Radical Cystectomy: Robotic, Laparoscopic, Open and Partial

and Michael E. Woods 



(1)
Division of Urology, Department of Surgery, University of North Carolina, Chapel Hill, NC, USA

 



 

Michael E. Woods





Keywords
Robotic surgeryRadical cystectomyBladder neoplasmUrothelial carcinomaLaparoscopyOutcomes



16.1 Bladder Cancer Epidemiology


Bladder cancer is a common disease with over 70,000 new cases and almost 15,000 deaths in the US in 2011 [1]. Untreated, muscle invasive bladder cancer is a lethal disease with a 2-year mortality rate approaching 85 % [2]. In addition to its morbidity and mortality, bladder cancer is the most expensive cancer to diagnose, treat, and survey, with a per-patient lifetime cost of $96,500 [3, 4]. In the United States and other developed countries, urothelial carcinoma (UC) represents 90 % of bladder cancers, with squamous cell carcinoma and adenocarcinoma comprising the majority of the remaining histologies. The predominant risk factors for developing UC of the bladder are age and environmental exposures, especially to tobacco smoke and aromatic amines from dyes and industrial chemicals. In addition, males are three to four times more likely to develop bladder cancer than females, presumably due to higher rates of carcinogenic exposures.

The prognosis and treatment for UC of the bladder is largely determined by the level of cellular de-differentiation (grade), and the depth of invasion (stage). According to the World Health Organization 2004 guidelines, bladder cancer grade is dichotomized to either low- or high-grade. Staging is based on the American Joint Committee on Cancer TNM staging system, which can be divided into two main groups: non-muscle invasive (Ta, T1, Tis, which are all superficial to the muscularis propria), and muscle invasive (T2–T4). Non-muscle invasive bladder cancers (NMIBC) generally carry a favorable prognosis and are amenable to transurethral resection (TURBT) and instillation of intravesical therapies. Conversely, muscle invasive bladder cancer is by definition high-grade, carries a poorer prognosis, and is usually treated with radical cystectomy and urinary diversion, with or without systemic chemotherapy.

Of all incident cases of bladder cancer, 70 % are non-muscle invasive, of which roughly two-thirds are low grade [5, 6]. The low-grade tumors commonly recur after treatment (48–71 %), however they rarely progress to muscle invasive disease (2–12 %). On the other hand, high-grade non-muscle invasive carcinomas have a high rate of both recurrence (55 %) and stage progression (27–61 %) within 3 years after treatment [7].

For muscle invasive bladder cancer and high-grade NMIBC that is recurrent or persistent despite TURBT and intravesical therapies, the standard of care is radical cystectomy combined with bilateral pelvic lymphadenectomy and urinary diversion. In addition, perioperative systemic chemotherapy in the setting of muscle invasive disease has been shown to provide a survival benefit, with patients with extravesical disease (≥pT3) receiving the most benefit [8].


16.2 Open Radical Cystectomy Outcomes, Past and Present


Open radical cystectomy (ORC) is the gold standard treatment for muscle invasive bladder cancer. In 2001, Stein et al. published a landmark paper describing the outcomes of over 1,000 radical cystectomy patients between 1971 and 1997 [9]. The overall recurrence-free survival at 5 and 10 years was 68 and 66 %, respectively. Twenty-four percent of patients had lymph node involvement and their recurrence free survival at 5 years was significantly lower (35 %) than patients with node-negative disease (78 %). The median time to recurrence was 12 months, of which approximately 75 % were distant (non-pelvic) metastases. There was a 2.5 % mortality rate within 30 days, and a 90-day overall complication rate of 28 %. These findings were corroborated in another large study of 507 ORC patients in which the 5-year recurrence-free and overall survival was 62 and 59 %, respectively, with a mean follow-up of 45 months. This cohort of patients had a mean age of 66, 57 % were > pT2, and 24 % were lymph node positive. Similar to Stein et al. extravesical disease and lymph node positivity were associated with poorer prognosis, and the majority of cancer-related deaths occurred in the first 2 years [10].

In 2004, Herr et al. analyzed the outcomes of the Bladder Cancer Collaborative Group in an attempt to better define surgical benchmarks for radical cystectomy. Studying outcomes from 1,091 radical cystectomies by 16 experienced surgeons from four institutions between 2000 and 2002, they concluded that pathologic goals for surgeons performing radical cystectomies should include a positive margin rate lower than 10 % and a lymph node yield of greater than ten [11]. These findings were corroborated by a prospective study which showed improved overall survival in patients with negative margins and > ten lymph nodes dissected, independent of other factors [12]. It should be noted however, that ten dissected lymph nodes represents a minimum rather than a goal, as there is linear relationship between lymph node positivity and overall number of lymph nodes removed [13].

Despite improvements in surgical technique and post-operative care pathways, radical cystectomy remains a morbid surgical procedure. In 2008, Lowrance et al. reported a minor and major complication rate of 38 and 7 %, respectively, with a 30-day mortality rate of 1.7 % [14]. In a large prospective study of over 1,000 patients between 1995 and 2005, Shabsigh et al. found the perioperative complication rates to be much higher (64 % within 90 days, with 13 % being high-grade) when using a strict complication reporting system. These complications were dominated by gastrointestinal events (29 %), infections (25 %), and wound-related complications (15 %). The 90-day mortality rate was found to be 2.7 %, 65 % of which was due to cardiopulmonary events [15].


16.3 Robotic-Assisted Radical Cystectomy


In an attempt to decrease perioperative morbidity, minimally invasive surgery has been applied to radical cystectomy. Due to a combination of the familiarity of urologists with the Da Vinci robotic system (Intuitive Surgical, Sunnyvale CA), as well as the technical challenges of pelvic surgery with a pure laparoscopic approach, robot-assisted radical cystectomy (RARC) has emerged as the most widely utilized minimally invasive approach in the United States [16]. Since the first reported case series in 2003, there has been a significant increase in the use of the robotic technique for bladder cancer surgery [17]. In theory, the robotic approach should provide superior visualization, decrease blood loss, and improve patient convalescence due to decreased incision length, retractor injury, and bowel manipulation leading to shorter length of stay. However with these theoretical advantages come the potential disadvantages of increased operative time and cost, as well as concerns over pathologic compromise secondary to loss of tactile feedback and thoroughness of pelvic lymph node dissection. A growing number of single and multi-institution case series described below have supported the continued utilization of RARC.


16.4 Perioperative Outcomes of RARC


With regards to perioperative outcomes, small prospective studies (including two randomized trials) have shown non-inferiority or superiority of RARC compared to ORC in terms of mortality, blood loss, transfusion requirement, hospital stay, narcotic use, and time to resumption of diet. In a randomized prospective trial of ORC vs RARC enrolling 40 patients, Nix et al. found that RARC patients experienced less estimated blood loss, quicker return of bowel function, and lower use of inpatient narcotics compared to the ORC patients [18]. Ng et al. showed in a prospective, non-randomized cohort study of 187 consecutive patients that the 30-day overall Clavien complication rate was higher in the open group compared with the robotic group (ORC 59 % vs RARC 41 %, p = 0.04), as well as the rate of major complications at 90 days (30 % vs 10 %, p = 0.007) [19]. In addition, post-operative length of stay has been found to be significantly shorter in RARC patients by several authors on retrospective analysis [1921] (Table 16.1). A recent meta-analysis of the head-to-head comparisons of RARC vs ORC has reinforced the above findings [31]. However, these advantages come at the expense of longer operative time in the robotic approach, which has been demonstrated by multiple studies [32, 33]. Whether these perioperative improvements result in more rapid patient convalescence after hospital discharge is an area of active investigation.


Table 16.1
Outcomes of ORC and RARC case series






























































































































































































































ORC series

n

Years

% male

Age

Peri-op death %

PSM %

LNY

%≤pT2

%≥pT3

+LN%

% neoadjuvant chemo

Follow up (months)

Complication rate

LOS (day)

% IC

5-year RFS

Stein et al. (2001) [9]

1,054

1971–1997

80

66

2.5 %

NR

NR

51

49

24 %

5 %

120

28 % (30 days)

NR

25

68 %

Madersbacher et al. (2003) [10]

507

1985–2000

80

66

2

NR

NR

48

52

24 %

0

45

NR

NR

41 %

62

Hautmann et al. (2006) [22]

788

1986–2003

83

63

5 (90 day)

NR

NR

67 %

33 %

18 %

0

31

NR

NR

25

68

Manoharan et al. (2009) [23]

432

1992–2007

80

69

2

5

10

61

39

21

13

38

33

NR

56

64

RARC series

Kauffman et al. (2011) [24]

85

2006–2008

79

73

NR

6

19

63

36

16

20

18

41

5.5

71

71 (2 years)

Pruthi et al. (2010) [25]

100

2006–2009

73

65

0

0

19

67

33

20

5

21

36

4.9

61

85 (2 years)

Martin et al. (2010) [26]

59

2005–2009

NR

NR

0

NR

NR

48

52

34

17

25

NR

NR

81

72 (3 years)

Kahn et al. (2011) [27]

50

2004–2008

88

66

0

2

17

72

28

NR

12

NR

34

10

90

NR

IRCC [28, 29]

527

2003–2009

79

69

NR

7

18

65

35

20

NR

NR

NR

NR

NR

NR

Hayn et al. (2011) [30]

164

2005–2010

79

68

1

8.5

22

50

50

29

8

8

64

NR

93

NR


ORC open radical cystectomy, RARC robot-assisted radical cystectomy, PSM positive surgical margin, LNY lymph node yield, LOS length of stay, IC ileal conduit, RFS recurrence free survival, IRCC International Robotic Cystectomy Consortium, NR not reported


16.5 Pathologic Outcomes


While long-term survival data continue to mature, pathologic outcomes such as lymph node yield and surgical margin status have been evaluated as surrogate markers of surgical quality during RARC. Critics of the robotic approach have focused on the ability to perform an adequate pelvic lymph node dissection, and have expressed concerns that the robotic approach results in poorer lymph node dissection [34]. In a multi-institutional international RARC database from 15 institutions, 527 patients underwent robotic lymphadenectomy and 83 % of them had a lymph node count of greater than ten [28]. Using this same series, positive surgical margins occurred in 6.8 % of patients [29]. Importantly, 36 % of this cohort harbored extravesical (≥pT3) disease, a number comparable to prior open series. Smith et al. reported in another multi-institution RARC case series of 227 patients an average lymph node yield of 18 and a positive surgical margin rate of 2 % [35]. Abaza et al. demonstrated that performing an extended lymph node dissection robotically resulted in equivalent lymph node yield compared with open surgery in a non-randomized comparison [36]. In a prospective cohort study, Richards et al. compared 70 consecutive patients (35 ORC vs 35 RARC) with equal rates of extravesical (40 %) and lymph node positive disease (29 %) and found a lower positive margin rate in RARC (3 %) compared to ORC (9 %) and equivalent lymph node yield [37]. Finally, two randomized prospective trials comparing ORC and RARC examined several perioperative outcomes including lymph node yield, and found RARC to be non-inferior to ORC. In the study by Nix et al. lymph node yield was not different between groups, and no positive surgical margins were identified in either group [18]. Parekh and colleagues recently published results of a RCT with 20 patients in each arm and found the average lymph node yield to be 23 in the ORC group and 11 in the RARC group (p = 0.135), and positive margin rate to be identical at 5 % in each group. These findings were despite a higher rate of extravesical disease in the RARC group (50 % vs 35 %) [38]. Using these surrogate surgical outcomes, oncologic efficacy of RARC appears comparable to ORC. However, these data must still be interpreted with caution as retrospective studies are inherently susceptible to selection bias, and the randomized prospective studies have been small. These head-to-head studies are summarized in Table 16.2.
Mar 18, 2017 | Posted by in UROLOGY | Comments Off on Radical Cystectomy: Robotic, Laparoscopic, Open and Partial

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