Recommendations and statements
ESOPHAGEAL STENTS IN MALIGNANT DISEASE
ESGE recommends placement of partially or fully covered self-expanding metal stents
(SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy,
and esophageal bypass (strong recommendation, high quality evidence).
ESGE recommends against the placement of nonexpandable and expandable plastic stents
for the palliation of malignant esophageal strictures (strong recommendation, high
quality evidence).
Efficacy
Photodynamic therapy (PDT), laser therapy, and esophageal bypass have not been shown
to be superior to SEMS placement for the palliation of malignant dysphagia in several
randomized controlled trials (RCTs) [6]
[7]
[8]
[9]
[10]
[11]. From 1993 up to 2005 several RCTs have compared SEMS versus rigid plastic stents
[12]
[13]
[14]
[15]
[16]
[17]
[18]. One of the largest published RCTs including 217 patients [17] showed a better improvement in dysphagia score at 1 and 6 weeks with SEMS compared
to rigid plastic stents and fewer late adverse events. Systematic reviews and meta-analyses
showed that SEMS insertion was superior to rigid plastic stents in terms of improvement
and recurrence of dysphagia, as well as occurrence of adverse events including perforation
and migration [19]
[20].
Multiple types of self-expandable stents are available. They differ in terms of design,
luminal diameter, radial force, flexibility, and degree of shortening after deployment.
In Europe, partially or fully covered SEMS are used for the treatment of malignant
dysphagia because recurrent dysphagia due to tumor ingrowth has been a major drawback
of uncovered SEMSs [21]. In most cases a 100 % technical success rate of stent placement has been reported
with an improvement in dysphagia score of at least 2 points (from 3 [liquids only]
to 1 [almost all solids]) within 1 – 2 days [20]. Most new stent designs have been evaluated in single-arm prospective or retrospective
series. SEPS are similar to SEMS with regard to relief of dysphagia in the short term,
but adverse events occurred more often with SEPS, especially migration, making SEMS
preferable over SEPS for malignant dysphagia [22].
Safety
The most prevalent adverse events following stent placement are shown in [Table e7] (Appendix e3, available online) and details are also presented in Appendix e3. Analysis of pooled data from RCTs and prospective and retrospective studies showed
that major adverse events occur in 18 %, 21 %, and 10 % of patients with PCSEMS, FCSEMS,
and SEPS, respectively, while recurrent dysphagia develops in 41 %, 29 %, and 37 %
of these patients, respectively [22]
[23]
[24]
[25]
[26]
[27]
[28]
[29]
[30]
[31]
[32]
[33]
[34]
[35]
[36]
[37]
[38]
[39]. Stent insertion-related mortality is 0 % – 2 % [23]
[40].
For patients with longer life expectancy, ESGE recommends brachytherapy as a valid
alternative or in addition to stenting in esophageal cancer patients with malignant
dysphagia. Brachytherapy may provide a survival advantage and possibly a better quality
of life compared to SEMS placement alone. (Strong recommendation, high quality evidence.)
Two RCTs have compared SEMS versus brachytherapy. One RCT compared a PCSEMS (Ultraflex)
with single-dose intraluminal brachytherapy in 202 patients with incurable esophageal
cancer [4]. Compared to SEMS placement, brachytherapy improved dysphagia less rapidly, but
after 1 month from treatment, dysphagia score improvement no longer differed significantly
between stent placement and brachytherapy. With respect to survival, patients treated
by brachytherapy had more days with almost no dysphagia during follow-up than those
treated by stent placement. In addition, major complications (i. e., perforation,
hemorrhage) occurred more frequently after stent placement than after brachytherapy.
There was no difference in recurrent dysphagia and median survival. Quality-of-life
(QoL) scores significantly favored brachytherapy, whereas total costs were similar
across the two groups. In the other RCT (n = 65), insertion of SEMS offered a more
immediate relief of dysphagia compared to brachytherapy, but quality of life was better
with brachytherapy for patients with longer survival [41]. The main limitations of brachytherapy include limited availability, technical difficulty,
and need for dedicated logistics and expertise. Therefore this treatment can only
be considered in dedicated centers.
Esophageal stent placement for malignant tracheoesophageal or bronchoesophageal fistula
Esophageal SEMS placement is recommended as the preferred treatment for sealing malignant
tracheoesophageal or bronchoesophageal fistula (strong recommendation, low quality
evidence).
Application of double stenting (esophagus and airways) can be considered when fistula
occlusion is not achieved by esophageal or airway prosthesis alone (strong recommendation,
low quality evidence).
Malignant tracheoesophageal or bronchoesophageal fistula develops in 5 % to 15 % of
patients with esophageal cancer and in less than 1 % of patients with lung carcinoma
[42]
[43]. Because of advances in palliative treatment, the incidence has increased over the
last 30 years to above 10 % among all nonresected esophageal cancers [44].
Tracheoesophageal or bronchoesophageal fistulas are usually late developments of advanced
cancer of the esophagus, lung, or mediastinum, caused by tumoral invasion or as an
adverse event of cancer therapies, in particular chemoradiotherapy [45]
[46]
[47]. Importantly, the condition of such patients has often already significantly deteriorated
when they develop a fistula and the remaining life expectancy is short (weeks to months).
Rapid relief of disabling symptoms due to the fistula, preferably by minimally invasive
treatment, is thus of pivotal importance in order to improve quality of life.
Esophageal stenting is the most widely used approach [48]. Multiple studies using SEMSs for sealing off esophageal – airway fistulas have
reported improvement in symptoms and sealing of the fistula in 75 % – 100 % of patients
[2]
[42]
[43]
[49]
[50]
[51]
[52]
[53]
[54]
[55]. Application of double stenting (esophagus and airways) can be considered when fistula
occlusion is not achieved by esophageal or airway prosthesis alone [51]
[56]
[57]
[58]. In the largest prospective series, Shin et al. successfully placed SEMSs in 61
patients with malignant esophageal – airway fistulas, sealing off the fistula in 49
patients (80 %), while 10 patients (16 %) required concomitant airway stents [42]. Re-opening of the fistula occurred in 17 patients (35 %); of these, 8 were successfully
re-treated with SEMSs, in 2 patients the fistula was closed spontaneously, and 7 patients
did not undergo further treatment [42].
Procedure-related complications are reported in 0 % – 27 % of patients with a mortality
rate of 0 % – 12 % [42]
[43]
[49]
[50]
[52]
[54].
In another study that compared quality of life following placement of a SEMS versus
gastrostomy or jejunostomy or best supportive care, quality of life improved more
with SEMS placement, particularly for symptoms of dyspnea, dysphagia, other eating
problems, dry mouth, cough, and hypersalivation [59]. In three large retrospective studies, esophageal stent placement was associated
with a significant improvement in survival compared with no sealing of the fistula,
a feeding gastrostomy or jejunostomy, or best supportive care [42]
[43]
[50].
Stent placement for malignant dysphagia as a bridge to surgery
ESGE does not recommend SEMS placement as a bridge to surgery or prior to preoperative
chemoradiotherapy. It is associated with a high incidence of adverse events, and other
satisfactory options such as placement of a feeding tube are preferable. (Strong recommendation,
low quality evidence.)
It is now accepted that neoadjuvant chemotherapy or chemoradiotherapy should be administered
to all patients with a resectable esophageal cancer, except for cancers staged 0 – IIA
[60]
[61]
[62]. In a systematic review and meta-analysis of 9 studies (n = 180 patients) on esophageal
stenting preceding or concomitant with neoadjuvant chemotherapy for esophageal cancer,
the procedural success rate was 95 % (95 % confidence interval [95 %CI] 90 % – 98 %)
[63]. There was a significant decrease in dysphagia score and a nonsignificant increase
in patient weight (0.6 kg) and serum albumin. However, major adverse events were extremely
frequent, including stent migration (incidence 32 %, 95 %CI 26 % – 40 %) and chest
discomfort (incidence 51.4 %, 95 %CI 21 % – 81 %). SEPS were used in 5 of the 9 studies
(41 % of patients). The negative impact on oncologic outcome of SEMS placement as
bridge to surgery was also confirmed in a large European cohort of 2944 patients [64]. This study showed an in-hospital postoperative mortality and morbidity rate for
the SEMS versus control groups of 13.2 % versus 8.6 % and 63.2 % versus 59.2 %, respectively.
In addition, significant differences in R0 resection (71.0 % vs. 85.5 %), median time
to recurrence (6.5 vs. 9.0 months), and 3-year overall survival (25 % vs. 44 %) were
found, to the disadvantage of the SEMS group. The results remained significant after
excluding SEMS-related esophageal perforations and after adjusting for confounding
factors. Similar unfavorable results have been reported with biodegradable stents
as a bridge to surgery [65].
Profound weight loss and malnutrition as a consequence of severe dysphagia and cancer
cachexia are cardinal symptoms in esophageal cancer [66]
[67]. To detect nutritional disturbances at an early stage, the European Society for
Clinical Nutrition and Metabolism (ESPEN) recommends regular evaluation of nutritional
intake, weight change, and body mass index (BMI), at the time of cancer diagnosis
and repeated according to the stability of the clinical situation [68]. In patients with digestive cancer, body composition may be quite easily assessed
from computed tomography scans [69]. ESPEN recommends nutritional support prior to major surgery in patients with severe
nutritional risk (e. g., those with weight loss > 10 – 15 % within 6 months) as a
grade A recommendation [70]. If oral feed intake is inadequate despite counseling and oral nutritional supplements,
supplemental enteral nutrition or, if the latter is not sufficient or possible, parenteral
nutrition is recommended [68]
[71]. In patients with severe dysphagia, this can be achieved through nasogastric tube
placement, percutaneous feeding tube placement, or parenteral nutrition. Percutaneous
endoscopic gastrostomy (PEG) or endoscopic jejunostomy is recommended by ESPEN in
place of nasogastric tube placement if enteral feeding is scheduled to last more than
2 – 3 weeks [72]
[73]. Furthermore, a Cochrane review of RCTs showed that intervention failure (e. g.,
feeding interruption, blocking or leakage of the tube, no adherence to treatment)
was more frequent with nasogastric tube placement compared with PEG feeding (risk
ratio [RR] 0.24, 95 %CI 0.08 – 0.76) [74]. However, in esophageal cancer patients who are scheduled to undergo a gastric tube
reconstruction a PEG placement may be contraindicated, in which case a feeding tube
is the preferred treatment. The proportion of patients who refuse placement of a feeding
tube in the setting of head and neck cancer patients treated with (chemo)radiation
has been found to be very low (4 % in an RCT) [75].
Esophageal stents and concomitant palliative treatment with radiotherapy
ESGE does not recommend the concurrent use of radiotherapy if an esophageal stent
is present (strong recommendation, low quality evidence).
ESGE suggests that SEMS placement with concurrent single-dose brachytherapy is safe
and effective for relief of dysphagia (weak recommendation, low quality evidence).
In contrast to the rapid improvement in dysphagia by stent placement, palliative radiotherapy
improves dysphagia after 4 to 6 weeks [76]. Temporary and permanent placement of retrievable metallic stents with concurrent
radiotherapy has been suggested as an effective method for increasing survival, immediately
improving dysphagia and dietary intake in the period before the effects of radiotherapy
become apparent [77]
[78]
[79]
[80]. However, a higher risk of life-threatening adverse events has been reported, suggesting
that palliative stenting should be delayed until radiotherapy has failed [81]
[82]
[83].
Potential scattering from the metal material in SEMSs may complicate radiation dosimetry.
In a simulated clinical protocol measuring the effects of esophageal stents of various
materials and designs on radiation effects on tissue adjacent to the stent in the
radiation field, a dose enhancement was seen with SEPSs and stainless steel stents,
and not with nitinol stents [84]. In another study, dose perturbation by SEMSs was related to the density of the
mesh, with a higher density having greater effect, while SEPS and biodegradable stents
had minimal-to-no dose effects outside of the radiopaque markers [85].
In contrast to external radiotherapy, the combination of SEMS and single-dose brachytherapy
has been reported to be feasible and safe as a palliative treatment in patients with
advanced esophageal cancer [77]
[86]. In an RCT that included 53 patients, Guo et al. compared conventional SEMS treatment
with SEMS loaded with iodine-125 seeds for brachytherapy; these authors reported a
significantly longer dysphagia-free period and longer survival in the irradiation
stent group [25]
[87].
Data on the use of biodegradable stents in patients receiving brachytherapy are limited,
but a high rate of major stent-related complications has been described and a normal
diet could not be tolerated because of retrosternal pain and vomiting in more than
one third of patients [78].
Esophageal stent placement after palliative chemotherapy and radiotherapy
Data are contradictory with respect to the risk of major adverse events in patients
receiving a stent for recurrent malignancy following radiotherapy alone or combined
with chemotherapy (RTCT). Some studies show an increased risk while other studies,
including a meta-analysis, do not report any relationship between SEMS placement after
RTCT and the incidence of life-threatening adverse events or survival; only minor
adverse events such as chest pain are associated, suggesting stenting is safe in these
patients [18]
[22]
[32]
[88]
[89]
[90]
[91]
[92]
[93]
[94]. In detail, the reported rate of life-threatening adverse events ranged from 16 %
to 77 % in patients treated with stents after RTCT compared to 0 % to 45 % in patients
without previous treatment [18]
[22]
[32]
[88]
[89]
[90]
[91]. Reported stent-related mortality ranged from 0 % to 54 % in patients with prior
RTCT compared to 0 % to 6 % in patients without prior RTCT.
It has been suggested that the increased risk, if any, of developing life-threatening
adverse events, in patients with prior RTCT may be related to the radiation-induced
damage on the esophageal wall, potentiated by chemotherapy. However, it is difficult
to discern whether such stent-related adverse events are due to stents and radiation
effects, the advanced nature of the disease process, or both. Radiotherapy can cause
esophagitis, ulcerations, submucosal fibrosis, and vasculitis, with ischemic damage
of the esophageal wall causing esophageal perforations and esophageal – respiratory
fistulas via local hypoxemia. Although SEMS placement is effective for short-term
palliation of malignant dysphagia, stent pressure on a damaged esophageal wall increases
the risk of necrosis [89]
[95]
[96]
[97]
[98]
[99]. The effect of radiation on the esophageal wall is dose-dependent, with serious
damage especially when doses greater than 6 Gy have been administered [97]
[99]. The risks of sudden fatal hemorrhage and formation of a respiratory fistula are
relatively high in patients with invasive (T4) cancer [47]
[96].
ESOPHAGEAL STENTS IN BENIGN DISEASE
Refractory benign strictures
ESGE recommends against the use of SEMSs as first-line therapy for the management
of benign esophageal strictures because of the potential for adverse events, the availability
of alternative therapies, and costs (strong recommendation, low quality evidence).
Most studies have used expandable stents for treatment of refractory or recurrent
esophageal strictures as defined by Kochman: generally when more than 3 to 5 dilations
(either mechanical or pneumatic) have been performed without clinical and endoscopic
response or when it was impossible to achieve a 14-mm lumen over 3 dilation sessions
[100]. No studies have compared the clinical efficacy of different initial strategies
(i. e., dilation vs. stent placement). Therefore, algorithms are mainly based on the
experience of tertiary referral centers [101]. Most experts agree that stent placement should be considered when other treatment
options (dilation with or without intralesional triamcinolone acetate injections and/or
incisional therapy) have failed, though a clear definition of clinical failure has
not been uniformly adopted.
ESGE suggests consideration of temporary placement of self-expandable stents for refractory
benign esophageal strictures (weak recommendation moderate quality evidence).
ESGE does not recommend a specific type of expandable stent (covered metal, plastic,
biodegradable) because none has been shown to be superior to any other for this indication
(strong recommendation, moderate quality evidence).
A recent systematic review and meta-analysis (10 prospective and 8 retrospective studies;
444 patients) evaluated the clinical outcome of stent placement for refractory benign
esophageal stricture (RBES) [102]. FCSEMS were used in 9 studies (227 patients), 8 trials used SEPS (140 patients)
and 4 studies used biodegradable stents (77 patients). Overall, the pooled clinical
success rate was 40.5 % (95 %CI 31.5 % – 49.5 %). Patients treated with SEPS and SEMS
did not have significantly different success rates compared with patients treated
with biodegradable stents. The overall migration rate was 28.6 % (95 %CI 21.9 % – 37.1 %).
Stent removal was successful in 99 % of cases. Finally, the overall adverse event
rate was 20.6 % (95 %CI, 15.3 % – 28.1 %) with no significant difference between the
three types of stents. Only one patient died; this was due to massive bleeding.
Factors predicting successful stent treatment
A systematic review demonstrated that the clinical success of stenting in RBES was
significantly lower in patients with cervical strictures and for strictures longer
than 2 cm [100]. The latter finding was confirmed by a prospective study showing stricture length
as the only factor associated with success, with longer strictures being at higher
risk of recurrence (hazard ratio [HR] 1.37, 95 %CI 1.08 – 1.75) [103]. The previously mentioned review and meta-analysis by Fuccio et al. [102] showed that the etiology of the stricture might influence outcome, with esophageal
strictures that had developed after surgical resection or radiation therapy being
potentially more responsive to stent treatment. However, no firm conclusion can be
drawn because many etiologies of stricture were under-represented and, in many studies,
the results were not stratified according to the stricture etiology.
ESGE does not recommend permanent stent placement for refractory benign esophageal
stricture; stents should usually be removed at a maximum of 3 months (strong recommendation,
weak quality evidence).
No studies have compared different strategies in terms of stenting duration. It is
generally accepted that FCSEMSs or SEPSs should remain in place for at least 6 – 8
weeks and no more than 12 weeks, to maximize success and to minimize the risk of hyperplastic
tissue reaction and stent embedment. Indeed, a large multicenter study that specifically
addressed the safety of endoscopic removal of self-expandable stents inserted to treat
RBES found no association between indwelling time and the risk of major adverse events
[104].
ESGE suggests that FCSEMSs be preferred over PCSEMSs for the treatment of refractory
benign esophageal stricture, because of their lack of embedment and ease of removability
(weak recommendation, low quality evidence).
The use of partially covered or uncovered SEMS in benign strictures should be avoided
because the hyperplastic tissue reaction of the esophageal mucosa to the bare metal
mesh often results in recurrent dysphagia. Furthermore, complete embedding of the
uncovered metal wires in the esophageal wall may preclude safe stent removal [105]
[106].
ESGE recommends the stent-in-stent technique to remove PCSEMSs that are embedded in
the esophageal wall (strong recommendation, low quality evidence).
In the case of embedded PCSEMSs, temporary placement of a second, fully covered, stent
in the first stent (“stent-in-stent” technique) has been shown to facilitate safe
removal of the embedded stent, by induction of pressure necrosis of the overgrowing
and ingrowing mucosa [103]
[107]
[108]
[109]
[110]. Stents used for the stent-in-stent technique should have a fully covered design
and a diameter at least equal to that of the partially covered embedded stent in order
to provide sufficient pressure at the site of embedment. In addition, the fully covered
stent needs to overlap completely tissue ingrowth inside the lumen of the partially
covered stent. The second stent is left in place for 10 – 14 days, before it is retrieved
and removal of the embedded PCSEMS is attempted. The success rate of the stent-in-stent
technique is above 90 %; in the case of failure, a second FCSEMS should be placed
and left in place for 10 – 14 days before a second attempt to remove the stent is
performed [103].
Esophageal stent placement in combination with other dilation approaches
ESGE suggests that a combined approach of stent placement with additional techniques
(e. g., corticosteroid injection, chemotherapeutic topical application) should not
be used in an attempt to improve the long-term benefit of temporary stenting (weak
recommendation, very low quality evidence).
Endoscopic incisional therapy has been proposed as either an alternative or additional
treatment to endoscopic dilation. Initially proposed for the treatment of recurrent
Schatzki rings, it has also been used for the treatment of anastomotic strictures.
To our knowledge there have been no studies that have reported using a combined or
sequential approach with incisional therapy followed by stent placement.
In order to prevent stricture recurrence, corticosteroid injection into the stricture
followed by dilation was proposed more than 10 years ago [111]. Small retrospective studies reporting corticosteroid injection before stent placement
do not allow conclusions to be drawn on the additional clinical value for prolonging
efficacy following temporary stent placement [112].
Topical application of mitomycin-C has been proposed for refractory corrosive esophageal
strictures. Mitomycin-C is a chemotherapeutic agent that inhibits the proliferation
of fibroblasts and collagen synthesis and has been proposed to prevent stricture relapse.
There are few available studies, mainly case reports and small series, to support
its use, and no studies of this treatment combined with stent placement [113]
[114].
Treatment options after stent failure for refractory benign esophageal stricture
If refractory benign esophageal stricture has not satisfactorily improved after 2
separate treatments with temporary stenting, ESGE suggests alternative treatment strategies
such as self-dilation or surgical treatment (weak recommendation, low quality evidence).
In poor surgical candidates, ESGE recommends self-dilation with rigid dilators (strong
recommendation, low quality evidence).
Stent placement for treatment of RBES may be repeated although the majority of studies
have demonstrated that additional stent placement does not produce significant incremental
benefit [106]
[115]. If sustained stricture resolution is not obtained after temporary stenting on two
occasions, the suggested treatment options are self-dilation and surgery. Surgery
is advised when possible according to anatomical extent as well as patient condition
and willingness to undergo such a complex surgical procedure. The best candidates
for self-dilation are those who are self-motivated, compliant, and poor surgical candidates
[116]
[117]. Based on two retrospective studies, esophageal self-dilation was successful in
treating 90 % of patients, with significant improvement in global dysphagia scores
and overall quality of life [116]
[117].
Benign esophageal leaks, fistulas, and perforations
ESGE recommends that temporary stent placement can be considered for treatment of
leaks, fistulas, and perforations. No specific type of stent can be recommended and
the duration of stenting should be individualized. (Strong recommendation, low quality
of evidence).
SEMSs have been used for management of perforations and leaks [118]
[119]. Closure of an iatrogenic perforation can also be performed by other endoscopic
methods [120]. [Table e5] (Appendix e2, available online) shows the results of the published studies on the efficacy and
safety of SEMS placement for benign rupture and leakage. In two systematic reviews,
the clinical success after placement of temporary stents (FCSEMSs, PCSEMSs, and SEPSs)
for benign rupture and anastomotic leaks of the esophagus was similar with different
stent types (FSEMS 85 %, PSEMS 86 %, SEPS 84 % [121]
[122]. The mean duration of stenting was 7 weeks. Stent migration occurred in 25 %, and
it occurred more often with SEPS (26 %) and FCSEMS (26 %).
Data on the use of biodegradable stents are limited. In a small study, 4 of 5 patients
with an esophageal leak or anastomotic perforation achieved long-term leak sealing
after placement of a covered biodegradable stent [123].
The optimal duration of stenting remains unknown. In most studies stent removal was
performed 6 – 8 weeks (range 4 – 10 weeks) after insertion. Stent-associated esophagorespiratory
fistula is a serious adverse event that may occur as a consequence of SEMS placement
for benign disease. In one retrospective study of 397 patients, 20 patients developed
esophagorespiratory fistulas after a median of 5 months following stent placement
[124]. Most fistulas occurred at the proximal edge of the stent and in the setting of
prior external radiation therapy; thus the cause may have been ischemic pressure necrosis.
Acute variceal bleeding
ESGE recommends considering placement of a SEMS for the treatment of esophageal variceal
bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial
therapy for patients with massive bleeding (strong recommendation, moderate quality
evidence).
[Table e6] (Appendix e2, available online) shows the results of the published studies to date on the applicability,
efficacy and safety of covered SEMS for acute esophageal variceal bleeding [125]
[126]
[127]
[128]
[129]
[130]
[131] Most published studies are observational studies [125]
[126]
[127]
[128]
[129]
[130]
[131]. Results from these studies are in agreement with a recently published systematic
review and meta-analysis showing that treatment with SEMSs is successful in controlling
severe or refractory acute variceal bleeding, without the occurrence of severe adverse
events and with a 1-month survival of more than 60 %; these findings confirmed that
this therapy can be used as a bridge to transjugular intrahepatic portosystemic shunt
(TIPS) or liver transplantation in a significant proportion of patients [132].
An RCT compared patient outcome after SEMS placement (SX-Ella Danis stent; n = 13)
versus balloon tamponade (Sengstaken-Blakemore tube; n = 15) in patients with esophageal
variceal bleeding refractory to medical and endoscopic treatment [133]. Successful therapy was significantly more frequent in the stent than in the balloon
tamponade group (66 % vs. 20 %) with a significantly higher rate for control of bleeding
(85 % vs. 47 %), lower transfusion requirements (3 ± 3.4 vs. 6 ± 4.8 packed red blood
cell units), and a lower incidence of serious adverse events (15 % vs. 47 %), mainly
due to differences in aspiration pneumonia (0 vs. 5) and esophageal tear (1 patient
in the balloon tamponade group). No significant difference in 6-week survival was
observed (54 % vs. 40 %).
Despite the efficacy of stent placement in controlling acute variceal bleeding, a
mortality rate of 25 % has been described in these patients, reflecting the seriousness
of the underlying condition of the patient in the case of refractory acute variceal
bleeding [129]. In published studies SEMSs have remained in place for up to 2 weeks [125]
[131]
[134]
[135]. When a dedicated SEMS is used retrieval is done using a specifically designed system
(PEX-Ella or extractor for SX-Ella Stent Danis).
This Guideline, produced by ESGE and endorsed by the European Society for Radiotherapy
and Oncology (ESTRO), the European Society of Digestive Oncology (ESDO), and the European
Society for Clinical Nutrition and Metabolism (ESPEN), represents a consensus of best
practice based on the available evidence at the time of preparation. The Guideline
may not apply in all situations and should be interpreted in the light of specific
clinical situations and resource availability. Further controlled clinical studies
may be needed to clarify aspects of the statements, and revision may be necessary
as new data appear. Clinical consideration may justify a course of action at variance
to the recommendations. The Guidelines is intended to be an educational device to
provide information that may assist endoscopists in providing care to patients. It
is not a set of rules and should not be construed as establishing a legal standard
of care or as encouraging, advocating, requiring, or discouraging any particular treatment.
Appendix e3 Adverse events of esophageal stenting
Table e7
Early and late adverse events associated with esophageal stent placement in malignant
disease.
|
Early adverse events
|
Late adverse events
|
|
Mean (range), %
|
Proportion of studies reporting
|
Mean (range), %
|
Proportion of studies reporting
|
|
Severe pain
|
8.7 % (2 % – 35 %)
|
(7/13)
|
15 % (2 % – 23 %)
|
(6/17)
|
|
Hemorrhage/bleeding
|
7.6 % (2 % – 26 %)
|
(5/13)
|
11.3 % (2 % – 21 %)
|
(12/17)
|
|
Migration
|
6.6 % (2 % – 10 %)
|
(6/13)
|
11 %(1 % – 33 %)
|
(13/17)
|
|
Perforation
|
3.3 % (0.9 % – 6 %)
|
(7/13)
|
4.5 % (3 % – 9 %)
|
(3/17)
|
|
Ingrowth/overgrowth
|
–
|
–
|
14 % (2.5 % – 36 %)
|
(9/17)
|
|
Obstruction (bolus impaction)
|
–
|
–
|
9 % (2 % – 27 %)
|
(11/17)
|
|
Reflux
|
9.3 % (5 % – 16 %)
|
(3/13)
|
15 % (2 % – 96 %)
|
(9/17)
|
|
Bronchoaspiration/pneumonia
|
3.5 % (2 % – 5 %)
|
(3/13)
|
10.3 % (7 % – 19 %)
|
(5/17)
|
|
Fistula
|
–
|
–
|
5 % (2 % – 8 %)
|
(6/17)
|
|
Others
(e. g. fever, incorrect position, pressure necrosis, foreign-body sensation, stricture)
|
2.8 % (2 % – 6 %)
|
(3/13)
|
10 % (2 % – 21 %)
|
(5/17)
|
Most common adverse events of esophageal stenting
Severe pain
Selecting the appropriate size of stent may reduce this complication. Also use of
stents that conform better to the esophageal anatomy, with good radial but low axial
force, may diminish excessive pressure and thereby reduce pain. If the distance between
the upper esophageal sphincter and the stricture is less than 2 cm, placement of large-diameter
SEMSs is associated with more pain and discomfort including foreign-body sensation.
Bleeding
Early bleeding is caused by passage of the endoscope or stent catheter across the
stricture and it is usually mild and self-limited. Delayed bleeding due to tumor progression
or the formation of an aortoesophageal fistula may be fatal. Patients with aortic
tumor involvement at the time of stent placement are particularly at risk and should
be informed of this potentially fatal complication [47]
[96]. Choice of an appropriate stent diameter minimizes the risk of bleeding due to ulcer
formation caused by pressure necrosis at the levels of both ends of the device. Adequate
prophylaxis with proton pump inhibitor is advisable to prevent bleeding due to severe
esophagitis in patients with stent placement across the gastroesophageal junction.
Recurrent dysphagia (migration, ingrowth, overgrowth, and food obstruction)
Use of large-bore stents decreases the risk of stent migration and of food impaction;
this can be recommended in mild strictures and in those involving the gastroesophageal
junction (GEJ) [22]
[31]
[136]. Some stent designs may also reduce the migration risk (e. g. stents with increased
resistance on the outside of the stent, stents with distinct shouldering of their
upper end, and stents with a flip-flop collar) [28]
[136]. Placement of a stent that is partially uncovered (both ends) can be suggested for
patients in whom a covered stent has migrated. Techniques of stent fixation with clips
have also been described, but without a clear advantage of this approach for the prevention
of stent migration [137]
[138]
[139]
[140]
[141].
Placement of a FCSEMS or SEPS prevents ingrowth. Neoplastic overgrowth can be reduced
by using a stent longer (at least 2 cm) than the stricture [136]. However, granulomatous overgrowth due to benign tissue hyperplasia may occur and
has been described with all types of stent.
Fistula
Fistula may be caused by the progression of cancer, previous radiotherapy, and by
erosion at the edge(s) of the stent, which are the widest parts of the device, into
the esophageal wall. The use of an FCSEMS in the mid-esophagus for malignant strictures
may prevent the development of late esophagorespiratory fistula [32]
[88]
[124]. In a large retrospective study no statistically significant relationship was detected
between stent diameter or presence of a flange and the development of esophagorespiratory
fistula [124]. Prior radiotherapy is the most important risk factor for the development of esophagorespiratory
fistula after SEMS placement [97]
[98]
[124].
Perforation
Dilation before stent placement is associated with a significantly increased risk
of major adverse events, in particular perforation [88]. Excessive manipulation of the guidewire, stricture dilation, and passage of the
endoscope across the stricture should all be avoided to minimize the risk of perforation
[22]
[31].
