Expandable metal stents versus laser combined with radiotherapy for palliation of unresectable esophageal cancer: a prospective randomized trial

BACKGROUND/AIMS: Because of the short life expectancy of patients with esophageal cancer, relief of dysphagia associated with low morbidity and mortality must be the aim of any therapeutic strategy. METHODOLOGY: A total of 39 patients with unresectable esophageal cancer were randomly allocated to either receive combined laser-percutaneous radiotherapy (group 1, n = 21) or to have a self-expanding metal stent placed (group 2, n = 18). Some patients in group 2 required initial laser therapy (group 2a, n = 8). Treatment efficacy was evaluated on the basis of improved dysphagia, restenosis, hospital stay, survival time and costs. RESULTS: Both treatments were able to significantly improve dysphagia. Restenosis occurred in 43% of group 1 and 22% of group 2 patients. In group 1, 2 patients had severe bleeding episodes and 2 patients developed esophago-tracheal fistulas. One group 1 patient died due to uncontrollable bleeding and 1 patient to recurrent aspiration. No treatment-related death was observed in group 2. Hospital stay was 30.0 (mean: 5.4) days in group 1, 18.9 (mean: 4.2) days in group 2a and 7.1 (mean: 3.1) days in group 2b. There was no statistical difference between the 3 groups with regard to survival. Costs were highest in group 1 and lowest in group 2b. CONCLUSIONS: The treatment of unresectable esophageal cancer with self-expanding metal stents appears to be simple, safe, as good as laser combined with radiotherapy and cost efficient.     

Self‐expandable esophageal stents placement for the palliation of dysphagia as a result of lung cancer

We report our experience with self‐expandable metallic stents for the palliation of malignant dysphagia and tracheoesophageal fistulae caused by lung cancer. Esophageal self‐expandable metallic stents were deployed in 28 patients with malignant dysphagia as a result of lung cancer between August 2002 and January 2009. Mean age was 62.1 (42–77) with 26 male patients. Twenty‐three patients received previous chemo‐radiotheraphy and two had pneumonectomy. Tracheoesophageal fistulae were coexisting in eight patients. Stents were inserted under fluoroscopic control over guide‐wire with the patient under conscious sedation. One stent was used in all patients except one fistula patient with two stents. Immediate improvement after stent insertion was seen in all patients. Fistulae were sealed off in all. No complication was seen except transitional pain in 12 patients (42%). During the follow‐up, all patients remained asymptomatic with no clinical appearance of dysphagia symptoms except one patient whom gastrostomy was applied. All patients with fistulae died with a mean survival of 15.4 weeks. Dysphagia patients without a fistulae died with mean survival of 6 months except one patient with 1 month follow‐up. Self‐expandable esophageal metallic stent insertion can manage malignant dysphagia in lung cancer patients with significant survival period via nonsurgical approach.     

Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial

BACKGROUND: Self-expandable metal stents deployed across the gastroesophageal junction predispose to gastroesophageal reflux. The efficacy of a stent with an antireflux mechanism in preventing gastroesophageal reflux was assessed. METHODS: Thirty patients with carcinoma of the distal esophagus or of the gastric cardia were randomized to receive either a stent with a windsock-type antireflux valve (FerX-Ella) (n = 15) or a standard open stent (n = 15) of the same design minus the valve. Gastroesophageal reflux was assessed by using standardized questionnaires and by 24-hour pH monitoring 14 days after treatment. RESULTS: Technical problems occurred during stent placement in 3 patients: migration (n = 2) and a problem with the introducing system (n = 1). Dysphagia improved from a median score of 3 (liquids only) to 1 (eat some solid food) in the antireflux group and from 3 to 0 (solid foods) in the open stent group ( p > 0.20). Reflux symptoms were reported by 3/12 patients (25%) with an antireflux stent and by 2/14 (14%) with an open stent. In 11 patients, 24-hour pH monitoring was obtained, and increased esophageal acid exposure (normal: <4%) was present with both types of stent: median 24-hour reflux time (9 patients) with the antireflux stent was 23% vs. 10% in (2 patients) with the open stent ( p = NS). Major complications occurred in 3 patients (20%) in each group and included bleeding (n = 3), severe pain (n = 2), and aspiration pneumonia (n = 1). The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%). CONCLUSIONS: The FerX-Ella antireflux stent provided relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia. However, the antireflux valve failed to prevent gastroesophageal reflux.     

Stent placement or brachytherapy for palliation of dysphagia from esophageal cancer: a prognostic model to guide treatment selection

BACKGROUND: Brachytherapy was found to be preferable to metal stent placement for the palliation of dysphagia because of inoperable esophageal cancer in the randomized SIREC trial. The benefit of brachytherapy, however, only occurred after a relatively long survival. The objective is to develop a model that distinguishes patients with a poor prognosis from those with a relatively good prognosis. METHODS: Survival was analyzed with Cox regression analysis. Dysphagia-adjusted survival (alive with no or mild dysphagia) was studied with Kaplan-Meier analysis. Patient data is from the multicenter, randomized, controlled trial (SIREC, n = 209) and a consecutive series (n = 396). Patients received a stent or single-dose brachytherapy. RESULTS: Significant prognostic factors for survival included tumor length, World Health Organization performance score, and the presence of metastases (multivariable p < 0.001). A simple score, which also included age and gender, could satisfactorily separate patients with a poor, intermediate, and relatively good prognosis within the SIREC trial. For the poor prognosis group, the difference in dysphagia-adjusted survival was 23 days in favor of stent placement compared with brachytherapy (77 vs. 54 days, p = 0.16). For the other prognostic groups, brachytherapy resulted in a better dysphagia-adjusted survival. CONCLUSIONS: A simple prognostic score may help to identify patients with a poor prognosis in whom stent placement is at least equivalent to brachytherapy. If further validated, this score can provide an evidence-based tool for the selection of palliative treatment in esophageal cancer patients.     

A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia

OBJECTIVES: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex). METHODS: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N=47) or a partially covered Ultraflex (N=54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded. RESULTS: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P=NS). CONCLUSIONS: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.     

Effect of stent size on complications and recurrent dysphagia in patients with esophageal or gastric cardia cancer

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 chi2 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.     

Endotube insertion for palliation of esophageal and cardia cancer: experiences with a new endoprosthesis

Therapy of inoperable carcinoma of the esophagus and cardia must be based on correction of the dysphagia. On that purpose, a new endoprosthesis (type ESKA-Buess) was used. 57 patients were treated by endoscopic placement of an endoprosthesis. The mortality was 3.5%, patients survived appr. 3 months. All patients experienced a marked improvement in swallowing ability, 61% of our patients could swallow normally. The new endoprosthesis showed no relevant alteration in regard to form and material.     

抗反流支架与常规支架治疗远端食管贲门处狭窄的系统评价

目的:评价置入抗反流支架和常规支架治疗食管癌远端食管贲门处狭窄患者的疗效及安全性.方法:计算机检索PubMed(1978-2011)、EMbase(1966-2011)、CBM(1978-2011)、Cochrane Library(2011年第10期)和CNKI(1979-2011)并手工检索中、英文已发表的资料和会议论文并追索纳入文献的参考文献,查找比较置入抗反流支架和普通支架治疗食管癌远端食管贲门处狭窄患者的随机对照试验(randomized controlled trials,RCTs).对纳入研究进行方法学质量评价之后,采用Rev Man5.1软件进行Meta分析.结果:共纳入5个RCTs,合计234例患者.Meta分析结果表明:抗反流支架与置入常规支架相比,术后患者出现疼痛(RR=0.41,95%CI:0.16,1.06),支架移位(RR=1.02,95%CI:0.50,2.11),梗阻(RR=1.02,95%CI:0.52,1.99),胃食管反流(RR=1.68,95%CI:0.52,5.48),出血(RR=1.39,95%CI:0.44,4.40),食管胃穿孔(RR=0.70,95%CI:0.25,2.00)等方面没有显著性差异.结论:食管癌远端食管贲门处狭窄患者治疗中置入抗反流支架和常规支架的疗效无明显差异.由于纳入研究数量少,加之质量普遍较低,上述结论尚需开展更多设计合理、执行严格的多中心大样本且随访时间足够的RCTs加以验证.     

Comparison of double-layered and covered Niti-S stents for palliation of malignant dysphagia

Background and Aim:  Covered metal stents have been accepted as the treatment of choice for malignant dysphagia caused by esophageal and gastric cardia cancer, but stent migration is a major shortcoming. A double-layered Niti-S stent was therefore introduced to obviate this problem. We aimed to compare double-layered and covered Niti-S stents regarding safety, efficacy, and feasibility in the treatment of malignant dysphagia.
Methods:  Thirty-seven consecutive patients with malignant dysphagia due to inoperable esophageal or gastric cardia cancer were enrolled in a prospective, randomized study. The main outcomes were technical success, improvement in dysphagia score after stent insertion, and complications.
Results:  Technical success was achieved at a similar rate in both groups (covered, 19/19 [100%] vs double layered, 16/17 [94%]). A week after stent insertion, the mean dysphagia score improved significantly in the covered and double-layered groups compared to baseline (from 2.95 ± 0.52 and 2.88 ± 0.33 to 1.00 ± 0.47 and 1.06 ± 0.24, respectively; P  < 0.001). There was no difference in the survival of the patients in the two groups. The overall complications, including stent migration and tumor overgrowth, occurred more frequently with covered stents (11/19 [58%]) than double-layered stents (2/17 [12%]; P  = 0.006).
Conclusion:  Newly-developed, self-expanding metal stents, (covered and double-layered Niti-S stents) were equally effective and feasible treatments for malignant dysphagia. However, double-layered Niti-S stents are preferable due to their favorable safety profile.     

Memory metal stents for palliation of malignant obstruction of the oesophagus and cardia.

Thirty patients with incurable malignant obstruction of the oesophagus and cardia were treated with self expanding oesophageal memory metal stents (Ultraflex) in a prospective study. The endoprostheses were successfully placed in all patients. Within one week after implantation dysphagia had improved in 25 of 30 patients (83%). Stent expansion was incomplete within one week after implantation in 12 of 30 patients (40%). After an average of two dilatation sessions eight of 12 stents had expanded completely. Five patients complained of retrosternal pain and three of them suffered from heartburn over several days despite acid inhibition. Major problems in the follow up period occurred in 10 of 30 patients (30%) and included late perforation (one) and tumour ingrowth/overgrowth (nine). All of these complications were treated endoscopically. Improvement of the dysphagia of the patients with tumour ingrowth/overgrowth lasted for about eight weeks (median; range: 2-38 weeks). Until November 1994 six of 30 patients were still alive with a survival time of 309 days (median; range: 103-368 days). It is concluded that oesophageal memory metal stents are easy to implant, prove effective in the palliation of malignant oesophageal obstructions, and have a low risk of severe complications. The only disadvantages are that incomplete initial stent expansion as well as tumour ingrowth/overgrowth occurred in nearly one third of the patients.     

Are metal stents effective for palliation of malignant dysphagia and fistulas?

BACKGROUND: One of the available treatments for unresectable oesophagogastric malignancies is the insertion of metal stents. AIMS: We evaluated prospectively 147 patients suffering from malignant dysphagia and/or fistula, after inserting a self-expandable metal stent. PATIENTS AND METHODS: The study included 147 patients (87 males, mean age 73 years). Dysphagia before and after stent placement was scored. Patients were divided in two groups according to dysphagia grade: group A (grade 0, 1) and group B (grades 2, 3, 4). Three types of stents were used: the Ultraflex stent (covered and uncovered) and the Flamingo one (covered). The total number of self-expandable metal stents placed was 183. A total of 92 of them were inserted following the combined endoscopic and fluoroscopic approach (42 by injecting lipiodol), while 91 were placed under endoscopic control only. Early and late complications were evaluated. RESULTS: Mean dysphagia score in group A, 1 day and 1 month after the procedure, was slightly reduced from 0.8 to 0.5/0.6 (p=NS), respectively. However, there was a statistically significant improvement (p<0.001) of mean dysphagia score in group B, from 2.4 initially to 1.1/1.4. Early complications occurred in 37 cases, late ones in 51. According to severity, minor complications occurred in 24 patients, major in 42, while life-threatening ones in 22. Survival ranged from 1 to 611 days and 1-week mortality was 9%. Stent-related death occurred in six patients. CONCLUSIONS: All kinds of endoscopic methods used for stenting in the present study were easy to perform even on an out-patient basis. Insertion of self-expandable metal stents is effective in patients with dysphagia scores > or = 2. It might not clinically improve patients with dysphagia score <2, so selection of patients for stenting is essential to avoid unnecessary procedures. Moreover, their high cost, high complication rates and low overall survival may improve following better selection criteria.     

A prospective, randomized, controlled trial of covered expandable metal stents in the palliation of malignant esophageal obstruction at the gastroesophageal junction

OBJECTIVE: Palliation of malignant esophageal obstruction is an important clinical problem. Expandable metal stents are a major advance in therapy, but many stents become obstructed because of tumor ingrowth. The aim of this study was to compare a new, membrane-covered expandable metal stent to conventional prostheses in a randomized controlled trial. METHODS: Sixty-two patients with malignant inoperable esophageal obstruction at the gastroesophageal junction participated in the study. Patients were randomly assigned to covered or uncovered stents. The principal outcome measure was the need for reintervention because of recurrent dysphagia or migration. Secondary endpoints were relief of dysphagia measured by a dysphagia score (grade 0 = no dysphagia, grade 1 = able to eat solid food, grade 2 = semisolids only, grade 3 = liquids only, grade 4 = complete dysphagia) and the rate of complications and functional status. All patients were observed at monthly intervals until death or for 6 months. RESULTS: One week after stenting the dysphagia score improved significantly in both the uncovered (n = 32, 3 +/- 0.1 to 1 +/- 0.1 [means +/- SEMs], p < 0.001) and covered (n = 30, 3 +/- 0.1 to 1 +/- 0.2 [means +/- SEMs], p < 0.001) stents. Obstructing tumor ingrowth was significantly more likely in the uncovered stent group (9/30) than in the covered group (1/32) (p = 0.005). Significant stent migration occurred in 2/30 patients with uncovered stents, as compared with 4/32 patients in the covered group (p = 0.44). Reinterventions for tumor ingrowth were significantly greater in the uncovered stent group (27%), as compared with 0% in the covered group (p = 0.002). Life table analysis showed similar survival in both groups. CONCLUSION: Membrane-covered stents have significantly better palliation than conventional bare metal stents because of decreased rates of tumor ingrowth that necessitate endoscopic reintervention for dysphagia.