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A, Standard self-expanding metal esophageal stent with no valve. B, Modified self-expanding metal esophageal stent with a tricuspid antireflux valve.
Source publication
Background and aims:
Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent.
Methods:
A phase III, mul...
Contexts in source publication
Context 1
... of these stents have shown mixed results. 21,[23][24][25][26][27][28][29][30][31] Valves of different designs, small case series, retrospective reviews, unblinded studies, and lack of randomization could explain these variable results. A new SEMS with a tricuspid antireflux valve (SEMS-V; EndoMaxx-EVT; Merit Medical, South Jordan, Utah) ( Fig. 1A) was cleared for use in Europe. The objective of this study was to evaluate the performance of this novel ...
Citations
... In addition to the cases presented, there have been 23 previously reported cases of complete fractures [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] and 37 of partial fractures [9,[25][26][27][28][29][30][31][32][33]. A summary of patient demographics and stent characteristics is shown in Table 1. ...
... The exact cause of this fracture remains unknown. Several potential reasons have been cited, including stent-related causes such as spontaneous fracture [9][10][11]24,28,31], defective material or design [10,11,18,27,30], corrosion effect [12,19,23,25], and the embedment of the uncovered part of a partially covered stent [21], and iatrogenic-related causes such as tumor ablation through a metal stent using Nd: YAG laser application, which can cause thermal overstraining [28], stent removal attempts [22], and post-deployment balloon dilatation [27]. We propose additional plausible etiologies that can be categorized into anatomical, physiological, mechanical, and chemical etiologies. ...
... 6 cases presented with dysphagia [25,28,29,31,32] 28 were asymptomatic [9,26,29,30] Second and seventh cases were asymptomatic The remaining presented as abdominal cramping, melena, dysphagia, chest pain, or nausea and vomiting Diagnosis Prior Literature ...
Background: Esophageal self-expandable metal stents (SEMS) are an important endoscopic tool. These stents have now been adapted successfully to manage post-bariatric surgery complications such as anastomotic leaks and strictures. In centers of expertise, this has become the primary standard-of-care treatment given its minimally invasive nature, and that it results in early oral feeding, decreased hospitalization, and overall favorable outcomes. Self-expandable metal stents (SEMS) fractures are a rare complication of unknown etiology. We aimed to investigate possible causes of SEMS fractures and highlight a unique endoscopic approach utilized to manage a fractured and impaled SEMS. Methods: This is a retrospective study of consecutive patients who underwent esophageal SEMS placement between 2015–2021 at a tertiary referral center to identify fractured SEMS. Patient demographics, stent characteristics, and possible etiologies of fractured SEMS were identified. A comprehensive literature review was also conducted to evaluate all prior cases of fractured SEMS and to hypothesize fracture theories. Results: There were seven fractured esophageal SEMS, of which six were used to manage post-bariatric surgery complications. Five SEMS were deployed with their distal ends in the gastric antrum and proximal ends in the distal esophagus. All stents fractured within 9 weeks of deployment. Most stents (5/7) were at least 10 cm in length with fractures commonly occurring in the distal third of the stents (6/7). The wires of a fractured SEMS were embedded within the esophagogastric junction in one case, prompting the use of an overtube that was synchronously advanced while steadily extracting the stent. Discussion: We suggest the following four etiologies of SEMS fractures: anatomical, physiological, mechanical, and chemical. Stent curvature at the stomach incisura can lead to strain- and stress-related fatigue due to mechanical bending with exacerbation from respiratory movements. Physiologic factors (gastric body contractions) can result in repetitive squeezing of the stent, adding to metal fatigue. Intrinsic properties (long length and low axial force) may be contributing factors. Lastly, the stomach acidic environment may cause nitinol-induced chemical weakness. Despite the aforementioned theories, SEMS fracture etiology remains unclear. Until more data become available, it may be advisable to remove these stents within 6 weeks.
... The reviewed articles were selected from among those extracted through a systematic review of the guidelines [5][6][7] to avoid bias from the article selection process. However, 14 articles [29][30][31][32][33][34][35][36][37][38][39][40][41][42] were added for the further exploration of topics that were not included in the guidelines. In the guidelines, the Japan Medical Library Association was entrusted with a systematic search of the literature published from January 2000 to August 2020. ...
... During the last decade, three randomized trials were conducted to compare the effectiveness and risk of different types of stents [30][31][32], and two of these studies evaluated the effectiveness of fully covered stents [30,31]. Didden et al. [30] compared recurrent obstruction, adverse events, and health-related QoL between fully covered and partially covered stents in 98 patients. ...
... A stent with an anti-reflux valve was designed to prevent acid reflux through the stent. The third of the three above-mentioned randomized studies [32] evaluated the efficacy and safety of this stent in 60 patients. The dysphagia scores, gastroesophageal reflux disease (GERD) symptom scores, and frequency of aspiration pneumonia were not different between stents with and without an anti-reflux valve during the follow-up period. ...
Malignant dysphagia is a common problem in patients with esophageal cancer. Endoscopic stenting can resolve dysphagia caused by malignant stricture; however, controversy exists regarding the use of esophageal stenting for the treatment of malignant stricture, including whether stenting or radiotherapy is superior, whether stenting before or after radiotherapy is safe, whether stenting before or after chemotherapy is safe, and whether low-radial-force stents are safer than conventional stents. Among treatment options for malignant dysphagia, stenting may have some disadvantages in terms of pain relief and the risk of adverse events compared with radiotherapy and in terms of survival compared with gastrostomy. Additionally, the risk of stent-related adverse events is significantly associated with prior radiotherapy. The risk of perforation is especially high when a radiation dose of >40 Gy is delivered to the esophagus after stenting, whereas perforation is not associated with prior chemotherapy or additional chemotherapy after stenting. Nevertheless, stenting remains an important palliative option, especially for patients with a short life expectancy and a strong desire for oral intake, because stenting can facilitate a more rapid improvement in dysphagia than radiotherapy or gastrostomy. The application of a low-radial-force stent should be considered to reduce the risk of adverse events, especially in patients with prior radiotherapy.
... Different stent designs have been developed in order to prolong stent patency and reduce AEs; however, this is hard to accomplish as stents do not affect natural history of the disease. Regarding antireflux stents, for example, a 2019 meta-analysis [8] and a subsequent RCT [9] failed to prove their superiority re-garding improvement of reflux, dysphagia score, or related AEs (stent migration, bleeding, and obstruction). ...
Endoscopic stenting is an area of endoscopy that has witnessed noteworthy advancements over the last decade, resulting in evolving clinical practices among gastroenterologists around the world. Indications for endoscopic stenting have progressively expanded, becoming a frequent part of the management algorithm for various benign and malignant conditions of the gastrointestinal tract, from esophagus to rectum. In addition to expanded indications, continuous technological enhancements and development of novel endoscopic stents have resulted in an increased success of these approaches and, in some cases, allowed new applications. This review aimed to summarize best practices in esophageal, gastroduodenal, and colonic stenting.
... The initial search strategy identified 7612 records, resulting in ten studies [17][18][19][20][21][22][23][24][25][26] (▶ Fig. 1). The 10 RCTs evaluated a total of 467 patients, 234 in the SEMS-V group, and 233 in the SEMS-NV group. ...
... The studies [17][18][19][20][21][22][23][24][25] included in the meta-analysis presented a low risk of bias, except for the study realized by Kaduthodil et al, which had a high risk of bias (▶ Fig. 2). The evidence quality of the evaluated outcomes was different as exposed by the GRADE illustrated in ▶ Fig. 3. ...
... Five RCTs [17,19,22,23,26] with a total of 172 patients (81 in the SEMS-V group and 91 in the SEMS-NV group), were included in this meta-analysis showing no statistically significant difference (SMD -0.22; 95 % CI -0.53, 0.08; P = 0.15; I 2 = 48 %) between the groups (▶ Fig. 6). This outcome presented a very low quality of evidence (▶ Fig. 3). ...
Background and study aims Self-expanding metal stents (SEMS) are an effective palliative endoscopic therapy to reduce dysphagia in esophageal cancer. Gastroesophageal reflux disease (GERD) is a relatively common complaint after non-valved conventional SEMS placement. Therefore, valved self-expanding metal stents (SEMS-V) were designed to reduce the rate of GERD symptoms. We aimed to perform a systematic review and meta-analysis comparing the two stents.
Material and methods This was a systematic review and meta-analysis including only randomized clinical trials (RCT) comparing the outcomes between SEMS-V and non-valved self-expanding metal stents (SEMS-NV) following the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Data were analyzed with Review Manager Software. Quality of evidence was evaluated using Grading of Recommendations Assessment, Development, and Evaluation guidelines.
Results Ten randomized clinical trials including a total of 467 patients, 234 in the SEMS-V group and 233 in the SEMS-NV group, were included. There were no statistically significant differences regarding GERD qualitative analysis (RD –0.17; 95 % CI –0.67, 0.33; P = 0.5) and quantitative analysis (SMD –0.22; 95 % CI –0.53, 0.08; P = 0.15) technical success (RD –0.03; 95 % CI –0.07, 0.01; P = 0.16), dysphagia improvement (RD –0.07; 95 % CI –0.19, 0.06; P = 0.30), and adverse events (RD 0.07; 95 % CI –0.07, 0.20; P = 0.32).
Conclusions Both SEMS-V and SEMS-NV are safe and effective in the palliation of esophageal cancer with similar rates of GERD, dysphagia relief, technical success, adverse events, stent migration, stent obstruction, bleeding, and improvement of the quality of life.
... However, there were a wide range of other uses, including assessing the patient experience (45 articles), pathophysiological studies (41 articles), alternative medicine studies (19 articles), and studies of diagnostic tests (11 articles). A few of the more unique and unexpected usages included osteopathic manipulation for GERD [11], acupoint therapy for GERD [12], a randomized trial of valved stents for malignant esophageal stricture [13] antibiotic treatment for chronic rhinosinusitis [14], GERD disease burden on school teachers in Saudi Arabia [15], and GERD incidence and prevalence during Ramadan [16]. Not surprisingly, GERD accounted vast majority of disease processes studied (Table 4), with hiatal hernia being the next most common. ...
Background:
The GERD-HRQL symptom severity instrument was developed and published 25 years ago. This seems like an apropos time to review how the instrument has been used in the "real-world."
Methods:
Google Scholar, PubMed, and Web of Science websites search was done using the keywords "GERD-HRQL" or its author, "Velanovich." Once articles were identified, the following information was obtained from each article: first author name, country of origin, journal published, year of publications, type of study design, subject of study, category of study, disease type studied, purpose of the study, how the GERD-HRQL scores were reported, how the GERD-HRQL scores were statistically reported, and results of the study. The total and change of scores were analyzed for descriptive statistics based on disease process studied and intervention studied.
Results:
A total of 767 articles by 562 different first authors were identified in 193 different journals from 53 different countries of study origin. After a period of steady usages, the number of publication employing the GERD-HRQL has rapidly increase over the last 5 years. There have been 8 validated translations into other languages, although there appears to be numerous, non-validated ad hoc translations. Most commonly used or studied: observational cohort study design, surgical treatment study category, GERD disease process, treatment effect study purpose, total GERD-HRQL scores reported as means or medians. However, there were a wide variety of other study designs, study categories, disease processes, and study purposes. In general, GERD and laryngopharyngeal reflux had the high pre-treatment scores (i.e., more severe symptoms), and surgical and endoscopic interventions the lowest post-treatment score (i.e., least severe symptoms) with the largest change in score (i.e., treatment impact.
Conclusions:
The GERD-HRQL has proven to be a reliable, responsive and versatile symptom severity instrument for studies involving GERD as a subject.
... The initial search strategy identified 7612 records, resulting in ten studies [17][18][19][20][21][22][23][24][25][26] (Figure 1). ...
... The studies [17][18][19][20][21][22][23][24][25] included in the meta-analysis presented a low risk of bias, except for the study realized by Kaduthodil et al, which had a high risk of bias ( Figure 2). The evidence quality of the evaluated outcomes was different as exposed by the GRADE illustrated in figure 3. ...
... Five RCTs [17,19,22,23,26] with a total of 172 patients (81 in the SEMS-V group and 91 in the SEMS-NV group), were included in this meta-analysis showing no statistically significant difference (SMD -0.22; 95% CI -0.53, 0.08; p = 0.15; I 2 =48%) between the groups ( Figure 6). This outcome presented a very low quality of evidence ( Figure 3). ...
... T HE ANTIREFLUX MECHANISM was first examined in esophageal SEMSs to reduce symptoms associated with acid reflux after SEMS placement for the gastroesophageal junction. [40][41][42] Subsequently, antireflux plastic stents harboring a valve against the duodenobiliary reflux at the duodenal end were developed. In a landmark work by Dua et al., 43 an in vitro examination showed that a long windsock-shaped antireflux valve attached to a plastic stent successfully exerted resistance to retrograde pressure while maintaining antegrade bile flow. ...
Endoscopic retrograde cholangiopancreatography with stent placement has been utilized as standard palliative management of distal malignant biliary obstruction. Compared to plastic stents, metal stents can provide longer‐term relief of symptoms. When a large‐bore metal stent is placed across the ampulla, patients are predisposed to the risk of cholangitis or stent dysfunction due to reflux of duodenal contents. To mitigate the risk of adverse events associated with the duodenobiliary reflux, efforts have been directed to development of antireflux metal stents (ARMSs). The antireflux property has been introduced through adding of an antireflux valve to the duodenal stent end. Evidence from clinical studies indicates that ARMSs may not only reduce the risk of ascending cholangitis during follow‐up but also prolong stent patency time. However, the results of clinical studies testing ARMSs are inconsistent owing to heterogeneous designs of antireflux valves and stent bodies. Metal stents are increasingly indicated for benign biliary strictures and malignant biliary obstruction in the setting of neoadjuvant chemotherapy, and therefore, research is warranted to evaluate ARMSs for those indications. Given that endoscopic ultrasound (EUS)‐guided transmural biliary drainage has gained popularity, the optimal timing of placing an ARMS in relation to EUS‐guided and percutaneous drainage should be investigated. Development and evaluation of ARMSs require integrative approach utilizing phantom and animal models, measurements of stent mechanical properties, and in vivo functional study after stent placement. In this review article, we summarize updated evidence on ARMSs for malignant biliary obstruction and discuss issues that should be addressed in future studies.
Gastrointestinal malignancies account for over 35% of cancer-related deaths with a projected 73% increase by 2040. Recent advances in endoscopic technique and devices have created exponential growth in the field of therapeutic gastroenterology and have enhanced diagnostic and treatment potential. As a result, palliative endoscopic therapies have experienced an equally tremendous amount of gain. Palliative endoscopy refers to maneuvers performed during gastrointestinal procedures with the intent to minimize patient suffering and discomfort. These procedures can be highly effective in providing rapid, non-operative relief and, as such, occupy an important role in the ability to alleviate symptoms of advanced malignancies throughout the gastrointestinal tract. Complications of end-stage malignances can result in tremendous discomfort, emotional trauma, and social embarrassment for the patient. Throughout the length of the gastrointestinal tract, there are a wide variety of endoscopic procedures that can provide relief in a minimally invasive fashion. The aim of this chapter is to provide insight into the current landscape of endoscopic procedures with the intent to minimize suffering, and provide a review of the indications, practice, and outcomes of endoscopic palliative therapies available.
Self-expanding metal stents (SEMS) have been established beyond doubt as an effective tool in the palliative management of malignant gastrointestinal tract strictures. The advent of fully covered retrievable SEMS has allowed its use in benign oesophageal strictures and gastric outlet obstruction, which are traditionally treated with balloon or bougie dilation. Although balloon and bougie dilations are effective, strictures may be refractory, requiring repeated sessions of dilation or complex surgeries. Endoluminal stenting spares the patient from complex surgical procedures and their associated complications. Here, the authors present four cases wherein fully covered SEMS were used as an effective therapy for the restoration of the gastrointestinal lumen in non-malignant conditions.
