, a recent randomized study comparing directly refluxing and antirefluxive implantation techniques (using serous-lined extramural troughs) did not find a significant difference between the techniques in terms of postoperative changes in renal function, as measured by [99m]Tc-MAG3-scintigraphy [24]. Therefore, not only the type of ureteral implantation technique but also the careful preparation of ureters during a cystectomy procedure may play a key role in the development of stricture formation during follow-up. The authors acknowledge several limitations of this study. The study includes a relatively moderate sample size, lack of data on continence status and short follow-up time for functional outcomes. As this study is retrospective, functional outcomes cannot be addressed on a longitudinal time basis. For this reason, the number of patients investigated at specific time-points during follow-up was provided (Table 2). As approximately one-third of the patients had a maximum functional follow-up of 3 months (and continued later on with follow-up examinations on an outpatient basis), missing examinations at later follow-up visits may have left possible additional upper or lower tract obstructions undetected. An attempt was made to adjust for this possible effect by analyzing for changes in serum creatinine level with increasing follow-up time, but no significant effect was found. Nonetheless, in the authors’ opinion, the data presented herein suggest that the outcomes of the I-Pouch neobladder are comparable to those of other neobladder techniques. Acknowledgement We thank Hannes Schramm (University Hospital Tu €bingen, Germany) for Figures 1,2,3,4,5. Declaration of interest: All authors have no conflicts of interest.
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