Effect of Self Expandable Metal Stent 2022
Effect of Self Expandable Metal Stent 2022
Effect of Self Expandable Metal Stent 2022
https://doi.org/10.1007/s00384-021-04081-8
ORIGINAL ARTICLE
Abstract
Introduction Acute gastrointestinal obstruction due to colorectal cancer occurs in 7–30% of cases and is an abdominal
emergency that requires urgent decompression. The safety and oncological effect of self-expandable metal stents (SEMS)
in these patients remains controversial. This study aimed to evaluate its impact on these variables and compare it with that
of emergency surgery (ES).
Methods Descriptive, retrospective and single-centre study, performed between 2008 and 2015, with follow-up until 2017.
One hundred eleven patients with diagnosis of left malignant colonic obstruction were included and divided according to
the treatment received: stent as bridge to surgery (SBTS group: 39), palliative stent (PS group: 30) and emergency surgery
with curative (ECS group: 34) or palliative intent (EPS group: 8). Treatment was decided by the attending surgeon in charge.
Results Technical and clinical general success rates for colorectal SEMS were 95.7% and 91.3%, respectively, with an asso-
ciated morbimortality of 23.2%, which was higher in the PS group (p = 0.002). The SBTS group presented a higher laparo-
scopic approach and primary anastomosis (p < 0.001), as well as a lower colostomy rate than the ECS group (12.8% vs. 40%;
p = 0.023). Postoperative morbidity and mortality were significantly lower in the SBTS group compared to the ECS group
(41% vs. 67.6%; p = 0.025). Overall survival (OS) and disease-free survival (DFS) were similar between the analysed groups.
Conclusion Colonic stent placement is a safe and effective therapeutic alternative to emergency surgery in the management
of left-sided malignant colonic obstruction in both curative and palliative fields. It presents a lower postoperative morbimor-
tality and a similar oncological prognosis.
Keywords Colonic stent · Colorectal obstructive cancer · Morbidity · Oncological prognosis · Palliative
4
* Carlos Bustamante Recuenco Universidad Europea de Madrid, Madrid, Spain
[email protected] 5
Department of General and Digestive Surgery, Hospital
1 Universitario de Salamanca, Salamanca, Spain
Department of General and Digestive Surgery,
6
Hospital Universitario Nuestra Señora del Prado, Department of General and Digestive Surgery, Hospital
Talavera de la Reina, Spain Universitario de Getafe, Madrid, Spain
2 7
Department of General and Digestive Surgery, Hospital Department of General and Digestive Surgery, Hospital
Universitario La Princesa, Madrid, Spain Universitario de Getafe, Madrid, Spain
3 8
Faculty of Medicine, General Surgery, Universidad Department of General and Digestive Surgery, Hospital
Complutense de Madrid, Madrid, Spain Universitario de Getafe, Madrid, Spain
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International Journal of Colorectal Disease
In 1990, Dohmoto et al. published the first case of According to the treatment received and its intention, the
obstructive colon cancer treated with stent placement [3]. sample was divided into four groups: SBTS group (stent as
This device effectively achieved colonic decompression bridge to surgery), PS group (palliative stent), ECS group
[4] and could be used as a bridge to elective surgery, (emergency curative surgery) and EPS group (emergency
with the consequent reduction in morbidity and mortality palliative surgery). Those patients with benign or extra-
compared to emergency surgery [5]; or as a palliative colonic disease, whose tumour was located in the rectum
measure in patients with advanced-stage cancer [6]. or proximal to the middle third of the transverse colon, as
These preliminary results caused a quick expansion of well as those who underwent scheduled stent placement or
the technique worldwide. However, its use is not without refused the treatment recommended were excluded from the
risks, as a morbidity and mortality rate of 25% is reported study.
in the principal reviews. In this sense, bowel perforation
constitutes the most feared complication, as a related Stent placement technique
mortality rate of 20–30% has been referred in certain series.
Thus, it has been the main subject of controversy regarding The procedure was available during weekdays’ morning
the safety of SEMS in the face of emergency surgery [7, 8]. shift and was performed in all cases by the Interventional
Despite the large existing evidence about the oncologi- Radiology Service after obtaining valid informed consent
cal prognosis provided by the different treatments, there is from the patient. The stent models available during the
still debate going on about this issue at the present time. study period were the following: Hanarostent™ (M.I.Tech,
Theoretically, it has been suggested that SEMS could Pyeongtaek, South Korea) and Wallstent™ (Boston
cause a greater tumour spread due to manipulation dur- Scientific, MA, USA), both models being self-expandable
ing the placement and to the radial compression of the and uncovered. The technique performed was similar to the
device [9–11]. Furthermore, contradictory results have standard description with two exceptions: fluoroscopy was
been obtained in clinical research, with some of them systematically used before the device insertion, and balloon
referring to a higher number of tumoral recurrences in dilation was not conducted unless the stenosis could not be
patients treated with stent [12–14]. canalized any other way. An abdominal X-ray was taken after
Due to the uncertainty of the short and long-term out- 24–48 h to check the SEMS position and expansion.
come conclusions and the considerable methodological
heterogeneity across different studies, the current investi- Definitions
gation aimed to evaluate the efficacy, morbidity, mortal-
ity and oncological prognosis of SEMS and emergency Technical success was defined as the correct placement and
surgery in patients with left colon cancer obstruction in expansion of the stent after completion of the procedure,
a tertiary hospital. and clinical success as the resolution of occlusive symptoms
by passage of gas and stool along with adequate liquid oral
tolerance. In case of clinical success, the case was presented
to the interdisciplinary committee (formed by the General
Material and methods and Digestive Surgery, Clinical Oncology and Radiology
teams), indicating elective surgery or definitive stent place-
Patients ment according to tumour staging and patient comorbidities.
Emergency palliative surgery was defined as any surgical
We undertook a longitudinal, observational and retrospective intervention that, because of the advanced locoregional or
study. All patients diagnosed with left colon or rectosigmoid metastatic stadification, did not have a curative intention,
junction malignant obstruction were included. The existence regardless of the procedure performed. All analysis was
of clinical or radiological signs of perforation or peritonitis performed on an intention-to-treat basis. Morbidity and
was considered an exclusion criteria. The treatment mortality were divided in general, including post-stent and
received (emergency surgery or stent placement), and postoperative adverse events; and postoperative, in which
its intention (curative or palliative) was recorded. This only complications that occurred after emergency or elective
management was decided by the attending surgeon in charge. surgery were taken into account. To quantify the severity of
No control over his surgical experience or subspecialty is these events, Dindo et al. classification was used [15].
performed in our centre. All the cases were discussed at the Follow-up was carried out by Clinical Oncology and Gen-
multidisciplinary committee to decide the post-emergency eral and Digestive Surgery services through regular medical
management. The recruitment period ranged from January 1, consultations according to the specific protocol of our cen-
2008, to December 31, 2015, and follow-up was maintained tre, whose maximum follow-up period is 5 years. Overall
until December 31, 2017. survival (OS) was calculated from the time of diagnosis to
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International Journal of Colorectal Disease
death or to the last recorded activity. Disease-free survival emergency surgery group; p < 0.001). This difference
(DFS) was defined as the time from diagnosis to relapse/ remained when analysed in the curative (48.7% SBTS gr. vs.
death from any cause, whichever came first. 11.8% ECS gr.; p = 0.001) and palliative setting (46.7% PS
This study received the approval of the Ethics committee gr. vs. 12.5% EPS gr.; p = 0.114).
of our centre. For its retrospective nature, specific informed Figure 1 shows the success rate of stent placement as
consent was not needed. The entire investigation was carried well as the main secondary adverse events of the procedure.
out following the STROBE recommendations for observa- Clinical and technical success were achieved in 66 (95.7%)
tional studies and the principles of the World Medical Asso- and 63 (91.3%) patients respectively. The post-placement
ciation Declaration of Helsinki [16]. complication rate was 23.2%, of which 15.9% were classified
as grades III–IV according to Clavien-Dindo classification.
Statistical analysis Perforation due to stent placement occurred in 9 patients
(13%: 5.1% in the SBTS group and 23.3% in the PS group),
Categorical variables were described as numbers and of which 7 underwent emergency surgery. Perforation due to
percentages. For continuous variables, Shapiro–Wilk or stent placement was not associated with higher early mortal-
Kolmogorov–Smirnov tests were used to determine the ity (OR = 0.922, IC95: 0.871–1.004); p = 1.000). A higher
Gaussian distribution. These variables were presented morbidity and mortality rate was detected in the PS group
as means and standard deviation if they followed a in the uni- (p = 0.002) and multivariate analyses (OR 8.947;
normal distribution or as median and interquartile ranges 95% CI: 2.116–37.829; p = 0.002).
otherwise. For hypothesis contrast, chi-square, Student’s Regarding morbidity, mortality and prognostic variables,
T, or Mann–Whitney U tests were used for qualitative or patients were compared according to the intention of the
quantitative variables, respectively. Bonferroni correction treatment received: curative (SBTS vs. ECS) or palliative
was used in case of multiple comparisons. OS and DFS were (PS vs. EPS). Table 2 presents the surgical and postoperative
estimated by Kaplan–Meier analysis and compared using the course of non-palliative patients. A higher rate of laparo-
log-rank Mantel-Cox test. A muItivariate stepwise logistic or scopic approach (56.3% vs. 8.8%; p < 0.001), and primary
a linear regression model was conducted to identify the risk anastomosis (92.3% vs. 55.8%; p < 0.001) was observed in
factors related to surgical morbidity and mortality. In this patients from the SBTS group. Also, a lower number of
sense, a stepwise proportional Cox hazard model was used colostomies (12.8% vs. 40%; p = 0.023) was recorded in
with the same intention in the survival analysis. p values elective cases.
lower than 0.05 were considered statistically significant. General morbidity and mortality rate (46.2% SBTS gr.
All statistical analyses were performed with SPSS 25.0® vs. 67.6% ECS gr.; p = 0.067) and hospital stay (15 days
software (IBM, SPSS Statistics for Windows, Version 25.0. SBTS gr. vs. 13.5 days ECS gr.; p < 0.946) were not sig-
Armonk, NY: IBM Corp.). nificantly different between the two groups, but in the post-
surgical specific context these results changed. In this field,
the complication rate was significantly lower after elective
Results surgery (41% vs. 67.6%; p = 0.025), and similar results were
obtained in terms of median postoperative stay (8 days SBTS
A total of 112 patients were identified, but one case was gr. vs. 13.5 days ECS gr.; p < 0.001). In all cases, statisti-
lost in the follow-up period, so 111 patients were finally cal significance was maintained in the multivariate logistic
included in the study (72♂, 39♀). This volume of population regression analysis.
constituted 15.9% of colorectal cancer patients managed Eleven of the 30 (36.6%) palliative patients treated with
in our centre, and made up 80% of colon cancer related stent had to undergo emergency surgery due to clinical fail-
emergencies. Sixty-nine (62.2%) were treated primarily by ure or stent-related complications. Only 81.8% (9/11) of the
stenting (SBTS group: 39, PS group: 30), while the remaining patients operated in the PS group, and 37.5% (3/8) in the
42 (37.8%) underwent emergency surgery (ECS group: 34, EPS gr. underwent an oncological resection of the primary
EPS group: 8). Demographic and oncologic characteristics tumour. Operative time (p = 0.933), isolated lymph node
are shown in Table 1. A trend towards greater anaesthetic risk number (p = 0.710) and primary anastomosis rate (p = 0.147)
was observed in patients treated with SEMS. Furthermore, were similar between the two groups (Table 3). Neverthe-
a higher rate of lymph node invasion and stage IV was also less, a significantly lower stoma rate was obtained in PS
detected in this subgroup (p < 0.05). Two-thirds of proximal group (30% vs. 87.5%; p = 0.039). No significant differences
tumours (12/18) underwent emergency surgery. The enlarged were found in general and postoperative morbimortality in
right colectomy was the most frequent technique (44.4%) in both groups. As regards hospital stay, a longer postoperative
this subgroup. A higher percentage of stent-treated patients hospitalization period was obtained in the PS group (17 days
received chemotherapy (47.8% SEMS group. vs. 11.9% vs. 9 days EPS gr.; p = 0.033). Nevertheless, no difference
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between groups was found in the total (post-SEMS + post- follow-up the bridge to surgery therapy presented a sig-
operative) hospital stay (6 days PS gr. vs. 9 days EPS gr.; nificantly higher relapse frequency compared to emergency
p = 0.268). surgery (43.2% vs. 21.4%; p = 0.049). This difference was
Figure 2 depicts the Kaplan–Meier survival curves of the due to an increased metastatic recurrence rate in SBTS
study sample. Patients in the SBTS group had a 5-year OS group (33.3% vs. 14.7%; p = 0.098). In these cases, manage-
and DFS of 58% and 43%, respectively, similar figures to ment was individualized but generally consisted in chemo-
those in the ECS group (60% and 45%). However, during therapy followed by metastasis resection when possible. A
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multivariate Cox regression model was generated to com- postoperative morbidity explain the diffusion and popular-
pare survival factors of patients who received treatment with ity this treatment has today. However, there is still concern
curative intent (Table 4). The use of the stent as bridging about its possible effect on morbidity and mortality, as dis-
therapy did not show a relationship with OS (HR 1.505; cordant conclusions exist in the available literature, referring
95% CI: 0.504–4.497; p = 0.464) or with DFS (HR 1.822; to an either similar or lower complication rate with SBTS
95% CI: 0.703–4.722; p = 0.217). Only stage pT4 was cor- therapy [5, 17–19]. Moreover, a considerable controversy
related with a worse oncological prognosis (HR 6.423; 95% about the oncological outcome provided by stent place-
CI: 2.055–20.073; p = 0.001). In the palliative setting, the ment exists, as this topic was little considered during the
treatment received also showed no influence on the progno- spread of the therapy. In this sense, although the majority of
sis of the different groups. reviews and meta-analysis do not refer differences between
emergency surgery or stenting [20, 21], there is still dis-
parity in smaller series that keep the debate open [14, 22,
Discussion 23]. Also, a recent meta-analysis found a higher perineural
and lymphatic invasion rate in stent-treated patients and a
The use of SEMS placement as a therapeutic alternative relation between these factors and a worse OS [24]. Being
entails clear advantages, with the main one converting an a centre that counts with more than 10 years of experience
emergency surgery into an elective one. Thus, it could per- in the technique and a specialized Colorectal Surgery Unit,
mit to complete a correct disease staging and an adequate we consider it useful to perform a detailed review of our
nutritional and anaesthesic optimization before the surgery. results. Due to the retrospective nature and the huge number
These advantages and the potentially secondary reduction of of clinical and oncological variables, we chose to perform
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International Journal of Colorectal Disease
an intention-to-treat basis analysis over a per protocol one. Used as a bridge to elective surgery, SEMS enabled the
Also, we consider its more conservative nature to contribute performance of more complex surgical procedures with a
to the honesty of our study. greater laparoscopic approach and primary anastomosis
We obtained a technical and clinical success of 95% and rate, as well as a lower stoma formation in our series. These
91%, respectively, rates slightly higher than those reported results are consistent with what has been previously reported
in other series with similar design [5, 25, 26]. The routine [5, 26, 28, 29]. The advantages of this management also
use of fluoroscopy and the absence of systematic dilation included a shorter hospital stay and a lower morbidity and
of the stenosis during the procedure, as well as counting mortality rate in the post-surgical setting, although these
with experienced radiologists, may explain this result. differences disappeared when post-stent stay and morbidities
Regarding stent-related morbidity, an unexpected 13% rate were included in the analysis. Similar results were obtained
of colonic perforations was detected. This event constitutes with respect to general morbidity and mortality (51.8% stent
the most feared complication, and was more frequent than group vs. 57.6% surgery group; p > 0.05) in the ESCO trial
in other reports [7]. The considerable 43.4% (30/69) of [30]. We believe, based on these results, that just the benefit
palliative stents and the significant relationship between of a minimally invasive approach and fewer stoma rate, in
this indication and a higher morbidity rate partially explain the absence of other differences, may justify the choice of
this result. In this regard, a possible relation between the SBTS therapy. Furthermore, the psychological impact of an
success rate and a prolonged stent-surgery time interval, unscheduled, prolonged and torpid admission may be far
found in a recent review [27], could not be investigated in more damaging than that of two shorter (post-stent and post-
our series, due to the small sample size of the SBTS group operative) and complication-free hospital stays. The quan-
and the great range of data detected. Also, the conditions tification of this item may be of interest for future projects.
(urgent or semi-elective) under which the stent was placed Major concern has been raised regarding oncologi-
could have influenced the success and morbimortality rate. cal safety of colonic stent. In our series, we detected a
As this variable was highly influenced by the availability of higher rate of relapse in the SBTS group (43.2% vs. 21.4%;
the Interventional Radiology Unit, the data obtained would p = 0.049), at the expense of metastatic recurrence (33.3%
have been random and therefore were not included in the vs. 14.7%). This result is not unique to our work [31], and
analysis. may be due to the higher pN2 lymph node stage found in
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Fig. 2 Kaplan–Meier curves and recurrence rate analysis. a Overall c Overall survival (OS) of patients treated with palliative intent,
survival (OS) of patients treated with curative intent, p = 0,649 (log- p = 0,891(log-rank Mantel-Cox test). d Locoregional and metastatic
rank Mantel-Cox test). b Disease-free survival (DFS) of patients recurrence rate subgroup analysis
treated with curative intent, p = 0,925 (log-rank Mantel-Cox test).
the SBTS group and the prolonged follow-up period. This European Society of Gastrointestinal Endoscopy (ESGE) guide-
disparity did not condition the OS or DFS, since these vari- line in 2014 and the most recommended in his last updated version
ables were similar in both groups. In this sense, our results [34, 35]. In terms of morbidity, our results are similar to those
are consistent with the ones referred by Matsuda and Cao in reflected in the main meta-analysis [36, 37]. Thus, we detected a
2015 and 2019 [20, 21], and more recently by Cirocchi et al. lower stoma formation in stent-treated patients without obtaining
[32]. In this regard, the higher percentage of chemotherapy any other difference in terms of morbimortality between groups.
treatment should have theoretically affected the prognosis Only a higher postoperative stay was detected in patients oper-
but the multivariate analysis did not show statistical sig- ated after stent placement. As the intervention in these cases was
nificance. In this sense, perhaps the higher rate of relapse a consequence of a stent failure or a secondary complication, the
in the SBTS gr. was compensated by a better oncological general condition of the patient may have been even worse than in
treatment. In reference to influencing factors to survival, the the EPS group. This factor, and the major difficulty of the surgery
lack of association between stent-related perforation and OS due to the local conditions, may explain this difference. Regarding
or DFS must be mentioned, as recent series found opposite oncological outcome, the absence of differences between PS and
results [33]. As in our study this complication occurred more EPS groups (OS: 11 vs. 8 months; p = 0.981) is consistent with the
frequently in the PS group (7/9 cases), perhaps its prognostic majority of the data previously reported by renowned investigators
influence was more difficult to detect. [36]. In certain series, an oncological resection after stent place-
Palliative use of SEMS has been object of less interest through ment has been related with a better outcome [38], a fact that could
the years, even though it is the only approved indication by the have influenced our results, as we found 9 patients in the PS gr.
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International Journal of Colorectal Disease
vs. 3 in the EPS gr. with a reduced tumour burden. Nevertheless, and we hope to reach more firm conclusions. Strong points
these patients were operated due to stent-related complications, to be highlighted were the inclusion of an exhaustive mul-
events whose consequences must be considered in an oncologic tivariate analysis and the long follow-up period, which adds
prognosis scenario. Thus, this possible OS improvement in the PS validity to our conclusions, particularly at the prognostic
group is a consequence of stent treatment selection, and therefore level. Future areas of focus should be performing a prospec-
we believe our analysis to be as correct as possible. As it may tive monitoring of the actual series, as well as standard-
improve the quality of life, avoiding the stoma should be consid- izing protocols for treatment decision based on patient and
ered a priority and justifies, in our opinion, the choice of the stent tumour characteristics.
over ES in palliative cases.
The lack of randomization and the retrospective nature Conclusion
of our investigation cause inevitably a certain grade of
selection bias, to which factors such as the availability of Although management of left-colon malignant obstruction
the interventional radiology team or the surgeon on call’s through stent placement is not without complications, it con-
preference may also have contributed. Likewise, this is a stitutes an effective alternative, as it has a clinical success
single-centre investigation, a fact that may condition the equivalent to that of emergency surgery. Its use as bridge to
generalizability of our results. Another limitation of our elective surgery significantly reduces morbidity and mor-
study could be the sample size. Although not much smaller tality and hospital stay without compromising oncological
than that of other retrospective series, it may have limited prognosis. In addition, the rate of laparoscopic approach and
the statistical results in certain sub-analysis. To solve this, primary anastomosis increases, consequently reducing the
we are collaborating in a multicentric retrospective study, number of stomas compared to emergency surgery. In the
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International Journal of Colorectal Disease
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Does stenting of left-sided colorectal cancer as a bridge to surgery
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