Background Fully covered stents are designed to resist tissue ingrowth that is often seen with partially covered stents. An issue with fully covered stents is the risk of migration. Objective We ...aimed to determine efficacy, recurrent dysphagia, and complications of the SX–ELLA stent Esophageal HV, which is fully covered to resist tissue ingrowth and has an antimigration ring to withstand migration. Design Prospective cohort study. Setting Two tertiary referral centers. Patients Forty-four patients with malignant esophageal strictures from inoperable or metastatic esophageal or gastric cardia cancer (n = 42) or lung cancer (n = 2). Interventions Placement of an SX–ELLA stent. Main outcome measures Functional outcome, recurrent dysphagia, complications, and survival. Results Dysphagia improved from a median score of 3 (liquids only) before stent placement to 1 (ability to eat some solid food) 4 weeks later ( P < .001). Twelve of 44 (Kaplan Meier analysis = 40%) patients developed 18 episodes of recurrent dysphagia of which 6 were caused by stent migration and 2 by tissue overgrowth. In total, 14 episodes of major complications developed in 10 of 44 (Kaplan Meier analysis = 29%) patients, 8 of which were caused by hemorrhage. After a median follow-up of 15 months, 39 patients had died (median survival 110 days), 5 (11%) from hemorrhage. Limitations Nonrandomized study design. Conclusions Dysphagia caused by esophageal cancer can be successfully palliated by placement of a new, fully covered esophageal stent (SX–ELLA). Although this single-wire braided stent with an antimigration ring is supposed to be less traumatic and to reduce migration, this was not substantiated in this study. Further improvements of stent features are needed to achieve the goals set for this study.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Colonoscopic surveillance for neoplasia is recommended for patients with inflammatory bowel disease (IBD)-related colitis. However, data on cost-effectiveness predate current international ...guidelines. Objective To compare cost-effectiveness based on contemporary data between the surveillance strategies of the American Gastroenterological Association (AGA) and British Society of Gastroenterology (BSG). Design We constructed a Markov decision model to simulate the clinical course of IBD patients. Setting We compared the 2 surveillance strategies for a base case of a 40-year-old colitis patient who was followed for 40 years. Patients AGA surveillance distinguishes 2 groups: a high-risk group with annual surveillance and an average-risk group with biannual surveillance. BSG surveillance distinguishes 3 risk groups with yearly, 3-year, or 5-year surveillance. Interventions Patients could move from a no-dysplasia state with colonoscopic surveillance to 1 of 3 states for which proctocolectomy was indicated: (1) dysplasia/local cancer, (2) regional/metastasized cancer, or (3) refractory disease. After proctocolectomy, a patient moved to a no-colon state without surveillance. Main Outcome Measurements Direct costs of medical care, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Results BSG surveillance dominated AGA surveillance with $9846 per QALY. Both strategies were equally effective with 24.16 QALYs, but BSG surveillance was associated with lower costs because of fewer colonoscopies performed. Costs related to IBD, surgery, or cancer did not affect cost-effectiveness. Limitations The model depends on the accuracy of derived data, and the assumptions that were made to reflect real-life situations. Study conclusions may only apply to the U.S. health care system. Conclusion The updated risk-profiling approach for surveillance of IBD colorectal carcinoma by the BSG guideline appears to be more cost-effective.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Stents are commonly used for the palliation of dysphagia from esophageal or gastric cardia cancer. A major drawback of stents is the occurrence of recurrent dysphagia. Large-diameter ...stents were introduced for the prevention of migration but may be associated with more complications. Objective To compare small- and large-diameter stents for improvement of dysphagia, complications, and recurrent dysphagia. Design Evaluation of 338 prospectively followed patients with dysphagia from obstructing esophageal or gastric cardia cancer who were treated with an Ultraflex stent (n = 153), a Gianturco Z-stent (n = 89), or a Flamingo Wallstent (n = 96) of either a small diameter (n = 265) or a large diameter (n = 73) during the period 1996 to 2004. Setting Single academic center. Patients Patients with an inoperable malignant obstruction of the esophagus or the gastric cardia, or recurrent dysphagia after prior radiation, with curative or palliative intent for esophageal cancer. Interventions Stent placement. Main Outcome Measurements Dysphagia score (on a scale from 0 no dysphagia to 4 complete dysphagia), complications, and recurrent dysphagia. Analysis was by χ2 test, log-rank test, and Cox regression analysis. Results Improvement in dysphagia was similar between patients with a small- or a large-diameter stent ( P = .35). The occurrence of major complications, such as hemorrhage, perforation, fistula, and fever, was increased in patients with a large-diameter Gianturco Z-stent compared with those treated with a small-diameter stent (4 40% vs 16 20%; adjusted hazard ratio HR 5.03, 95% confidence interval CI 1.33-19.11) but not in patients with a large-diameter Ultraflex stent or a Flamingo Wallstent. Moreover, minor complications, particularly pain, were associated with prior radiation and/or chemotherapy in patients with a large- or a small-diameter Gianturco Z-stent (HR 4.27, 95% CI 1.44-12.71) but not in those with an Ultraflex stent or a Flamingo Wallstent. Dysphagia from stent migration, tissue overgrowth, and food bolus obstruction reoccurred more frequently in patients with a small-diameter stent than in those with a large-diameter stent (Ultraflex stent: 54 42% vs 3 13%, adjusted HR 0.16, 95% CI 0.04-0.74; Gianturco Z-stent: 21 27% vs 1 10%, adjusted HR 0.97, 95% CI 0.11-8.67; and Flamingo Wallstent: 21 37% vs 6 15%, adjusted HR 0.40, 95% CI 0.03-4.79). Limitations Nonrandomized study design. Conclusions Large-diameter stents reduce the risk of recurrent dysphagia from stent migration, tissue overgrowth, or food obstruction. Increasing the diameter in some stent types may, however, increase the risk of stent-related complications to the esophagus.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Self-expanding stents are a well-accepted palliative treatment modality for strictures resulting from esophageal carcinoma. However, the use of stents close to the upper esophageal ...sphincter (UES) is considered to be limited by patient intolerance caused by pain and globus sensation and an increased risk of complications, particularly tracheoesophageal fistula formation and aspiration pneumonia. Objective Our purpose was to determine the efficacy and safety of stent placement in patients with a malignant obstruction close to the UES. Design Evaluation of 104 patients with dysphagia from a malignant stricture close to the UES treated in the period 1996-2006. Setting Single university center. Patients Patients with primary esophageal carcinoma (n = 66) or recurrent cancer after gastric tube interposition (n = 38) within 8 cm distance distal of the UES. Twenty-four (23%) patients also had a tracheoesophageal fistula. Interventions Stent placement. Main Outcome Measurements Functional and technical outcome, survival, complications, and recurrent dysphagia. Analyses were performed by χ2 test, Kaplan-Meier curves, and log-rank testing. Results Mean distance from the UES to the upper tumor margin was 4.9 ± 2.6 cm and to the upper stent margin 3.1 ± 2.3 cm. The procedure was technically successful in 100 of 104 (96%) patients. Fistula sealing was achieved in 19 of 24 (79%) patients. After 4 weeks, dysphagia had improved from a median score of 3 (liquids only) to 1 (some difficulties with solids). Total complications were seen in 34 of 104 (33%) patients. Of these, major complications (aspiration pneumonia 9, hemorrhage 8, fistula 7, and perforation 2) occurred in 22 (21%) patients, whereas pain after stent placement was observed in 16 (15%) patients. Recurrent dysphagia occurred in 29 (28%) patients and was mainly caused by tissue ingrowth or overgrowth (n = 10), food bolus obstruction (n = 7), stent migration (n = 3), or other reasons (n = 11), such as persistent fistula (n = 5), difficulty with swallowing (n = 4), and dislocation of the stent (n = 2). Eight (8%) patients complained of globus sensation; however, in none of the patients was stent removal indicated. Limitations Retrospective design. Conclusions Stent placement is safe and effective for the palliation of dysphagia and sealing of fistulas in patients with a malignant stricture close to the UES. On the basis of these results, stent placement may be considered for palliation in this group of patients with an otherwise dismal prognosis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Covered, rather than uncovered, metal stents are used for the palliation of dysphagia from esophageal cancer, but a major drawback is the risk of stent migration, which occurs in up to 20% ...of patients. To overcome this problem, a double-layered stent, the Niti-S stent (Taewong Medical, Seoul, Korea), has been developed. The Niti-S stent consists of an inner polyurethane layer to prevent tumor ingrowth and an outer uncovered nitinol wire tube to allow the mesh of the stent to embed itself in the esophageal wall. Methods Between June 2003 and May 2004, 42 patients with malignant dysphagia caused by inoperable carcinoma of the esophagus or gastric cardia were treated with a Niti-S stent. Patients were prospectively followed and data collection focused on recurrent dysphagia, functional outcome, complications, and survival. Results At 4 weeks, the dysphagia score had significantly improved from a median of 3 (liquids only) to 0 (ability to eat a normal diet). Five of 42 (12%) patients with a Niti-S stent developed recurrent dysphagia, mainly due to tissue overgrowth (2 of 42; 5%) and stent migration (3 of 42; 7%). Major complications (perforation, 1; aspiration pneumonia, 2; hemorrhage, 2) occurred in 5 of 42 (12%) patients. Pain following stent placement was observed in 5 of 42 (12%) patients and symptomatic gastroesophageal reflux occurred in 2 of 42 (5%) patients. Conclusions The Niti-S stent provides symptomatic relief of malignant dysphagia and effectively reduces recurrent dysphagia. Its double-layered design is probably important in preventing migration. In addition, the complete covering of the Niti-S stent may be a factor in preventing tissue overgrowth at both ends of the stent.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Performing a full-thickness intestinal wall resection of a sessile polyp located on the mesenteric side with a compression clip may lead to compression of mesenteric vessels. The ...application of such a clip may therefore cause a compromised blood supply in the particular bowel segment, leading to perforation. Objective To evaluate the performance of a newly developed, nitinol compression clip, called the NiTi clamp, for full-thickness resection of the bowel wall, while the clip is deliberately deployed endoluminally on the mesenteric side. Design Prospective animal study. Multinational, multidisciplinary; gastroenterology and general surgery, research cooperation. Setting Animal research laboratory. Intervention Six pigs were operated upon and endoscopically evaluated and then killed after 3 weeks. Linear compression closure clips based on nitinol springs were used. Three longitudinal enterotomies were performed: in the cecum, spiral colon, and proximal rectum. Four clips were deployed in each animal. Main Outcome Measurements A total of 23 clips were deployed. The average expulsion day was 9 days. Results All but 3 clips were normally expelled. One pig developed bowel ischemia due to intussusception. In endoscopic procedures, no signs of significant segmental mucosal ischemia were found. The macroscopic appearance of the compression closure lines was thin and delicate, but epithelialization was significantly delayed at 5 sites. Limitation Differences between porcine and human colorectal anatomy. Conclusion Full-thickness clamping of the bowel with the NiTi clamp, including the local mesenteric vasculature, does not significantly impair local healing of the clamp site and gives hope to further development of novel full-thickness endoscopic resection technologies.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background The management of patients with refractory hypopharyngeal strictures after surgery in combination with radiation therapy is disappointing, and nutrition through feeding tubes is often ...required. Objective To evaluate the efficacy and safety of a modified self-expanding Niti-S metal stent in the treatment of hypopharyngeal strictures after combined therapy for laryngeal cancer. Design Case series. Setting A general hospital and a university hospital. Patients Seven consecutive patients were included. One of them did not have laryngectomy. Interventions All patients received a modified Niti-S stent. Main Outcome Measurements Improvement of dysphagia, avoiding periodic bougienage, and enteral nutrition through feeding tubes. Results After placement of the first stent, dysphagia improved in all patients. Six of 7 patients developed stent migration and/or granulomatous tissue ingrowth or overgrowth. Additional stents were placed in all patients after a median of 3 months after the previous stent placement. One patient developed an esophagorespiratory fistula caused by a Polyflex stent. Two patients died of causes unrelated to the stent. The remaining 5 patients remained alive and asymptomatic after a median follow-up of 10 months. Limitations Periodic stent exchange. Stent placement did not resolve the stricture definitively. We had a limited number of patients and have no long-term outcome data yet. Conclusions The use of this modified Niti-S stent avoids both enteral nutrition through feeding tubes and the need for periodic bougienage in patients with difficult-to-treat benign hypopharyngeal strictures.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background When an esophageal stent is placed through the lower esophageal sphincter (LES), gastroesophageal reflux symptoms may persist despite high-dose proton pump inhibitor therapy. A recently ...developed, short segment, uncovered nitinol stent with a tricuspid-like valve can be placed inside a previously placed esophageal stent. Objective To evaluate the technical feasibility and safety of a reflux control system (RCS) in distally placed esophageal stents. Design A prospective case series. Setting Two tertiary-care referral centers. Patients This study involved 10 patients who had an “open” stent placed through the LES and 1 patient with severe bile reflux after esophagojejunostomy. Intervention Placement of an RCS with fluoroscopic and (in selected cases) endoscopic guidance, from April to October 2010. Main Outcome Measurements Technical success of RCS placement and complications. Results Placement of an RCS was successful on the first attempt in all patients; complete expansion to the wall of the host stent was confirmed by fluoroscopy in all cases. In 3 patients, the host stent migrated in <1 month with the RCS still inside. In 8 patients, the RCS was in place for a median of 134 days (range 33-225 days). Three patients died because of malignant disease progression. Eight RCSs were removed endoscopically, together with the host stent without complications. RCS migration did not occur. Limitations Small number of patients, nonrandomized design, lack of pH measurements. Conclusion Placement of an RCS in a host stent is technically feasible and safe. An RCS can be considered in symptomatic patients with open esophageal stents to prevent gastroesophageal reflux.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
