A prospective evaluation of short-term and long

Surg Endosc
DOI 10.1007/s00464-012-2520-0
and Other Interventional Techniques
A prospective evaluation of short-term and long-term results
from colonic stenting for palliation or as a bridge to elective
operation versus immediate surgery for large-bowel obstruction
Luca Gianotti • Nicolò Tamini • Luca Nespoli • Matteo Rota •
Elisa Bolzonaro • Roberto Frego • Alessandro Redaelli •
Laura Antolini • Antonella Ardito • Angelo Nespoli • Marco Dinelli
Received: 29 March 2012 / Accepted: 31 July 2012
Ó Springer Science+Business Media, LLC 2012
Abstract
Background The efficacy and safety of self-expandable
metallic stent (SEMS) placement as a bridge to elective
surgery or definitive palliation versus emergency operation
to treat colorectal obstruction is debated. This study aimed
to evaluate the outcomes of patients with colorectal
obstruction treated using different strategies.
Methods Subjects admitted to the authors’ department
with colorectal obstruction (n = 134) were studied prospectively. They underwent endoscopic stenting as a bridge
to elective surgery (SEMS group: n = 49) or for definitive
palliation (n = 34). A total of 51 patients underwent
immediate surgery without stenting (NO-SEMS). Treatment was decided by the senior on-call surgeon.
Results Placement of SEMS was technically successful in
95.3 % and clinically successful in 98.7 % of cases. The
short-term complications in the SEMS group were
L. Gianotti (&) N. Tamini L. Nespoli E. Bolzonaro A. Ardito A. Nespoli
Department of Surgery, University of Milano-Bicocca,
San Gerardo Hospital, Via Pergolesi 33,
20900 Monza, Italy
e-mail: [email protected]
M. Rota L. Antolini
Department of Clinical Medicine and Prevention,
Centre of Biostatistics for Clinical Epidemiology,
University of Milano-Bicocca, Monza, Italy
R. Frego A. Redaelli M. Dinelli
Unit of Digestive Endoscopy, Department of Internal Medicine,
San Gerardo Hospital, Monza, Italy
A. Ardito
Division of Surgical Oncology, IRCCS Istituto Clinico
Humanitas, Rozzano, Italy
perforation (n = 1, 1.2 %), migration (n = 4, 4.9 %),
occlusion (n = 4, 4.9 %), colon bleeding (n = 3, 3.7 %),
and abdominal pain (n = 6, 7.4 %). The postoperative
complication rate was 32.7 % in the SEMS group versus
60.8 % in the NO-SEMS group (P = 0.005), with a significant reduction in wound infections (26.5 vs 54.9 %;
P = 0.004), abdominal abscess (14.3 vs 39.2 %; P =
0.006), respiratory morbidity (10.2 vs 37.3 %; P = 0.002),
and intensive care treatment (10.2 vs 33.3 %; P = 0.007).
The median postoperative hospital stay was 10 versus
15 days (P = 0.001). The in-hospital mortality rate in both
groups was 2 %. Long-term follow-up evaluation showed
less incisional hernia (6.3 vs 22.0 %; P = 0.04) and
definitive stoma formation (6.3 vs 26.0 %; P = 0.01) in the
SEMS group than in the NO-SEMS group, respectively.
Kaplan–Meier survival curves showed a benefit for the
SEMS group (log-rank test, 0.004). The long-term SEMSrelated complication rate for the palliative patients was
43.8 %. The hospital readmission rate for SEMS complications was 34.4 %. Overall clinical success was 81.2 %.
Conclusions In case of colorectal obstruction, endoscopic
colon stenting as a bridge to elective operation should be
considered as the treatment of choice for resectable patients
given the significant advantages for short- and long-term
outcomes. Palliative stenting is effective but associated
with a high rate of long-term complications.
Keywords Colon Endoscopy Obstruction Outcome Stent Surgery
Despite the worldwide implementation of screening programs, approximately one fifth of colorectal cancer diagnoses still are made in emergency settings by the appearance
of large bowel obstruction [1–3]. Regardless of disease
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stage, bowel decompression and restoration of intestinal
patency must be performed immediately to alleviate the risk
of bowel perforation and gut-derived sepsis [4]. The two
main treatment options are emergency surgery and endoscopic placement of a colon self-expandable metallic stent
(SEMS) [1, 5–8].
For patients with resectable disease, the intent should
always be a complete local radical resection that can be
achieved by either strategy [5–8]. However, the optimal
choice still is a matter of debate. The use of SEMS as a
bridge to elective surgery appears superior to emergency
surgery considering the short-term outcomes in observational studies [9–13], whereas randomized trials report
inconsistent results [14–17]. Moreover, long-term oncologic studies comparing the two options are sparse [13, 18,
19]. Among stage 4 patients, a high rate of severe complications with SEMS led to the early closure of a multicenter trial [20]. Another study [21] reported a long-term
clinical failure rate exceeding 50 % for SEMS placed to
achieve palliation.
The uncertainty in recent guidelines [8] suggests that
additional comparative trials need to be performed before
any conclusion can be reached. Furthermore, few studies
have evaluated contemporaneous short- and long-term
outcomes of SEMS versus various surgical options, or have
investigated cancer-related survival of resectable patients
treated with different strategies.
The current study aimed to evaluate the short- and longterm outcomes of patients admitted with large bowel
obstruction and treated with different methods.
Fig. 1 Flowchart of patient
treatment according to initial
disease and clinical judgment
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Materials and methods
Patients
This report follows the strengthening the reporting of
observational studies in epidemiology (STROBE) statement [22].
The baseline, surgical, endoscopic, oncologic, and followup characteristics of all patients with a clinical and radiologic
diagnosis of large bowel obstruction (eligible patients)
admitted to the Department of Surgery of Milano-Bicocca
University, Monza, Italy were collected prospectively in an
electronic database from April 2004 to 2011. Patients
admitted with clinical and radiologic signs of perforation or
peritonitis were excluded from this analysis (Fig. 1). The
ethics committee of Milano-Bicocca University approved the
electronic registration of patient data.
The follow-up evaluation of patients was conducted
during routine office visits (every 3 months during the first
year and every 6 months thereafter) and telephone interviews. Oncologists collected relevant variables related to
chemotherapy and survival.
Treatment
Eligible patients underwent a complete physical examination and a chest-abdomen-pelvis computed tomography
(CT) scan with intravenous contrast infusion for disease
staging. A water-soluble contrast enema also was performed.
Surg Endosc
All the participating surgeons agreed to consider a
patient as nonresectable if that patient presented with an
advanced metastatic disease (bilobar multiple liver metastases or a tumor involving the hepatic hilum or veins, lung
metatases, or peritoneal carcinomatosis) or a severe
comorbidity [American Society of Anesthesiology (ASA)
class [4, Karnofsky performance score B20, or Child
Turcotte Pugh class C] that could greatly increase the risk
of perioperative mortality or have a negative prognostic
impact on life expectancy. If those conditions were
excluded, a patient was considered to have a potentially
curable disease by surgery and neoadjuvant therapy
(resectable patient). All patients considered unresectable
underwent attempted SEMS placement.
The decision to refer a patient for immediate surgery or for
SEMS placement with a later elective operation was made by
the senior on-call surgeon (Fig. 1). All surgical procedures
were performed by general surgeons who had experience
with more than 100 colorectal resections. However, none of
them was a dedicated colorectal specialist. Ten surgeons
were involved in the decision-making process.
The type of operation and the technique to be used were
determined by the surgeon according to the location of the
primary disease and the intraoperative conditions. The
interval from SEMS placement to elective surgery also was
chosen by the attending surgeon based on clinical condition
and bowel function.
All the patients undergoing elective surgery after successful SEMS placement received bowel preparation with
2 l of an iso-osmotic solution the evening before the operation, whereas the patients who underwent urgent procedures
were treated with intraoperative colonic washout.
All the patients received preoperative antibiotic prophylaxis with a single dose of cefotetan (2 g) 30 min before
the induction of anesthesia. Antibiotic administration was
repeated if the operation lasted more than 3 h. In case of
intraabdominal contamination, antibiotic therapy was continued according to the surgeon’s prescription. Deep vein
thrombosis prophylaxis was provided by administration of
low-molecular-weight heparin (50 IU/kg/day).
Endoscopic technique
After CT scan and water-soluble contrast enema, the
patients underwent colonoscopy. Sedation was achieved by
meperidine (0.5 mg/kg) and midazolam (1 mg). If needed,
propofol (3 mg/kg) infusion was used under anesthetist
supervision. The attending surgeon was always present
during the procedure.
All procedures were performed by three endoscopists
expert with SEMS procedures (experience: 207 cases of biliary SEMS, 52 cases of gastroduodenal SEMS, and 106 cases
of esophageal SEMS) in an endoscopic room dedicated to
radiology-assisted procedures and under fluoroscopic guidance. A standard colonoscope (Pentax EC3470FR, Pentax
Europe GmbH, Hamburg, Germany) with an operating
channel large enough to accept the stent, or in case of rectal
stricture, a large channel gastroscope (Pentax EG3430K,
Pentax Europe GmbH, Hamburg, Germany) was used.
With the patient lying on the left side, the endoscope
was advanced to the point of stricture, and multiple biopsies were taken. Attempts to advance past the stricture were
made if a residual lumen was recognized. Contrast medium
was injected through a standard endoscopic retrograde
cholangiopancreatography (ERCP) multi-lumen catheter to
study the length and diameter of the stricture. If no obvious
lumen was visible or there was a tight angulation, we used
a papillotome exploiting the angulation to pass a standard
guidewire (0.7 mm) through the stricture. A stiff Amplatzlike guidewire was used in the case of angulated or long
stricture or difficult relative position of the endoscope.
Contrast medium was injected to confirm the correct
luminal position of the guidewire. Balloon dilation of the
stricture was never attempted. Next, a 3.3-mm coaxial
release system was passed on the guidewire, and a nitinol
uncovered stent was inserted through the working channel
of the endoscope, advanced over the stricture, and finally
deployed under fluoroscopic guidance. According to the
length of the stricture, either an 80- or 110-mm stent length
(Hanarostent NNN; M.I.Tech Co., Gyeonggi-Do, Korea)
was used. The diameter was always 22 mm.
The procedure was stopped in cases of significantly
varied patient vital signs, uncontrolled pain, or significant
abdominal distension, or if the relative position between
the colonoscope and the visible part of the stricture was not
stable. At the end of the procedure, the endoscopist scored
the procedure as ‘‘difficult’’ or ‘‘not difficult.’’ After 24 h, a
plain abdominal X-ray was taken to check the correct
SEMS position and to exclude signs of perforation.
Definitions
For the patients who underwent a SEMS placement
attempt, technical success was defined as passage of the
stent across the neoplastic stricture. Clinical success was
defined as colonic decompression and relief of obstructive
symptoms within 24 h for those patients who had SEMS
placed. Late success was defined as maintenance of colonic
decompression without recurrence of obstruction for
60 days after discharge. Early complications were defined
as those occurring within 30 days after hospital discharge,
and late complications were defined as those occurring
more than 30 days after discharge. The occurrence of
complications was documented after discharge during
regular office visits. Overall survival was calculated for
cancer patients only from the time of diagnosis to death.
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Complete obstruction was defined as no passage of
water-soluble contrast during enema through the stricture
or invisible lumen during colonoscopy and based on a
patient history that included no passage of flatus or stools
in the preceding 12 h.
Statistical analysis
Patient characteristics were analyzed by descriptive statistics. For continuous variables, the median and range
were calculated. For discrete (categorical) variables,
numbers and percentages in each category were recorded.
The characteristics of the SEMS and NO-SEMS groups
were compared using the nonparametric Wilcoxon ranksum test for continuous variables and Fisher’s exact test for
categorical variables. Survival time was calculated from
surgery to death or to the date of the last follow-up visit up
to 36 months. No patient was lost to follow-up evaluation.
The Kaplan–Meier method was applied to estimate the
overall survival curves and the median survival times of the
SEMS, NO-SEMS, and palliative groups. The nonparametric log-rank test was used to compare SEMS and
NO-SEMS survival curves.
The receiver operating characteristic (ROC) curve
anaysis was performed to indetify a potential optimal
threshold time from SEMS placement to elective operation.
Risk factors related to surgical morbidity [age, sex, body
mass index (BMI), weight loss, ASA score, comorbidity,
site of obstruction, primary cause of obstruction, type of
stricture, cancer staging, time from hospital admission to
surgery, SEMS placement difficulty, length of surgery,
SEMS procedure] were assessed by means of a multivariate
stepwise logistic regression model. A stepwise Cox proportional hazard model also was performed to determine
factors related to overall survival of resectable patients
(age, sex, BMI, weight loss, ASA class, comorbidity, site
of obstruction, primary cause of obstruction, cancer staging, microperforation, positive nodes, time from hospital
admission to SEMS placement, site of obstruction, SEMS
placement difficulty, length of surgery, surgical outcomes,
type of complications, hospital length of stay (LOS), chemotherapy, interval from surgery to chemotherapy, chemotherapy interruption).
In both models, the stepwise procedure added the
independent variables to the model one at a time by
simultaneous removal of variables if the retention criterion
of a P value at 0.05 or lower was not met.
All P values lower than 0.05 were considered statistically significant, and all performed tests were two sided.
All statistical analyses were performed with SAS 9.1.3
(SAS Institute, Cary, NC, USA).
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Results
Short-term outcome of SEMS
Placement of SEMS was attempted in 85 cases. Technical
success was obtained in 95.3 % (81/85) of the cases.
Failure occurred for two resectable patients and two nonresectable patients. These four patients underwent surgery
(2 definitive ileostomies for palliation and 2 colon resections). All unsuccessful procedures occurred in cases of
complete obstruction by neoplastic stricture.
The baseline characteristics of the patients who had
technically successful SEMS placement are reported in
Table 1 Baseline characteristics of 81 patients who underwent selfexpandable metallic stent (SEMS) placement
Median age: years (range)
70 (25–96)
Male sex: n (%)
53 (65.4)
Median BMI: kg/m2 (range)
23.4
(15.4–46.9)
Weight loss [10% in the last 6 months: n (%)
38 (46.9)
Comorbidities (n)
Diabetes
12
Cardiovascular
44
Respiratory
21
Neurological
10
Gastrointestinal
16
Others
18
Site of obstruction: n (%)
Right colon
1 (1.2)
Transverse colon
6 (7.4)
Left colon
Rectosigmoid
29 (35.8)
45 (55.6)
Primary cause of obstruction: n (%)
Cancer
74 (91.4)
IBD
2 (2.5)
Diverticular disease
4 (4.9)
Adhesion
1 (1.2)
Cancer stage: n (%)
2
16 (19.7)
3
23 (31.1)
4
35 (47.3)
Type of stricture: n (%)
Complete
Incomplete
38 (46.9)
43 (53.1)
Median time from hospital admission to SEMS
placement: days (range)
1 (0–18)
Median time from SEMS placement to bowel
canalization: h (range)
26 (6–72)
Median length of procedure: min (range)
30 (15–75)
SEMS placement difficulties: n (%)
35 (43.2)
BMI body mass index, IBD inflammatory bowel disease
Surg Endosc
Table 2 Short-term complications of self-expandable metallic stent
(SEMS) placement (n = 81)
Type of complication
n (%)
Bowel perforation
1 (1.2)
SEMS migration
4 (4.9)
SEMS occlusion
4 (4.9)
Tenesmus
1 (1.2)
Abdominal-rectal pain
6 (7.4)
Colorectal bleeding
3 (3.7)
Cardiac arrhythmia
Overall no. of SEMS complicated patients
1 (1.2)
12 (14.8)
Table 1. Clinical success was achieved in 98.7 % (80/81)
of the cases.
The short-term complications of the procedure are
shown in Table 2. Stent occlusion always resulted from
stool impaction and was treated by endoscopically guided
Table 3 Baseline characteristics of 32 patients who underwent
self-expandable metallic stent (SEMS) placement for palliation
Median age: years (range)
79 (35–93)
Male sex: n (%)
23 (71.9)
Median BMI: kg/m2 (range)
Weight loss [10% in the last 6 months: n (%)
23.1 (15.4–46.9)
20 (62.5)
Comorbidities, no.
Diabetes (n)
6
Cardiovascular (n)
24
Respiratory (n)
9
Neurologic (n)
6
Gastrointestinal (n)
7
Others (n)
4
Site of obstruction: n (%)
Right colon
1 (3.1)
Transverse colon
3 (9.4)
Left colon
9 (28.1)
Rectosigmoid
19 (59.4)
Primary cause of obstruction: n (%)
Cancer
29 (90.6)
IBD
Adhesion
2 (6.3)
1 (3.1)
Cancer staging: n (%)
colon irrigation. In all cases of acute stent migration,
SEMS was immediately replaced successfully. Patients
with colorectal bleeding did not require endoscopic
hemostasis or blood transfusion. We correlated any type of
short-term complications with SEMS placement procedure difficulty, but no significant associations were found
(minimum P = 0.19).
Long-term outcome of SEMS
The indicator leading to palliative SEMS was a nonresectable cancer in 81.2 % (26/32) of cases and severe
comorbidity in 18.8 % (6/32) of cases. The baseline characteristics of these patients are reported in Table 3.
The type and rate of SEMS-related complications are
reported in Table 4. The median interval between SEMS
placement and the occurrence of stent-related complications was 116 days (range, 37–350 days). Hospital readmission for a SEMS-related complication was necessary
for four patients due to SEMS migration, with further stent
replacement; for two patients due to SEMS occlusion by
cancer in-growth treated with stent-in-stent; and for four
patients because of colon bleeding (1 needing endoscopic
hemostasis and 3 requiring blood transfusions).
Postplacement morbidities not related to SEMS were
cardiac complications (9.4 %), respiratory complications
(9.4 %), and chemotherapy-related side effects (6.3 %).
Five (62.5 %) of these eight patients needed hospital
admission.
Figure 2 depicts the Kaplan–Meier survival curve of the
29 cancer patients. The median survival time for the palliative group was 10 months [95 % confidence interval
(CI), 4–16 months].
Short-term outcome for surgically treated patients
The baseline characteristics of patients undergoing SEMS
placement as a bridge to elective surgery (SEMS group) or
for immediate surgery (NO-SEMS group) are shown in
Table 4 Long-term complications of self-expandable metallic stent
(SEMS) placement (n = 32)
Type of complication
3
6 (20.7)
4
23 (79.3)
Type of stricture: n (%)
Complete
15 (46.9)
Incomplete
17 (53.1)
n (%)
Bowel perforation
1 (3.1)
SEMS migration
4 (12.5)
SEMS occlusion
3 (9.4)
Tenesmus
7 (21.9)
Recurrent abdominal pain
7 (21.9)
Median time from hospital admission
to SEMS placement: days (range)
2 (0–18)
Median length of procedure: min (range)
26 (20–65)
Overall no. of patients with SEMS-related complications
14 (43.8)
SEMS placement difficulties: n (%)
14 (43.8)
Clinically successful
26 (81.2)
Hospital readmission
11 (34.4)
BMI body mass index, IBD inflammatory bowel disease
Colorectal bleeding
8 (25.0)
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Fig. 2 Kaplan–Meier survival curve of 29 cancer patients treated
with palliative intent
Table 5. The median interval from diagnosis to surgery
was 1 day (range, 0–23 days) in the NO-SEMS group
versus 6 days (range, 2–20 days) in the SEMS group
(P = 0.001).
The ASA score was recalculated by the anesthetist for
the SEMS group at the time of elective surgery. The
reevaluation showed a significant ASA down-scoring. As a
result, 40 patients (81.6 %) were rated as ASA 2, 9 patients
(18.4 %) as ASA 3, and no patients as ASA 4 (P = 0.0008
vs NO-SEMS group). A possible explanation for the ASA
down-scoring in the SEMS group was adequate medical
resuscitation and optimization of comorbid disorders
obtained during the interval between SEMS placement and
elective surgery.
The ROC curve analysis could not identify the most
favorable elapsed time between SEMS placement and
elective surgery (area under the ROC curve, 0.466), but the
curve showed an increased risk of short-term complications
when surgery was performed within 6 days after SEMS
placement (Fig. 3). The short-term surgical morbidity rate
and the postoperative LOS due to postoperative complications were significantly lower in the SEMS group than in
the NO-SEMS group (Table 6).
The stepwise multivariate logistic regression analysis of
surgical morbidity showed that SEMS placement [relative
risk (RR), 0.346; 95 % CI, 0.147–0.816; P = 0.015] was
the only variable significantly correlated with the postoperative complication rate.
Long-term outcome for surgically treated patients
All the patients who underwent surgical resection in both
the SEMS and the NO-SEMS groups were followed up
123
until death or the last visit. The subjects who died within
30 days after surgery (n = 2) were excluded from this
analysis.
The patients treated with SEMS as a bridge to surgery
had a significantly lower rate of incisional hernia and
definitive stoma formation than the patients who underwent
immediate surgery (Table 7).
The incidence of long-term medical complications in the
SEMS group versus the NO-SEMS group were 16.7 %
(8/48) versus 33.3 % (16/48) (P = 0.07) for cardiovascular
complications, 12.5 % (6/48) versus 20.8 % (10/48)
(P = 0.20) for respiratory complications, and 12.5 %
(6/48) versus 22.9 % (11/48) for neurologic complications
(P = 0.13). Figure 4 depicts the Kaplan-Maier survival
curve of the 45 cancer patients in the SEMS group and the
46 cancer patients in the NO-SEMS group.
The Cox stepwise regression model showed that SEMS
placement was the only variable significantly correlated
with long-term outcome (hazard ratio, 0.412; 95 % CI,
0.217–0.785; P = 0.007).
Discussion
The data presented confirm the experience of several
experienced centers [23–27] reporting short-term technical
and clinical success rates exceeding 90 % for SEMS
placement as a palliation measure or as a bridge to elective
surgery. In the current study, most of the major complications (e.g., stent migration and occlusion) were treated
successfully by immediate stent replacement, whereas
colorectal bleeding and pain were self-limiting or easily
controlled by medical therapy. Moreover, we observed
only one case of immediate bowel perforation and two
cases of silent tumor perforation. These types of complications are a major concern for both the short-term and
oncologic safety of SEMS. In fact, the high rate of evident
or silent bowel perforation was the most important event
suggesting inadequate use of stenting in patients with
cancer-related colon obstruction [20, 21, 28]. This complication may result in distant seeding of malignant cells
and convert a potentially curable cancer into an incurable
one. A high standard of endoscopic technique has been
shown to reduce this risk as well as the potential oncologic
consequences of overt perforation, as shown by the survival curve of patients with SEMS used as a bridge to
elective surgery.
The interpretation of our results may be ascribed to the
experience of the endoscopist [29] and the relatively low
rate of complete obstructions. The type of stent also may be
important. Although there are no data comparing the SEMS
used in this study with other types of stents, some recent
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Table 5 Baseline
characteristics of patients
undergoing self-expandable
metallic stent (SEMS)
placement as a bridge to surgery
(SEMS group) or for immediate
surgery (NO-SEMS group)
SEMS
(n = 49)
NO SEMS
(n = 51)
P value
Median age: years (range)
69 (25–96)
72 (40–86)
0.0956
Male sex: n (%)
30 (61.2)
29 (56.9)
0.6886
Median BMI: kg/m2 (range)
24.2 (16.3–35.5)
24.2 (14.2–36.3)
0.7880
Weight loss [ 10% in the last 6 months: n (%)
18 (36.7)
24 (47.1)
0.3180
Mean hemoglobin (g/dl)
13.7 ± 1.6
13.0 ± 1.8
0.0725
Mean albumin (g/dl)
3.8 ± 0.3
3.7 ± 0.4
0.2357
Mean cholinesterase (UI/ml)
6,107 ± 1,904
6,008 ± 2,176
0.1083
White blood cells (103 cells/ml)
9.5 ± 3.5
10.7 ± 4.9
0.1574
Diabetes
6
5
0.7575
Cardiovascular
Respiratory
20
12
25
8
0.2352
0.3226
Neurological
4
3
0.8541
Gastrointestinal
9
11
0.7253
Others
14
9
Comorbidities (n)
ASA class: n (%)
2
19 (38.8)
22 (43.1)
3
22 (44.9)
23 (45.1)
4
8 (16.3)
6 (11.8)
0 (0.0)
3 (5.9)
Site of obstruction: n (%)
0.2578
Right colon
Transverse colon
3 (6.1)
3 (5.9)
Left colon
20 (40.8)
17 (33.3)
Rectosigmoid
26 (53.1)
28 (54.9)
Cancer
IBD
45 (91.8)
0 (0.0)
47 (92.1)
1 (2.0)
Diverticular disease
4 (8.2)
1 (2.0)
Adhesion
0 (0.0)
2 (3.9)
2
16 (35.5)
12 (26.1)
3
17 (37.8)
19 (40.0)
4
12 (26.7)
15 (30.6)
23 (10–41)
18 (5–35)
Primary cause of obstruction: n (%)
0.1874
Cancer staging: n (%)
0.5760
Median no. of nodes harvested (range)
0.0832
Median no. of positive nodes (range)
7 (0–12)
5 (0–12)
0.1069
Microperforation by pathology: n (%)
2 (4.1)
4 (7.8)
0.1861
23 (46.9)
21 (41.1)
Type of stricture: n (%)
0.8747
Complete
Incomplete
BMI body mass index,
ASA American Society of
Anesthesiology, IBD
inflammatory bowel disease
0.3386
0.7462
26 (53.1)
30 (58.9)
Median surgery time: min (range)
160 (105–430)
195 (65–560)
0.3138
Open/laparoscopy (n)
30/19
51/0
0.0001
Chemotherapy administration: n (%)
Median time from surgery to chemotherapy: days (range)
21 (46.7)
64 (24–231)
16 (34.0)
101 (32–388)
0.2880
0.1985
Chemotherapy interruption: n (%)
2 (9.5)
3 (18.8)
0.6339
observations suggest that the characteristics of the device
may affect the safety and efficacy of the procedure [30, 31].
The long-term SEMS-related outcomes of patients with a
stent placed for palliation are consistent with the majority
of the data reported by renowned tertiary centers [23–27,
32–35].
Although associated with a high morbidity rate, hospital
readmission was considered necessary for stent-related
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Fig. 3 Receiving operating characteristic (ROC) curve showing the
trade-off between sensitivity and specificity by considering the
elapsed time from self-expandable metallic stent (SEMS) placement
to the occurrence of postoperative complications (n = 49)
complications in 34 % of cases, with an overall success
rate of 81 %. Most of the complications were effectively
treated by endoscopic maneuvers and did not require
invasive surgical procedures. There were several other
cases of rehospitalization, but these were related to the
Table 6 Short-term outcomes
of patients undergoing
self-expandable metallic stent
(SEMS) placement as a bridge
to surgery (SEMS group) or for
immediate surgery (NO-SEMS
group)
poor health condition of the patients with advanced-stage
cancer and severe comorbidities.
For patients with resectable disease, it is a common
experience that performing urgent operations for cancerrelated colonic obstruction is demanding even for an
experienced surgeon. Moreover, immediate surgery frequently offers only a temporary or palliative option and is
associated with an elevated risk of morbidity and mortality
[1–8].
Used as a bridge to elective surgery, SEMS may
effectively achieve decompression and intestinal patency,
providing sufficient time for medical resuscitation, optimization of comorbid disorders, and bowel preparation
before surgery. This strategy is supported by the positive
results of several observational studies [9, 10, 12, 24, 36]
and systematic reviews [1, 5–8, 37, 38].
The optimal time interval from SEMS placement to
elective surgery has not clarified to date by existing reports.
Our data suggest that different time thresholds do not
correlate with the occurrence of postoperative morbidity,
but the ROC curve suggests that waiting at least 6 days
may be appropriate surgical timing.
Although observational studies are more suitable for
detecting rare or late adverse effects of treatments and
more likely to provide an indication of what is achieved in
daily practice [39, 40], the optimal treatment choice should
come more from randomized clinical trials (RCTs). In
SEMS
(n = 49)
P value
0.0654
Resumption of oral feeding: median days median (range)
5 (2–12)
6 (3–12)
Canalization to passing gas: median days (range)
3 (0–6)
3 (0–9)
0.2152
Canalization to feces: median days (range)
4 (0–9)
5 (1–12)
0.7700
10 (20.4)
26 (51.0)
0.0018
0.0599
Need for parenteral nutrition: n (%)
Hartmann’s resection: n (%)
1 (2.0)
7 (13.7)
Protective ileostomy: n (%)
7 (14.3)
11 (21.6)
0.4376
17 (34.7)
30 (58.8)
0.0177
Blood transfusion: n (%)
Electrolyte abnormality: n (%)
Wound infection: n (%)
4 (8.2)
15 (29.4)
0.0098
13 (26.5)
28 (54.9)
0.0047
0.3580
Urinary tract infection: n (%)
4 (8.2)
8 (15.7)
Intraabdominal abscess: n (%)
7 (14.3)
20 (39.2)
0.0066
Anastomotic leak: n (%)
6 (12.2)
10 (19.6)
0.4157
Peritonitis: n (%)
Septic shock: n (%)
2 (4.1)
2 (4.1)
5 (9.8)
6 (11.8)
0.4367
0.2695
Respiratory tract complication: n (%)
5 (10.2)
19 (37.3)
0.0020
Need for postoperative ICU care: n (%)
5 (10.2)
17 (33.3)
0.0073
Reoperation: n (%)
3 (6.1)
10 (19.6)
0.0521
16 (32.7)
31 (60.8)
0.0055
1 (2.0)
1.0000
Overall no. of complicated patients: n (%)
In-hospital mortality: n (%)
123
NO SEMS
(n = 51)
1 (2.0)
Median postoperative LOS: days (range)
10 (4–30)
15 (4–125)
0.0001
Median overall LOS: days (range)
18 (10–39)
19 (8–128)
0.2190
Surg Endosc
Table 7 Long-term outcomes during the follow-up period (median,
43 months) of patients undergoing self-expandable metallic stent
(SEMS) placement as a bridge to surgery (SEMS group) or for
immediate surgery (NO-SEMS group)
SEMS
(n = 48)a
(%)
Recurrent abdominal pain
6 (12.5)
NO SEMS
(n = 50)a
(%)
P value
12 (24.0)
0.1933
Incisional hernia
3 (6.3)
11 (22.0)
0.0410
Definitive stoma (ileostomy
or Hartmann’s colostomy)
3 (6.3)
13 (26.0)
0.0124
Colorectal bleeding
4 (8.3)
6 (12.0)
0.7410
New episodes of intestinal
obstruction
3 (6.3)
5 (10.0)
0.7152
Tenesmus
4 (8.3)
4 (8.0)
1.0000
Overall no. of complicated
patients
12 (25.0)
18 (36.0)
0.2773
Hospital readmissions
11 (22.9)
17 (34.0)
0.2673
a
One SEMS patient and one NO SEMS patient died during hospitalization (see Table 6)
Fig. 4 Kaplan–Meier survival curves of cancer patients undergoing
self-expandable metallic stent (SEMS) placement as a bridge to
elective surgery (SEMS group: n = 45) or for immediate surgery
(NO-SEMS group: n = 47)
2009, Cheung et al. [16] demonstrated that SEMS placement as a bridge to elective surgery versus emergency
operation offered major clinical advantages, with a significant reduction in infectious and systemic complications
and definitive stoma formation. An attractive possibility is
to perform laparoscopic resection in patients treated with
preoperative SEMS, which is even less invasive than open
surgery [41–43]. Similar results were reported by Ho et al.
[17].
Two subsequent multicenter RCTs did not confirm any
distinct benefits in terms of morbidity or mortality of colon
stenting versus emergency surgery for patients with leftsided malignant colon obstruction [14, 15]. A key issue
related to these negative results seemed to be the low rate
of successful SEMS placement, which affected the possibility of complete restoration of colonic patency before
elective surgery. It is noteworthy that the French RCT [15]
showed an uneventful surgical course in all cases with
preoperative successful technical and clinical SEMS
placement (12/30; 40 %). By this interpretation, the results
of this subgroup of patients are much more consistent with
previous data from RCT [16, 17] and cohort studies [9, 10,
12, 24, 36] showing an improved outcome for patients
treated with SEMS as a bridge to elective surgery when
colonic decompression by stenting was effectively
achieved. In this light, it might be interesting to know
whether a per protocol analysis of the Dutch RCT [14],
including only the patients with successful preoperative
stenting, could have resulted in similar findings. The difficulty demonstrating the benefits of preoperative SEMS
may suggest that the procedure was performed either in
patients for whom it was not appropriate or by endoscopists
with inadequate training.
Even with the shortcomings of a non-RCT and the
potential bias of patient selection by the surgeon, our
findings are more consistent with the majority of data
showing that SEMS as a bridge to elective surgery should
be considered the most advantageous strategy for treating
colonic obstruction. Indeed, we observed a significantly
lower rate of short-term surgery-related complications and
less stoma formation in the group receiving a preoperative
stenting than in the group undergoing emergency surgery
with a subsequent shorter hospital stay. These results may
be attributable not only to the possibility of performing
laparoscopic resections but also to the optimization of
comorbid diseases and to the reduction of preoperative risk,
as shown by the ASA down-scoring.
Evaluation of the long-term surgical outcome for the
patients who underwent elective surgery after colon stenting or emergency surgery is lacking. Our results suggest
that preoperative SEMS placement may be advantageous
due to the lower incidence of incisional hernia and stoma
formation.
The most unexpected result of our study was the
increased long-term survival in the group receiving SEMS
as a bridge to elective surgery. Little is known about the
oncologic outcome of patients treated with preoperative
stenting versus immediate surgery for cancer-related bowel
obstruction with radical intent. Three trials [13, 18, 19]
showed similar long-term prognoses of the two strategies
for patients receiving potential curative resection, whereas
Kim et al. [44] showed an adverse oncologic outcome of
stenting for colon cancer obstruction compared with nonobstructive elective surgery.
123
Surg Endosc
The significantly better survival of the SEMS group
observed in the current study may be attributable to several
factors. The occurrence of postoperative septic complications and a prolonged inflammatory state are correlated with
poor cancer-related survival [45, 46]. The mechanisms are
speculative, but chronic inflammation associated with
infections can contribute to induction of oncogenic mutations, genomic instability, and enhanced angiogenesis [47].
An additional reason may be that the patients in the
current study who underwent immediate surgery had a
lower rate of chemotherapy administration, a higher rate of
chemotherapy interruption, and a longer interval between
surgery and initiation of adjuvant chemotherapy than the
patients treated with SEMS. None of these parameters
reached statistical significance, but together they may have
contributed to the differences in survival rates. These events
were likely linked to the incidence of postoperative complications delaying the start of chemotherapy or affecting
the chemotherapy indication for the poor health condition.
Thus, our data are consistent with a recent metaanalysis by
Biagi et al. [48] showing that a longer time to adjuvant
chemotherapy was associated with reduced survival rates
among patients with resected colorectal cancer.
In conclusion, the current results suggest that successful
SEMS placement can be safely achieved in a high proportion of cases involving colorectal obstruction and that it
can be used for palliative purposes. Colon stenting also
should be considered as the treatment of choice for preparing patients to undergo a later elective operation with
the significant short- and long-term advantages of relevant
surgical outcomes compared with emergency procedures.
The generalization of our results may be limited by the
single-center nature of the study, the particular expertise of
the endoscopists/surgeons, the type of stent, and the patient
characteristics.
Acknowledgment This study was supported by a grant of MilanoBicocca University. The authors thank Mr. David Costin, Lee Costin,
and Iain Styles for proofreading for English grammar and spelling.
The authors are grateful to Prof. J. Wesley Alexander for the
thoughtful comments and suggestions.
Disclosures Luca Gianotti, Nicolò Tamini, Luca Nespoli, Matteo
Rota, Elisa Bolzonaro, Roberto Frego, Alessandro Redaelli, Laura
Antolini, Antonella Ardito, Angelo Nespoli, and Marco Dinelli have
no conflicts of interest or financial ties to disclose.
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