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S0016-5107(16)30014-1
DOI:
10.1016/j.gie.2016.03.1498
Reference:
YMGE 9945
To appear in:
Gastrointestinal Endoscopy
Please cite this article as: Yamao K, Kitano M, Kayahara T, Ishida E, Yamamoto H, Minaga K,
Yamashita Y, Nakajima J, Asada M, Okabe Y, Osaki Y, Chiba Y, Imai H, Kudo M, Factors Predicting
Through-the-Scope Gastroduodenal Stenting Outcomes in Patients with Gastric Outlet Obstruction: A
Large Multicenter Retrospective Study in West Japan, Gastrointestinal Endoscopy (2016), doi: 10.1016/
j.gie.2016.03.1498.
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Original article
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Kentaro Yamao1 , MD, Masayuki Kitano1, MD, PhD, Takahisa Kayahara2 , MD, PhD,
Etsushi Ishida2, MD, Hiroshi Yamamoto2, MD, PhD, Kosuke Minaga3, MD, Yukitaka
Yamashita3, MD, PhD, Jun Nakajima4, MD, Masanori Asada4, MD, PhD, Yoshihiro
Okabe4, MD, PhD, Yukio Osaki4, MD, PhD, Yasutaka Chiba5, PhD, Hajime Imai1, MD,
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Corresponding author:
Masayuki Kitano, MD, PhD
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Fax: +81-72-366-0206
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E-mail: m-kitano@med.kindai.ac.jp
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Abstract
Background and Aims: Endoscopic gastroduodenal stenting for malignant gastric outlet obstruction
has recently become more effective, but the factors that predict gastroduodenal stenting outcomes are
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poorly defined. This multicenter retrospective cohort study evaluated the clinical outcomes of
gastroduodenal stenting in malignant gastroduodenal obstruction and identified factors predicting
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Methods: All consecutive patients with malignant gastroduodenal obstruction who underwent
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through-the-scope gastroduodenal stenting from 2009 to 2014 at 4 tertiary medical centers, were
identified. Clinically ineffective stenting was defined as symptom recurrence and gastric outlet
obstruction scoring system (GOOSS) score <2.
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Results: Of the 278 patients (mean age, 71.7 11.4 years), 121 (43.5%) and 87 (31.3%) had
pancreatic and gastric cancer, respectively. Technical success was achieved in 277 (99.6%). GOOSS
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scores rose from 0.5 0.6 to 2.6 0.8. Stenting was ineffective in 32 (12.6%). Stent dysfunction that
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caused symptom recurrence during follow-up developed in 46 patients (16.6%). Adverse events
occurred in 49 patients (17.7%). Three or more stenosis sites (OR=6.11, P<0.01) and Karnofsky
performance scores 50 (OR=6.63, P<0.01) predicted clinical ineffectiveness. Karnofsky
performance scores 50 predicted stent dysfunction (HR=3.63, P<0.01). Bile duct stenosis
(HR=9.55, P=0.02) and liver metastasis (HR=9.42, P<0.01) predicted stent overgrowth. Covered
stent predicted stent migration (HR=12.63, P<0.01). Deployment of 2 stents predicted perforation
(HR=854.88, P<0.01).
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Conclusions: Through-the-scope gastroduodenal stenting tended to be ineffective in patients with
poor performance status and long stenosis sites. Stent dysfunction occurred more frequently in
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patients with poorer performance status. Deployment of 2 stents was a risk factor for perforation.
Identification of these risk variables may help yield better gastroduodenal stenting outcomes.
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Key words: through-the-scope gastroduodenal stenting, predictive factors, gastric outlet obstruction,
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Abbreviations: CI: confidence intervals, GJ: gastrojejunostomy, GOO: gastric outlet obstruction,
GOOSS: gastric outlet obstruction scoring system, HR: hazard ratios, KPS: Karnofsky performance
Introduction
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Patients with gastric or pancreatobiliary cancer sometimes develop gastric outlet obstruction (GOO)
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due to gastric or duodenal stenosis. Considering the systemic condition and its poor prognosis, it is
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better to treat unresectable cases of GOO with minimally invasive methods. In the past, the standard
minimally invasive treatment for malignant duodenal obstruction was gastrojejunostomy (GJ).
However, endoscopic gastroduodenal stenting for malignant GOO has recently become more
effective, safer, and less expensive than GJ; it also has better short-term outcomes than GJ,
particularly a shorter hospital stay and a more rapid return to oral intake [1-4]. The technical and
clinical success rates of endoscopic gastroduodenal stenting using the recently developed
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through-the-scope stent have been reported to be 95.5% to 100% and 82.3% to 91.0%, respectively
[5-8]. However, through-the-scope gastroduodenal stenting is still ineffective in some patients, and
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stent dysfunction and adverse events can occur due to various reasons.
Despite the many studies on the clinical efficacy of through-the-scope gastroduodenal
stenting, the factors that predict poor stent efficacy, stent dysfunction, and adverse events are
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relatively poorly understood [9-14]. The purpose of the present retrospective multicenter cohort
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This multicenter retrospective clinical study was approved by the institutional ethics committees of
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Patients
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All consecutive patients who underwent through-the-scope gastroduodenal stenting for malignant
GOO between March 2009 and March 2014 at 4 tertiary medical centers (Kinki University,
Kurashiki Central Hospital, Japanese Red Cross Wakayama Medical Center and Osaka Red Cross
Hospital) were identified by searching the medical databases of the 4 centers. Patients were included
in the study if (1) they had undergone endoscopic gastroduodenal stenting with through-the-scope
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stents, (2) they had documented unresectable malignant cancers, and (3) they had obstruction of the
stomach or duodenum or jejunum that was causing nausea, vomiting, dysphagia, and difficulties in
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oral intake. Patients were excluded if (1) there was clinical evidence of perforation or peritonitis, (2)
intestinal roentogenography with contrast medium revealed multiple small bowel obstructions, and
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pyloric/duodenal stent, uncovered type (both from Taewoong Medical, Seoul, South Korea). All
stents were deployed under endoscopic and fluoroscopic guidance. Patients were sedated with
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as possible away from the site of stenosis. The distal or proximal lumen of the stenosis site was
captured, and after confirming the position and length of the site of stenosis, the appropriate length
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and position of the stent were determined. Thereafter, while considering the shortening of the stent
after extension, the duodenal stent was placed under endoscopic and fluoroscopic guidance.
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Follow-up
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If the duodenal stent was placed without any immediate adverse events, the patient could start clear
fluid intake 1 to 5 days after stenting. An abdominal radiograph was performed 1 to 3 days after
intervention to check the expansion and location of the stent. If, after receiving clear fluids, the
patient showed no GOO symptoms, no stent dislocation, and sufficient stent expansion, the patient
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could start a semisolid diet. Recurrence of GOO was diagnosed if the patient presented with appetite
loss, nausea, and vomiting, and if the stenosis was confirmed by imaging with endoscopic,
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across the stenosis, as confirmed by a combination of endoscopy and fluoroscopy. The degree of
dysphagia was assessed before and after stent placement by using an adaptation of the gastric outlet
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obstruction scoring system (GOOSS)[15], where swallowing ability is divided into 4 categories: 0,
no oral intake; 1, liquids only; 2, soft solids; and 3, low-residue or full diet. Stenting was deemed to
be clinically effective if, 7 days after stenting, the patient achieved a GOOSS score 2 and/or relief
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of gastric outlet obstruction symptoms. Stenting was deemed to be ineffective when the GOOSS
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scores were <2 and relief from gastric outlet obstruction symptoms was not observed 7 days after
stenting. Stent patency was defined as the period between initial stent placement and recurrence of
obstructive symptoms due to stent dysfunction. In calculating stent patency, patients were censored if
they did not exhibit cessation of stent patency during their life. A stent was deemed to be
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dysfunctional when the patient showed a return of GOO symptoms and the stent was found by
imaging to be ingrown, overgrown, kinked, collapsed, broken, dislocated, or food impacted. Early
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stenting, respectively.
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and late adverse events were defined as those occurring within 7 days and later than 7 days after
The following factors were evaluated for their ability to predict clinical ineffectiveness, stent
dysfunction that caused recurrence of obstruction, and adverse events: age, sex, diagnosis (pancreatic
cancer, gastric cancer, or intrinsic disease), main organ of obstruction (stomach or duodenum),
number of stenosis sites, GOOSS before stenting, Karnofsky performance status (KPS), presence of
bile duct stenosis, liver metastasis, ascites, use of a covered or uncovered stent, number of stents
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used to cover a stenosis at the first treatment, and use of chemotherapy after stenting. A stenosis was
considered to be intrinsic when the diagnosis was gastric, duodenal, or ampullary cancer and to be
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extrinsic when the diagnosis was pancreatic, bile duct, gallbladder cancer, or another cancer. The
stenosis sites were divided into 8 sites: gastric body, angle, antrum, bulb, and second, third, and
fourth portion of the duodenum and jejunum, and the number of sites to which stenosis extended was
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measured.
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All patients were followed-up to assess their symptom resolution until study termination
(October 2014) or patient death. When patients could not be followed up directly for specific reasons,
Statistical analysis
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such as a move to another area, their families or personal physicians were contacted by telephone.
Continuous variables were expressed as means standard deviation (SD). Categorical data were
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expressed as n (%). Cumulative stent patency and survival were evaluated by using KaplanMeier
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analysis. Logistic regression model was applied to explore factors that associated independently with
clinical ineffectiveness. Odds ratios (ORs) and the 95% confidence intervals (CIs) were reported.
Cox proportional hazards model was applied to explore prognostic factors that associated
independently with the time until obstruction recurrence caused by overall stent dysfunction or,
specifically, stent ingrowth, stent overgrowth, or stent migration. Cox proportional hazards model
was also applied to explore predictive factors for time until overall adverse events or, specifically,
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jaundice, bleeding, or perforation. Hazard ratios (HRs) and the 95% CIs were reported. All statistical
analyses were performed by using SPSS Statistics version 19 (SPSS, Chicago, Ill, USA). P-values
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In total, 304 patients who underwent through-the-scope gastroduodenal stenting for malignant
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gastroduodenal obstruction during the study period were identified. Of these, 26 were excluded
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because there was clinical evidence of perforation (n = 1), there was evidence of multiple small
bowel obstructions on intestinal roentogenography (n = 5), or the patient had undergone upper GI
Patient characteristics
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reconstruction surgery (n = 20). As a result, 278 patients formed the study cohort.
The demographic and clinical characteristics of the 278 patients are shown in Table 1. Their mean
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age was 71.7 11.4 years. The etiology of the gastroduodenal obstruction was pancreatic cancer (n =
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121, 43.5%), gastric cancer (n = 87, 31.3%), bile duct cancer (n = 22, 8.0%), lymph node metastasis
from another cancer site (n = 13, 4.7%), duodenal cancer (n = 12, 4.3%), and gallbladder cancer (n =
12, 4.3%). The preoperative GOOSS scores were 0, 1, and 2 in 156 (56.1%), 100 (36.0%), and 22
(7.9%) patients, respectively. The average GOOSS score was 0.5 0.6. The KPS score was 60 and
50 in 220 (79.1%) and 58 (20.9%) patients, respectively.
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Technical success and clinical effectiveness of stenting
The mean follow-up time was 124.1 165.6 days. Technical success was achieved in 277 of the 278
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patients (99.6%). The single case of technical failure occurred because the guidewire could not pass
through the obstructed areas due to the severity of the stricture. Clinical effectiveness (GOOSS score
2 and/or relief of gastric outlet symptoms 7 days after stenting) was achieved in 242 of 277
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technically successful patients (87.4%). In the remaining 35 patients, stenting was ineffective in 32
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(11.7%), and 3 patients (1.1%) died within 7 days of stenting. The mean procedure time was 23.1
11.8 minutes. The mean times from stenting to resumption of oral fluids and resumption of solids
were 2.8 1.7 and 4.2 2.9 days, respectively. The GOOSS scores improved from 0.5 0.6 before
stenting to 2.6 0.8 (change in GOOSS scores: 2.0 1.0). Median patient survival was 88 days.
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Median stent patency was 242 days. In total, 266 and 11 patients needed 1 and 2 stents, respectively,
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jaundice (n = 17, 6.1%). The remaining early adverse events were hyperamylasemia (n = 3, 1.1%),
aspiration pneumonia (n = 3, 1.1%), pancreatitis (n = 2, 0.7%), bleeding (n = 2, 0.7%), and
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perforation (n = 1, 0.4%). The late adverse events all consisted of bleeding (n = 9, 3.2%), jaundice (n
= 7, 2.5%), and perforation (n = 5, 1.8%).
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The 274 patients in whom stent placement was technically successful and who survived past the first
7 days of stenting were divided into 2 groups according to clinical efficacy. Thus, there were 242 and
32 patients in the clinically effective and ineffective groups, respectively. Multiple logistic regression
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model was applied to explore factors that predicted clinical ineffectiveness (Table 3). Three or more
stenosis sites (OR, 6.11; 95% CI, 2.1617.30; P < 0.01) and KPS 50 (OR, 6.63; 95% CI, 2.89
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stent dysfunction, namely, stent ingrowth, overgrowth, and migration (Supplementary tables 2-4).
Predictive factors for stent ingrowth were not found. However, bile duct stenosis (HR, 9.55; 95% CI,
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1.4662.68; P = 0.02) and liver metastases (HR, 9.42; 95% CI, 2.1141.95; P < 0.01) were predictive
of time until stent overgrowth. Covered stent (HR, 12.63; 95% CI, 2.3567.80; P < 0.01) was the
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The 277 patients in whom stent placement was technically successful were divided according to
whether they developed an adverse event (n = 49) or not (n = 228). Cox proportional hazards model
revealed that use of uncovered stents (HR for covered stents = 0.27; 95% CI, 0.100.69; P < 0.01)
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and lack of chemotherapy after stenting (HR for chemotherapy after stenting = 0.42; 95% CI, 0.19
0.95; P = 0.04) predicted adverse events (Supplementary table 5). A similar analysis searching for
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predictive factors for specific adverse events, namely, perforation, bleeding, and jaundice, revealed
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that deployment of 2 stents in the same session (HR, 854.88; 95% CI, 11.3664356.6; P < 0.01) was
predictive of perforation (Supplementary table 6). There were no significant predictive factors for
bleeding and jaundice (data not shown).
Discussion
This multicenter retrospective study was performed to identify factors that predicted the clinical
outcomes of through-the-scope gastroduodenal stenting for malignant gastroduodenal obstruction.
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The rate of clinical ineffectiveness after stenting was 11.7% (32/274), and the predictive factors for
clinical ineffectiveness were KPS 50 (P < 0.01) and 3 or more stenosis sites (P < 0.01). The rate of
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stent dysfunction during follow-up was 16.6% (46/277), and stent dysfunction was predicted by KPS
50 (P < 0.01). The adverse event rate was 17.7% (49/277), and the use of an uncovered stent (P <
0.01) and lack of chemotherapy (P = 0.04) predicted adverse events.
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stenting are relatively poorly understood. Sato et al12 proposed that KPS 50, peritoneal
dissemination, and ascites were significant predictive factors of clinical ineffectiveness. Sasaki et al11
also found that KPS 50 and ascites were risk factors for restricted solid oral intake. We found that
KPS 50, but not ascites, predicted clinical ineffectiveness. Note that Mendelsoh et al[5] argued that
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ascites should not be a contraindication to duodenal stenting, because the clinical success of this
procedure in patients with carcinomatosis was 81%. The apparent discrepancy between our study and
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those of Sato et al and Sasaki et al in terms of the predictive value of ascites probably reflects the
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different indications for gastroduodenal stenting. The previous studies did not confirm stenosis at the
anal side of the small intestine by imaging with intestinal roentogenography with contrast medium.
By contrast, in our study, we used intestinal roentogenography before stenting to confirm passage
through the small intestine. If the contrast medium collected in the small intestine, we did not
perform gastroduodenal stenting. In the case of peritonitis carcinomatosis, clinical ineffectiveness
may result from not only ascites, but from poor motility or stenosis of the small intestine.
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The present study is the first to show that a large number of stenosis sites (which indicates a
long invasive area) significantly predicted the clinical ineffectiveness of gastroduodenal stenting.
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This result suggest that poor motility of the stomach and/or duodenum, caused by a long invasive
area, may worsen GOO [16, 17].
The present study showed that the rate of overall stent dysfunction during follow-up was
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16.6% (46/277). A closer examination of the causes of stent dysfunction revealed that the rates of
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stent ingrowth, overgrowth, and migration were 5.8% (16/277), 4.0% (11/277), and 4.0% (11/277),
respectively.
Uncovered stent did not predict stent ingrowth, but covered stent did predict stent migration
(P < 0.01). Several recent studies compared the clinical outcomes of covered and uncovered
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duodenal stents for the palliation of GOO [6-9, 14, 18, 19]. A prospective randomized study
comparing uncovered and covered stents showed that the uncovered group had more frequent stent
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ingrowth (18.0% vs 3.4%, P = 0.02), equally frequent stent overgrowth (3.4% vs 3.3%, P = 0.99),
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and less frequent stent migration (0% vs 13.6%, P < 0.01)[20]. A similar prospective randomized
study also showed that the uncovered group had more frequent tumor ingrowth (25.0% vs 0%, P <
0.01) and less frequent stent migration within 8 weeks (25.8% vs 2.8%, P < 0.01)[18]. Similarly, the
retrospective cohort study of Waidmann et al showed that the uncovered and covered groups were
similar in terms of stent overgrowth rates (19% vs 13%, P = 0.73) and that all stent migrations were
observed in the covered group (0% vs 56%, P < 0.01)[21]. However, they did not detect any tumor
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ingrowth in either group (0% vs 0%). Thus, in all reports, including ours, stent migration occurs
more frequently with covered stents than with uncovered stent. However, whether stent ingrowth
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relates to the use of uncovered stents remains unclear. Discrepancies between the studies on this
issue may reflect differences in terms of stent materials or patient selection. Further large multicenter
prospective studies that compare uncovered and covered self-expandable metallic stents are
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warranted.
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The present study also showed that bile duct stenosis and liver metastases predicted stent
overgrowth in the present study. This reflects the close correlation between tumor progression and
these 2 factors.
The present study also showed that the rate of perforation after stenting was 2.2% (6/277)
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and that the single predictive factor for perforation was deployment of 2 stents in the same session
(P < 0.01). Little is known about perforation associated with gastroduodenal stenting. However, 2
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studies reported the risk factors for perforation after colonic stenting: the meta-analysis of Van
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Halsema et al22 suggested that colonic perforation can be predicted by the use of stents with high
axial force, a benign etiology, and bevacizumab treatment, whereas the subsequent retrospective
cohort analysis of Boyle et al reported that longer stenosis predicts colonic perforation[23]. The
possibility that perforation is more likely to occur when the stent has high axial force and the
stenosis is long is supported by our study on gastroduodenal stents, which showed deployment of 2
stents increased the risk of perforation. Deployment of 2 stents may increase the axial force of the
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stent compared with when just one stent is placed: the force is likely to be particularly strengthen by
overlapped placement. In addition, 2 stents are needed in cases of long stenosis. Thus, regardless of
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the gastrointestinal organ undergoing stenting, these observations together suggest that higher axial
force and longer stenosis may promote perforation. This in turn suggests that deploying 2 stents
should be avoided.
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A major concern of patients with advanced digestive cancer is the maintenance of oral
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intake because it is important for their quality of life. GJ is also indicated in cases of stenosis at anal
sites from antrum because the anastomosis is created at the gastric body. Because oral intake
improves more rapidly after gastroduodenal stent placement than after GJ, and stenting is less
invasive, gastroduodenal stenting is increasingly becoming the first choice for GOO. This preference
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is bolstered by the fact that the 2 procedures do not differ in terms of technical and clinical success or
the incidence of early adverse events. However, compared with GJ, gastroduodenal stenting is
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associated with a shorter time to late adverse events, recurrent obstructive symptoms, and
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re-intervention [2]. The current study is consistent with the other studies that show duodenal stenting
is safe (namely, it has a low incidence of major adverse events), there is a rapid progression of diet,
and the hospital stay is relatively short [3, 4, 24, 25]. However, given that we found that longer
stenosis promotes the risk of gastroduodenal stenting ineffectiveness, GJ may be more suitable for
cases with longer stenosis, particularly at anal sites from the antrum.
This study has 2 limitations. First, our study had a non-randomized and retrospective design,
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which inherently decreases the statistical power of the study. Second, several different types of stents
were used. To best identify the factors that predict gastroduodenal stent efficacy, dysfunction, and
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adverse events, a large prospective randomized controlled study on the same stent is needed.
In conclusion, we showed that several factors influence the clinical outcomes of
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with poor performance status and long stenosis sites, stent dysfunction occurred more frequently in
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patients with poorer performance status, and deployment of 2 stents was a risk factor for perforation.
The identification of these predictive factors may help to generate better gastroduodenal stenting
outcomes.
Acknowledgments
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References
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The present study was supported by grants from the Japan Society for the Promotion of Science.
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Mean age SD (years)
71.7 11.4
Sex, n (%)
Male
163 (58.6)
Female
115 (41.4)
121 (43.5)
87 (31.3)
22 (8.0)
13 (4.7)
Duodenal cancer
12 (4.3)
Gallbladder cancer
12 (4.3)
Ampullary cancer
5 (1.8)
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Gastric cancer
Others
6 (2.2)
89 (32.0)
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Stomach
Body
1 (0.4)
Angle
28 (10.1)
Antrum
60 (21.6)
Duodenum
189 (68.0)
D1 (bulb)
63 (22.7)
D2 (2nd portion)
76 (27.3)
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D
D3 (3rd portion)
D4 (4th portion)
Small intestine
Jejunum
EP
GOOSS, n (%)
0
1
9 (3.2)
0 (0)
0 (0)
156 (56.1)
100 (36.0)
22 (7.9)
AC
C
41 (14.7)
Mean SD GOOSS
0.5 0.6
58 (20.9)
220 (79.1)
21
ACCEPTED MANUSCRIPT
Late period (%)
Total (%)
Stent dysfunction
5 (1.8)
41 (14.8)
46 (16.6)
Stent ingrowth
1 (0.4)
15 (5.4)
16 (5.8)
0 (0)
11 (4.0)
11 (4.0)
Stent migration
2 (0.7)
9 (3.2)
11 (4.0)
Food impaction
0 (0)
3 (1.1)
Kinking
1 (0.4)
1 (0.4)
Stent collapse
1 (0.4)
1 (0.4)
Stent breakage
0 (0)
1 (0.4)
1 (0.4)
28 (10.1)
21 (7.6)
49 (17.7)
3 (1.1)
2 (0.7)
2 (0.7)
SC
M
AN
U
Stent overgrowth
RI
PT
17 (6.1)
7 (2.5)
24 (8.7)
Bleeding
2 (0.7)
9 (3.2)
11 (4.0)
Perforation
1 (0.4)
5 (1.8)
6 (2.2)
Hyperamylasemia
3 (1.1)
0 (0)
3 (1.1)
Aspiration pneumonia
3 (1.1)
0 (0)
3 (1.1)
0 (0)
2 (0.7)
Pancreatitis
TE
D
Jaundice
2 (0.7)
AC
C
EP
22
ACCEPTED MANUSCRIPT
Ineffective
(n = 242)
(n = 32)
154
15
Male
146
20
Female
96
12
Pancreatic cancer
112
Gastric cancer
71
15
Intrinsic disease
Age, 71
Sex
OR
95% CI
0.37
0.69
0.301.55
0.33
1.54
0.653.64
0.08
0.38
0.131.11
0.82
1.12
0.442.86
SC
Diagnosis
P value
RI
PT
Effective
M
AN
U
88
15
0.15
1.84
0.804.24
74
13
0.76
1.18
0.413.43
168
19
20
11
<0.01
6.11
2.1617.30
GOOSS score of 0
134
20
0.35
1.47
0.663.26
KPS, 50
38
17
<0.01
6.63
2.8915.20
111
18
0.16
1.86
0.784.46
70
0.98
1.01
0.432.38
77
12
0.46
1.34
0.612.93
67
10
0.74
1.15
0.512.59
Deployment of 2 stents
0.05
3.84
0.9914.95
79
0.12
0.01
0.015.12
AC
C
Covered stent
EP
Ascites
TE
D
3 stenosis sites
23
ACCEPTED MANUSCRIPT
Author contributions:
Kentaro Yamao: manuscript writing, drafting conception and design, performing
stenting, and data collection.
RI
PT
Masayuki Kitano: manuscript writing, drafting conception and design, and performing
stenting.
Takahisa Kayahara: manuscript writing, drafting conception and design, and performing
SC
stenting.
M
AN
U
TE
D
EP
AC
C
ACCEPTED MANUSCRIPT
(n = 231)
(n = 46)
120
18
Male
136
32
Female
95
14
Pancreatic cancer
101
19
Gastric cancer
72
15
Intrinsic disease*
85
Stomach
Duodenum
Age, 71
P value
HR
RI
PT
95% CI
0.10
0.56
0.281.12
0.24
1.52
0.763.04
0.55
0.76
0.311.86
0.48
0.49
0.073.55
19
0.68
1.30
0.374.54
72
16
0.33
2.45
0.4114.69
159
30
3 stenosis sites
27
0.39
0.60
0.191.89
GOOSS score of 0
126
30
0.59
1.20
0.622.31
KPS, 50
48
10
<0.01
3.63
1.558.50
110
21
0.44
1.34
0.642.81
66
14
0.73
1.13
0.572.25
79
11
0.49
0.78
0.391.57
62
16
0.20
1.54
0.802.95
Deployment of 2 stents
11
>0.99
<0.01
57
22
0.66
1.18
0.562.46
AC
C
Covered stent
EP
Ascites
TE
D
M
AN
U
Diagnosis
SC
Sex
ACCEPTED MANUSCRIPT
(n = 261)
(n = 16)
132
Male
161
Female
100
Pancreatic cancer
115
Gastric cancer
80
Age, 71
Intrinsic disease*
M
AN
U
Diagnosis
HR
95% CI
0.33
0.54
0.151.87
0.15
0.45
0.151.33
0.71
0.72
0.124.21
0.85
1.32
0.0822.41
SC
Sex
P value
RI
PT
No ingrowth
95
0.56
1.90
0.2216.45
81
0.60
0.47
0.037.46
180
29
0.79
1.27
0.227.24
146
10
0.63
0.76
0.262.29
54
0.09
3.45
0.8314.41
127
0.43
0.57
0.142.35
77
0.93
0.94
0.243.68
87
0.86
0.89
0.233.37
77
0.06
0.13
0.021.05
Deployment of 2 stents
11
>0.99
<0.01
72
0.89
1.10
0.303.99
AC
C
Covered stent
EP
Ascites
TE
D
GOOSS score of 0
ACCEPTED MANUSCRIPT
(n = 266)
(n = 11)
134
Male
159
Female
107
Age, 71
Diagnosis
116
Gastric cancer
83
Intrinsic disease*
95% CI
0.76
0.193.03
0.30
2.51
0.4314.58
0.09
0.14
0.011.34
0.84
1.68
0.01247.90
M
AN
U
Pancreatic cancer
HR
0.69
SC
Sex
P value
RI
PT
No overgrowth
99
0.83
1.33
0.1018.64
84
0.66
3.67
0.011198.04
182
29
0.81
1.28
0.1610.13
147
0.30
2.54
0.4414.76
56
0.22
3.58
0.7426.95
124
0.02
9.55
1.4662.68
73
<0.01
9.42
2.1141.95
86
0.38
1.88
0.467.74
74
0.49
1.63
0.416.48
Deployment of 2 stents
11
>0.99
<0.01
74
0.72
1.36
0.267.11
AC
C
Covered stent
EP
Ascites
TE
D
GOOSS score of 0
ACCEPTED MANUSCRIPT
(n = 266)
(n = 11)
133
Male
159
Female
107
Pancreatic cancer
113
Gastric cancer
85
Intrinsic disease*
101
Stomach
Duodenum
HR
95% CI
0.78
1.26
0.256.26
0.24
2.90
0.4917.16
0.44
2.54
0.2426.76
0.70
3.35
0.011586.32
0.95
1.10
0.0522.62
86
0.88
1.63
0.01763.35
180
3 stenosis sites
31
>0.99
<0.01
GOOSS score of 0
151
0.80
0.82
0.183.83
KPS, 50
56
0.89
0.86
0.107.33
125
0.92
0.92
0.165.42
77
0.22
0.36
0.071.86
88
0.31
0.41
0.082.26
69
<0.01
12.63
2.3567.80
Deployment of 2 stents
11
>0.99
<0.01
73
0.81
1.24
0.236.69
Sex
AC
C
Covered stent
EP
Ascites
TE
D
M
AN
U
Diagnosis
SC
Age, 71
P value
RI
PT
No migration
ACCEPTED MANUSCRIPT
(n = 228)
(n = 49)
109
29
Male
136
32
Female
92
17
Age, 71
Diagnosis
94
Gastric cancer
78
Intrinsic disease*
1.21
0.652.25
0.14
1.60
0.863.01
26
0.47
1.35
0.593.10
0.48
0.50
0.073.49
M
AN
U
Pancreatic cancer
95% CI
0.54
SC
Sex
HR
RI
PT
91
13
>0.99
0.99
0.283.46
78
10
0.82
0.82
0.154.38
150
39
24
0.21
1.88
0.705.09
133
23
0.29
0.72
0.391.33
47
11
0.49
1.31
0.612.77
105
26
0.71
0.88
0.461.70
68
12
0.90
1.05
0.512.13
73
17
0.63
1.16
0.632.15
72
<0.01
0.27
0.100.69
Deployment of 2 stents
0.28
2.03
0.577.28
70
0.04
0.42
0.190.95
AC
C
Covered stent
EP
Ascites
TE
D
GOOSS score of 0
ACCEPTED MANUSCRIPT
(n = 271)
(n = 6)
135
Male
165
Female
106
Age, 71
Pancreatic cancer
116
Gastric cancer
86
Intrinsic disease*
103
95% CI
2.41
0.1637.57
>0.99
1.00
0.147.93
0.23
5.91
0.32109.14
0.99
3837361.00
0.99
<0.01
87
0.42
0.01
0482.86
184
30
0.55
5.43
0.022.92
GOOSS score of 0
M
AN
U
Diagnosis
HR
0.53
SC
Sex
P value
RI
PT
No perforation
154
0.12
0.11
0.011.86
KPS, 50
56
0.08
18.87
0.68520.31
129
0.05
0.03
0.011.08
78
0.05
17.74
0.92341.32
88
0.98
1.04
0.0911.95
76
0.35
0.25
0.014.58
Deployment of 2 stents
<0.01
854.88
11.3664356.6
77
0.82
1.39
0.0823.74
AC
C
Covered stent
EP
Ascites
TE
D
3 stenosis sites