Transcript median, range - Università degli Studi di Milano

18 Novembre 2011 – Università MilanoBicocca GIORNATA DELLA RICERCA
OCCLUSIONE COLICA: LO STENT VS.
L’INTERVENTO CHIRURGICO IN URGENZA
N Tamini, L Gianotti, L Nespoli, E Bolzonaro, R Frego, A Redaelli, A
Ardito, A Nespoli, M Dinelli
Dipartimento di Chirurgia
Università Milano – Bicocca
Ospedale S. Gerardo
Monza
BACKGROUND
•
Up to 20% of patients with colonic cancer are admitted with symptoms of acute
obstruction
•
The majority of cases of acute colonic obstruction is due to colorectal cancer
•
Emergency surgery for acute colonic obstruction is associated with a significant
risk of mortality and morbidity and with a high percentage of stoma creation
(either temporary or permanent)
•
Colon stenting may represent a valuable option both for palliation and as a bridge
to elective surgery.
Phillips RK - Br J Surg 1985.
Mella J - Br J Surg 1997
Serpell JW - Br J Surg 1989.
Umpleby HC - Dis Colon Rectum 1984
Ansaloni - World Journal of Emergency Surgery 2010
Khot UP - Br J Surg 2002
Breitenstein S. - Br J Surg 2007
Villar JM - Surg Today 2005
January 2005-April 2011
Non resectable
n = 34
Patients admitted with
large bowel obstruction
n = 157
Clinical evaluation
and staging
n = 134
Excluded from analysis
for perforation-peritonitis
n = 23
Resectable
n = 100
Surgeon judgment
SEMS
Successful
n = 32
Unsuccessful
n=2
Emergency operation
with palliative intent
Oncology
Emergency
operation
n = 49+2
SEMS attempt
as a bridge to
elective operation
n = 51
Unsuccessful
n=2
Successful
n = 49
Elective operation
n = 49
Oncology
Non resectable patients (palliation)
• Bilobar multiple liver metastasis or involving
the hepatic hileum or veins
• Lung metastasis
• Peritoneal carcinomatosis
• ASA > 4
• Karnofsky < 30
• Child C
Baseline characteristics of patients with SEMS placement (n=81)
Age [median, range], yr
70 (25-96)
Sex (male, %)
53 (65.4)
BMI [median, range], kg/m²
Weight loss > 10% in the last 6 months, n° (%)
23.4 (15.4-46.9)
38 (46.9)
Co-morbidity, n° (%)
Diabetes
12 (14.8)
Cardiovascular
54 (66.6)
Respiratory
21 (25.9)
Neurological
10 (12.3)
Gastrointestinal
26 (30.1)
Others
28 (34.6)
Site of obstruction, n°(%)
Left colon
29 (35.8)
Rectosigmoid
45 (55.6)
Transverse colon
6 (7.4)
Right colon
1 (1.2)
Primary cause of obstruction, n° (%)
Cancer
74 (91.3)
IBD
2 (2.5)
Diverticular disease
4 (4.9)
Adhesion
1 (1.2)
Type of stricture, n° (%)
Incomplete
45 (55.5)
Complete
36 (44.5)
Difficult SEMS placement, n° (%)
35 (43.2)
Length of procedure [median-range], min
30 (15-75)
Time from haspital admission to SEMS placement, Days
1 (0-18)
[median, range]
Cancer staging, n° (%)
II
16 (20.8)
III
23 (31.1)
IV
35 (47.3)
Succesful , n° (%)
Technical
81 (95.3)
Clinical
80 (98.7)
Time from SEMS to bowel canalization, hrs [median, range]
26 (6-72)
Short-term complications of SEMS (n=81)
Type of complication
Bowel perforation, n° (%)
1 (1.2)
Stent migration, n° (%)
4 (4.9)
Stent occlusion, n° (%)
3 (3.7)
Arrhythmia, n° (%)
1 (1.2)
Colorectal bleeding, n° (%)
4 (4.9)
Abdominal or rectal pain, n° (%)
6 (7.4)
Overall number of complicated patients
12 (14.8)
Baseline characteristics of
palliative patients (n=32)
Age, y, median (range)
79 (35-93)
Sex, male, no. (%)
23 (71.9%)
BMI, median (range)
23.1 (15.4-46.9)
Weight loss, no. (%)
20 (62.5%)
Comorbidities, no. (%)
Diabetes 6 (18.8%)
Cardiovascular 24 (75.0%)
Respiratory 9 (28.1%)
Gastrointestinal 17 (53.1%)
Others 15 (46.9%)
Site of obstruction, no. (%)
Right colon 1 (3.1%)
Transverse colon 3 (9.4%)
Left colon 9 (28.1%)
Rectosigmoid 19 (59.4%)
Primary cause of obstruction, no. (%)
Cancer 29 (90.6%)
Inflammatory bowel disease 2 (6.3%)
Diverticular disease 0 (0.0%)
Adhesion 1 (3.1%)
Type of stricture, n° (%)
Complete
Incomplete
15 (46.9)
17 (53.1)
Cancer staging, no. (%)
1 0 (0.0%)
2 0 (0.0%)
3 6 (20.7%)
4 23 (79.3%)
Time from hospital admission to SEMS placement, days,
2 (0-18)
median (range)
Procedure time, min, median (range)
26 (20-45)
SEMS placement difficulties, no. (%)
14 (43.8%)
Long-term complications of SEMS (n=32)
Median follow-up: 19 months (95%CI 16-22)
Type of complication
Bowel perforation, n° (%)
1 (3.1)
SEMS migration, n° (%)
4 (12.5)
SEMS occlusion, n° (%)
3 (9.4)
Tenesmus, n° (%)
7 (21.8)
Recurrent abdominal pain, n° (%)
7 (21.8)
Colorectal bleeding, n° (%)
8 (25.0)
Clinical successful, n° (%)
26 (81.2)
Overall number of compicated patients, n° (%)
14 (43.8)
Hospital readmission, n° (%)
11 (34.4)
Long-term survival (Kaplan-Meier curve)
Palliation
Stent “bridge” V.S. Chirurgia d’urgenza:
3 RCT
Results
PRIMARY OUTCOME
STOMA PLACEMENT: ES n=17 (57%) versus SEMS n=13 (43%) (p=0.30)
STOMA CLOSURE: ES n=9 (30%) versus SEMS n=4 (13%) (p=0.12)
SECONDARY OUTCOME
No statistically significant
ENDOSCOPIC PROCEDURE
Successo Tenico n=14 (47%)
Successo clinico n=12 (40%)
Technical failure  n=16 (53%)
- 13 impossibile superare la
stenosi con filo guida
- 1 malfuzionamento stent
- 2 perforazioni
These major side effects, associated with the unexpected high rate of technical failures, led the steering committee to
interrupt the trial after 65 patient inclusions.
Results
•
PRIMARY OUTCOME: no difference in global health status
between the treatment groups
•
SECONDARY OUTCOMES: no differences in the secondary
outcomes of mortality and morbidity between study groups
STOMA RATE: After the first operation:
SEMS 24/48 vs ES 38/51 (p=0.016)
After 6 months fup:
SEMS 27/47 vs ES 34/51 (p=0.35)
•
STENTING PROCEDURE:
- Technical success 33/47 (70.2%) = clinical success
- SEMS-related perforations: 6/47 (12.8%)
Baseline characheristics of resectable patients who underwent surgery
SEMS
n=49
NO SEMS
n=51
P VALUE
Age [median, range],yrs
69 (28-96)
72 (40-95)
0.09
Sex (male, %)
30 (61)
29 (57)
0.66
BMI, kg/m²
24.1 ± 3.7
23.8 ± 4.2
0.70
Weight loss
18 (36)
24 (47)
0.30
0.18
Co-morbidity, n° (%)
Diabetes
6 (12.2)
5 (9.8)
Cardiovascular
30 (61.2)
25 (49.0)
Respiratory
12 (24.4)
8 (15.7)
Gastrointestinal
19 (38.8)
11 (21.5)
Neurologic
4 (8.2)
3 (5.9)
Others
3 (6.1)
5 (9.8)
Hemoglobin, [mean±SD], g/dL
SEMS
n=49
13.7±1.6
NO SEMS
n=51
13.0±1.8
Albumin, [mean±SD], g/dL
3.8±0.3
3.7±0.4
0.23
Cholinestarase, [mean±SD], UI/mL
6107±1904
6008±2176
0.10
White cell, [mean±SD], 103 cells/mL
9.5±3.5
10.7±4.9
0.15
0.07
0.77
Primary cause of obstruction, n° (%)
Cancer disease
45 (91.8)
46 (90.2)
IBD
0
1 (1.9)
Diverticular disease
4 (4.4)
2 (3.9)
Adhesion
0
2 (3.9)
0.71
Type of stricture, n° (%)
Complete
Incomplete
Time from admission to surgery, days
[median,range]
P VALUE
21 (42.8)
28 (57.2)
19 (37.2)
32 (62.8)
6 (2-20)
2 (0-23)
0.003
Type of resection and surgery, n° (%)
Left colon
Rectum
Transverse colon
Right colon
Primary anastomosis
Diverting ileostomy
Laparotomy/laparoscopy, n°
Length of operation [median, range], min
SEMS
n=49
NO SEMS
n=51
P VALUE
35 (71.4)
9 (18.4)
3 (6.1)
1 (2.0)
48 (97.9)
4 (10.2)
30/19
31 (60.8)
4 (7.8)
3 (5.9)
4 (7.8)
44 (86.3)
9 (17.6)
51/0
0.37
0.20
0.70
0.38
0.03
0.44
0.0001
160 (105-430)
195 (65-560)
0.3138
Nodes harvested, median (range)
23 (10-41)
18 (5-35)
0.08
Positive nodes, median (range)
7 (0-12)
5 (0-12)
0.10
Microperforation by pathology, n° (%)
2 (4.1)
4 (7.8)
0.18
0.75
Tumor staging, n° (%)
II
III
IV
11 (24.4)
22 (48.9)
12 (26.7)
12 (26.1)
19 (41.3)
15 (30.6)
21 (46.6)
17 (36.9)
0.33
Time from surgery to CT initiation [mean, SD], days
64 (42)
101 (107)
0.19
CT interruption, n° (%)
2 (4.4)
4 (8.7)
0.20
Chemotherapy, n° (%)
SEMS
NO SEMS
P value
0.0002
ASA Score, n° (%)
II
40 (81.6)
22 (43.1)
III
9 (18.4)
23 (45.1)
IV
0
6 (11.8)
Short-term outcomes of resectable patients who underwent surgery
SEMS
NO SEMS
n=49
n=51
P VALUE
Resumption of oral feeding, days, median (range)
5 (2-12)
6 (3-12)
0.0654
Canalization to GAS, days, median (range)
3 (0-6)
3 (0-9)
0.2152
Canalization to faeces, days, median (range)
4 (0-9)
5 (1-12)
0.7700
10 (20.4%)
26 (51.0%)
0.0018
1 (2.0%)
7 (13.7%)
0.0399
17 (34.7%)
30 (58.8%)
0.0177
4 (8.2%)
15 (29.4%)
0.0098
13 (26.5%)
28 (54.9%)
0.0047
4 (8.2%)
8 (15.7%)
0.3580
Need of parenteral nutrition, no. (%)
Hartmann resection, no. (%)
Blood transfusion, no. (%)
Electrolyte abnormality, no. (%)
Wound infections, no. (%)
Urinary tract infections, no. (%)
SEMS
NO SEMS
n=49
n=51
P VALUE
Intra-abdominal abscess, no. (%)
7 (14.3%)
20 (39.2%)
0.0066
Anastomotic leak, no. (%)
6 (12.2%)
10 (19.6%)
0.4157
Peritonitis, no. (%)
2 (4.1%)
5 (9.8%)
0.4367
Septic shock, no. (%)
2 (4.1%)
6 (11.8%)
0.2695
Respiratory tract complications, no. (%)
5 (10.2%)
19 (37.3%)
0.0020
Need of ICU transfer, no. (%)
5 (10.2%)
17 (33.3%)
0.0073
Re-operation, no. (%)
3 (6.1%)
10 (19.6%)
0.0521
Post-operative LOS, days, median (range)
10 (4-30)
15 (4-125)
0.0001
Overall LOS, days, median (range)
18 (10-39)
19 (8-128)
0.2190
Overall number of complicated patients, no. (%)
16 (32.7%)
31 (60.8%)
0.0055
1 (2.0%)
1 (2.0%)
1.0000
In hospital mortality, no. (%)
ROC curve on surgical complications and time
interval from SEMS placement to operation
Long-term complications of patients who underwent surgery
(median follow-up = 43.5 months)
SEMS
NO SEMS
P VALUE
n=48
n=50
New episode of intestinal obstruction, n° (%)
3 (6.3%)
5 (10.0%)
0.4832
Recurrent abdominal pain, no. (%)
6 (12.5%)
12 (24.0%)
0.1933
Incisional hernia, no. (%)
3 (6.3%)
11 (22.0%)
0.0410
Permanent stoma, no. (%)
3 (6.3%)
13 (26.0%)
0.0124
GI bleeding, no. (%)
4 (8.3%)
6 (12.0%)
0.7410
Tenesmus, no. (%)
4 (8.3%)
4 (8.0%)
1.0000
New hospital admissions, no. (%)
11 (22.9%)
17 (34.0%)
0.2673
Overall number of complicated patients, no. (%)
12 (25.0%)
18 (36.0%)
0.2773
Long-term survival (Kaplan-Meier curve)
SEMS
NO SEMS
Log-rank
Conclusioni
• L’uso di SEMS per trattare l’occlusione colica è
sicuro, fattibile ed efficace (esperienza
endoscopista)
• SEMS per palliazione sembra promettente ma
sono necessari ulteriori dati
• SEMS “as a bridge to elective surgery”
dovrebbe essere considerata l’opzione
ottimale.