Background: Self-expandable metal stents (SEMS) are frequently used for the palliation of malignant dysphagia. Recurrent dysphagia due to stent migration in covered stents and non-tumoral or tumoral tissue growth in uncovered stents is the main cause of stent failure and occurs in 15-30% and 10-30% of patients, respectively. Aim: We aimed to determine efficacy, recurrent dysphagia, particularly due to migration and tissue growth, and complications of the SX-ELLA stent Esophageal HV (Ella-CS, Hradec Kralove, Czech Republic). This novel design is fully covered to resist tissue ingrowth and has an anti-migration ring to resist migration. Furthermore, it is braided in one piece to improve flexibility and expected to resist hyperplastic tissue reaction. Methods: Between February 2007 and May 2008, 45 patients with malignant dysphagia from inoperable or metastatic esophageal or gastric cardia cancer (n=43) or lung cancer (n=2) underwent placement of an SX-ELLA stent Esophageal HV in two tertiary referral centers. Patients were followed by scheduled telephone calls at 14 days after stent placement, and then monthly until death. Outcome measures were dysphagia score, recurrent dysphagia, complications, endoscopic reinterventions and mortality. Results: At 4 weeks, dysphagia score improved from a median of 3 (liquids only) prior to stent placement to a median of 1 (ability to eat some solid food) (p<0.001). Twelve of 45 (27%) patients developed recurrent dysphagia, in 6 (13%) patients due to stent migration and in 2 (4%) due to tissue overgrowth. Others causes of recurrent dysphagia were food obstruction, stent fracture and partial stent deployment. Major complications (severe pain, hemorrhage, fistula and fever) occurred in 10/45 (22%) patients. Minor complications, i.e., mild pain and gastro-esophageal reflux were observed in 12/45 (27%) patients. In total, 26 endoscopic reinterventions were performed in 18 patients (40%) for recurrent dysphagia or complications. Until November 2008, 39 patients died of whom 5 (11%) due to hemorrhage after a median of 107 days, most likely due to a combination of tumor progression and/or stent compression. Conclusions: The use of the SX-Ella stent Esophageal HV is effective and relatively safe for the palliation of malignant dysphagia. Recurrent dysphagia due to tissue growth and stent migration was reduced compared with other currently available covered stents, although still 40% of patients needed a reintervention for recurrent dysphagia or complications.

Self-expanding stents are frequently used to relieve dysphagia from inoperable or metastatic esophageal or gastric cardia cancer. One of the remaining issues is however the ingrowth of nontumoral or tumoral tissue in partly covered stents. Therefore, a new stent design, the Alimaxx-E™ stent (Alveolus Inc., Charlotte, North Carolina, USA), was recently developed, which is made of nitinol and fully covered with polyurethane to resist tissue ingrowth. The aim of this study was to determine efficacy and safety of the Alimaxx-E™ stent, and to evaluate whether this stent reduced tissue ingrowth without increasing the risk of stent migration.

Background: Visualization methods used in stent implantation procedures are often dictated by the delivery method. Direct visualization during the stent implant procedure is possible via side-saddle flexible endoscopy; however, the distal end of the stent is not visible using this method. To enhance direct visualization, an esophageal stent delivery system has been introduced that allows visualization of the entire stent deployment from the distal end to the proximal end. The objective of this study is to describe early observations using this direct visualization deployment system. Methods: The novel device is a covered self-expanding metal stent (SEMS) with a dedicated delivery system. The delivery catheter fits over the endoscope and features a window at the proximal end of the stent. These features allow direct visualization and positioning at both the distal and proximal stent ends. Sixteen stent implants were performed with 14 placements in the esophagus and 2 in the gastric cardia. Results: The stent delivery system allowed direct visualization of the distal and proximal stent ends in all patients. In one patient, the proximal esophageal lumen could not be visualized through the window in the catheter because of friability and consequently bleeding from the tumor. Deployment was executed without complication in 11 cases with good catheter insertion, ease of deployment, stent expansion and ease of catheter removal. In 5 cases, stent placement was also possible, however, tight fibrotic strictures delayed full stent deployment (2 cases) or made repositioning (2 cases) and retraction of the delivery device (1 case) more difficult. Conclusion: The delivery device allows visualization of the distal end of the stent during deployment without the use of fluoroscopy unlike other stent delivery systems. Our initial experience in 16 patients suggests that further modifications to the device, including an increase in flexibility and a tapered tip, would make it suitable to pass more readily through tight strictures. This device is especially useful in stent placements at the GE junction and for real-time visual verification of fistula coverage. Further assessment of the delivery system is needed, however, to provide definitive conclusions.

Background: Stents are commonly used for the palliation of obstruction due to irresectable esophageal or gastric cardia cancer. One of the drawbacks of the presently used stents is the high percentage of recurrent dysphagia due to stent migration and tissue growth. New stents have been designed to overcome this unwanted sequel of stent placement. Aim: To compare the partially-covered Ultraflex stent (Boston Scientific, Natick, USA), with the newly designed fully covered Polyflex stent made of silicone with an encapsulated monofilament braid of polyester (Boston Scientific), and the Niti-S stent consisting of an inner polyurethane layer over its complete length and an outer uncovered nitinol wire (Taewoong Medical, Seoul, Korea) in patients with inoperable carcinoma in the esophagus or gastric cardia. Methods: Between June 2004 and May 2006, 125 patients were randomized to treatment with an Ultraflex stent (n = 42), Polyflex stent (n = 41) or Niti-S stent (n = 42). Patients were followed by scheduled telephone calls at 14 days after treatment, and then monthly for six months or until death. Recurrence of dysphagia, technical and functional outcome, and complications were analyzed with Kaplan-Meier curves and log rank testing. Health-related quality of life was assessed by EORTC C30 and EORTC OES18 questionnaires. Results: Technical problems occurred in 9 (7%) patients, mainly with a Polyflex stent (n = 7). Dysphagia improved from a median score of 3 (liquids only) to 1 (ability to eat some solid food) in all 3 stent groups. Recurrent dysphagia occurred more frequently with Ultraflex stents (p = 0.03), and was caused by tissue growth (Ultraflex stent 13/42 (31%) vs. Polyflex stent 4/41 (10%) vs. Niti-S stent 10/42 (24%)), stent migration (Ultraflex stent 7/42 (17%) vs. Polyflex stent 12/41 (29%) vs. Niti-S stent 5/42 (12%)), and food bolus impaction (Ultraflex stent 10/42 (24%) vs. Polyflex stent 2/41 (5%) vs. Niti-S stent 1/42 (2%)). There were no differences in complications between the three stent types, however two perforations occurred with Polyflex stents. No differences were found in general and disease-specific quality of life scores between the three stent types. Conclusions: All three stents are safe and offer the same degree of palliation from malignant dysphagia. The new fully covered stents have the advantage that re-interventions are less frequently needed, as the Polyflex particularly reduces tissue growth and the Niti-S stent migration rates. It may well be that recurrent dysphagia could be even more reduced by designing a stent that combines the non-metal material used for the Polyflex stent with the anti-migration wire of the Niti-S stent.

Background: Covered stents are used for the palliation of dysphagia from obstructing esophageal cancer. A drawback of stents is the risk of stent migration, which may occur in up to 20% of patients. To overcome this problem, the Niti-S stent (Taewong Medical, Seoul, Korea) has been developed, which has a double layer, consisting of an inner polyurethane layer over its complete length to prevent tissue ingrowth and an outer uncovered nitinol wire to allow the stent to embed itself in the esophageal wall. Aim: To study the effectiveness of the Niti-S stent in the palliation of dysphagia and the prevention of migration in patients with carcinoma of the esophagus and gastric cardia. Methods: Between June 2003 and May 2004, 42 patients with inoperable carcinoma of the esophagus (79%) or gastric cardia (21%) were treated with a Niti-S stent. Patients were followed prospectively and were compared with 3 historical groups of 175 patients treated with a partially-covered Ultraflex stent (n = 34), a partially-covered Flamingo stent (n = 71) or a completely-covered Z-stent (n = 70) for the same indication. Differences in clinical outcome were assessed by chi-square tests and Kaplan-Meier log rank tests. Results: At 4 weeks, improvement in dysphagia score was similar in all patient groups (median from 3 [liquids only] to 1 [eat some solid food]). Only 4/42 patients (10%) with a Niti-S stent developed recurrent dysphagia, in contrast to 9/34 (26%) with an Ultraflex stent, 19/71 (27%) with a Flamingo stent, and 16/70 (23%) with a Z-stent (p = 0.006). This was mainly related to differences in tissue overgrowth (1/42 [2%]; p = 0.008) and stent migration (3/42 [7%]; p = 0.09). Major complications (perforation [1], aspiration pneumonia [2] and hemorrhage [2]) occurred in 5/42 (12%) patients, which was not different compared with other stent types (Ultraflex stent 8/34 [24%], Flamingo stent 12/71 [17%], and Z-stent 18/70 [26%]; p = 0.30). Also minor complications (mainly pain) were not different between the 4 stent types (Niti-S stent 7/42 [17%]; p = 0.16). Conclusions: The Niti-S stent provides good symptomatic relief of malignant dysphagia, and it effectively reduces recurrent dysphagia. Its double-layered, completely covered design may be important in preventing the occurrence of migration and the growth of tissue/tumor at both ends of the stent.