Treatment of malignant esophageal/cardiac stricture with self‐expanding antireflux metallic stents: A preliminary report from 17 patients

BACKGROUND : Different types of self‐expanding metallic stents are available for the palliative treatment of malignant strictures at the gastroesophageal junction. To overcome some of the disadvantages in the design of these metallic stents, we designed a silicone‐covered self‐expanding antireflux metallic stent that can prevent free gastroesophageal reflux after stent placement. METHODS : Seventeen silicone‐covered antireflux prototypes were used in 17 patients with dysphagia caused by inoperable malignant tumors involving the gastroesophageal junction. RESULTS : Stent implantation was technically successful in all 17 patients. There were no procedure‐related perforations or deaths. As a group, the mean dysphagia grade improved significantly (2.56 ± 0.49 vs 1.00 ± 0.51, P < 0.001) and the mean lumenal diameter was greatly increased (4.11 ± 1.02 vs 14.72 ± 4.01, P < 0.001) after stent placement. Ten patients received ambulatory 24‐h esophageal pH monitoring and compared with the healthy volunteers, there were no postprocedural abnormal gastroesophageal refluxes in any patient. Three patients had substantial chest pain requiring long‐term analgesics. No other complications were observed. CONCLUSIONS : The newly developed self‐expanding antireflux metallic stent is safe and effective for use in the palliation of dysphagia caused by malignant strictures at the gastroesophageal junction. A larger patient population would be required to give valid conclusions.     

Fully versus partially covered self‐expandable metal stents in benign esophageal strictures

Self‐expandable plastic stents are currently recommended for refractory benign esophageal strictures but they show disappointing results in terms of migration and long‐term efficacy. We report here our experience in the management of benign esophageal strictures with partially covered (PCSEMS) and fully covered self‐expandable metal stents (FCSEMS). We performed a retrospective analysis of self‐expandable metal stent (SEMS) placements for benign esophageal strictures from 1998 to 2011 in Rouen University Hospital. Twenty‐two patients (15 men, 7 women) attempted 40 esophageal SEMS placements (17 PCSEMS, 23 FCSEMS) during this period. All technical complications were migrations. Migration was noted after 3/17 PCSEMS (17.6%) and 4/23 FCSEMS placement (17.4%, P = ns). Clinical complications occurred after 6/17 PCSEMS and 2/23 FCSEMS placements (35.3% vs. 8.7%, P = 0.053). PCSEMS caused two major complications (fistulae) whereas FCSEMS did not cause any major complication (11.7% vs. 0%). Mean dysphagia score was significantly lower after SEMS placement (1.68 vs. 3.08, P < 0.001) with similar results for PCSEMS and FCSEMS. Stent placement resulted in long‐term clinical success for 23.5% of PCSEMS and 34.7% of FCSEMS (P = 0.0505). FCSEMS provide satisfying clinical success rate with an acceptable complication rate and they could constitute a relevant therapeutic option in the management of benign esophageal strictures.     

Economic analysis of esophageal stenting for management of malignant dysphagia

Over half of patients diagnosed with esophageal cancer are unsuitable for curative resection. A significant proportion of these patients will subsequently require palliative stenting to alleviate dysphagia. There is growing consensus in the literature that the deployment of a Self‐Expanding Metal Stent is the optimum stenting strategy; however, it remains unclear whether covered or uncovered metal stents are more cost‐effective. In order to determine which type of prosthesis is more cost‐effective, we compared the different stenting strategies in terms of 1‐year stent‐related mortality, health‐related quality of life, and cost. A decision analytical model was constructed to compare the 1‐year stent‐related mortality, health‐related quality of life, and cost between covered and uncovered stents. Probabilistic sensitivity analysis was performed to quantify the uncertainty associated with our results. Value of Information analysis was performed to assess the value of further research. In order to fully characterize the uncertainty associated with this decision, plastic stents were included in our analysis. Stent‐related mortality was slightly lower following covered stent deployment compared with uncovered stent deployment (1.00% vs. 1.26%). Covered stents were more effective by 0.0013 Quality‐Adjusted Life Years (Standard Deviation [SD] 0.0013 Quality‐Adjusted Life Years). They were also less expensive by $729.58 (SD $390.63). Probabilistic sensitivity analysis suggested that these results were not sensitive to model parameter uncertainty. Plastic stents deployment was $2832.64 (SD $1182.72) more expensive than uncovered metal stent deployment. Value of Information analysis suggests that the maximum value of further research in the UK is $61 124.30. The results of this study represent strong evidence for the cost‐effectiveness of covered compared with uncovered self‐expanding metal stents for the palliation of patients with malignant dysphagia. The findings support previously published literature asserting the dominance of self‐expanding metal stents over plastic stents. Value of Information analysis suggests that further research may not be cost‐effective. These findings have significant implication for both current clinical practice and future clinical research.     

PYLORIC STENTING FOR MALIGNANT GASTRODUODENAL OBSTRUCTION: THE KOREAN EXPERIENCE

Self‐expanding metal stents (SEMS) have been widely used for palliation of malignant gastrointestinal (GI) obstruction. Through‐the‐scope (TTS) stent has the advantage of direct placement through the endoscopic channel in malignant gastroduodenal and intestinal obstruction. We prospectively studied the effectiveness of a newly designed uncovered self‐expanding nitinol TTS stent (Niti‐S stent) with an 18 mm diameter and 60 or 80 mm in length, which was inserted through the 3.7 mm working channel of a therapeutic upper GI endoscope (Olympus GIF‐2T200) for palliation of malignant gastroduodenal and intestinal obstruction. However, the uncovered metal stent is apt to permit tumor ingrowth through the interstices. To overcome this limitation, a polyurethane‐covered self‐expanding nitinol TTS stent (Niti‐S covered stent) has been developed. Placement of TTS stent is an easy, rapid, and safe procedure and offers effective palliation of inoperable malignant gastroduodenal and intestinal obstruction, although tumor ingrowth remains to be resolved.     

Fully Covered Alimaxx Esophageal Metal Stents in the Endoscopic Treatment of Benign Esophageal Diseases

Background  

Expandable esophageal stents are widely used for the palliation of dysphagia in patients with esophageal cancer and are also beginning to be used in patients with benign esophageal diseases such as refractory strictures and fistulas. There is concern regarding the increased risk of migration of the fully covered Alimaxx metal esophageal stent and experience with this stent in benign esophageal pathology has been reported in only a small series of patients.     

TEMPORARY USE OF A NEW FULLY‐COVERED SELF‐EXPANDING METAL STENT FOR THE MANAGEMENT OF POST‐ESOPHAGECTOMY STRICTURES

Perioperative morbidity rates following esophagectomy for esophageal cancer remain quite high (26–41%) even at high‐volume centers. Complications may include stricture at the esophagogastric (EG) anastomosis, as well as tracheo‐esophageal or tracheo‐gastric fistula formation. Fully‐covered self‐expanding metal stents (FCSEMS) have only recently been described for use in benign esophageal disease. The use of FCSEMS for the management of postoperative complications following esophagectomy has not been well studied. We report our observations in three consecutive patients that underwent placement and subsequent removal of a new, fully‐covered metal stent (Wallflex^® esophageal stent) for treatment of dysphagia due to a persistent stricture at the EG anastomosis.     

Self‐expanding metal stent insertion for inoperable esophageal carcinoma in Belfast: an audit of outcomes and literature review

Successful palliation of dysphagia in patients with inoperable esophageal carcinoma has a major effect on quality of life. Self‐expanding metal stents (SEMS) are currently recommended for rapid symptomatic relief when life expectancy is less than 3 months. We assessed complication and reintervention rates along with survival outcomes in patients with inoperable esophageal carcinoma undergoing stent insertion. A retrospective audit was performed from April 2007 to June 2009 for all inoperable primary esophageal carcinoma patients who had an esophageal stent inserted for dysphagia. Case notes were reviewed for clinical, pathological, stent and complication details, while ICD‐10 causes of death were obtained from the Department of Health and Social Services, Northern Ireland. Fifty‐six stents were inserted into 53 patients (66.0% male, mean age of 70 years). Inoperability was defined by metastatic spread (n= 34, 64.2%), locally advanced disease (n= 7, 13.2%), and severe medical comorbidities (n= 12, 22.6%). The median time from diagnosis to stent insertion was 109 (interquartile range [IQR] 43–187) days. Fifty stents (94.3%) were successfully deployed, while three patients (5.7%) required an additional stent as the primary stent had not bridged the tumor (proximal deployment = 2, suboptimal stent length = 1). Post‐SEMS dysphagia scores were significantly better than pre‐SEMS scores (2.90 vs. 1.54, P < 0.001). There were 27 complications identified in 23 (43.4%) patients (major complications = 9, minor complications = 14). Twelve patients (22.6%) required additional endoscopic procedures. The 30‐day mortality rate was 11.3% (n= 6). Only one patient (1.9%) remains alive with a cumulative median survival rate of 84 (IQR 38–156) days. Esophageal stent insertion in this group of patients still presents a clinical challenge, with complication and endoscopic reintervention rates of 43.4 and 22.6%, respectively. Our results are comparable with previously published series, and as a palliative modality stent insertion remains appropriate when expected survival is less than 3 months. A range of SEMS is currently available with broadly similar efficacy and safety profiles. Data regarding the newly available fully covered SEMS suggest that they should be avoided.     

Gastrointestinal and biliary stents

Advances in stent design have led to a substantial increase in the use of stents for a variety of malignant and benign strictures in the gastrointestinal tract and biliary system. Whereas early stents were mostly composed of plastic, the majority of contemporary stents are self‐expanding metal stents that are composed of either nitinol or stainless steel. These stents are able to exert an adequate expansile force and, at the same time, are highly flexible and biocompatible. Covered stents have been introduced to minimize tumor ingrowth through the metal mesh but are associated with higher rates for spontaneous migration. This has led to the development of covered stents with uncovered ends and stents with both covered and uncovered layers. Drug‐eluting and biodegradable stents are also likely to become available in the near future. Although stents appear to be the preferred form of palliation for some patients with advanced cancer, many patients will benefit from a multidisciplinary approach that usually includes surgeons and oncologists.     

Esophageal stents in benign and malignant diseases

Esophageal stenting was originally offered to patients with advanced esophageal malignancy, for whom it was considered as a costly modality of palliation. Advances in stent design and technology have resulted in more varieties of stents like the fully covered and removable metallic stents as well as self expanding plastic stents. As a result, the use of esophageal stents has been expanded to various benign conditions as well as to neoadjuvant settings in malignancy. This article tries to outline the current status of stenting in a variety of benign and malignant conditions of the esophagus.     

食管带膜支架治疗食管恶性梗阻12例

目的探讨置入食管带膜支架治疗食管恶性狭窄患者的疗效。方法采用内镜下植入食管带膜支架术。结果内镜下一次放置食管支架成功率为100％，术后吞咽困难明显好转，治疗近期有效率100％。结论带膜支架置入对食管恶性梗阻患者是一种安全有效的治疗方法。     

Preliminary study of enteroscopy-guided, self-expandable metal stent placement for malignant small bowel obstruction

Background and Aims: Technical limitations of conventional endoscopes and delivery systems frequently hamper palliative endoscopic placement of self‐expandable metal stents for malignant small bowel obstruction. This study examined feasibility of the double balloon enteroscope‐guided withdrawal‐reinsertion method as a rescue procedure in patients with failed palliative stent placement for malignant small bowel obstruction. Methods: We enrolled 19 consecutive patients with small bowel obstruction due to metastatic gastric (n = 15) or colorectal cancer (n = 2), or primary small bowel carcinoma (n = 2), in whom previous attempts to place self‐expandable metal stents using conventional endoscopy had failed. Ten patients had undergone previous gastric surgery. After passing a guide‐wire using an enteroscope with or without the double‐balloon method, the enteroscope was withdrawn. A conventional endoscope was re‐inserted along the guide‐wire, and through‐the‐scope self‐expandable metal stent placement was performed. Results: Obstruction sites were efferent jejunal loop, proximal jejunum, and third duodenal portion. Technical success was achieved with 94.7% (18/19) of stents, and clinical success occurred with 84.2% (16/19) of patients. The gastric outlet obstruction score (pre‐procedure: 0.68 ± 0.58) increased by one week (2.05 ± 0.52, P < 0.001). Stent migration and restenosis occurred in two (10.5%) and four (21.1%) of 19 stents, respectively. Median stent patency duration was 67 days and median survival was 93 days; these did not differ significantly by palliative chemotherapy (P = 0.76 and 0.67, respectively). Conclusions: The double‐balloon enteroscopy‐guided method followed by conventional endoscopic self‐expandable metal stent delivery was effective for rescue palliation of malignant small bowel obstruction.     

Fully covered,retrievable self-expanding metal stents (Niti-S) in palliation of malignant dysphagia: Long-term results of a prospective study

Abstract

Background. In the palliative treatment of malignant dysphagia, fully covered, retrievable metal stents are not commonly used, mainly due to the high risk of migration. Therefore, we performed a prospective study to evaluate the clinical efficacy of a fully covered, retrievable self-expanding metal stent (Niti-S). Method. Between October 1998 and February 2009, 100 consecutive patients with malignant esophageal obstruction treated with the fully covered Niti-S stent (Niti-S, Taewoong Medical, Seoul, South Korea) were included. Data collected contained functional outcome, feasibility of endoscopic stent retrieval, recurrent dysphagia, complications, and survival. Result. At 4 weeks after stent placement, dysphagia significantly improved in all patients (p = 0.000). Recurrent dysphagia occurred in 19 of 100 patients treated with Niti-S stents (19%) mainly due to tumor overgrowth (7/100, 7%), stent migration (6/100, 6%), and food impaction (6/100, 6%). Endoscopic stent retrieval was successful in all the attempted 17 patients (17/100, 17%) – 7 overgrowth, 6 stent migration, 2 stent degradation, and 2 severe pain. Major complications were 2 hemorrhage, 2 severe pain, and 1 tracheal compression (5/100, 5%), and minor complications were 10 retrosternal pain and 7 symptomatic gastroesophageal reflux (17/100, 17%). After a median follow-up of 142 days, 97 patients had expired. There was no stent-related mortality or 30-day mortality. Conclusion. The fully covered, retrievable Niti-S stent has proved its effectiveness for palliation of malignant dysphagia and feasibility of endoscopic retrieval. We estimate its dog-bone shaped flanges at both ends and it being completely covered provide good resistance to migration and overgrowth.     

Treatment of recurrent malignant obstruction with a flexible covered metal stent after gastric surgery

BACKGROUND: The management of gastric outlet obstruction with expandable metallic stents is difficult and frequently is associated with late complications. A new, flexible, covered metal stent has been developed, which may be suitable for treatment of patients with recurrent malignant strictures after gastric surgery. METHODS: The stainless-steel stent is covered by a polyethylene membrane. It has a proximal funnel attached to an expanded antimigratory segment 29 mm in diameter. The flexible covering membrane connects isolated distal segments that are 20 mm in diameter. The stent is preloaded in a 6.7-mm-diameter introducer system. The structural features and the increased flexibility of this new prosthesis are intended to reduce the risk of migration and the frequency of late complications, and to broaden the range of applications. RESULTS: This stent was used to successfully treat two patients with recurrent tortuous malignant strictures after partial or complete gastrectomy. CONCLUSIONS: This new flexible, polyethylene-covered stent potentially is a new alternative for the palliation of patients with recurrent, inoperable gastric malignant strictures.     

Prospective evaluation of the partially covered nitinol “ComVi” stent for malignant non hilar biliary obstruction

BackgroundBiliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.AimsTo assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.MethodsSeventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.ResultsOverall median survival time was 190 days (30–856). Forty-four patients (62.8%) died after median 175.5 days (30–614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44–836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35–485) after treatment. Median survival after re-treatment was 66 days (13–597). Cholecystitis occurred in one patient (1.7%).ConclusionsThe ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.     

The impact of prior radiotherapy on fatal complications after self‐expandable metallic stents (SEMS) for malignant dysphagia due to esophageal carcinoma

The esophageal stent has been demonstrated to serve as a safe and effective palliative treatment for advanced inoperable esophageal carcinoma. However, the safety of esophageal stents in patients with prior radiotherapy (RT) remains debated. This article aims to investigate the impact of prior RT on the incidence of fatal complications after self‐expandable metallic stents for palliation of malignant dysphagia because of esophageal carcinoma. Between January 2007 and July 2010, 93 patients with malignant dysphagia because of esophageal carcinoma underwent placement of self‐expandable metallic stents in our hospital. Patients were retrospectively separated into two groups: patients with RT before stent placement (RT group, n = 57) and patients with no treatment before stent placement (no RT group, n = 35).The median survival after stent placement was 77 days (7–842 days) in the RT group and 246 days (15–878 days) in the no RT group. Improvement in dysphagia score was similar in both groups. The fatal complications included fatal gastrointestinal hemorrhage and uncontrolled pneumonia. The incidence of fatal gastrointestinal hemorrhage and uncontrolled pneumonia were 28.1% and 5.7% (P = 0.009), 28.1% and 5.7% (P = 0.009), respectively. Logistic regression analysis showed a significant interaction between prior RT and fatal gastrointestinal hemorrhage (relative risk 7.82, 95% confidence interval 1.54–39.61; P = 0.013). Mortality of massive hemorrhage was 5.7% (2/35), 0% (0/4), 12.5% (3/24), and 44.8% (13/29), respectively, in patients who received 0, 1Gy～49Gy, 50Gy～60Gy, and >60Gy (χ² = 17.761; P = 0.000). Logistic regression analysis disclosed prior RT did not significantly increase the risk of uncontrolled pneumonia (relative risk 1.47, 95% confidence interval 0.21–10.12; P = 0.697).     

A three year follow up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction.

Effective palliation of malignant biliary obstruction with conventional 10 or 12 French gauge straight polyethylene endoprostheses is limited by stent occlusion, which typically occurs four to five months after insertion. Short term follow up studies of self expanding metal stents (Wallstent, Schneider, UK) in the treatment of patients with malignant biliary obstruction have shown that their use is associated with fewer episodes of stent occlusion compared with plastic stents. There are few data, however, on the longterm patency and durability of metal stents in malignant disease. Between May 1989 and May 1992, metal stents were inserted in 28 patients with malignant bile duct strictures secondary to ampullary tumour (n = 10), pancreatic carcinoma (n = 10), cholangiocarcinoma (n = 7), and porta hepatis nodes from colorectal carcinoma (n = 1). The follow up of these patients until May 1993 is reported with a median follow up of 14.6 months. Twenty two of 28 (78.6%) patients remained free of jaundice or cholangitis. The median period of stent patency was 8.2 months (range 1.0-32.5). Thirteen patients represented with jaundice or cholangitis and endoscopic retrograde cholangiopancreatography showed evidence of stent occlusion due to tumour ingrowth. Successful clearance of metal stents was achieved by balloon trawling, or insertion of a polyethylene stent. In conclusion, metal stents provide improved longterm palliation for patients with malignant biliary strictures with fewer episodes of occlusion compared with conventional stents.     

Clinical remission following endoscopic placement of retrievable,fully covered metal stents in patients with esophageal achalasia

Metal stents may represent an alternative therapy in the treatment of achalasia. We therefore evaluated the effectiveness of retrievable, fully covered metal stents in patients with achalasia. Fifty‐nine patients with achalasia were treated with retrievable, fully covered metal stents. Symptoms using a global symptom score (0–10), lower esophageal sphincter (LES) resting pressure, LES relaxation, and simultaneous contraction of the esophagus were analyzed before and 1 week and 1 month after intervention. Complications and treatment outcomes were followed up at 6, 12, 18, and 24 months postoperatively. Stent placement was successful, and clinical symptoms resolved (P < 0.01) in all patients. Regurgitation, dysphagia and chest pain improved significantly (all P < 0.01). Therapy improved LES resting pressure (51.4 ± 9.7 mmHg pretherapy vs. 20.9 ± 8.1 mmHg post‐therapy), LES relaxation (58.1 ± 17.1% pretherapy vs. 84.5 ± 18.9% post‐therapy), and simultaneous contraction of the esophagus (36.1 ± 8.6% pretherapy vs. 69.4 ± 23.1% post‐therapy) 1 month after stent placement (all P < 0.01). The cumulative clinical remission rates 6, 12, 18, 24, 30, and 36 months after stent removal were 90.9%, 81.8%, 76.4%, 69.1%, 65.5%, and 49.1%, respectively. All patients tolerated stent placement. Twelve patients (25.5%) complained of substernal pain and five (10.6%) had substernal burning. Stents migrated in four patients (8.5%). Insertion of retrievable, fully covered metal stents is an effective and safe treatment in patients with achalasia.     

Removable, Fully Covered, Self-expandable Metal Stents for the Treatment of Refractory Benign Esophagogastric Anastomotic Strictures

The use of metal stents for malignant esophageal strictures for palliation is well accepted. However, utilization of metal stents for benign esophageal diseases has been controversial. Given the availability of removable, fully covered, self-expandable metal stents (RFCSEMSs), this study was undertaken to evaluate the effectiveness and safety of RFCSEMSs in patients with refractory benign esophagogastric anastomotic strictures. Twenty-four patients with RFCSEMSs were enrolled in this study. All patients had undergone endoscopic Savary-Gilliard bougie dilatation five times or more but there was no significant improvement in symptoms. For all 24 patients, the symptom of dysphagia was alleviated significantly while the stent was in place and for a short time after stent removal, and dysphagia scores decreased from 3-4 to 0-1. After 12?months of follow-up, 18 patients were free from dysphagia but the other 6 patients still suffered obvious dysphagia. RFCSEMSs are still not perfect and can induce some complications. The treatment failure rate of restenting was remarkably high after the first failure. Given that effective methods for treating refractory stricture have not been found, RFCSEMSs could be considered for treating refractory benign esophagogastric anastomotic stricture.     

Palliation of malignant esophageal Dysphagia: would you like plastic or metal?

Advanced esophageal carcinoma has a rather dismal prognosis with dysphagia to solids and liquids as a common symptom. Self-expanding metal stents provide immediate and durable relief of dysphagia. Recently, self-expanding plastic stents have been developed for refractory benign esophageal strictures but may have applications in malignant strictures as well. In this issue of The American Journal of Gastroenterology , a multicenter, prospective, randomized, comparative trial evaluates the safety and efficacy of self-expanding metal versus plastic stents for palliation of dysphagia due to esophageal cancer. While the stents compared equivalently for symptom relief, complications were observed more commonly in the plastic stent group.     

Endoprosthetics in the treatment of benign esophageal strictures

Benign esophageal strictures are a common problem in endoscopic practice. The predominant symptom of patients is dysphagia. The initial treatment option for a benign esophageal stricture is dilation. A small subgroup of strictures, that is, those that are long (>2 cm), are tortuous, and have a narrow diameter, or are associated with caustic or postradiotherapy etiology, tend to recur and are therefore called refractory. Temporary stent placement, with either a self-expandable metal stent or a self-expandable plastic stent, can be considered as a treatment option in these patients. From a technical point of view, placement of an expandable stent in benign strictures does not differ from placement in cases of palliation of malignant dysphagia. Deep sedation and careful stent placement, especially in proximal locations, is extremely important. Results of temporary stenting are still inconclusive; long-term clinical resolution of the stricture is achieved in less than 50% of patients. Moreover long-term data on safety and efficacy are scant. These disappointing results are mainly because of hyperplastic tissue ingrowth or overgrowth and stent migration. New stent designs are needed for this indication. Promising initial results show that biodegradable stents may be useful for refractory benign esophageal strictures; however, these preliminary data need to be further elucidated in future studies.