Introduction
Acute malignant large bowel obstruction (MLBO) represents an
urgent or emergent condition and occurs in up to 20 % of pa-
tients with colon cancer [1]. In patient s with incurable obs truc-
tive colorecta l carcinoma (CRC), a palliative diver t ing colost-
omy has been considered the treatment of choice. Many pa-
tients with MLBO are poor operative candidates and have a
high incidence of post-surgical adverse events (AEs) including
prolonged hospitalization, abscess formation, anastomotic
leakage and sepsis [2]. Emergent surger y for colonic obstruc-
tion has historically had a high mor talit y rate of 10 % to 30%
[3]. Furthermore, patient s with a permanent colostomy have
been found to have lower health-related q ualit y of life and in-
creasedcostsrelatedtoavarietyoffactors,manyofwhichre-
late to colostomy care [4].
The role of colonic self-expanding m etal stents (SEMS) in pa-
tients with MLBO is well established as a therapeutic option in
patients with locally unresectable distal (descending colon, sig-
moid colon, rectosigmoid, and rect um) colorectal carcinomas
Long-term outcomes of palliative colonic stenting versus emer-
gency surger y for acute proximal malignant colonic obstruction:
a multicenter trial
Authors
Ali Siddiqui
1
, Natalie Cosgrove
1
,LindaH.Yan
1
,DanielBrandt
1
,
Raymond Janowski
1
,AnkushKalra
1
, Tingting Zhan
1
,ToddH.Baron
2
,
Allesandro Repici
3
,LindaJoTaylor
4
, Douglas. G. Adler
4
Institutions
1 Jefferson University School of Medicine, Gastroenterology and
Hepatology, Philadelphia, Pennsylvania, United States
2 University of Nor th Carolina, Gastroenterology and Hepatology,
Chapel Hill, North Carolina, United States
3 Depar t ment o f Gastroe nterol ogy, IRCCS Ist ituto C lini co
Humanitas, Milan, Italy
4 University of Utah School of Medicine, Gastroenterology and
Hepatology, Salt Lake Cit y, Utah, United States
submitted 18.3.2016
accepted after revision 17.1.2017
Bibliography
DOI http://dx.doi.org/10.1055/s-0043-102403 |
Endoscopy Internationa l Open 2017; 05: E232–E238
© Georg Thieme Verlag KG Stuttgart · Ne w York
ISSN 2364-3722
Corresponding a uthor
Douglas G. Adler MD, FACG, AGAF, FA SGE, Professor of Medicine,
Director of Therapeutic Endoscopy, Director, GI Fellowship
Program, Gastroenterology and Hepatology, University of Utah
School of Medicine, Huntsman Cancer Center, 30N 1900E 4R118,
Salt Lake City, Utah 84132
douglas.adler@hsc.utah.edu
ABSTRACT
Background and stud y aims Long-term data are limited regarding
clinical outcomes of self-expanding metal stent s as an alternative
for sur ger y in the treatmen t of acut e proxima l MBO. The aim of
this stud y was to compa re the long- term out comes o f ste nting to
surgery for palliation in patients with incurable obstructive CRC for
lesions proximal to the splenic flexure.
Patients an d m ethods Retrospective multicenter cohor t study of
obstructing proximal CRC patients with who underwe nt inser tion
of a SEMS (n= 69) or surgery (n=36) from 1999 to 2014. The pri-
mary endpoint was relief of obstruction. Secondary endpoints in-
cluded technical success, duration of hospital stay, early and late
adver se e vent s (AE s) and survi val .
Results Technical success was achieved in 62/69 (89.8%) patients
in the SEMS group and in 36 /36 (100 %) patients who under went
surger y (P =0.09). In the SEMS group, 10 patients underwent stent-
ing as a bridge to surger y and 59 under went stent placement for
palliation. Clinical relief was achieved in 78% of patients with stent-
ing and in 100 % of patients who under went surger y (P < 0.001). Pa-
tients with SEMS had significantly less acute AEs compared to the
surger y gr oup (7.2 % vs. 30.5 %, P =0.003). Hospital mortalit y for
the SEMS group was 0 % compared to 5 .6 % in the surger y group
(P = 0.11). Patients in the SEMS group had a significantly shor ter
median hospital stay (4 days) as compared to the surger y group
(8 days) (P < 0 .01). Ma inten ance of decompress ion wi thout the re-
currence of bowel obstruction until death or last follow-up was
lower in the SEMS group (73.9 %) than the surger y group (97.3 %;
P =0.003). SEMS placement was associated with higher long-term
complication rates compared to surger y (21 % and 11 % P =0.27).
Late SEMS AEs included occlusion (10 %), migration (5 %), and colo-
nic ulcer (6 %). At 120 weeks, sur vival in the SEMS group was 5.6 %
vs. 0% in the surgery group (P =0.8).
Conclusions Technical and clinical success associated w ith pr oxi-
mal colonic obstruction are higher with surgery when compared to
SEMS, but surgery is associated with longer hospital stays and
more early AEs. SEMS should be considered the initial mode of
therapy in pa tient s with a cute proximal MBO and surger y shoul d
be reser ved for SEMS failure, as surger y involves a high morbidit y
and mortalit y.
Original a rticl e
E232
Siddiqui Ali et al. Long-ter m outcomes o f … Endoscopy International Open 2017; 05: E232–E238
and is first line therapy at many centers [1, 5,6]. SEMS allow re-
lief of colonic obstruction and allow for medical r esuscitation,
optimization of comorbid disorders, bowel preparation, and
staging [5]. Emergent surgery and a surgical stoma can thus of-
ten be avoided in these patients [4]. Colonic SEMS can also de-
crease hospital stay and reduce hospital costs compared to
emergency surger y [7, 8].
In patients with acute proximal CRC obstruction (defined as
caused by lesions proximal to the splenic f lexure), the current
standard of care at many centers is still surgical resection and
primary anastomosis, with older literature suggesting that out-
comes in patients undergoing emergent surger y are compar-
able to those undergoing elective surger y. However, recent
data suggest that emergent right-sided colonic resections may
have a significantly higher mor talit y and morbidity when com-
pared to elective procedures [9].
There is a paucit y of data on the role of colonic SEMS for
therapy of acute obstruc tion from proximal colonic lesions.
Campbell et al. have reported successful placement of SEMS to
relieve a proximal transver se colon obstruction [10]. Repici a nd
Dronamraju et al. have both performed small retrospective, sin-
gle-arm analysis demonstrating that SEMS appear to be safe
and effective in the treatment of malignant obstruction of the
proximal colon [11, 12]. However, there continues to be signifi-
cant concern about the safety of SEMS in the proximal colon, in
par ticular about their long-term patency rates and AEs [13, 14].
We conducted a retrospective multicenter trial to compare
long-term outcomes of endoscopic stenting and surgery for in
patients with unresectable obstruc ting colorectal cancer (CRC)
and lesions proximal to the splenic flexure.
Patients and methods
Patie nt s
We performed a retrospective cohor t study of patients with
acute proximal malignant colon obstruction from unresectable
colon cancer at 5 intuitions (Molinette Hospital in Turin, Italy,
University of Texas– Hous ton Medical School, Istituto Clinico
Humanitas, Milan, Italy, Thomas Jefferson Universit y Hospital
and Mayo Clinic in Rochester, MN) who under went either place-
ment of a colonic SEMS or surger y for palliation bet ween Febru-
ary 1999 and October 2015.
Patients who were eligible for the study had clinical and ra-
diological findings of acute colonic obstruction. The medical re-
cords of patients identified were then reviewed by p hysicians
who used a structured data form to collect the following data:
demographic information (age, race, and g ender), presenta-
tion, tumor histological diagnosis, and location of the colonic
stricture. All p atients underwent contrast-enhanced computed
tomography scanning or a gastrograffin enema study to deter-
mine the site of the lesion and the presence of distant metasta-
ses. Patient s were excluded from the study if they had clinical
and/or radiological evidence of bowel per foration, peritonitis
or significant gastrointestinal bleeding.
Endoscopic placement of colonic SEMS
All patients under went enema preparation prior to the endos-
copy. Patients were sedated with intravenous midazolam and
meperidine or general endotracheal anesthesia (GETA). The en-
doscope was passed to the site of the obstruc tive tumor and a
guide wire w as passed across the stricture under endoscopic
and f luoroscopic guidance. Water-s olu b le cont ras t w as i nj ec t ed
to determine the length of the lesion. Based upon the length of
stenosis, a 6-, 9- or 12-cm uncovered Wallstent™ or WallFlex™
Colonic Stent (Boston Scientific, Natick, USA) was used to tra-
verse the stenosis. The stent was placed so as to extend at least
2 cm on each end beyond the tumor margin using both endo-
scopic and fluoroscopic visualization.
Emergent surger y for therapy of colonic obstruc tion
In patients who underwent surgery, the type of operation was
decided on by the attending surgeon. Palliative resection with
primary anastomosis was att empted if possible. If a primar y co-
lostomy was per formed, then res toration of bowel continuity
bysurgicalanastomosiswasconsideredin4to6months.Inpa-
tients in whom stents were placed as a bridge to s urgery, elec-
tivesurgerywasperformedwithin1to4weeksafterstent
placement.
Definitions
In the SEMS group, technical success was defined as successful
deployment of the colonic stent across the stric ture. Immedi-
ate clinical success was defined as colonic decompression and
relief of obstructive symptoms within 24 hour s after stent
placement. In the surgery group, clinical success was defined
as colonic decompression and relief of obstructive symptoms
within 24 hours af ter surger y [15, 16]. In both groups, late suc-
cess was defined as maintaining colonic decompression with-
out the recurrence of intestinal obstruction until death or last
follow-up [16].
Patient adverse events
AEs were defined as those leading to new symptoms, reobstruc-
tion, or alteration of management [17]. Early AEs were defined
as those that presented within 30 days of stent p lacement or
surge ry ; la te ad ver se eve nt s we re tho se tha t occur re d af ter 30
days of the t ime of procedure [12,17].
Patient outcomes an d statistical analysis
All values are presented as mean, median (range), or percen-
tage. The primar y outcomes of this study were to evaluate the
success and complication rates bet ween the SEMS group and
the surgery group.Secondary outcomes were patient AEs,
duration of hospital stay and overall sur vival rates in the 2
groups.
Data were analyzed using cross tabulation. Categorical vari-
ables were evaluated using Chi-Square or Fisher’ sExactTest,
where a ppropr iate. Conti nuous data were compared using the
unpaired t-test or Mann-Whitney test s. Sur vival analysis was
per formed using the Kaplan-Meyer actuarial method, and sur-
vival cur ves were compared using the log-rank method. All val-
Siddiqui Ali et al. Long-term outcomes of … Endoscopy International O pen 2017; 05: E 232–E238
E233
ues were p resented as means. Statistica l signi ficance was deter -
mined a priori at P≤ 0.05.
Results
Baseline patient characteristics (
▶
Table 1)
During the stud y period, a total of 105 patients p resented with
acute colonic obstruction from a tumor that was located prox-
imal to the splenic f lexure. Sixty-nine patients were treated
endoscopically by placement of a colonic SEMS while 36 pa-
tients under went surgery. Twent y-four patients underwent a
right colectomy and primar y anastomosis and 12 had a right
colectomy and an ostomy. In the S EMS group, stenting was at-
tempted as a bridge for surger y in 10 patients and a palliative
treatment in 59 patient s. The choice of therapy was decided
per local practice and the physician’s discretion. Patient charac-
teristics are summarized in
▶
Table 1. There were no statistical-
ly significant differences in the sex or ethnicit y bet ween the 2
groups. The mean age of patients who under went SEMS was
statistically greater as compared to patients that underwent
surger y (63 vs. 58 years respectively; P = 0.04). All stents placed
were 22 mm in diameter.
The site of colonic obstruc tion in the SEMS group was as fol-
lows: cecum/ascending colon =31 (44.4%), hepatic f lexure= 6
(8.4 %), transver se colon= 32 (47.2 % ). The site of colonic ob -
struction in t he surger y group was as follows: cecum/ascending
colon= 15 (42 %), hepatic flexure = 7 (20.3 %), transverse colon
= 14 (37.7%). A greater number of patients with a hepatic flex-
ure obstruction underwent surger y compared to undergoing a
colonic SEMS (P = 0.006). Conversely, in patient s with a trans-
verse colon obstruction, there were a greater number of pa-
tients in the SEMS g roup as compared to those who under went
surger y (P = 0.001).
Early patient outcomes and adverse events
(Within 30 days of initial SEMS placement)
Procedural technical success was achieved in 62/69 (89.9%) p a-
tients in the SEMS group and in 36/36 (100%) patients who un-
derwent surgery (P = 0.09). In the 62 patient s in which the tech-
nical success with the SEMS was achieved, clinical relief of t he
colonic obstruction was achieved in 54 (78%) patient s in the
SEMS group and in all 36 (100 %) patients who under went sur-
gery (P < 0.01).
There were no technical failures in the surgery group. In the
SEMS group, technical failure occurred in 7 patient s (10.1 %)
because of inabilit y to pass a guidewire across the lesion (n =
2), failure of stent expansion ( n= 2), stent malposition (n = 2),
and colonic p er foration during the procedure (n = 1). In the pa-
tients with the failure of stent expansion, one occurred in the
ascendi ng colo n and t he other in t he hepa tic f l exu re; b oth
these patients did not improve their obstructive symptoms
within 24 hours and were referred for surger y. The one case of
bowel p er foration was caused by the passage of t he Wallflex™
stent through the wall of the ascending colon during inser tion.
Stent malposition occurred in 1 patient with a lesion a t the he-
patic f lexure and 1 patient where the lesion was in the proximal
transverse colon. This was felt to be a result of an acute angula-
tion at the site of obstruction.
After the procedure, the SEMS group had a significantly low-
er rate of early AEs compared to the surger y group (7.2 % vs.
30.5%; P = 0.003). In the SEMS group, delayed colonic perfora-
tion developed in 1 patient at day 15 after stenting ; this patient
under went emergent right hemicolectomy with colostomy.
Stent reobs truction occurred in 1 patient due to tumor over-
growth and in 1 patient who developed a stool impaction; the
stent reobstruction occurred on day 19 and day 28 af ter initial
placement respectively. Both these patients under went a suc-
cessful second stenting with relief of their bowel obstruction.
There were no stent related deaths during within 30 days of
stent placement.
In the surgery group, 4 p atients developed a wound infec-
tion requiring intravenous antibiotics, 1 patient had an anasto-
motic leak requiring s urgical revision, 2 patients developed re-
spirator y failure that warranted an intensive care unit admis-
sion, 1 patient had a iatrogenic ruptured spleen that did not re-
quire surger y, 1 patient had urinary dysfunction and 2 patients
died in the early (<30 days) postoperative period.
Patients in the SEMS g roup had a significantly shor ter medi-
an hospital stay (4 days) as compared to the surger y g roup (8
days) (P < 0.01).
▶
Table1 Patient demographics.
Surgery SEMS P value
Number of patient s
36 69
Age (mean, years)
58 63 0.04
Sex ratio M:F
18:18 40:29 0.536
Site o f colon obstruc tion (%)
▪ Cecum/ascending colon
44.4 42 0.83
▪ Transverse colon
8.4 37.7 0.001
▪ Hepatic f lexure
47.2 20.3 0.006
Median follow-up, weeks
29.3 (range, 1 – 121 weeks) 26.3 ( range, 2 – 80 weeks) 0.7
SEMS, self-expanding metal stent
E234
Siddiqui Ali et al. Long-ter m outcomes of … E ndoscopy Internationa l Open 2017; 0 5: E232–E238
Original a rticl e
Late patient outcomes and adverse events
(30 days af ter initial SEMS placement)
Among patients who under went colonic stenting as a palliative
procedure, the mean duration of follow-up in the SEMS group
was 26.3 week s (range, 2 – 80 weeks). T he m ean duration of fol-
low-up in the surger y group was 29.3 weeks (range, 1– 121
weeks). Maintenance of colonic d ecompression without the re-
currence of bowel obstruc tion until patient death or last follow-
up was lower in the SEMS group (73.9 % ) than in the surger y
group (94.4 %; P =0.02).
The median duration of first stent patenc y was 19 weeks
(range 12 – 44 weeks). Seven of 10 patients in whom stent fail-
ure developed were able to be managed by placement of a sec-
ond stent while the other 3 required a surgical ostomy based on
the discretion of the primary surgical team although gastroen-
terology was not consulted prior to this decision. The cause of
recurrence of bowel obstruction in the SEMS group was tumor
overgrowth leading to stent occlusion (n= 7) or stent migration
(n = 4), while bowel obstruc tion recurrence in the s urgery group
(n = 1) occurred as a result of small bowel obstruction from ad-
hesions.
Although the overall late AE rate w as higher in the SEMS
group (n = 14; 21 %) as compared to the surger y group (n =4;
11 %), this did not reach statistical significance (P = 0.29). Late
AEs in the SEMS group included stent occlusion due to tumor
ingrowth (n=8), stent migration (n=4), delayed perforation
(n = 1), and colonic ulcer leading to hematochezia (n = 1) (
▶
Ta-
ble 2). Late AEs of surger y occurred i ncluding formation of an
enterocutaneous fistula (n =1), small bowel obstruction from
adhesions (n = 1), anorectal abscess (n =1), and ventral hernia
formation (n =1). Only the pre sence of a tr ansverse colon ob -
struction independently predic ted late adverse events in the
SEMS group ( P < 0.001). Age, sex, race, and t ype of stent were
all not found to be risk fac tors for late adverse events in the
SEMS group.The outcomes and AEs of both groups are sum-
marized in
▶
Table 3.
At gastrografin 120 weeks, patient sur vival in the SEMS
group was 5.6 % compared to 0 % in the surger y group (P =0.8)
(
▶
Fig.1)
Discussion
This multicenter stud y demonstrated t hat in p atients wi th pri-
mary proximal CRC and obstructive symptoms both SEMS a nd
surger y are both viable clinical options. The technical success
and maintenance of colonic decompression without r ecurrence
of bowel obstruction until patient death or last follow-up was
higher with surger y as compared to the SEMS group in patient s
with unresectable disease. However, patients who under went
surger y had a significantly longer hospital stay and a higher
rate of early AEs compared to the SEMS group, highlighting
the risks and the more invasive nature of emergent surgical
hemicolectomy when compared to colon stents. Long-term
AEs and sur vival were similar in both groups.
The current literature suppor ts the non-surgical approach of
placing colonic SEMS to relieve di stal colonic obstruction (le-
sions distal to the splenic flexure). Colonic stents in this subset
of patient s have been shown to a highly effective and safe ther-
apy to relieve colonic obstruction. In addition, patients who re-
ceive S EMS ha ve less acute mor tal it y and mor bidi t y compare d
to patients who undergo emergent surgical decompression for
distal malignant colonic obstruction [4,5, 17 – 19] Two large
studies comparing SEMS to surgical inter vention for predomi-
nantly distal colonic obstruc tion have supported the above
mentioned findings [16, 20].
▶
Table2 Early and late adver se events of colon surger y and SEMS.
Adver se events Surge r y (n = 3 6) SEMS (n = 6 9)
Overall
▪ Early 11 (30.5 %) 5 (7. 2 %)
▪ Late 4 (11 %) 14 (21 %)
Perfora tion
▪ Early 0 2 (2. 8 %)
▪ Late 0 1(1.4%)
Hematochezia
▪ Early 0 1 (1. 4 %)
▪ Late 0 1 (1.4 %)
Tumor outgrow th
▪ Early 0 1(1.4 %)
▪ Late 0 0 (0 %)
Tumor ingrow th
▪ Early 0 0 (0 %)
▪ Late 0 8 (11. 6 %)
Stool impacti on
▪ Early 0 1 (1.4 %)
▪ Late 0 0 (0 %)
Ste nt m ig r a ti o n
▪ Early – 0(0%)
▪ Late – 4(5.8%)
Enterocutaneous fistula
▪ Early 0 0 (0 %)
▪ Late 1 (2.8 %) 0 (0 %)
Small bowel ob struction
▪ Early 0 0 (0 %)
▪ Late 1 (2.8 %) 0 (0 %)
Other
▪ Early 0 0 (0 %)
▪ Late 2 (5.6 %) 0 (0 %)
SEMS, self-expanding metal stent
Siddiqui Ali et al. Long-term outcomes of … Endoscopy International O pen 2017; 05: E 232–E238
E235
There continues to be much debate about the role of colonic
SEMS for proximal colonic obstruc tion in patients with unre-
sectable disease [13, 21]. As opposed to distal colonic obstruc-
tions, proximal lesions can sometimes be managed with a much
simpler 1-stage laparoscopic surgical operation with resection
and ileocolonic anastomosis without the need for a formal bow-
el preparation. Repici et al. reported their experience with 13
patients who under went palliative colonic stent placement for
“right-sided malignant colonic obstruc tion” (proximal to the
mid transverse colon) [12]. In this series, they repor ted that
SEMS were a safe and effective treatment for malignant ob-
struction of the proximal colon, with technical and clinical suc-
cess rates comparable to those s een with distal colonic stent-
ing. Similar findings were also repor ted in a small cases series
of 16 patients with proximal colonic obstruction by Dronamraju
et al. [11]. Conversely, Jung et al. repor ted that proximal loca-
tion of the colon obstruc tion was a significant factor associated
with poorer outcome for colonic stenting. Patients with a distal
colorectal obstruction that were stented had significantly bet-
ter outcomes than those with a proximal colorectal obstruction
(P = 0.015) [22]. T he author s hypothesized that proximal colo-
nic lesions may be dif ficult to reach due to the unprepped colon
as well as cur vatures of the colon. Lastly, C ho et al showed that
technical success and clinical improvement with SEMS used to
treat proximal colon obstruct ion was lower than p atients with
distal colon obstruction [23].
In our study, the procedural success rate for placement of
the colonic SEMS was 89 % compared to 100 % technical success
achieved by surger y. Similarly, relief of colonic obstruction initi-
ally achieved by surger y was significantly greater when com-
pared to the SEMS group (100 % v s. 87 % respec tively; P = 0.02).
The lower rate of clinical improvement in the SEMS was mostly
due to technical failure of stent insertion which included inabil-
it y to pass the guidewire across the lesion, failure of stent ex-
pansion, and stent malposition as a result of an excessively an-
gulated site t hrough a fixated str icture [24]. Excessive angula-
tion, especially at the hepatic f lexure or proximal transverse co -
lon can lead to stent malposition and failure for the stent to ex-
pand adequately as we seen in our cohor t. We hypothesize that
other causes of technical failures leading to dif ficulties in cor-
rect colonic stent deployment included the long distance from
the anus, the bowel being tor tuous, and poor endoscopic view
due to incomplete bowel preparation [23,25].
Early complication rates (< 30 days after the initial proce-
dure) were statistical ly si gnificant ly l ower in pa tients who un-
derw en t succes sf ul coloni c SEMS pla cem ent comp ar ed to the
surger y group (7.2 % vs. 30.5 %; P = 0.003). No deaths were
seen in the SEMS group.There was 1 anastomotic leak requiring
surgical revision and 2 deaths in the surger y group during the
early post-operative period. The 2 patients died to anastomotic
dehiscence that led to sepsis. All these factors contributed to a
longer median hospital stay in the surgery group compared to
the SEMS g roup.
One of the findings in our study was that colonic decompres-
sion without the recurrence of bowel obstruc tion until patient
death or last follow-up was lower in the SEMS group (73.9 %)
than in the surger y group (97.3 %; P = 0.003). The mean dura-
▶
Table3 Comparison of patients havi ng inser tion of a SEMS or emergenc y surger y.
Surgery (n= 36) SEMS (n = 69) P value
Early success, no. (%)
▪ Technical Success 36 (100 %) 62 (89.9 %) 0.09
▪ Clinical su ccess af ter procedure 36 (100 %) 54 (78 %) < 0.001
Maintenance of colonic decompressi on until patient death or last follo w-up, no. (%) 34 (94.4 %) 51 (73.9 %) 0.02
Adve r se eve nt s , n o. (%)
▪ Early 11 (30.5 %) 5 (7.2 %) 0.003
▪ Late 4 (11 %) 14 (21 %) 0.29
Acutemortality(within30daysofprocedure) 2(5.5%) 0(0%) 0.12
Mean ho spit al st ay (day s)
8 3.5 < 0.001
SEMS, self-expanding metal stent
0604020 100 12080
Surgery
SEMS
Weeks
Percent survival
P = 0.552
100
80
60
40
20
0
▶
Fig.1 Patient sur vival in the SEMS and Surgery group at 120
week s. SEM S, sel f-ex pa nd ing met al sten t
E236
Siddiqui Ali et al. Long-ter m outcomes of … E ndoscopy Internationa l Open 2017; 0 5: E232–E238
Original a rticl e