This systematic review aimed to analyse the use of the SX-ELLA biodegradable stent (BDS) for benign oesophageal strictures through the assessment of clinical and technical success, differences in pre- and post-BDS insertion dysphagia scores, rates of stent migration, and safety.

A systematic review was reported according to PRISMA guidelines, with a prospectively registered protocol. The databases PubMed, Embase, SCOPUS, and ClinicalTrials.gov were searched up to March 2022. Studies assessing the use of the SX-ELLA BDS in adults with benign oesophageal strictures were included. A pooled data analysis was conducted to analyse the clinical and technical success associated with BDS use, rate of stent migration, and safety.

Of the 1509 articles identified, 16 studies treating 246 patients were eligible for inclusion. BDS was clinically successful in 41.9% of cases (95% CI = 35.7 - 48.1%), defined as those who experienced complete symptom resolution following BDS insertion. Technical success was achieved in 97.2% of patients (95% CI = 95.1 - 99.3%). A pooled analysis concluded a decrease in mean dysphagia score of 1.8 points (95% CI = 1.68 - 1.91) following BDS insertion. Re-intervention was required in 89 patients (36.2%, 95% CI = 30.2 - 42.2%), whilst stent migration occurred in 6.5% of patients (95% CI = 3.4 - 9.6%). A total of 37 major clinical complications related to BDS insertion were reported (15.0%, 95% CI = 10.5 - 19.5%).

The pooled data analysis demonstrates the high technical and moderate clinical success of the SX-ELLA biodegradable stent, supporting its use for benign oesophageal strictures in adults. However, greater evidence is required for more robust conclusions to be made in terms of success when compared to alternative methods of intervention, such as endoscopic dilation.

Luminal strictures can occur as part of many different gastrointestinal (GI) disorders anywhere along the GI tract and affect all age groups. The end goal of managing any stricture is to re-establish an adequate and durable luminal patency that is sufficient to resolve the presenting clinical symptoms. Treatment options can be generally categorized into medical, endoscopic, and surgical. However, within each of these categories, multiple different options are available. Therefore, choosing the best treatment modality is often challenging and depends on multiple factors including the type, location, and complexity of the stricture, as well as the preference of the treating physician. In this article, we will review the most current literature regarding foregut strictures, particularly esophageal and gastric, beyond dilation.

Self-expanding metal stents provide rapid improvement of dysphagia in oesophageal cancer but are associated with complications. The aim of the present study was to test the effectiveness of an alternative treatment of combining biodegradable stents with radiotherapy.

A Simon two-stage single-arm prospective phase II trial design was used to determine the efficacy of biodegradable stents plus radiotherapy in patients with dysphagia caused by oesophagus cancer who were unsuitable for radical treatment. Fourteen patients were recruited and data from 12 were included in the final analyses.

Five of 12 patients met the primary end point: one stent-related patient death; four further interventions for dysphagia within 16 weeks of stenting (41.7%, 95% confidence interval 15.2-72.3%). The median time to a 10-point deterioration of quality of life was 2.7 weeks. Nine patients died within 52 weeks of registration. The median time to death from any cause was 15.0 weeks (95% confidence interval 9.6-not reached).

The high re-intervention observed, which met the pre-defined early stopping criteria, meant that the suggested alternative treatment was not sufficiently effective to be considered for a larger scale trial design. Further work is needed to define the place of biodegradable stents in the management of malignant oesophageal strictures.

This review attempts to present the available evidence regarding the use of biodegradable stents in refractory benign esophageal strictures, especially highlighting their impact on clinical success and complications. A comprehensive literature search was conducted in PubMed, using the terms "biodegradable" and "benign"; evidence from cohort and comparative studies, as well as data from one pooled analysis and one meta-analysis are presented. In summary, the results from these studies indicate that the effectiveness of biodegradable stents ranges from more than one third to a quarter of cases, fairly similar to other types of stents used for the same indication. However, their implementation may reduce the need for re-intervention during follow up. Biodegradable stents also seem to reduce the need for additional types of endoscopic therapeutic modalities, mostly balloon or bougie dilations. Results from pooled data are consistent, showing moderate efficacy along with a higher complication rate. Nonetheless, the validity of these results is questionable, given the heterogeneity of the studies included. Finally, adverse events may occur at a higher rate but are most often minor. The lack of high-quality studies with sufficient patient numbers mandates further studies, preferably randomized, to elucidate the exact role of biodegradable stents in the treatment of refractory benign esophageal strictures.

Benign strictures of the bile duct may be difficult to treat endoscopically due to altered bowel anatomy. Furthermore, recurrence of stenosis and symptoms remains high. The aim of the Spanish Prospective Registry BiELLA study was to investigate the safety and efficacy of absorbable stents in the treatment of benign biliary strictures and their outcomes on the medium and long-term follow-up.

A prospective, multicenter, observational, non-randomized study (the BiELLA study) was conducted from January 2014 to September 2018. One hundred fifty-nine patients with benign biliary strictures, mostly postsurgical, were enrolled for implantation of absorbable biliary stents in the 11 participating Spanish tertiary hospitals. The average patient follow-up was 45.4 ± 15.9 months (range, 12-60 months). The follow-up data included symptoms, biochemical parameters, and ultrasound images at 1, 6, and 12 months and then yearly for up to 60 months.

The immediate technical and clinical success rates were 100%. In all patients, stent placement resulted in improvement of clinical symptoms and biochemical parameters. The primary mean patency for stent was 86.7, 79.6, and 78.9% at 12, 36, and 60 months, respectively (95% CI). Biliary restenosis and occlusion occurred in 40 (26.6%) patients. Of the 40 patients, 18 (12%) patients were treated with a second stent and 22 (14.6%) patients had operative repair of the recurrent strictures. There were no major complications associated with stent implantation.

Implantation of an absorbable polydioxanone biliary stent is safe and effective for treatment of benign biliary strictures refractory to balloon dilatation or other biliary intervention.

• Percutaneous implantation of biodegradable prostheses for the treatment of benign postsurgical biliary strictures is a safe and effective procedure. • More than 75% of the patients presented patency of the stented biliary tree at 5 years follow-up. • Absorbable stents improved clinical symptoms and signs (jaundice, itching, fever), and laboratory parameters in a few days after stent placement.

Stent insertion can effective alleviate the symptoms of benign esophageal strictures (BES). Magnesium alloy stents are a good candidate because of biological safety, but show a poor corrosion resistance and a quick loss of mechanical support in vivo.

To test the therapeutic and adverse effects of a silicone-covered magnesium alloy biodegradable esophageal stent.

Fifteen rabbits underwent silicone-covered biodegradable magnesium stent insertion into the benign esophageal stricture under fluoroscopic guidance (stent group). The wall reconstruction and tissue reaction of stenotic esophagus in the stent group were compared with those of six esophageal stricture models (control group). Esophagography was performed at 1, 2, and 3 weeks. Four, six, and five rabbits in the stent group and two rabbits in the control groups were euthanized, respectively, at each time point for histological examination.

All stent insertions were well tolerated. The esophageal diameters at immediately, 1, 2 and 3 wk were 9.8 ± 0.3 mm, 9.7 ± 0.7 mm, 9.4 ± 0.8 mm, and 9.2 ± 0.5 mm, respectively (vs 4.9 ± 0.3 mm before stent insertion; P < 0.05). Magnesium stents migrated in eight rabbits [one at 1 wk (1/15), three at 2 wk (3/11), and four at 3 wk (4/5)]. Esophageal wall remodeling (thinner epithelial and smooth muscle layers) was found significantly thinner in the stent group than in the control group (P < 0.05). Esophageal injury and collagen deposition following stent insertion were similar and did not differ compared to rabbits with esophageal stricture and normal rabbits (P > 0.05).

Esophageal silicone-covered biodegradable magnesium stent insertion is feasible for BES without causing severe injury or tissue reaction. Our study suggests that insertion of silicone-covered magnesium esophageal stent is a promising approach for treating BES.

Background and study aims  Fully covered self-expanding metal stents (FCSEMS) provide an alternative to bougie dilation (BD) for refractory benign esophageal strictures. Controlled studies comparing temporary placement of FCSES to repeated BD are not available. Patients and methods  Patients with refractory anastomotic esophageal strictures, dysphagia scores ≥ 2, and two to five prior BD were randomized to 8 weeks of FCSEMS or to repeated BD. The primary endpoint was the number of BD during the 12 months after baseline treatment. Results  Eighteen patients were included (male 67 %, median age 66.5; 9 received metal stents, 9 received BD). Technical success rate of stent placement and stent removal was 100 %. Recurrent dysphagia occurred in 13 patients (72 %) during follow-up. No significant difference was found between the stent and BD groups for mean number of BD during follow-up (5.4 vs. 2.4, P  = 0.159), time to recurrent dysphagia (median 36 days vs. 33 days, Kaplan-Meier: P  = 0.576) and frequency of reinterventions per month (median 0.3 vs. 0.2, P  = 0.283). Improvement in quality of life score was greater in the stent group compared to the BD group at month 12 (median 26 % vs. 4 %, P  = 0.011). Conclusions  The current data did not provide evidence for a statistically significant difference between the two groups in the number of BD during the 12 months after initial treatment. Metal stenting offers greater improvement in quality of life from baseline at 12 months compared to repeated BD for patients with refractory anastomotic esophageal strictures.

Peptic oesophageal stricture can be considered as the end result of prolonged gastro-oesophageal reflux. The 'gold standard' treatment for peptic stricture is endoscopic dilatation with balloon or bougie. It is predicted that up to 40% of patients remain symptomatic with dysphagia due to refractory (resistant to treatment) or recurrent strictures, needing frequent interventions at short intervals. Such patients have poor nutritional status due to the primary disease and are susceptible to complications related to repeated endoscopic dilatation such as bleeding and perforation. This general review aims to analyse existing published evidence and address the role of biodegradable stents in resistant peptic strictures as an alternative treatment to provide long-term dysphagia-free intervals.

Tracheoesophageal fistula (TEF) is frequently congenital and requires surgical correction. TEF can also occur secondary to malignant esophageal tumors or benign diseases and these cases are managed by endoscopic means, such as closing the defect with metallic stents. Although esophageal injury can occur secondary to nonsteroidal anti-inflammatory drugs (NSAIDs), TEF secondary to chronic NSAIDs use has not been described in the literature. We report the case of a male patient with refractory migraine and chronic use of NSAIDs, with a history of esophageal stenosis presenting with acute-onset total dysphagia. Upper gastrointestinal endoscopy and CT-scan revealed TEF located at 25 cm from the incisors. An esophageal stent was placed endoscopically, and 6 weeks a second stent was placed in a stent-in-stent manner to allow removal of both stents. Endoscopic control after the removal of the stents showed the persistence of the fistula, so a third stent was placed as a rescue therapy. Against medical advice, the patient continued to use OTC painkillers and NSAIDs in large doses. Three months later, he was readmitted with total dysphagia and recent-onset dysphonia. CT scan revealed a new fistula above the already placed stent. A second metallic stent was endoscopically placed through the old stent to close the newly developed fistula. The patient was discharged on the third day with no complications and he remains well at 6 months follow-up. Due to small cases studies, recurrent TEF remains a therapeutic challenge. Endoscopic therapy is usually an effective solution, but complex cases might require multiple treatment sessions.