Treatment of Esophageal Obstruction With Covered, Self-Expanding Esophageal Wallstents

Transcription

1 Treatment of Esophageal Obstruction With Covered, Self-Expanding Esophageal Wallstents Darroch W. O. Moores, MD, and Riivo Ilves, MD Division of Cardiothoracic Surgery,,, Albany Medical Center; and Department of Thoracic Surgery, St. Peter's Hospital, Albany, New York Background. Conventional endoluminal plastic prostheses used for relieving esophageal obstruction allow variable palliation. Covered, expandable metal stents provide an 18-mm lumen to allow improved deglutition. Methods. From December 1994 to December 1995, 20 patients underwent placement of self-expanding, silicone-covered Wallstents (Schneider, Plymouth, MN) for esophageal obstruction. Fifteen patients had obstruction secondary to carcinoma and 5 patients had benign esophageal stricture. There were 13 men and 7 women, ranging in age from 54 to 94 years. All patients underwent esophageal dilation using a flexible gastroscope and Savary bougies. After dilation to 42F or 45F, placement of the stent was performed under fluoroscopic control. Results. Follow-up was complete in all patients, rang- ing from 4 weeks to 12 months. Technical success was achieved in all patients. There was one postoperative death (bronchoesophageal fistula) and one migration of the stent requiring removal (peptic stricture). The remaining stents were well tolerated, even in the cervical region (4 patients). All patients successfully intubated were able to eat well, including solid foods. Conclusions. Covered, self-expanding esophageal Wallstents are technically simple and safe to insert and appear to provide durable, excellent palliation of esophageal obstruction due to either benign or malignant conditions. A larger patient population is required to make firm conclusions. ~Ann Thorac Surg 1996;62:963-7) E sophageal obstruction from any cause is debilitating. Most cases of nonmalignant esophageal obstruction are due to peptic stricture or lye ingestion. Peptic stricture almost always can be dilated and treated with antireflux measures, with or without the need for an antireflux operation. There is a small subset of patients with benign esophageal obstruction who cannot be managed adequately with medical therapy and who are not suitable for operative intervention. Malignant esophageal obstruction is usually caused by primary, esophageal carcinoma or, less commonly, by For editorial comment, see page 961. metastatic tumor within the mediastinum that invades or compresses the esophagus. For patients with unresectable or inoperable tumors, palliation to relieve dysphagia, discomfort, and pain is the primary goal. Such treatments should be effective, safe, and well tolerated. Adequate palliation may be effected by operation, radiation, laser, repeat dilation, endoprostheses, or a combination of these measures [1]. Endoscopic implantation of an endoesophageal prosthesis is a relatively simple procedure that usually provides effective palliation of esophageal obstruction from benign and malignant causes. Recently, a new class of endoesophageal prosthesis has Presented at the Poster Session of the Thirty-second Annual Meeting of The Society of Thoracic Surgeons, Orlando, FL, Jan 29-31, Address reprint requests to Dr Moores. Albany Cardiothoracic Surgeons, PC, 319 S Manning Blvd, Suite 301, Albany, NY become available [2-5]. Initial experience with uncovered, expandable metal stents for esophageal obstruction had the disadvantage of regrowth of tissue through the metal interstices, producing recurrence of obstruction [6, 7]. Recent improvement of these stents by covering with silicone offers the potential advantage of preventing recurrent obstruction due to tumor ingrowth and thereby providing longer palliation than from the earlier selfexpanding devices. They are also suitable for tracheoesophageal fistulas [8, 9]. Material and Methods From December 1994 to December 1995, 20 patients underwent placement of self-expanding, siliconecovered Wallstents (Schneider, Plymouth, MN) for esophageal obstruction (Figs 1-3). There were 13 men and 7 women, ranging in age from 54 to 94 years. Twelve patients had obstruction from esophageal carcinoma (unresectable disease in 6, recurrent anastomotic disease in 4, and bronchoesophageal fistula in 2), 3 had other obstructive carcinoma (gastric in 1, lung in 1, and mesothelioma in 1), and 5 had benign disease (peptic stricture in 3 and anastomotic stricture in 2). All patients underwent esophageal dilation using a flexible gastroscope and Savary bougies. After dilation to 42F or 45F, the length of the obstruction was marked, and placement of the esophageal Wallstent was performed under fluoroscopic control (Fig 4). Wallstents self expand and do not require additional internal dilation after placement. All patients underwent barium esophagography after place by The Society of Thoracic Surgeons Published b~ Elsevier Science Inc PII S (96)

2 964 MOORES AND ILVES Ann Thorac Surg COVERED, SELF-EXPANDING ESOPHAGEAL WALLSTENTS 1996;62:963-7 Fig 1. Wallstent within introducer. ment of the stent to ensure adequate placement and luminal patency (Fig 5). After deployment of the stent, the surgeon must be patient and allow the stent to expand for 5 to 10 minutes before removing the introducer, to avoid dislodgment of the stent. The stent will continue to expand for a further 24 hours after removal of the introducer. Results Follow-up was complete in all patients and ranged from 4 weeks to 12 months. Technical success was achieved in all patients. There was one postoperative death in a 78-year-old woman with bronchoesophageal fistula. Two hours after stent placement, tension pneumothorax and subcutaneous emphysema developed; she suffered cardiac arrest and died in the recovery room. It was believed that dilation of the stricture and stent placement most likely converted the bronchoesophageal fistula into a bronchoesophagomediastinal fistula, thereby causing the tension pneumothorax. No autopsy was performed. The other patient with bronchoesophageal fistula survived 7 weeks and had no further episode of aspiration after stent placement. Stent migration occurred in a 79-year-old man with hiatal hernia, longstanding tight peptic stricture, and severe inoperable coronary artery disease. Migration most likely occurred because a 4-cm Wallstent had been placed too low in the peptic stricture. The stent, which migrated into the stomach, required limited laparotomy with gastrotomy for removal. A 6-cm covered Wallstent then was placed through the stricture, with no further problems. All other stents were well tolerated, and patients were able to eat normally, including solid foods. x ~ Fig 3. Wallstents measuring 4, 6, and 9 cm long. mors may be unresectable and incurable because of local invasion, regional lymph node metastasis, distant metastasis, or irreversible cardiopulmonary conditions that may preclude an attempt at operative resection. When esophageal carcinoma cannot be resected completely, palliative esophagectomy or bypass procedures may be possible, but produce high morbidity rates and poor results [10]. For this group of patients, the options for palliation are repeated esophageal dilation, laser therapy or photodynamic therapy, radiation therapy, combination chemotherapy, and endoesophageal prostheses. Laser therapy or photodynamic therapy may be successful in relieving dysphagia and provides good palliation with reasonably low morbidity, but usually requires multiple tedious, time-consuming sessions [11-13]. Radiation therapy can relieve esophageal obstruction with a response rate of approximately 80%. An adequate response from radiotherapy, however, may take several weeks, Comment For patients who have inoperable carcinoma of the esophagus, a means of palliation is necessary to provide comfort and to restore gastrointestinal continuity. Tu- Fig 2. Partially deployed Wallstent. Fly. 4. Fluoroscopic picture of Wallstent between radiopaque markers.

3 Ann Thorac Surg MOORES AND ILVES ;62:963 7 COVERED, SELF-EXPANDING ESOPHAGEAL WALLSTENTS A B Fig 5. (A~,4 94-year-ohi woman with prima~3j esophageal carcinoma bqlcorc use qfi the Wallstent. (B),4tier Wallstent placement, she survived fi~r 4 months without.fi~rther dysphagia. and the relief is often short lived [14, 15]. Combination chemotherapy consisting of cisplatin, vindesine, and bleomycin has been shown to provide a marked clinical response in 65% of patients with carcinoma of the esophagus [16]. Although this chemotherapy regimen can achieve good results and relieve dysphagia, the treatment is toxic, expensive, and time consuming. In one recent study, severe side effects occurred in 44% of patients receiving combination chemotherapy and radiotherapy. Life-threatening side effects occurred in 20%, and only 58'!;, had improvement in their ability to swallow [171. Endoluminal esophageal prostheses for esophageal obstruction have been in use for more than 100 years [18]. Over this time, many tubes of the pulsion and traction variety have been described. The original tubes were made of decalcified ivory or metal. They were of small diameter, were dangerous to insert because of esophageal perforation, and led to high complication rates and poor palliation. In 1956, Mousseau and associates [19] developed a method of inserting an esophageal tube prosthesis by traction, requiring laparotomy. This technique was modified by Celestin in 1959 [20]. The Celestin tube was again a traction tube placed at laparotomy and became verv widely used for palliation of esophageal obstruction. Atkinson and Ferguson in 1977 [21] introduced a pulsion tube similar to the Celestin tube, which was placed at fiberoptic endoscopy. The major advantage of the Atkinson tube, and of subsequent modifications developed bv others, was that the tube could be placed safely without the need for laparotomy. In 1974, Girardet and colleagues [22] published a collective review of 2,459 patients who were treated with esophageal tubes. The overall hospital mortality rate was 13.9%. Patients who underwent placement of traction tubes had a mortality rate of 23.5%; patients who underwent placement of pulsion tubes had a rate of 11%. The overall complication rate was 25.4%, with the most common complication being tube dislodgment and obstruction. The average survival after placement of an esophageal stent was 4.2 months. In a study by Gasparri and co-workers [23], only slightly over 50% of patients with placement of endoscopic tubes had satisfactory improvement in their ability to swallow. Self-expanding metal endoprostheses, previously used for vascular, urethral, and biliary strictures, have been developed recently for esophageal stenting. Two different self-expanding metal endoprostheses are currently available commercially: the Wallstent and a modified Gianturco stent (Cook, Bloomington, IN). These selfexpanding metal prostheses are easily placed endoscopically using either local or general anesthesia. The original self-expanding metal stents for esophageal obstruction were uncovered and allowed tumor ingrowth through the metal interstices, with reobstruction of the esophagus. Covering the metal stents with silicone has the advantage of preventing tumor ingrowth, and therefore allows longer periods of durable palliation. Fragmentation of the silicone, reported with the prototypes of the covered stent, has been eliminated with improvements in design. The current commercially available Wallstent incorporates the silicone between two layers of wire mesh. Since this modification, there have been no reports of fragmentation of Wallstents. In our series, we treated patients with both benign and malignant esophageal obstruction. The malignant group included patients with unresectable and inoperable prima D' esophageal tumors, recurrent malignant anastomotic stricture, and metastatic disease in the mediastinum causing invasion or obstruction of the esophagus. The benign group included elderly patients with peptic strictures that could not be managed adequately by dilation and patients with benign anastomotic strictures after transhiatal esophagectomy. Two patients in our series had a malignant esophagorespiratory fistula. We placed stents at all levels in the esophagus, including the cervical esophagus and the gastroesophageal junction, with excellent palliation. Caution must be exercised when stents are placed through the gastroesophageal junction, as stents in this location may cause free gastroesophageal reflux. After stent placement through the gastroesophageal junction, patients should be managed with elevation of the head of the bed and long-term omeprazole and cisapride therapy. Using this regimen in patients with stents through the gastroesophageal junction, we have had no episode of significant aspiration or further esophageal stricture formation proximal to the Wallstents. Obstruction in the cervical esophagus is believed to be a contraindication to the placement of conventional plastic esophageal stents [18]. Patients in our series who underwent placement of the Wallstent in the cervical

4 966 MOORES AND ILVES Ann Thorac Surg COVERED, SELF-EXPANDING ESOPHAGEAL WALLSTENTS 1996;62:963-7 Fig 6. Computed tomographic scan showing cross-section of a Wallstent in the upper esophagus. The esophageal lumen is widely patent with no tracheal compression. esophagus tolerated the prosthesis well, and there was no evidence of erosion into the trachea or migration of the stent proximally across the cricopharyngeus. If the Wallstent must be placed high in the cervical esophagus, the stent may be removed completely from the introducer before the procedure and the proximal exposed wires cut off to allow placement just below the cricopharyngeus (Fig 6). Previously available conventional plastic prostheses (Wilson Cook [Winston-Salem, NC] and the Atkinson tube) have an outer diameter of 16 mm and an inner diameter of only 12 mm. To place one of these rigid tubes, one must dilate the esophageal obstruction to at least 16 mm, which corresponds to 48F. Placement of these rigid plastic stents is more difficult than placement of the covered Wallstent. The Wallstent has a slim delivery system 13 mm in diameter before deployment, and therefore can be placed by dilating the esophagus to only 42F. It has been our practice to dilate the stricture, if possible, to 45F before stent placement. Once the selfexpandable Wallstent is placed, it can expand up to 18 mm in maximum internal diameter. This large internal diameter allows much better swallowing than the smaller-diameter, conventional rigid plastic stent. The Wallstent is available in 4-, 6-, and 9-cm lengths. For patients with obstructing lesions longer than 9 cm, Wallstents may be stacked on end. Complications associated with insertion are also fewer for the metal expandable stents than for conventional plastic prostheses [22, 23]. Extreme care must be exercised to place the stent precisely through the stricture. When partially deployed, the stents may be recaptured within the introducer; once fully deployed, however, the stents are virtually impossible to remove. Placement of a self-expanding metal esophageal prosthesis does not prevent or preclude the patient from undergoing subsequent radiotherapy or chemotherapy. It has been reported that in patients with conventional stents, postinsertion radiotherapy creates sufficient tumor necrosis that tube dislodgment may occur [24]. This complication theoretically also can occur in patients with indwelling conventional prostheses who undergo che- motherapy. The advantage of the covered esophageal Wallstent is its facility to expand, thereby remaining in place despite the changes from the response to chemotherapy. One of the patients in our series who had placement of the Wallstent subsequently underwent extensive chemotherapy. Despite a substantial response to the chemotherapy and a reduction of tumor size, the Wallstent remained in place and did not migrate. In conclusion, the covered, expandable Wallstent is safe and easy to place. It provides excellent and durable palliation of benign and malignant esophageal obstruction at all levels. The delivery system has a low profile of only 13 ram. Once fully expanded, the stent has an internal diameter of 18 mm. Use of the Wallstent is compatible with antineoplastic therapy. The stent is available in 4-, 6-, and 9-cm lengths. For patients with obstructing lesions longer than 9 cm, Wallstents may be stacked on end. The Wallstent is suitable for use in patients with esophagorespiratory fistula. References 1. Coia LR, Sauter ER. Esophageal cancer. Curr Probl Cancer 1994;18: 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: Ell C, Hochberger J, May A, Fleig WE, Hahn EG. 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: Song HY, Do YS, Han YM, et al. Covered, expandable esophageal metallic stent tubes: experiences in 119 patients. Radiology 1994;193: Wu WC, Katon RM, Saxon RR, et al. Silicone-covered self-expanding metallic stents for the palliation of malignant esophageal obstruction and esophagorespiratory fistulas: experience in 32 patients and a review of the literature. Gastrointest Endosc 1994;40: Wagner HJ, Stinner B, Schwerk WB, Hoppe M, Klose KJ. Nitinol prostheses for the treatment of inoperable malignant esophageal obstruction. J Vasc Interv Radiol 1994;5: Raijman I, Lalor E, Marcon NE. Photodynamic therapy for tumor ingrowth through an expandable esophageal stent. Gastrointest Endosc 1995;41: Weigert N, Neuhaus H, Rosch T, Hoffmann W, Dittler HJ, Classen M. Treatment of esophagorespiratory fistulas with silicone-coated self-expanding metal stents. Gastrointest Endosc 1995;41: Wong K, Goldstraw P. Role of covered esophageal stents in malignant esophagorespiratory fistula. Ann Thorac Surg 1995;60: Ginoux M, Segal P. Palliative surgical treatment for carcinoma of the esophagus. Int Surg 1984;69: Buset M, des Marez B, Baize M, et al. Palliative endoscopic management of obstructive esophagogastric cancer: laser or prosthesis? Gastrointest Endosc 1987;33: Hahl J, Salo J, Ovaska J, Haapiainen R, Kalima T, Schroder T. Comparison of endoscopic Nd:YAG laser therapy and oesophageal tube in palliation of an esophagogastric malignancy. Scand J Gastroenterol 1991;26: Sankar MY, Joffe SN. Endoscopic contact Nd:YAG laser resectional vaporization (ECLRV) and esophageal dilatation (ED) in advanced malignant obstruction of the esophagus. Am Surg 1991;57: Cliffton EE. Surgery and irradiation in the treatment of esophageal cancer. Hosp Pract 1969;4:88-91.

5 Ann Thorac Surg MOORES AND ILVES ;62:963-7 COVERED, SELF-EXPANDING ESOPHAGEAL WALLSTENTS 15. Earlam R, Cunha-Melo JR. Oesophageal squamous cell carcinoma: II. A critical review of radiotherapy. Br J Surg 1980;67: Kelsen D, Hilaris B, Coonlev C, et al. Cisplatin, vindesine, and bleomycin chemotherapy of local-regional and advanced esophageal carcinoma. Am J Med 1983;75: Herskovic A, Martz K, AI-Sarraf M, et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 1992;326: Mehran RJ, Duranceau A. The use of endoprosthesis in the palliation of esophageal carcinoma. Chest Surg Clin North Am 1994;4: Mousseau M, Le Forestier J, Barbin J, Hardy M. Place de l'intubation a demeure dans le traitement palliatif du cancer de l'oesophage. Arch Fr Mal Appar Dig 1956;45: Celestin LR. Permanent intubation in inoperable cancer of the oesophagus and cardia: a new tube. Ann R Coll Surg Engl 1959;25: Atkinson M, Ferguson R. Fiberoptic endoscopic palliative intubation of inoperable esophagogastric neoplasms. BMJ 1977;1: Girardet RE, Ransdell HT Jr, Wheat MW Jr. Palliative intubation in the management of esophageal carcinoma. Ann Thorac Surg 1974;18: 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: Fell SC, Grunwald RP, Hurwitt ES. Palliation of esophageal carcinoma by prosthetic intubation. J Thorac Cardiovasc Surg 1966;51: Important Announcement In addition to postal services and FAX, The Annals of Thoracic Surgery Editorial Office may now be reached by . The address is: ats@wudos2.wustl.edu The Annals of Thoracic Surgery Web site address is: http'//