- Email: [email protected]
5-YEAR BIOCHEMICAL PROGRESSION FREE AND CANCER SPECIFIC SURVIVAL FOLLOWING LAPAROSCOPIC RADICAL PROSTATECTOMY
269 INCIDENCE AND RISK FACTORS OF SYMPTOMATIC DEEP VENOUS THROMBOSIS IN PROSTATE CANCER PATIENTS UNDERGOING LAPAROSCOPIC RADICAL PROSTATECTOMY 1
2
3
4
5
6
7
8
1
Secin F. , Abbou C.C. , Gill I. , Fournier G. , Piéchaud T. , Schullman C. , Turk I. , Janetschek G. , Karanikolas N. , Serio A.1, Vickers A.1, Touijer K.1, Guillonneau B.1 1
Memorial Sloan Kettering Cancer Center, Urology, New York, United States, 2Centre Hospitalier Universitaire Henri Mondor, Urology, Creteil, France, 3Urological Institute Cleveland Clinic Foundation, Urology, Cleveland, United States, 4 Hôpital De La Cavale Blanche, Urology, Brest Cédex, France, 5Clinique St. Augustin, Urology, Bordeaux, France, 6 Erasme Hospital, University Clinics of Brussels, Urology, Brussels, Belgium, 7Lahey Clinic, Urology, Burlington, United States, 8KH der Elisabethinen, Teaching Hosp. of University of Innsbruck, Urology, Linz, Austria INTRODUCTION & OBJECTIVES: There is no data regarding the incidence and variables associated with symptomatic deep venous thrombosis (DVT) and or pulmonary embolism (PE) in patients undergoing laparoscopic radical prostatectomy (LRP). Our objective was to report the multi-centric incidence and risk factors for perioperative symptomatic DVT and PE after LRP. MATERIAL & METHODS: Eight centres from both the USA and Europe participated. Inclusion criteria: All patients with symptomatic DVT and or PE taking place within 2 months of surgery since start of their respective LRP experience. Both diagnoses should have been confirmed by at least any of the following imaging studies: Doppler ultrasound and or venography for DVT; and Lung Ventilation/perfusion scan (V/Q), chest computed tomography (CT) and or pulmonary artery arteriography for PE. Estimation of incidences, comparison of proportions and logistic regression analysis were generated to find variables predicting DVT and PE. RESULTS: Fourteen of 3111 patients were diagnosed with symptomatic DVT (0.5%), of these, 5 developed PE, that is, 35% of patients with DVT (0.2% of the total patients). The median time to VDT diagnosis was 10 days (range, 1-32 days).
270 5-YEAR
BIOCHEMICAL
SPECIFIC
SURVIVAL
PROGRESSION
FOLLOWING
FREE AND
LAPAROSCOPIC
CANCER RADICAL
PROSTATECTOMY Rozet F., Braud G., Cathelineau X., Barret E., Harmon J., Almeida D., Vallancien G. IMM, Urology, Paris, France INTRODUCTION & OBJECTIVES: To assess the mid-term progression free probability after laparoscopic radical prostatectomy. MATERIAL & METHODS: From 1998 to 2005, 2600 laparoscopic prostatectomies were performed at our institution. Patient data was recorded prospectively. Analysis was conducted for only those patients having five years of follow-up. The first 100 patients, which represent the “discovery curve” of the 2 surgeons, were also excluded from the study. The absence of biochemical
Prophylaxis Leading Surgeon, Centre
Heparin
PCD/GCS*
DVT n
Patients n
DVT %
progression was defined by a PSA less than 0.2 ng/ml. RESULTS: 330 patients with at least 5 years follow-up were included in this
Preop
Postop
C. Abbou, Creteil, Fr
Yes
15 a / hosp
GCS
3
727
0.4
I. Gill, OH, USA
No
No
PCD
3
604
0.5
G. Fournier, Brest, Fr
Yes
10-21 days
GCS
3
348
0.9
study. The mean preoperative PSA was 10 ± 6 ng/ml and the mean number of positive biopsies was 2. According to the d’Amico criteria, 46% of patients were
T.Piéchaud, Bordeux, Fr
No
20 days
GCS
1
387
0.3
preoperatively stratified in the low risk group, 41% in the intermediate, and 13% in
C. Schullman, Brussels, Bel.
No
14 days
GCS
1
268
0.4
the high risk group. The incidence of positive margins for the pT2a, pT2b, pT2c,
I. Turk, MA, USA.
Yes
No
PCD
1
266
0.4
pT3a, and pT3b was 5, 18, 21, 30, and 11%, respectively. No cases of port seeding
G.Janetschek, Linz, Austria
Yes
9 days
GCS
0
100
0
B. Guillonneau, NY, USA
Yes
until d/c
PCD
2
411
0.5
14
3111
0.5
Total
or peritoneal carcinosis have been reported. The 5-year biochemical progression free survival for the low, intermediate, and high risk groups was 86, 68, and 43%
* PCD: pneumatic compressive devices; GCS: gradual compressive stockings
respectively. For patients without positive margins, the biochemical progression free
Patient re exploration was the only variable significantly associated with increased risk of symptomatic DVT (p=0.01). Transperitoneal approach (p=0.07), tobacco exposure (p=0.07) and prior history of DVT (p=0.09) approached significance. The non use of perioperative heparin was not a risk factor (p=0.7). No deaths related to the thromboembolic event were reported.
survival was 81% compared to 41% for those with positive margins (p<0.0001).
CONCLUSIONS: The incidence of symptomatic DVT in LRP was less than 1%, despite different types of prophylaxis. The lack of obvious differences in DVT rates between the different prophylactic regimens suggests that the value of heparin for low risk patients undergoing LRP should be reconsidered. A multicentric prospective randomised study will be required to determine the need for thromboembolic prophylaxis in patients undergoing LRP.
The 5-year cancer specific survival was 99%. CONCLUSIONS: The laparoscopic radical prostatectomy offers 5 years cancer control similar to that of the open technique.
271 VALUE OF FROZEN SECTIONS DURING LAPAROSCOPIC RADICAL PROSTATECTOMY
NERVE-SPARING
Naspro R.1, Guazzoni G.2, Freschi M.3, Cestari A.2, Salonia A.2, Buffi N.2, Montorsi F.2, Rigatti P.2 Università Vita-Salute, San Raffaele Hospital, Urology, Milan, Italy, 2Univeristà Vita-Salute, San Raffaele Hospital, Urology, Milan, Italy, 3Univeristà Vita-Salute, San Raffaele Hospital, Pathology, Milan, Italy
272 EVALUATION OF SEXUAL ACTIVITY AFTER RADICAL PROSTATECTOMY
LAPAROSCOPIC
Mombet A., Cathala N., Giuliano F., Prapotnich D., Cathelineau X., Rozet F., Barret E., Vallancien G.
1
INTRODUCTION & OBJECTIVES: A prospective study to assess feasibility and value of intraoperative frozen section (IFS) during nerve sparing transperitoneal laparoscopic radical prostatectomy for clinically localised prostate cancer. MATERIAL & METHODS: From September 2004 to August 2005, 85 consecutive patients underwent laparoscopic radical prostatectomy with bilateral or monolateral nerve sparing technique at our Department. Once removed, the prostate was inked bilaterally starting from the base to apex in the bundles area. The specimen was then sent to the pathologist who cut the inked areas for 0,5-0,6 cm in depth, performed serial sections of 0.2-0.3 cm wide that were embedded in OCT compound to obtain frozen sections of 5 microns stained with Hematoxylin and Eosin and analysed under the microscope. When a positive margin occurred at IFS the corresponding neurovascular bundle was excised intra-operatively after the completion of the urethro-vesicle anastomosis. RESULTS: Patients age was 62,3±7.4 (mean±SD) and pre-operative total PSA values (mean±SD) were 6.1±2.5ng/dl. The mean volume of the prostates was (mean±SD) 82.5±24.5 gr. Bilateral and monolateral nerve sparing was performed in 72 (84.7%) and in 13 (17.3%) cases, respectively. Overall operative time was (mean±SD) 235±49.9 min and the extra time to remove additional tissue when positive margin was (mean±SD) 12±5 min. Post-operative Gleason score was <7 and >7 in 70 (82.3%) and 15 (17.6%) cases, respectively. Pathological stage was: 69 (81.1%) cases of T2 and 16 (18.8%)cases of pT3. The accuracy, sensitivity, specificity, positive and negative predictive value of IFS performed at the neurovascular bundle to predict cancer in the permanent section was 94%, 81%, 97%, 78%, and 93%, respectively. Wide resections of the neurovascular bundles in the area of capsule infiltration were performed in 23 patients with cancer at IFS; Five of these patients (21.7%) had cancer in the additional resected tissue. In 4 cases IFS was negative but at the permanent section a positive margin was found: in particular, 1 case of right/left inversion, 1 case of focal involvement present only in definitive sections and 2 cases of incorrect interpretation due to the irregular surgical margins. IFS decreased the overall positive surgical margins at the neurovascular bundles by 10% in our series. CONCLUSIONS: The use of IFS evaluation of the neurovascular bundles during laparoscopic radical prostatectomy is feasible, reproducible and has a relatively high negative predictive value. Therefore, IFS can help to increase chances of performing a good nerve sparing procedure in oncological safety and can be recommended as a tool to reduce the rate of positive surgical margins especially during the learning curve.
Eur Urol Suppl 2006;5(2):90
Institut Montsouris, Paris, France INTRODUCTION & OBJECTIVES: To evaluate objectively erectile function following Laparoscopic Radical Prostatectomy. MATERIAL & METHODS: We reviewed our prospective, quality of life data from database of 981 patients undergoing laparoscopic radical prostatectomy between September 2003 and October 2005. Patients completed IIEF-5 self-administered questionnaire prior to and at 3, 6, 12, 18, and 24 months following surgery. All patients were followed by the same two medical doctors (AM, NC) independent from the surgeons. Excluded from analysis were patients: living abroad (102), who underwent a non-nerve sparing procedure (94) or who denied interest in sexual relations (162). On post-operative day five, all patients initiated 10 mg oral Tadalafil therapy; this was continued every other day. Men who failed to achieve erections with oral therapy were then started on intracavernous injections (ICI) after either 3 or 6 months, depending upon patient interest. RESULTS: 623 patients underwent either a unilateral 165 (27%) or bilateral 458 (73%) nerve-sparing laparoscopic prostatectomy. The median age at surgery was 59,9 years. Preoperative sexual status: IIEF-5 > 20: 64% of patients; IIEF-5 10-20: 32%; IIEF-5< 10: 4%. 40 (6%) patients failed to comply with the Tadalafil regimen secondary to side effects or cost. At 6 months post-op, 70% of patient had started ICI therapy. Table shows the results after bilateral nerve sparing on 458 patients. of those patients at least 2 years from surgery, 63% are potent using no drug at all (median IIEF-5 – 20), 27% require intermittent oral Tadalafil (median IIEF-5 – 15) and 3% require intermittent ICI. Pre-op
6M
12M
18M
24M
IIEF5 (median)
> 20
5.5
13
17
20
% Potency
100%
29%
65%
75%
93%
IIEF5 (median)
10-20
5
5.5
8
8
% Potency
100%
21%
33%
76%
54%
CONCLUSIONS: Following nerve-sparing laparoscopic radical prostatectomy, erectile function continues to improve up to 2 years. Post-prostatectomy recovery of erectile function is best among men with a pre-operative erectile IIEF-5 score of > 20 and those undergoing bilateral nerve-sparing plus early medical therapy.
2
3
4
5
6
7
8
1
Secin F. , Abbou C.C. , Gill I. , Fournier G. , Piéchaud T. , Schullman C. , Turk I. , Janetschek G. , Karanikolas N. , Serio A.1, Vickers A.1, Touijer K.1, Guillonneau B.1 1
Memorial Sloan Kettering Cancer Center, Urology, New York, United States, 2Centre Hospitalier Universitaire Henri Mondor, Urology, Creteil, France, 3Urological Institute Cleveland Clinic Foundation, Urology, Cleveland, United States, 4 Hôpital De La Cavale Blanche, Urology, Brest Cédex, France, 5Clinique St. Augustin, Urology, Bordeaux, France, 6 Erasme Hospital, University Clinics of Brussels, Urology, Brussels, Belgium, 7Lahey Clinic, Urology, Burlington, United States, 8KH der Elisabethinen, Teaching Hosp. of University of Innsbruck, Urology, Linz, Austria INTRODUCTION & OBJECTIVES: There is no data regarding the incidence and variables associated with symptomatic deep venous thrombosis (DVT) and or pulmonary embolism (PE) in patients undergoing laparoscopic radical prostatectomy (LRP). Our objective was to report the multi-centric incidence and risk factors for perioperative symptomatic DVT and PE after LRP. MATERIAL & METHODS: Eight centres from both the USA and Europe participated. Inclusion criteria: All patients with symptomatic DVT and or PE taking place within 2 months of surgery since start of their respective LRP experience. Both diagnoses should have been confirmed by at least any of the following imaging studies: Doppler ultrasound and or venography for DVT; and Lung Ventilation/perfusion scan (V/Q), chest computed tomography (CT) and or pulmonary artery arteriography for PE. Estimation of incidences, comparison of proportions and logistic regression analysis were generated to find variables predicting DVT and PE. RESULTS: Fourteen of 3111 patients were diagnosed with symptomatic DVT (0.5%), of these, 5 developed PE, that is, 35% of patients with DVT (0.2% of the total patients). The median time to VDT diagnosis was 10 days (range, 1-32 days).
270 5-YEAR
BIOCHEMICAL
SPECIFIC
SURVIVAL
PROGRESSION
FOLLOWING
FREE AND
LAPAROSCOPIC
CANCER RADICAL
PROSTATECTOMY Rozet F., Braud G., Cathelineau X., Barret E., Harmon J., Almeida D., Vallancien G. IMM, Urology, Paris, France INTRODUCTION & OBJECTIVES: To assess the mid-term progression free probability after laparoscopic radical prostatectomy. MATERIAL & METHODS: From 1998 to 2005, 2600 laparoscopic prostatectomies were performed at our institution. Patient data was recorded prospectively. Analysis was conducted for only those patients having five years of follow-up. The first 100 patients, which represent the “discovery curve” of the 2 surgeons, were also excluded from the study. The absence of biochemical
Prophylaxis Leading Surgeon, Centre
Heparin
PCD/GCS*
DVT n
Patients n
DVT %
progression was defined by a PSA less than 0.2 ng/ml. RESULTS: 330 patients with at least 5 years follow-up were included in this
Preop
Postop
C. Abbou, Creteil, Fr
Yes
15 a / hosp
GCS
3
727
0.4
I. Gill, OH, USA
No
No
PCD
3
604
0.5
G. Fournier, Brest, Fr
Yes
10-21 days
GCS
3
348
0.9
study. The mean preoperative PSA was 10 ± 6 ng/ml and the mean number of positive biopsies was 2. According to the d’Amico criteria, 46% of patients were
T.Piéchaud, Bordeux, Fr
No
20 days
GCS
1
387
0.3
preoperatively stratified in the low risk group, 41% in the intermediate, and 13% in
C. Schullman, Brussels, Bel.
No
14 days
GCS
1
268
0.4
the high risk group. The incidence of positive margins for the pT2a, pT2b, pT2c,
I. Turk, MA, USA.
Yes
No
PCD
1
266
0.4
pT3a, and pT3b was 5, 18, 21, 30, and 11%, respectively. No cases of port seeding
G.Janetschek, Linz, Austria
Yes
9 days
GCS
0
100
0
B. Guillonneau, NY, USA
Yes
until d/c
PCD
2
411
0.5
14
3111
0.5
Total
or peritoneal carcinosis have been reported. The 5-year biochemical progression free survival for the low, intermediate, and high risk groups was 86, 68, and 43%
* PCD: pneumatic compressive devices; GCS: gradual compressive stockings
respectively. For patients without positive margins, the biochemical progression free
Patient re exploration was the only variable significantly associated with increased risk of symptomatic DVT (p=0.01). Transperitoneal approach (p=0.07), tobacco exposure (p=0.07) and prior history of DVT (p=0.09) approached significance. The non use of perioperative heparin was not a risk factor (p=0.7). No deaths related to the thromboembolic event were reported.
survival was 81% compared to 41% for those with positive margins (p<0.0001).
CONCLUSIONS: The incidence of symptomatic DVT in LRP was less than 1%, despite different types of prophylaxis. The lack of obvious differences in DVT rates between the different prophylactic regimens suggests that the value of heparin for low risk patients undergoing LRP should be reconsidered. A multicentric prospective randomised study will be required to determine the need for thromboembolic prophylaxis in patients undergoing LRP.
The 5-year cancer specific survival was 99%. CONCLUSIONS: The laparoscopic radical prostatectomy offers 5 years cancer control similar to that of the open technique.
271 VALUE OF FROZEN SECTIONS DURING LAPAROSCOPIC RADICAL PROSTATECTOMY
NERVE-SPARING
Naspro R.1, Guazzoni G.2, Freschi M.3, Cestari A.2, Salonia A.2, Buffi N.2, Montorsi F.2, Rigatti P.2 Università Vita-Salute, San Raffaele Hospital, Urology, Milan, Italy, 2Univeristà Vita-Salute, San Raffaele Hospital, Urology, Milan, Italy, 3Univeristà Vita-Salute, San Raffaele Hospital, Pathology, Milan, Italy
272 EVALUATION OF SEXUAL ACTIVITY AFTER RADICAL PROSTATECTOMY
LAPAROSCOPIC
Mombet A., Cathala N., Giuliano F., Prapotnich D., Cathelineau X., Rozet F., Barret E., Vallancien G.
1
INTRODUCTION & OBJECTIVES: A prospective study to assess feasibility and value of intraoperative frozen section (IFS) during nerve sparing transperitoneal laparoscopic radical prostatectomy for clinically localised prostate cancer. MATERIAL & METHODS: From September 2004 to August 2005, 85 consecutive patients underwent laparoscopic radical prostatectomy with bilateral or monolateral nerve sparing technique at our Department. Once removed, the prostate was inked bilaterally starting from the base to apex in the bundles area. The specimen was then sent to the pathologist who cut the inked areas for 0,5-0,6 cm in depth, performed serial sections of 0.2-0.3 cm wide that were embedded in OCT compound to obtain frozen sections of 5 microns stained with Hematoxylin and Eosin and analysed under the microscope. When a positive margin occurred at IFS the corresponding neurovascular bundle was excised intra-operatively after the completion of the urethro-vesicle anastomosis. RESULTS: Patients age was 62,3±7.4 (mean±SD) and pre-operative total PSA values (mean±SD) were 6.1±2.5ng/dl. The mean volume of the prostates was (mean±SD) 82.5±24.5 gr. Bilateral and monolateral nerve sparing was performed in 72 (84.7%) and in 13 (17.3%) cases, respectively. Overall operative time was (mean±SD) 235±49.9 min and the extra time to remove additional tissue when positive margin was (mean±SD) 12±5 min. Post-operative Gleason score was <7 and >7 in 70 (82.3%) and 15 (17.6%) cases, respectively. Pathological stage was: 69 (81.1%) cases of T2 and 16 (18.8%)cases of pT3. The accuracy, sensitivity, specificity, positive and negative predictive value of IFS performed at the neurovascular bundle to predict cancer in the permanent section was 94%, 81%, 97%, 78%, and 93%, respectively. Wide resections of the neurovascular bundles in the area of capsule infiltration were performed in 23 patients with cancer at IFS; Five of these patients (21.7%) had cancer in the additional resected tissue. In 4 cases IFS was negative but at the permanent section a positive margin was found: in particular, 1 case of right/left inversion, 1 case of focal involvement present only in definitive sections and 2 cases of incorrect interpretation due to the irregular surgical margins. IFS decreased the overall positive surgical margins at the neurovascular bundles by 10% in our series. CONCLUSIONS: The use of IFS evaluation of the neurovascular bundles during laparoscopic radical prostatectomy is feasible, reproducible and has a relatively high negative predictive value. Therefore, IFS can help to increase chances of performing a good nerve sparing procedure in oncological safety and can be recommended as a tool to reduce the rate of positive surgical margins especially during the learning curve.
Eur Urol Suppl 2006;5(2):90
Institut Montsouris, Paris, France INTRODUCTION & OBJECTIVES: To evaluate objectively erectile function following Laparoscopic Radical Prostatectomy. MATERIAL & METHODS: We reviewed our prospective, quality of life data from database of 981 patients undergoing laparoscopic radical prostatectomy between September 2003 and October 2005. Patients completed IIEF-5 self-administered questionnaire prior to and at 3, 6, 12, 18, and 24 months following surgery. All patients were followed by the same two medical doctors (AM, NC) independent from the surgeons. Excluded from analysis were patients: living abroad (102), who underwent a non-nerve sparing procedure (94) or who denied interest in sexual relations (162). On post-operative day five, all patients initiated 10 mg oral Tadalafil therapy; this was continued every other day. Men who failed to achieve erections with oral therapy were then started on intracavernous injections (ICI) after either 3 or 6 months, depending upon patient interest. RESULTS: 623 patients underwent either a unilateral 165 (27%) or bilateral 458 (73%) nerve-sparing laparoscopic prostatectomy. The median age at surgery was 59,9 years. Preoperative sexual status: IIEF-5 > 20: 64% of patients; IIEF-5 10-20: 32%; IIEF-5< 10: 4%. 40 (6%) patients failed to comply with the Tadalafil regimen secondary to side effects or cost. At 6 months post-op, 70% of patient had started ICI therapy. Table shows the results after bilateral nerve sparing on 458 patients. of those patients at least 2 years from surgery, 63% are potent using no drug at all (median IIEF-5 – 20), 27% require intermittent oral Tadalafil (median IIEF-5 – 15) and 3% require intermittent ICI. Pre-op
6M
12M
18M
24M
IIEF5 (median)
> 20
5.5
13
17
20
% Potency
100%
29%
65%
75%
93%
IIEF5 (median)
10-20
5
5.5
8
8
% Potency
100%
21%
33%
76%
54%
CONCLUSIONS: Following nerve-sparing laparoscopic radical prostatectomy, erectile function continues to improve up to 2 years. Post-prostatectomy recovery of erectile function is best among men with a pre-operative erectile IIEF-5 score of > 20 and those undergoing bilateral nerve-sparing plus early medical therapy.