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Ann Thorac Surg 1996;62:1603-1607
© 1996 The Society of Thoracic Surgeons

Original Articles: General Thoracic

Palliation of Inoperable Esophageal Carcinoma With the Wallstent Endoprosthesis

Richard H. Feins, MD, David W. Johnstone, MD, Eleftherios S. Baronos, MD, Scott M. O'Neil, MD

University of Rochester Medical Center and Park Ridge Hospital, Rochester, New York

Accepted for publication June 24, 1996.


   Abstract
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 Footnotes
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 References
 
Background. Palliation of malignant dysphagia can be achieved by insertion of an endoprosthesis. Recently, metallic self-expanding prostheses have been introduced that offer the advantage of a lower complication rate over their plastic counterpart.

Methods. Thirteen patients with dysphagia due to inoperable carcinoma of the esophagus were treated with coated Wallstent (Schneider (USA) Inc, Minneapolis, MN) endoprostheses, which were placed under fluoroscopic control. All patients were given general anesthesia during the procedure.

Results. After successful insertion of all endoprosthe-ses, the dysphagia of 12 of the patients improved while in the hospital. Average length of stay was 4.4 days. Two patients required a second stent because of migration or tumor overgrowth. Seven patients died with a mean survival of 54 days (range, 14 to 144 days), and 6 are alive a mean of 112 days (range, 32 to 263 days) after treatment.

Conclusions. Coated Wallstent insertion is an effective, single treatment that quickly improves the patients' quality of life. Its effect on survival is yet to be established when used as a last resort in patients with inoperable esophageal carcinoma and poor general condition.


   Introduction
Top
 Footnotes
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 References
 
Carcinoma of the esophagus has a very poor prognosis, with a 5-year survival rate of 5% [1]. Even though early disease is potentially curable, it is most often not detected. Patients usually present late because symptoms, mainly dysphagia, only occur after a 60% reduction in the lumen diameter [2]. As a consequence, 50% to 60% of patients have inoperable advanced tumors at the time of presentation [1, 3]. Palliation of the dysphagia in these patients is of the utmost importance to improve their quality of life and prevent starvation.

In patients with refractory dysphagia, poor general medical condition, and extrinsic carcinoma compressing the esophagus, palliation can be achieved with insertion of endoprostheses [3]. Endoprostheses have been available for the palliation of esophageal tumors since the 1880s [4], and since then there have been great advances in the design of these devices. Recently, expandable esophageal metallic stents have been developed and used in Europe with fewer complications than the conventional plastic endoprostheses [5, 6]. The purpose of this article is to present our initial experience in using the self-expanding Wallstent (Schneider (USA) Inc, Minneapolis, MN) in treating 13 patients with malignant esophageal obstruction.


   Material and Methods
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 References
 
Patients
Between January 1995 and September 1995, 13 patients with malignant dysphagia were treated using 15 esophageal Wallstents. All required one stent except for 2 patients in whom an additional stent was placed at a later date.

The patients consisted of 5 women and 8 men with a mean age of 72 years (range, 46 to 94 years). Eight of the patients had adenocarcinoma and 5 had squamous cell carcinoma of the esophagus. Two patients had carcinoma of the upper, 3 of the middle, and 8 of the lower esophagus. The mean length of the strictures was 4.7 cm (range, 2 to 7 cm), which was determined by endoscopy. The position and severity of the strictures were evaluated with barium studies (Fig 1AGo) and endoscopy. Eleven of the patients had dysphagia with soft diet and 2 patients had dysphagia with liquids. Surgical resection was not feasible in any of the patients because of distant metastases, airway involvement, or poor general medical condition. Palliative treatment had previously failed in 6 patients. Four of these patients had received radiation therapy, 1 was treated with brachytherapy and chemotherapy, and 1 had received endoscopic laser therapy. All patients were treated, and none were refused treatment because of their age, spread of disease, or general condition.



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  		Fig 1. . (A) Esophagogram demonstrating a malignant stricture in the middle esophagus. (B) Plain radiograph obtained after insertion of the stent, showing good placement and expansion relieving the obstruction.

 
Stent Design
The esophageal Wallstent is a self-expanding stent and is flexible in the longitudinal axis. It is knitted into two layers of superalloy monofilament wire. The central portion of the stent has a polymer layer (Permalume; Schneider) sandwiched between these two layers and aims at restricting tumor ingrowth (Fig 2Go). The inner diameter of the central portion of the stent measures 18 mm when fully expanded, and the outer diameter is 20 mm. Its flanged ends measure 28 mm in diameter and facilitate anchoring of the stent to the esophageal wall. A 38F (13-mm) delivery system is used for insertion and consists of three coaxially arranged polypropylene tubes. The stent is preloaded on the inner tube while the outer tube compresses the stent. The central lumen of the inner tube can accept a 0.038-inch guidewire. This assists the introduction of the stent delivery system across an esophageal stricture. Once fully deployed the Wallstent cannot usually be repositioned (Fig 3BGo). A 23% shortening occurs after full deployment. It is available in three different lengths (unconstrained): 80 mm, 100 mm, and 130 mm.



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  		Fig 2. . The Wallstent measuring 100 mm x 20 mm is shown fully released. The central portion with the polymer layer is shown. The distal end of the delivery system (double black arrows) with its outer tube (black arrow) constraining a Wallstent (white arrow) can be seen.

 


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  		Fig 3. . (A) Positioning of the Wallstent under fluoroscopic control. The picture shows the metallic markers attached to the skin as well as the radiopaque markers of the delivery system. (B) The Wallstent is fully deployed.

 
Stent Insertion
All patients were given general anesthesia for precise stent placement and patient comfort. Each lesion was assessed endoscopically, and the length of the stenosis was marked under fluoroscopic control using metallic markers attached to the skin (Fig 3Go). To facilitate rapid expansion, all strictures were progressively dilated to 15 mm (45F) using Savary dilators. The 100 mm by 20 mm Wallstent with a central lumen length of 60 mm was used in all patients. This allowed for a 2-cm portion of the stent beyond the proximal and distal margins of the gross tumor. The guidewire was inserted through the stricture via the accessory chanel of an endoscope, and the stent system was passed over it. The radiopaque markers of the delivery system are useful in the identification of the central part of the stent and allow for accurate positioning of the stent across the strictures. In patients with lesions near the gastroesophageal junction, the lower end of the stent was positioned in the fundus of the stomach, with the majority of the stent in the lower esophagus. The patients were advised to have small frequent meals followed by effervescent drinks, eat meals sitting upright, and those with esophagogastric junction lesions were also adviced to sleep at 30 degrees to reduce reflux. Some were given H2-receptor blockers to relieve symptoms of reflux.

Postoperatively, a chest roentgenogram was taken to exclude perforation and check the stent position (Fig 1BGo).


   Results
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 References
 
All patients presented with dysphagia due to esophageal carcinoma. Insertion of the stents was successfully completed in all patients. In 12 of the 13 patients the dysphagia improved after the stent insertion such that they were able to eat a soft diet while in the hospital. The swallowing in the other patient did not improve.

The mean duration of stay was 4.4 days (range, 2 to 18 days). Early complications included chest pain, hematemesis, and nausea. Of the 8 patients who complained of chest pain, 3 required narcotics for relief. One patient suffered an episode of hematemesis and another continued to have intermittent hematemesis. In addition to the latter 2 patients, another 6 patients complained of nausea, which was associated with chest pain. Two late complications occurred: stent migration and tumor overgrowth. The stent in 1 patient, which initially was placed in the esophagogastric junction, migrated distally 2 months after stent insertion. A second patient had stent obstruction caused by tumor overgrowth 3 months postoperatively. Both were treated by insertion of a second stent partly into the first stent. Both enjoyed a semisolid diet after the placement of the second stent. One of them died 52 days after treatment for the tumor overgrowth.

At initial follow-up (1 to 2 weeks), 11 patients could tolerate soft diet whereas 2 could only tolerate fluids. All surviving patients have been followed up a mean of 112 days (range, 32 to 263 days). Five of 6 patients continue to be free of dysphagia, tolerating a soft diet, and 1 patient is tolerating liquids.

Seven patients have died, with a mean survival of 54 days (range, 14 to 144 days). Six of these patients died as a result of the natural progression of the tumor. One patient died 18 days postoperatively due to aspiration pneumonia and bleeding from the tumor site after stent insertion. Five of these 7 patients had a squamous cell carcinoma and 2 patients had adenocarcinoma, whereas all the surviving patients had adenocarcinoma of the esophagus. Only 3 patients received additional postoperative treatment including chemotherapy, radiotherapy, or both. Two of these patients are surviving to date.


   Comment
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
References
 
Carcinoma of the esophagus is diagnosed in 10,000 patients annually in the United States [7], and only 40% of these patients have a potentially curable lesion at presentation. The remaining patients are treated symptomatically with repeated dilation of the esophagus, insertion of endoprostheses, laser therapy, resection of the tumor, radiotherapy, chemotherapy, or some combination of these. Recently, palliation by insertion of an expandable metallic endoprostesis is becoming more popular than the conventional plastic stents. Although the cost of the Wallstent ($1,695) is much greater than the cost of its plastic counterpart, one may argue that it is a cost-effective treatment compared with conventional endoprostheses for several reasons: (1) The length of hospitalization is 50% less in our study compared with that reported for plastic stents [6, 8]. Although in this series general anesthesia was used for stent placement, the stent can be placed under topical anesthesia on an outpatient basis. (2) There is a reduction in the incidence of perforations: more than 10% for plastic stents [6, 8, 9] compared with no perforations in our study and in other reported series [2, 5, 6, 10]. (3) Stent migration is seen less frequently with metallic stents. Knyrim and associates [6] reported no occurrence of migration with the Wallstent and a 24% incidence with plastic prostheses. (4) Stent blockage by food is more often associated with plastic stents, with a reported incidence of up to 30% [9, 11]. In our series, no food blockage occurred. Recent studies demonstrated that Wallstents are also effective in treating extrinsic esophageal obstruction, perforation, and fistulization [2, 3, 5].

Complications did occur after Wallstent insertion and included chest pain, nausea, hematemesis, tumor overgrowth, and stent migration. Chest pain is a common complaint following metallic stent insertion, with a reported incidence of up to 100% [10, 12, 13]. In our series, 62% of patients complained of retrosternal pain for several days (2 of them requiring narcotics), and this is most probably due to the dilation and stretching of the strictures. Severe pain was related to the degree of stricture. Although no nausea has been reported in previous reports with Wallstents, intermittent nausea was another frequently encountered symptom in our series. Hematemesis is also a possible complication with Wallstents, and its incidence in our study is greater than previously reported [5, 6, 10, 13]. This complication could have been the result of pressure necrosis, the natural progress of the disease, or trauma from the sharp, uncovered end of the stent.

Stent overgrowth occurred in 1 patient and was treated by placing a second overlapping stent. This extended past the tumor and relieved the obstruction. In previous studies, stent overgrowth occurred in less than 10% [5, 6], and this correlates with our results. Ingrowth of tumor is not a substantial problem with silicone-covered Wallstents [5]. To decrease the incidence of stent migration, the Wallstent we used had the proximal and distal ends uncovered, which increased the friction between the stent and esophageal lumen [5, 6, 10, 13, 14]. However, when partly covered Wallstents are used for lesions at the esophagogastric junction with only the proximal end in contact with the esophagus, the likelihood of stent migration increases [5]. In our series, this occurred in 1 patient and was treated by placing a second stent within the first one (Fig 4Go). The second stent extended proximally, increasing the friction of the stent. For this reason, further improvement in the design is required.



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  		Fig 4. . (A) Image taken at fluoroscopy illustrating an angulated Wallstent after migration distally into the stomach. (B) A second stent was placed proximally and relieved the obstruction.

 
It is important that the stricture be dilated to at least 15 mm to allow the stent to adequately distend and the introducer to be removed. The introducer system is also very stiff and can be difficult to deploy in a tortuous esophagus. Finally, the exposed wire ends used for better stability make it very difficult to pass a flexible esophagoscope into the stent without tearing the scope's distal end. This results in a very costly repair.

Intubation with metallic stents for inoperable esophageal carcinoma is associated with a high mortality rate (59% to 91%) and a low survival time (70 to 78 days) [5, 10, 13]. In our series, similar results were obtained, with a mortality rate of 55% (7/13 patients) and a mean survival thus far of 54 days (range, 14 to 144 days). This short survival can be attributed to the poor general condition of these patients and the very advanced stage of the disease [9, 15].

In conclusion, palliation of esophageal carcinoma using the Wallstent is an effective, single treatment maintaining a patent esophageal lumen and improving the patients' quality of life quickly. This stent is very expensive compared with the conventional plastic stents but is associated with a reduced rate of complications and decreased length of hospitalization. In addition, it can be used in conjunction with other treatments such as radiotherapy or laser therapy. In patients with poor general condition and more advanced tumors, rapid relief of dysphagia with minimum morbidity, enabling them to return home quickly and remain home during the terminal stage of their disease, is the ultimate goal. The Wallstent accomplished this task in all but 1 patient. Larger studies with longer follow-up periods are needed to determine the effect of the Wallstent on the patient's survival, its place in the management of patients with a better performance status, how it compares with other treatments (including other stents) with respect to morbidity and mortality, and finally whether it is truly cost-effective.


This article has been selected for the open discussion forum on the STS Web site: http://www.sts.org/annals The discussion leaders for this article are Dr Arthur Baue, St. Louis, MO; Dr Mark Orringer, Ann Arbor, MI; and Dr David Skinner, New York, NY.

 


   Footnotes
Top
 Footnotes
Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Address reprint requests to Dr Feins, Division of Cardiothoracic Surgery, University of Rochester, 601 Elmwood Ave, PO Box Surg, Rochester, NY 14642.


   References
Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

  1. Earlam R, Cunha-Melo JR. Oesophageal squamous cell carcinoma. A critical review of surgery. Br J Surg 1980;67:381–90.[Medline]
  2. Watkinson A, Ellul J, Entwisle K, Farrugia M, Mason R, Adam A. Plastic-covered metallic endoprostheses in the management of oesophageal perforation in patients with oesophageal carcinoma. Clin Radiol 1995;50:304–9.[Medline]
  3. Garcia M, D'Altorio RA, Glowacki D. Palliative treatment of malignant esophageal obstruction with metallic Wallstent. Dig Dis Sci 1994;39:2685–8.[Medline]
  4. Kozarek RA. Expandable endoprostheses for gastrointestinal stenoses. Gastrointest Endosc Clin N Am 1994;4:279–95.[Medline]
  5. Watkinson AF, Ellul J, Entwisle K, Mason RC, Adam A. Esophageal carcinoma: initial results of palliative treatment with covered self-expanding endoprostheses. Radiology 1995;195:821–7.[Abstract/Free Full Text]
  6. Knyrim K, Wagner H-J, Bethge N, Keymling M, Vakil N. A controlled trial of an expansile metal stent for palliation of esophageal obstruction due to inoperable cancer. N Engl J Med 1993;329:1302–7.
  7. Herskovic A, Martz K, al Sarraf, et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 1992;326:1593–8.[Abstract]
  8. Loizou LA, Grigg D, Atkinson M, Robertson C, Gown SG. A prospective comparison of laser therapy and intubation in endoscopic palliation for malignant dysphagia. Gastroenterology 1991;100:1303–10.[Medline]
  9. Ogilvie AL, Dronfield MW, Ferguson R, Atkinson M. Palliative intubation of esophagogastric neoplasms at fiberoptic endoscopy. Gut 1982;23:1060–7.[Abstract/Free Full Text]
  10. Ell C, Hochberger J, May A, Fleig W, Hahn E. Coated and uncoated self-expanding metal stents for malignant stenosis in the upper GI tract: preliminary clinical experiences with Wallstents. Am J Gastroenterol 1994;89:1496–500.[Medline]
  11. Gasparri G, Casalegno PA, Camandona M, et al. Endoscopic insertion of 248 prostheses in inoperable carcinoma of the esophagus and cardia: short-term and long-term results. Gastrointest Endosc 1987;33:354–6.[Medline]
  12. Song HY, Choi KC, Kwon HC, Yang DH, Cho BH, Lee ST. Esophageal strictures: treatment with a new design of modified Gianturco stent. Radiology 1992;184:729–34.[Abstract/Free Full Text]
  13. Vermeijden JR, Bartelsman JFWM, Fockens P, Meijer RCA, Tytgat GNJ. Self-expanding metal stents for palliation of esophageal malignancies. Gastrointest Endosc 1995;41:58–63.[Medline]
  14. Fleischer DE, Bull-Henry K. A new coated self-expanding metal stent for esophageal strictures. Gastrointest Endosc 1992;38:494–6.[Medline]
  15. Rutgeerts P, Vantrappen G, Broeckaert L, et al. Palliative Nd:YAG laser therapy for cancer of the esophagus and gastroesophageal junction: impact on the quality of remaining life. Gastrointest Endosc 1988;34:87–90.[Medline]



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