Prospective evaluation of a new self-expanding plastic stent for inoperable esophageal strictures

BACKGROUND: High stent cost is considered the major drawback of self-expanding metal stents for dysphagia palliation in patients with inoperable esophageal strictures. We report our experience with a self-expanding plastic (Polyflex) stent, the cost of which is half that of the metal stents. METHODS: Between September 1999 and April 2001, 16 dysphagic patients (15 men; mean age, 69.4 +/- 14.5 years; range, 49-100 years; mean dysphagia score, 3.31 +/- 0.6) with esophageal strictures who underwent Polyflex stent placement (insertion device diameter, 12-14 mm; postexpansion inner stent diameter, 16-21 mm; stent length, 9, 12, and 15 cm) were studied prospectively. The strictures were caused by postsurgical recurrence of gastric/esophageal cancer at the anastomotic site in five patients, primary esophageal cancer in four patients, esophagocardia junction cancer in four patients, metastatic mediastinal lymph nodes from a primary lung cancer invading the esophagus in 1 patient, and benign peptic stricture in two elderly patients. All the patients were prospectively followed until death. RESULTS: Stent insertion was technically successful in 12 patients (75%). Stent placement failed in four patients (25%) because of failure to pass the delivery catheter across the stricture in three patients and failure of the stent to open in one patient. Early and late stent migration occurred in two patients and 1 patient, respectively. Tumor overgrowth occurred in 1 patient. The mean dysphagia score 7 days after stent placement was 1.1 +/- 0.9. Mean survival was 100.6 +/- 71.2 days (range, 8-225 days). CONCLUSION: Self-expanding Polyflex stents are safe and effective for inoperable esophageal strictures and have an acceptable technical success rate. Further experience, better selection criteria, and design improvements should improve results.     

Our experience with the use of a plastic prosthesis and self-expanding stents in the palliative treatment of malignant neoplastic stenoses of the esophagus and cardia. Comparative analysis of results

Rapid palliation of malignant dysphagia is usually possible by means of the endoscopic implantation of a plastic prosthesis, but this device has a high morbidity rate. Recently, expandable metal stents have become available and may reduce the morbidity and mortality rates. The aim of this retrospective study was to evaluate self-expanding metal stents compared with conventional plastic prosthesis in malignant strictures of the oesophagus and cardia. One hundred and thirteen endoscopic tube implantations were carried out in 120 patients with malignant stenosis of the oesophagus and cardia using a plastic prosthesis over the period 1980-1993 (72 cases) and self-expanding metal stents over the period 1993-2001 (48 cases). The underlying causes of strictures were oesophageal or cardial cancer in 108 cases and oesophageal invasion by lung cancer in 12. The indications for endoscopic intubation were advanced tumour stage and/or risk factors which made resection inadvisable. The stents used in the conventional group were the Celestin pulsion tube in 18, the Atkinson prosthesis in 23 and the Wilson-Cook tube in 27, while the Ultraflex stent was always employed in the other group. Dysphagia was scored according to the Atkinson and Ferguson classification and the preoperative median score (3.6) was comparable in the two groups. The technical success rate was 94.4% with the plastic prosthesis (68/72) and 93.7% with the self-expanding metal stents (45/48) because in 4 and 3 patients, respectively, it proved impossible to implant the stent. After intubation the dysphagia score was improved in both groups (median score = 0.9) and the functional success rates were 85.2% (58/68) and 88.8% (40/45), respectively, while 10 and 5 patients showed no improvement of symptoms. The early complication rate was 5.9% (4/68) in the conventional stent group (1 perforation, 2 severe bleedings and 1 stent proximal migration) and nil in the other group. Late complications occurred in 14 (20.6%) (7 food obstruction, 4 neoplastic obstructions and 3 dislodgements) and 9 patients (20%) (3 neoplastic obstructions, 1 food obstruction, 3 distal migrations and 2 bleedings), respectively, but all the complications were easily corrected. Three deaths occurred with the plastic prosthesis (4.4%), while the mortality was nil with the metal stents. The median survival times were 183 (range: 58-486) and 151 days (range; 25-545), respectively. Our experience suggests that endoscopic placement of self-expanding metal stents is effective and safe for the management of dysphagia in malignant strictures of the oesophagus and cardia and has to be preferred to conventional plastic prostheses for easier implantation. The technical and functional success rates are similar in both groups, but the acute complication and mortality rates of the Ultraflex prosthesis are lower as compared to the traditional prosthesis.     

Self-expanding Polyflex plastic stents in esophageal disease: various indications,complications, and outcomes

Background Esophageal stenting has become an important technique in the treatment of different clincal problems such as malignant or benign stenosis, anastomotic leaks after surgery, or fistulas. In this study we present our experience with the self-expanding Polyflex plastic stent in various indications, arising complications, and patient’s outcomes. Methods Over a three-year period, 35 patients underwent self-expanding Polyflex plastic stent placement for esophageal stenosis (n = 23) with 22 malignant, and for perforations, fistulas, or anastomotic leaks after surgery (n = 12). The short-term efficacy and long-term outcomes were analyzed. Results In patients with stenosis, implantation was performed without any complications in 91% (21/23). In one patient perforation occurred while passing the stenosis; in another patient the stent dislocated during the insertion procedure. Dysphagia score improved from 3.0 to 1.0 after stenting. In all patients with perforations, fistulas, or anastomotic leaks (n = 12), stents were placed successfully without any complication. Complete sealing of the mucosal defect was proven by radiography in 92% (n = 11) and healing was seen in 42% (n = 5). If indicated, stent removal was performed without any complications. Stent migration (n = 13; 37%) was the most common long-term complication. Conclusions The placement of self-expanding Polyflex plastic stents is a highly sufficient and cost-effective treatment for malignant and benign esophageal disorders. Because the long-term results were highly favorable, self-expanding plastic stent placement could be used as the initial treatment for various conditions.     

Palliation of dysphagia from inoperable oesophageal carcinoma using Atkinson tubes or self-expanding metal stents

Until recently, intubation for the palliation of malignant dysphagia has relied upon the insertion of a variety of plastic tubes. Self-expanding metal stents are reported to have a lower complication rate. We have compared the results of Atkinson tube insertion with self-expanding metal stents in patients with inoperable oesophageal carcinoma. From 1990 to 1994 Atkinson tubes were inserted for the palliation of dysphagia from oesophageal cancer, from 1994 onwards self-expanding metal stents were used. Complications, mortality and hospital stay were compared in both groups of patients. In all, 87 patients with inoperable oesophageal carcinoma were treated, 46 with an Atkinson tube and 41 with metal stents. Complications occurred at similar rates in both groups (56% Atkinson tubes, 44% metal stents). There was a significantly higher perforation rate associated with Atkinson tube insertion (8 patients, 17%) compared with metal stents (1 patient, 2.4%, P = 0.02, chi 2). The length of stay was also significantly higher in the Atkinson tube group (median 10 days) compared with the metal stent group (3 days, P < 0.01, Mann-Whitney U test). Mortality rates were similar in both groups. The use of metal stents for the palliation of dysphagia in inoperable oesophageal carcinoma results in a lower perforation rate and a reduced length of stay and they represent a significant advantage over Atkinson tubes.     

Use of the Polyflex stent in the palliative therapy ofesophageal carcinoma

BACKGROUND: Several prospective randomized trials have shown that self-expanding stents have advantages over conventional plastic tubes. Nevertheless, the optimal stent has not yet been developed. The Polyflex stent is a completely new model that represents an improvement over the old metal stents. We have used this stent in a prospective study and herein our present preliminary results. METHODS: In 14 patients with nonresectable esophageal carcinoma, the Polyflex stent was implanted to reduce dysphagia. The grade of dysphagia, the complications following intervention, and the patients' total survival time were documented prospectively every 4 weeks. RESULTS: The implantation of the stent was successful in all cases. The grade of the dysphagia was reduced from 3.0 to 0.5 after stent implantation. One patient died during the hospital stay from a non-stent-induced complication. Stent dislocation occurred once, and tumor overgrowth at the stent margins was observed twice. The mean survival time was 6.2 months, and the reintervention rate was 21.3%. CONCLUSION: The new Polyflex stent, which is based on a completely new design, can be implanted without any difficulty and has had very good short- and long-term results. Therefore, it is a worthy alternative to the metal stents in current use.     

A new cuffed oesophageal prosthesis for the management of malignant oesophago-respiratory fistula.

Malignant oesophago-respiratory fistula is an incurable and distressing condition. Surgery is difficult, unsatisfactory or impossible, and standard oesophageal tubes often fail to occlude the fistula. A new tube is described which relieves dysphagia and occludes the fistula without risk of pressure necrosis. After insertion of the tube, the patients may be treated by radiotherapy.     

Use of Polyflex stents in treatment of acute esophageal and gastric leaks after bariatric surgery.

BACKGROUND: This study examined the feasibility of using Polyflex stents in the treatment of enteric leaks after various bariatric operations. Chronic and acute leaks were treated. METHODS: We performed a retrospective case series review. Four patients received 6 Polyflex stents to treat complications of bariatric surgery. Two presented with early sepsis before stenting. One presented with abdominal pain. One presented with a chronic persistent fistula with an associated abscess. Stenting was performed under endoscopy with fluoroscopic guidance. The stents were left in place for 6 weeks. RESULTS: All patients tolerated a clear liquid diet within 24 hours of stenting and were able to be advanced to a pureed diet. All patients improved clinically after stenting. Three patients with acute leaks sealed their leaks after stent placement. One patient with a chronic leak persisted and required operative closure after a second stent was placed and failed. All patients experienced short-term nausea, as well as early satiety that lasted the duration of the stenting. One patient experienced hypersialisis while the stent was in place. Two stents migrated, although this had no effect on leak closure. One patient had an anastomotic stenosis successfully treated with a second stent. CONCLUSIONS: Polyflex stents are useful in bypassing acute upper intestinal leaks after various bariatric operations. They provide a temporary bridge for wound healing with continued oral intake. Stenting provides a minimally invasive option in the management of acute leaks and, in our experience, had no serious associated morbidity.     

Treatment with self-expanding metallic enteral stents in occlusion caused by neoplastic stenosis of the sigmoid and rectum

From January 1999 to today 5 patients have been treated with self-expanding enteral stents for low intestinal occlusion in our General and Emergency Surgery Department. The patients' ages ranged from 75 to 90 years. Their general clinical condition was precarious and the emergency surgical treatment necessary was at very high risk. After a brief period of clinical monitoring the patients were submitted to a colonoscopy which revealed a tight neoplastic stenosis in the lowest portion of the colon. Self-expanding enteral stents measuring 9 by 20 mm were implanted in 4/5 patients, while, in the fifth patient, in view of the extent of the cancer, an oesophageal enteral stent measuring 12 by 23-28 mm was used. Over the following 24 hours we observed canalization and consequent disocclusion of the colorectum. It was thus possible to readjust the altered metabolic parameters, improve the respiratory and circulatory compliance and begin the study and the staging of the malignancy. Only two patients in acceptable general condition were submitted to radical surgery, while the other three were referred to our oncological radiotherapy centre. On the basis of this preliminary study we believe that in given clinical conditions and in a situation of emergency the use of self-expanding enteral stents, when indicated, is the only therapeutic measure capable of avoiding surgery carrying a very high risk and of creating the basis for appropriate, in-depth study of the cancer. In addition, it enables a better balance to be restored in the patient's general condition.     

Palliation and survival in malignant oesophago-respiratory fistula

Survival in the presence of malignant oesophago-respiratory fistula is usually limited to a few weeks. In this paper we describe our experience with 3 cases treated by retrosternal oesophagogastric bypass with oesophageal exclusion, and review the experience of previous authors using this and other forms of bypass. The results indicate that both survival and quality of life are considerably better with surgical bypass and exclusion than with any other form of treatment. Indeed, the survival times are frequently better than those achieved after palliative resection of oesophageal carcinoma without fistula. Retrosternal oesophagogastric bypass with oesophageal exclusion is recommended as a simple method of bypass for this condition.     

The palliation of dysphagia secondary to esophageal-cardial carcinoma with self-expandable metal prostheses. The authors' personal experience with 92 patients]

BACKGROUND: Endoscopic insertion of a stent is an important option in the palliative management of esophageal obstruction and esophagorespiratory fistula. Plastic stents have been available for over 20 years. A new class of self-expanding metal stents for palliation of esophageal and cardial cancer is now available. METHODS: Between September 1992 and October 1997, 92 patients underwent implantation of self-expanding metal stents for palliation of dysphagia due to inoperable esophageal or cardial cancer (65 patients) or for locally recurrent carcinoma after surgery (12 patients), laser-therapy (11 patients) or radiotherapy (4 patients). RESULTS: Successful stent implantation was achieved in 89/92 patients (96.7%). After stent implantation the dysphagia score improved from 3.0, on average, to 0.5, on average. Early complications were observed in 4.5% and peroperative mortality was 2.1%. Late complications were observed in 25.6%, with a mortality rate of 1.1%. The mean survival time was 6.9 months. CONCLUSIONS: Self-expanding metal stents are a new effective alternative for palliation of dysphagia due to esophageal and cardial cancers.     

Randomized clinical trial comparing self-expanding metallic stents with plastic endoprostheses in the palliation of oesophageal cancer

BACKGROUND: There is little evidence of the clinical and cost effectiveness of self-expanding metallic stents in the palliation of oesophageal cancer. The aims of this randomized trial were to evaluate the immediate and medium-term clinical outcomes following palliative intubation, examine patient quality of life, and evaluate costs and benefits from the perspective of the health service. METHODS: Fifty patients with inoperable oesophageal cancer were randomly allocated a metallic stent (n = 25) or plastic endoprosthesis (n = 25). Patients were followed up monthly until death. RESULTS: There was no significant difference in procedure-related complications or mortality rate between the two groups. There was a trend towards significance in favour of metallic stents with respect to quality of life and survival (median survival 62 versus 107 days for plastic prosthesis and metallic stent respectively). The cost of the initial placement of metallic stents was significantly higher than that of plastic endoprostheses ( pound 983 versus pound 296). After 4 weeks, cost differences were no longer significant. CONCLUSION: Metallic stents may contribute to improved survival and quality of life in patients with oesophageal cancer. Although initially more expensive, this cost difference does not last beyond 4 weeks. A larger trial involving approximately 300 patients would be required to detect a quality of life benefit of the magnitude observed in this trial.     

Management of tracheobronchial strictures and fistulas: a report and review of literature

The treatment of tracheobronchial (TB) strictures and fistulas is an exceedingly difficult problem; therefore, the management needs to be individualized. The recent development and use of self-expanding endotracheal and bronchial stents have allowed for the successful management of many of these clinical entities. Such expandable metallic stents have provided definite advantages over solid stents by potentially offering a suitable long-term treatment for patients with neoplastic airway obstruction and fistulas. The silicone stents, which can be easily removed, are useful in instances requiring short-term relief. In the case of lung transplantation, a continued major source of concern is the prevalence of anastomotic complications secondary to impaired healing. Use of silicon, balloon-expandable, and self-expandable wire stents has allowed for the successful management of this complex patient population. An aggressive surgical approach to resect stricture or fistula with benign etiology may still be warranted for those that are fit for such procedures.     

Management of a difficult malignant tracheoesophageal fistula

Malignant tracheoesophageal fistula is a pre terminal condition in oesophageal cancer and is associated with significant patient distress. Various treatment options have been described and the general consensus is to use stents to cover them and relieve patient symptoms. We describe a case in which a modified Wilson-Cook prosthesis was successfully used to palliate tracheoesophageal fistula in a markedly dilated oesophagus.     

Esophago-bronchial fistula in adults

The authors report five cases of benign oesophago-bronchial fistula in adults. These chronic bronchitic patients presented with recurrent episodes of secondary lung infections (or even haemoptysis). Questioning of the patients revealed a history of coughing when swallowing liquids in three cases. Two women concealed this symptom, which was only revealed retrospectively. The fistula was detected by upper GI series in three cases and by oesophageal fibroscopy in one case. In the remaining case, it was discovered at operating for severe haemoptysis. In four of the five cases, the fistula was situated on the right and was of post-tuberculous origin. In one case of post-traumatic fistula, it involved the left main bronchus. All of the patients were operated: a resection-suture of the fistula was performed via the oesophageal approach and, via the bronchial approach, simple suture of the fistula was possible in two cases, while resection of the destroyed pulmonary parenchyma was necessary in three cases (one right lower lobectomy, two bilobectomies). Demonstration of the oesophago-bronchial fistula, definition of its site and assessment of the condition of the pulmonary parenchyma are essential steps to be performed prior to surgery.     

Palliative side-to-side oesophagogastrostomy for unresectable carcinoma of the oesophagus and cardia.

The distressingly low resectability rate of carcinoma of the oesophagus and gastric cardia emphasises the need for palliative restoration of the act of swallowing. Side-to-side oesophagogastrostomy was performed in 10 cases of unresectable tumours. Eight anastomoses were made low in the left chest for lower third oesophageal and cardiac lesions and two high on the right for midoesophageal tumours. There were no anastomotic leaks or other complications, and no postoperative deaths. All patients swallowed well for an average of five months until their deaths. The decision to use this procedure is made at the time of thoracotomy when resection of the cancer is impossible because of local invasion and when sufficient proximal oesophagus is available for the anastomosis. The operation involves a single suture line only. It provides immediate palliation of dysphagia and makes unnecessary additional technical manoeuvres such as preparation of colonic or jejunal loops insertion of endoluminal tubes, or even transection of the oesophagus, pyloroplasty, gastrostomy or cervical oesophagostomy. It does not interfere with any subsequent radiotherapy or chemotherapy.     

Palliation of malignant rectal obstruction with self-expanding metal stents

BACKGROUND: Surgical management of patients with metastatic or recurrent rectal cancer remains controversial. Self-expanding metal stents are increasingly used for palliative treatment of advanced tumors, although long-term results are not yet available. METHODS: Between 1996 and 2003, 521 patients underwent surgery for rectal neoplasms. In the same time period, self-expanding metal stents were used for palliation of 34 patients with malignant rectal obstruction and incurable disease. The outcome of the patients was analyzed retrospectively. RESULTS: Rectal stents were successfully placed in 33 of 34 patients (97%) without major complications. Early failure occurred in 7 patients (21%) because of stent migration, pain, or incontinence. Long-term success with a mean patency of 5.3 months was observed in 26 patients (79%), but restenting was required in 2 patients. Despite the initial success of stenting, a colostomy was created in 2 other patients after 3.4 months and 9.2 months because of incontinence and rectovesical fistula. Overall, 6 of 33 patients (18%) underwent palliative surgery because of early complications (n = 4) or long-term failure of stent treatment (n = 2). CONCLUSIONS: Self-expanding metal stents are useful to avoid a colostomy in selected patients with incurable rectal cancer and limited life expectancy. Nonetheless, a considerable number (18%) of patients will require surgical palliation because of failure of stent treatment.     

Abdominocervical oesophagectomy in the elderly

Abdominocervical (transhiatal) oesophagectomy was carried out in 8 patients. Five of 6 with oesophageal cancer were elderly (aged 75-88 years), and one was 59 years old. Two patients (aged 54 and 74 years) had recurrent achalasia and megaoesophagus 30 years after cardiomyotomy. Chest complications were common, but there were no anastomotic leaks and no deaths. In 2 patients with large paraoesophageal hiatal hernias oesophagectomy had not been planned; the procedure was undertaken for an unexpected carcinoma of the cardia and an oesophageal tear. Three patients have died of recurrent cancer at 12, 17 and 21 months. The 5 survivors are swallowing satisfactorily, although one has required two dilatations of an anastomotic stricture.     

Temporary Placement of Self-Expanding Oesophageal Stents as Bridging for Neo-Adjuvant Therapy

Background  

Placement of self-expanding stents is an effective palliation for dysphagia in non-resectable oesophageal or proximal gastric cancer. The aim of this analysis was to assess the efficacy of temporary stent placement for dysphagia relief during neo-adjuvant treatment for locally advanced disease.     

Self-expanding esophageal metallic stents in the treatment of esophageal obstruction

Esophageal obstruction from any cause is debilitating. In patients with malignant obstruction palliation to relieve pain and dysphagia is the primary goal. Conventional endoluminal prostheses allow variable palliation. Covered expandable metallic stents with an 18-mm lumen allow improved deglutition. From December 1994 through December 1998, 59 patients underwent placement of self-expanding silicone-covered esophageal stents for esophageal obstruction. There were 36 men and 23 women ranging in age from 41 to 94. All patients underwent esophageal dilation using a flexible gastroscope and Savary bougies. After dilation placement of the stent was performed under fluoroscopic control. Follow-up was complete in all patients. Technical success was achieved in all patients. There was one postoperative death (bronchopulmonary fistula), one migration of the stent requiring removal, and one recurrent obstruction. The remaining stents were well tolerated even in the cervical region (four patients). All patients returned to a diet of solid foods. We conclude that covered self-expanding esophageal metallic stents are technically simple and safe to insert and appear to provide durable excellent palliation of esophageal obstruction due to either benign or malignant conditions.     

Emergency management of aorto-bronchial fistula after implantation of a self-expanding bronchial stent.

We report a case of aorto-bronchial fistula 7 years after implantation of a self-expanding metal stent into the left main bronchus. The clinical presentation was characterised by left-sided chest pain, dyspnea and a single bout of haemoptysis. The fistula was surgically managed by aortic resection and primary repair of the aorta, and patch repair of the left main bronchus over a Polyflex covered bronchial stent. When haemoptysis occurs in a patient with a history of bronchial stent implantation, the presence of an aorto-bronchial fistula should be considered. Early diagnosis offers the only possibility of recovery through a lifesaving surgical procedure.