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Placement of Polyflex stents in patients with locally advanced esophageal cancer is safe and improves dysphagia during neoadjuvant therapy
ORIGINAL ARTICLE: Clinical Endoscopy
Placement of Polyflex stents in patients with locally advanced esophageal cancer is safe and improves dysphagia during neoadjuvant therapy Douglas G. Adler, MD, John Fang, MD, Robert Wong, MD, Jason Wills, MD, Kristen Hilden, MS Salt Lake City, Utah, USA
Background: Patients with locally advanced esophageal cancer who require neoadjuvant therapy have significant dysphagia. Objectives: To prospectively evaluate Polyflex stents to treat malignant dysphagia and to ameliorate weight loss in patients with locally advanced esophageal cancer who will undergo neoadjuvant therapy. Design: A prospective nonrandomized study. Setting: Tertiary-referral cancer center. Patients: Thirteen patients with esophageal cancer (11 adenocarcinoma, 2 squamous-cell carcinoma). All patients were men, with a mean age of 63 years. Interventions: EUS followed by stent placement. Main Outcome Measurements: Dysphagia scores and patient weights. Results: There were no perforations and no episodes of bleeding. Immediate complications included chest discomfort in 12 of 13 patients. The mean dysphagia score at the time of stent placement was 3. Mean dysphagia scores obtained at 1, 2, 3, and 4 weeks after stent placement were 1.1 (P Z .005), 0.8 (P Z .01), 0.9 (P Z .02), and 1.0 (P Z .008), respectively. Stent migration occurred at some point in 6 of 13 patients (46%). Limitations: A single center and small size of study. Conclusions: Simultaneous EUS staging and Polyflex stent placement is safe and allows oral feeding during neoadjuvant therapy. Dysphagia scores improved in a statistically significant manner. Stent migration was a common event, although not all patients with a migrated stent will require stent replacement, because migration may be a sign of tumor response to neoadjuvant therapy. (Gastrointest Endosc 2009;70:614-9.)
Most patients with advanced esophageal cancer have significant dysphagia, which contributes to weight loss and malnourishment. Esophageal stents have been shown to palliate dysphagia in patients with incurable esophageal cancer. Historically, esophageal stents used in patients with esophageal cancer have been self-expanding metal stents (SEMSs), and are generally reserved for patients
Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.01.026
with incurable esophageal cancer. As of this writing, only one self-expanding plastic stent has been approved by the U.S. Food and Drug Administration in the United States for use in patients with malignant dysphagia. The Polyflex polyester mesh stent (Microvasive Endoscopy, Boston Scientific, Natick, Mass) consists of polyester netting completely covered in a silicone membrane. Early studies of this device demonstrated an improvement in dysphagia that was thought to be comparable with that seen with SEMSs, although with a higher migration rate.1 Subsequent studies reported similar improvements in dysphagia, with acceptable rates of stent migration (4.5%-8.3%).2-4 Rates of migration with this device were reported to be lower in patients with malignant disease when compared with benign disease.2,5 Also, Polyflex stents can be removed by endoscopy.
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Abbreviations: PEG-J, PEG-jejunostomy; SEMSs, self-expanding metal stents. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
Adler et al
Polyflex stents may be appropriate for the management of malignant dysphagia in patients with locally advanced esophageal cancer. In general, these patients are candidates for neoadjuvant chemoradiation and experience ongoing dysphagia and weight loss before and during treatment. In the cohort of patients who respond to neoadjuvant therapy, a Polyflex stent could function as a temporary palliative measure until definitive surgical resection. The stent could either be removed by endoscopy immediately before or at the time of surgery. In patients without a response or with progressive disease, the Polyflex stent could be left in place indefinitely for palliation. In this prospective, nonrandomized, single-institution study, we report our experience with placing Polyflex stents in patients with locally advanced esophageal carcinoma who were to undergo neoadjuvant therapy. This stent was specifically chosen, given that it was easily removable, would not interfere with follow-up imaging (CT, CT–positron emission tomography, or magnetic resonance imaging) and would minimize difficulties for surgeons at the time of esophagectomy. The stents were placed immediately after EUS staging (while the patient was still under sedation) in appropriate patients, in an effort to provide rapid improvement in dysphagia and to allow oral feeding during neoadjuvant therapy. The aim of the study was to evaluate the effectiveness of this device in this specific setting with regard to relief of malignant dysphagia during neoadjuvant therapy.
Placement of stents in patients with esophageal cancer
Capsule Summary What is already known on this topic d
Neoadjuvant therapy, the current standard of care for patients with locally advanced esophageal cancer, may improve dysphagia but can take time.
What this study adds to our knowledge d
d
Polyester mesh stents were successfully placed in 13 patients with locally advanced esophageal cancer causing dysphagia and resulted in significantly improved dysphagia scores. Stent migration occurred in 46% of patients.
such as magnetic resonance imaging, CT, or CT–positron emission tomography. Polyflex stents can also be removed much more easily than can metal stents if need be. Dysphagia was graded before the procedure on a 5point scale as follows: 0, normal; 1, solid-food dysphagia weekly; 2, solid-food dysphagia daily (able to swallow semisolid foods at least 50% of the time); 3, solid-food dysphagia daily (able to swallow semisolid foods less than 50% of the time); 4, unable to swallow semisolid foods; and 5, unable to swallow secretions.6
Endoscopic procedure
This study was performed at the University of Utah School of Medicine/Huntsman Cancer Center. Between April 2006 and November 2007, patients referred for EUS staging who met entry criteria were enrolled in the study. Patients were observed until death or stent removal, or until 6 months had elapsed after stent placement (whichever came first). Informed consent was obtained before EUS. Inclusion criteria were the following: (1) patients R18 years of age, with biopsy-confirmed esophageal cancer (either adenocarcinoma or squamous-cell carcinoma), (2) locally advanced esophageal carcinoma (defined as at least stage IIa), and the absence of distant metastatic disease as assessed by physical examination, CT, and EUS in patients who were thought to be candidates for neoadjuvant therapy, and (3) symptoms of dysphagia. This study was approved by the institutional review board at the University of Utah Health Sciences Center. Polyflex stents were used, because it is the policy of our institution not to place metal esophageal stents in patients with potentially resectable esophageal cancer. In our experience metal stents can interfere with restaging studies,
A radial echoendoscope (13.8-mm outer diameter) and a linear echoendoscope (13.8-mm outer diameter) (GIFUE160 and GF-UC140P, respectively; Olympus Endoscopy, Center Valley, Pa) were used for all examinations. EUS examinations were performed with the patient in the left lateral decubitus position on the fluoroscopy table. EUS examinations were performed by experienced endosonographers (D.G.A., J.W., and R.W.), all of whom had performed at least 500 EUS examinations before the initiation of the study. Patients were considered for placement of a Polyflex stent based on tumor and lymph-node staging as seen by EUS, as well as based on the results of EUS-guided FNA of the lymph nodes of concern. Patients with uT3Nx or uTxN1 esophageal cancers who were thought to be candidates for neoadjuvant therapy and in whom it was thought that surgery was likely to occur then underwent stent placement immediately after EUS. After the EUS examination, the patients were placed in the supine position. Stents were deployed in the standard manner over guidewires and with the aid of fluoroscopy. Dilation to facilitate either the EUS examination or stent placement (to accommodate the 12-mm-wide stent delivery catheter) was performed if it was thought to be warranted by the endoscopist. The stents were placed by the same physician who performed the EUS examination. All 3 endoscopists had extensive experience with Polyflex stents. Stents were sized based on the location and size of the tumor, the length and severity of the stricture, and the
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PATIENTS AND METHODS Patients
Placement of stents in patients with esophageal cancer
diameter of the proximal and distal esophagus. Endoscopic and fluoroscopic confirmation of an adequate stent position was obtained. The patients were advised to use over-the-counter proton pump inhibitors as needed after stent placement.
Postprocedure evaluation and follow-up Patients were prospectively assessed for dysphagia by telephone calls at 1-week intervals for 1 month and then at monthly intervals until stent removal (endoscopic or surgical) or death. Data on the dysphagia score, immediate and early complications after the procedure (up to 1 week), and late complications (occurring O1 week after stent placement) were collected. Patients were weighed before stent placement. Dysphagia scores were obtained via telephone. Patients were reevaluated by endoscopy and/or chest radiographs, as needed, to evaluate the position and patency of the stent.
Statistical analysis Dysphagia scores were analyzed as nonparametric data by using the Wilcoxon signed rank test. A P value!.05 was considered significant.
Adler et al
TABLE 1. Patient demographics Parameter Mean age (y) Men, no. (%)
Result 63.3 (range 45-83) 13 (100)
Type, no. (%) Adenocarcinoma Squamous cell
11 (85) 2 (15)
Location, no. (%) Middle
1 (8)
Middle-lower
3 (23)
Lower
9 (69)
Mean length (cm) Mean serum albumin (mg/dL)
7.3 (range 5-15) 3.9 (3.3-4.5)
Balloon dilation at time of endoscopy, no. (%) No
7 (54)
Yes
6 (46)
Mean dysphagia score
3 (range 2-5)
RESULTS During the study period, 31 patients were referred for evaluation of esophageal cancer. Patients with disease that was unresectable at presentation were not offered enrollment in the study. All patients who were potential surgical candidates and in whom neoadjuvant therapy was planned were offered enrollment, and this constituted the 13 patients who met entry criteria and were enrolled in the study. All patients were men, with a mean (SD) age of 63.3 12.3 years (range 45-83 years). Eleven patients had a diagnosis of adenocarcinoma (85%), and 2 patients (15%) had squamous-cell cancer. The mean tumor length was 7.3 cm (range 5-15 cm). Tumors were located in the mid esophagus in 1 patient, the mid to distal esophagus in 3 patients, and the distal esophagus in 9 patients. Eight patients had circumferential tumors; the other patients had tumors that were partially circumferential. Seven patients (54%) required balloon dilation (range 12-16.5 mm, although only one patient underwent dilation to 16.5 mm) to allow passage of the EGD scope and/or the echoendoscope or to facilitate stenting. Six patients required no dilation at all. Endoscopy was performed with the patient under conscious sedation (by using either a combination of intravenous midazolam and fentanyl, or propofol and fentanyl) in 9 of 13 patients (69%) and under general anesthesia in 4 of 13 patients (31%). These data are summarized in Table 1. Nine of 13 patients had their disease staged as uT3N1, one patient’s disease was staged as uT3N0, one patient’s disease was staged as uT2N1. Two patients had their disease staged as uT4N1.
These 2 patients had borderline aortic involvement and were thought to be candidates for neoadjuvant therapy per institutional protocol. All 13 patients underwent stent placement. Stents lengths used were either 9 or 15 cm long, and stent widths ranged from 16 to 20 mm and 21 to 25 mm (the center diameter and the proximal stent diameter, respectively). All stents were inserted via a 12-mm delivery catheter. In 2 patients, the position of the stent after placement was thought to be suboptimal, and the stent was removed and redeployed in proper position at the same procedure. In the remaining 11 patients, initial stent deployment was successful, with good positioning on the first attempt. There were no perforations and no episodes of bleeding. Immediate complications included some degree of chest discomfort after stent placement in 12 of 13 patients. Chest pain severity did not correlate with the size or location of stents. Chest discomfort was generally mild to moderate, although 1 patient complained of severe discomfort after the procedure and required admission for observation. This patient had severe pain, despite narcotic analgesic medications, and the stent was removed 2 days later because of patient intolerance, which resulted in relief of pain. One patient experienced stent migration 2 days after initial placement and underwent removal of the stent, with subsequent placement of a new Polyflex stent, without difficulty. Twelve of 13 patients were discharged to home the same day. All patients were given a prescription for oral narcotic analgesics. With
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the exception of the aforementioned patient with intractable pain, all patients had resolution of chest pain within 7 days. All patients were offered neoadjuvant therapy, with chemotherapy combined with radiation therapy. Neoadjuvant therapy was typically started 2 weeks after stent placement. Twelve of 13 patients elected to proceed with neoadjuvant therapy. One patient opted for palliation only and declined neoadjuvant therapy. The Polyflex stent in this patient was left in place as a palliative measure. Stents remained in place for a mean of 65.9 days (range 2-180 days). The mean dysphagia score at the time of stent placement was 3. Mean dysphagia scores obtained at 1, 2, 3, and 4 weeks after stent placement were 1.1 (P Z .005), 0.8 (P Z .01), 0.9 (P Z .02), and 1.0 (P Z .008), respectively. All the dysphagia scores were significantly improved when compared with baseline. Afterward, the dysphagia scores were obtained on a monthly basis until stent removal or patient death, although patients started to exit the study because of surgery or death after the 1-month time point, which limited analysis because of few data points. Stent migration occurred at some point in 6 of 13 patients (46%). Five of these patients underwent stent removal at a mean of 6.4 weeks (range 2-48 days). Three of the 6 patients (50%) with migrated stents underwent esophagectomy at a mean of 8.5 weeks after stent placement. One of 6 migrated stents was removed from the stomach during esophagectomy; 5 of 6 were removed via EGD. Two patients (15%) required PEG tubes during follow-up for supplemental caloric intake. In one of these patients, his stent had migrated, and there was a patent esophageal lumen, but the oncology service thought that supplemental nutrition was required. Two patients died with stents in place. One patient developed neutropenic fever with a rash and hypokalemia during neoadjuvant therapy, which was managed medically and thought to be unrelated to the stent. These data are summarized in Table 2.
Placement of stents in patients with esophageal cancer
TABLE 2. Outcomes after stent placement Mean (%)
Range
65.9
2-180
Wk 1 (n Z 11)
1.1
0-4
.005
Wk 2 (n Z 9)
0.8
0-3
.01
Wk 3 (n Z 8)
0.9
0-3
.02
Wk 4 (n Z 9)
1
0-4
.008
Parameter Days of follow-up with stent in situ (n Z 13)
P value
Dysphagia scores
Final outcomes (n Z 13) Migrations
6 (46)
Tumor overgrowth
1 (8)
Esophagectomy
3 (23)
PEG tubes placed with stent in situ
2 (15)
Chemoradiation therapy
12 (93)
Death with stent in situ
2 (15)
Most patients with locally advanced esophageal cancer have malignant dysphagia, and the current standard of care in the United States is to offer these patients neoadjuvant therapy.7,8 The goal of such therapy is to decrease tumor burden and to eradicate malignant lymphadenopathy.9 Neoadjuvant therapy can improve dysphagia symptoms via decreasing tumor size and increasing the esophageal luminal diameter, but this can take time. In addition, some patients will experience a worsening of their dysphagia because of mucositis, and these patients often require enteral feeding.10 Nasogastric tubes, gastrostomy (PEG) tubes, gastrojejunostomy (PEG-jejunostomy [PEG-J] tubes, and direct jejunostomy tubes are all effective options for delivering both hydration and nutrition, but none allow
oral feeding.11-14 Although some investigators have stated that PEG or PEG-J tubes are safe in these patients, this is a controversial issue, with some concerns regarding whether or not a prior PEG or PEG-J leads to worse operative outcomes.15 The Polyflex stent is a self-expanding plastic stent and is established to be useful in a variety of esophageal diseases, both benign and malignant. These include treatment of malignant dysphagia, benign esophageal strictures, and esophageal leaks and fistulas.16-21 As of this writing, the Polyflex stent is the only U.S. Food and Drug Administration–approved and commercially available self-expanding plastic esophageal stent in the United States. Early studies of this device demonstrated relief of dysphagia that was thought to be roughly comparable with that seen with SEMSs, although the rate of migration with these devices is relatively high (4.5%-37%),1,3,22 Drawbacks to this device include a relatively thick and rigid delivery catheter, which typically requires esophageal dilation before deployment, and a complicated delivery system.23 The current study aimed to provide immediate relief of malignant dysphagia and to ameliorate nutritional deterioration via the placement of Polyflex stents as soon as patients with esophageal cancer were thought to be candidates for neoadjuvant therapy. This study was novel in that it was the first study to prospectively evaluate this device in this specific context. This study was also novel in another respect, because the stents were placed
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DISCUSSION
Placement of stents in patients with esophageal cancer
at the same time that EUS staging was performed, thus saving the patients a second procedure and allowing oral intake to resume as quickly as possible. Although the investigators recognize that the Polyflex stent may not be the ideal esophageal stent for all clinical situations, we thought that, in this setting, this device was the best one to undergo formal study in this context, given its removability, metal-free design, and lack of interference with standard imaging modalities (which would be more prominent with metal stents and would have complicated subsequent restaging evaluations). In this study, stents were successfully placed in all patients. Perforations during EUS and stent placement in patients in esophageal cancer have been reported but did not occur in this study.24 Immediate complications were limited to chest pain, which was severe in one patient and required stent removal. Migration was a common problem and occurred in just under half of all patients at some point. Some of these migrations were likely a consequence of the stent design, whereas others were likely a sign that the patients were responding to neoadjuvant therapy (because of a decrease in the severity of the malignant esophageal stricture, which allowed the stent to anchor in place). Migration of the stent did not necessarily trigger an automatic stent replacement, because often the lumen was thought to be adequate for at least a liquid diet (comparable with what could be introduced via a PEG tube). Dysphagia scores improved compared with baseline in a statistically significant manner at all time points during the first month after stent placement. Dysphagia scores continued to stay low thereafter, but, as patients started to exit the study via surgery or death, there were inadequate data points for further statistical analysis. Polyflex stents were previously evaluated in a similar context in a limited manner in 2 smaller retrospective studies. Siddiqui et al25 published a retrospective study of 6 patients with malignant dysphagia who underwent Polyflex stent placement before neoadjuvant therapy. Stents were placed at some point after an esophageal-cancer diagnosis. Stent placement was successful in 5 of 6 patients. Patients had a statistically significant improvement in dysphagia after the procedure, although scores were only tracked before the procedure, 1 week after the procedure, and at the time of surgery. Another retrospective study that looked at a mixed group of presurgical and postsurgical patients with esophageal cancer included 5 patients in whom Polyflex stents were placed in preparation for neoadjuvant therapy. There was good technical and clinical success in these patients, with oral fluid and nutrition goals met. The stent migration rate in this study was 20%.26 Our study showed good outcomes with regard to improvement in dysphagia scores and a lack of serious complications, although our migration rate was higher than previously reported. No patients were harmed by placement of stents, and patients voiced appreciation for having 2 endoscopic procedures performed in one setting. Patients also were eager to return to oral feed618 GASTROINTESTINAL ENDOSCOPY Volume 70, No. 4 : 2009
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ing and avoid a nasogastric, PEG, or jejunostomy tube during neoadjuvant therapy for a more normal day-to-day life. Although this study has closed, the practice of simultaneous EUS staging and stent placement has been incorporated into clinical practice at our institution. The high migration rate may have been from a variety of factors, including the diameter of the endoscopes used during staging, the frequent need for dilation during placement, and the high rate of patients undergoing neoadjuvant therapy. Only one patient underwent dilation to 16.5 mm. All other patients who required dilation only received dilation to 12 to 15 mm. We believe that neoadjuvant therapy likely played a major role in stent migration, although we acknowledge that dilation could have contributed as well. Neoadjuvant chemoradiation therapy probably played a key role in decreasing tumor size overall, which led to a decrease in the severity of the malignant esophageal stricture and, thus, stent migration. In conclusion, placement of Polyflex stents in patients with locally advanced esophageal cancer at the time of EUS staging to allow oral nutrition and hydration during neoadjuvant therapy appears safe and relatively effective. These stents were chosen because of their lack of interference with subsequent reimaging studies and their removability. Our study is limited by a small number of patients. Patients may be able to avoid nasogastric, PEG, or jejunostomy tube feedings. In this study, stent migration was relatively common in this patient subset. Not all patients with a migrated stent will require stent replacement because the stent migration may be a sign of tumor response to neoadjuvant therapy. Patients who do not proceed to surgery can have the stent left in place as a palliative measure.
REFERENCES 1. Radecke K, Gerken G, Treichel U. Impact of a self-expanding, plastic esophageal stent on various esophageal stenoses, fistulas, and leakages: a single-center experience in 39 patients. Gastrointest Endosc 2005;61:812-8. 2. Conigliaro R, Battaglia G, Repici A, et al. Polyflex stents for malignant oesophageal and oesophagogastric stricture: a prospective, multicentric study. Eur J Gastroenterol Hepatol 2007;19:195-203. 3. Dormann AJ, Eisendrath P, Wigginghaus B, et al. Palliation of esophageal carcinoma with a new self-expanding plastic stent. Endoscopy 2003;35:207-11. 4. Szegedi L, Ga´l I, Ko´sa I, et al. Palliative treatment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol 2006;18:1197-201. 5. Pennathur A, Chang AC, McGrath KM, et al. Polyflex expandable stents in the treatment of esophageal disease: initial experience. Ann Thorac Surg 2008;85:1968-72, discussion 1973. 6. Mellow MH, Pinkas H. Endoscopic laser therapy for malignancies affecting the esophagus and gastroesophageal junction. Analysis of technical and functional efficacy. Arch Intern Med 1985;145:1443-6. 7. Siersema PD, van Hillegersberg R. Treatment of locally advanced esophageal cancer with surgery and chemoradiation. Curr Opin Gastroenterol 2008;24:535-40. 8. Ku GY, Ilson DH. Preoperative therapy in esophageal cancer. Clin Adv Hematol Oncol 2008;6:371-9.
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Placement of stents in patients with esophageal cancer
9. Mougey A, Adler DG. Esophageal stenting for the palliation of malignant dysphagia. J Support Oncol 2008;6:267-73. 10. Stockeld D, Tennvall J, Wagenius G, et al. A Swedish study of chemoradiation in squamous cell carcinoma of the esophagus. Acta Oncol 2001;40:566-73. 11. Stockeld D, Fagerberg J, Granstro¨m L, et al. Percutaneous endoscopic gastrostomy for nutrition in patients with oesophageal cancer. Eur J Surg 2001;167:839-44. 12. Kight CE. Nutrition considerations in esophagectomy patients. Nutr Clin Pract 2008;23:521-8. 13. Sparrow P, David E, Pugash R. Direct percutaneous jejunostomy: an underutilized interventional technique? Cardiovasc Intervent Radiol 2008;31:336-41. 14. Lin CH, Liu NJ, Lee CS, et al. Nasogastric feeding tube placement in patients with esophageal cancer: application of ultrathin transnasal endoscopy. Gastrointest Endosc 2006;64:104-7. 15. Margolis M, Alexander P, Trachiotis GD, et al. Percutaneous endoscopic gastrostomy before multimodality therapy in patients with esophageal cancer. Ann Thorac Surg 2003;76:1694-7; discussion 1697-8. 16. Conio M, Repici A, Battaglia G, et al. A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia. Am J Gastroenterol 2007;102:2667-77. 17. Adler DG, Pleskow DK. Closure of a benign tracheoesophageal fistula by using a coated, self-expanding plastic stent in a patient with a history of esophageal atresia. Gastrointest Endosc 2005;61:765-8. 18. Gelbmann CM, Ratiu NL, Rath HC, et al. Use of self-expandable plastic stents for the treatment of esophageal perforations and symptomatic anastomotic leaks. Endoscopy 2004;36:695-9. 19. Langer FB, Wenzl E, Prager G, et al. Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent. Ann Thorac Surg 2005;79:398-403; discussion 404.
20. Schubert D, Scheidbach H, Kuhn R, et al. Endoscopic treatment of thoracic esophageal anastomotic leaks by using silicone-covered, self-expanding polyester stents. Gastrointest Endosc 2005;61:891-6. 21. Freeman RK, Ascioti AJ, Wozniak TC. Postoperative esophageal leak management with the Polyflex esophageal stent. J Thorac Cardiovasc Surg 2007;133:333-8. 22. Szegedi L, Ga´l I, Ko´sa I, et al. Palliative treatment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol 2006;18:1197-201. 23. Radecke K, Gerken G, Treichel U. Impact of a self-expanding, plastic esophageal stent on various esophageal stenoses, fistulas, and leakages: a single-center experience in 39 patients. Gastrointest Endosc 2005;61:812-8. 24. American Society for Gastrointestinal Endoscopy, Adler DG, Jacobson BC, et al. Complications of EUS. Gastrointest Endosc 2005;61:8-12. 25. Siddiqui AA, Loren D, Dudnick R, et al. Expandable polyester siliconcovered stent for malignant esophageal strictures before neoadjuvant chemoradiation: a pilot study. Dig Dis Sci 2007;52:823-9. 26. Martin R, Duvall R, Ellis S, et al. The use of self-expanding silicone stents in esophageal cancer care: optimal pre-, peri-, and postoperative care. Surg Endosc 2009;23:615-21.
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Received December 8, 2008. Accepted January 15, 2009. Current affiliations: Division of Gastroenterology and Hepatology, Huntsman Cancer Center, University of Utah School of Medicine, Salt Lake City, Utah, USA. Reprint requests: Douglas G. Adler, MD, Gastroenterology and Hepatology, 30N 1900E 4R118, University of Utah, Salt Lake City, UT 84132. If you would like to chat with an author of this article, you may contact him at [email protected]; [email protected].
Placement of Polyflex stents in patients with locally advanced esophageal cancer is safe and improves dysphagia during neoadjuvant therapy Douglas G. Adler, MD, John Fang, MD, Robert Wong, MD, Jason Wills, MD, Kristen Hilden, MS Salt Lake City, Utah, USA
Background: Patients with locally advanced esophageal cancer who require neoadjuvant therapy have significant dysphagia. Objectives: To prospectively evaluate Polyflex stents to treat malignant dysphagia and to ameliorate weight loss in patients with locally advanced esophageal cancer who will undergo neoadjuvant therapy. Design: A prospective nonrandomized study. Setting: Tertiary-referral cancer center. Patients: Thirteen patients with esophageal cancer (11 adenocarcinoma, 2 squamous-cell carcinoma). All patients were men, with a mean age of 63 years. Interventions: EUS followed by stent placement. Main Outcome Measurements: Dysphagia scores and patient weights. Results: There were no perforations and no episodes of bleeding. Immediate complications included chest discomfort in 12 of 13 patients. The mean dysphagia score at the time of stent placement was 3. Mean dysphagia scores obtained at 1, 2, 3, and 4 weeks after stent placement were 1.1 (P Z .005), 0.8 (P Z .01), 0.9 (P Z .02), and 1.0 (P Z .008), respectively. Stent migration occurred at some point in 6 of 13 patients (46%). Limitations: A single center and small size of study. Conclusions: Simultaneous EUS staging and Polyflex stent placement is safe and allows oral feeding during neoadjuvant therapy. Dysphagia scores improved in a statistically significant manner. Stent migration was a common event, although not all patients with a migrated stent will require stent replacement, because migration may be a sign of tumor response to neoadjuvant therapy. (Gastrointest Endosc 2009;70:614-9.)
Most patients with advanced esophageal cancer have significant dysphagia, which contributes to weight loss and malnourishment. Esophageal stents have been shown to palliate dysphagia in patients with incurable esophageal cancer. Historically, esophageal stents used in patients with esophageal cancer have been self-expanding metal stents (SEMSs), and are generally reserved for patients
Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.01.026
with incurable esophageal cancer. As of this writing, only one self-expanding plastic stent has been approved by the U.S. Food and Drug Administration in the United States for use in patients with malignant dysphagia. The Polyflex polyester mesh stent (Microvasive Endoscopy, Boston Scientific, Natick, Mass) consists of polyester netting completely covered in a silicone membrane. Early studies of this device demonstrated an improvement in dysphagia that was thought to be comparable with that seen with SEMSs, although with a higher migration rate.1 Subsequent studies reported similar improvements in dysphagia, with acceptable rates of stent migration (4.5%-8.3%).2-4 Rates of migration with this device were reported to be lower in patients with malignant disease when compared with benign disease.2,5 Also, Polyflex stents can be removed by endoscopy.
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Abbreviations: PEG-J, PEG-jejunostomy; SEMSs, self-expanding metal stents. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
Adler et al
Polyflex stents may be appropriate for the management of malignant dysphagia in patients with locally advanced esophageal cancer. In general, these patients are candidates for neoadjuvant chemoradiation and experience ongoing dysphagia and weight loss before and during treatment. In the cohort of patients who respond to neoadjuvant therapy, a Polyflex stent could function as a temporary palliative measure until definitive surgical resection. The stent could either be removed by endoscopy immediately before or at the time of surgery. In patients without a response or with progressive disease, the Polyflex stent could be left in place indefinitely for palliation. In this prospective, nonrandomized, single-institution study, we report our experience with placing Polyflex stents in patients with locally advanced esophageal carcinoma who were to undergo neoadjuvant therapy. This stent was specifically chosen, given that it was easily removable, would not interfere with follow-up imaging (CT, CT–positron emission tomography, or magnetic resonance imaging) and would minimize difficulties for surgeons at the time of esophagectomy. The stents were placed immediately after EUS staging (while the patient was still under sedation) in appropriate patients, in an effort to provide rapid improvement in dysphagia and to allow oral feeding during neoadjuvant therapy. The aim of the study was to evaluate the effectiveness of this device in this specific setting with regard to relief of malignant dysphagia during neoadjuvant therapy.
Placement of stents in patients with esophageal cancer
Capsule Summary What is already known on this topic d
Neoadjuvant therapy, the current standard of care for patients with locally advanced esophageal cancer, may improve dysphagia but can take time.
What this study adds to our knowledge d
d
Polyester mesh stents were successfully placed in 13 patients with locally advanced esophageal cancer causing dysphagia and resulted in significantly improved dysphagia scores. Stent migration occurred in 46% of patients.
such as magnetic resonance imaging, CT, or CT–positron emission tomography. Polyflex stents can also be removed much more easily than can metal stents if need be. Dysphagia was graded before the procedure on a 5point scale as follows: 0, normal; 1, solid-food dysphagia weekly; 2, solid-food dysphagia daily (able to swallow semisolid foods at least 50% of the time); 3, solid-food dysphagia daily (able to swallow semisolid foods less than 50% of the time); 4, unable to swallow semisolid foods; and 5, unable to swallow secretions.6
Endoscopic procedure
This study was performed at the University of Utah School of Medicine/Huntsman Cancer Center. Between April 2006 and November 2007, patients referred for EUS staging who met entry criteria were enrolled in the study. Patients were observed until death or stent removal, or until 6 months had elapsed after stent placement (whichever came first). Informed consent was obtained before EUS. Inclusion criteria were the following: (1) patients R18 years of age, with biopsy-confirmed esophageal cancer (either adenocarcinoma or squamous-cell carcinoma), (2) locally advanced esophageal carcinoma (defined as at least stage IIa), and the absence of distant metastatic disease as assessed by physical examination, CT, and EUS in patients who were thought to be candidates for neoadjuvant therapy, and (3) symptoms of dysphagia. This study was approved by the institutional review board at the University of Utah Health Sciences Center. Polyflex stents were used, because it is the policy of our institution not to place metal esophageal stents in patients with potentially resectable esophageal cancer. In our experience metal stents can interfere with restaging studies,
A radial echoendoscope (13.8-mm outer diameter) and a linear echoendoscope (13.8-mm outer diameter) (GIFUE160 and GF-UC140P, respectively; Olympus Endoscopy, Center Valley, Pa) were used for all examinations. EUS examinations were performed with the patient in the left lateral decubitus position on the fluoroscopy table. EUS examinations were performed by experienced endosonographers (D.G.A., J.W., and R.W.), all of whom had performed at least 500 EUS examinations before the initiation of the study. Patients were considered for placement of a Polyflex stent based on tumor and lymph-node staging as seen by EUS, as well as based on the results of EUS-guided FNA of the lymph nodes of concern. Patients with uT3Nx or uTxN1 esophageal cancers who were thought to be candidates for neoadjuvant therapy and in whom it was thought that surgery was likely to occur then underwent stent placement immediately after EUS. After the EUS examination, the patients were placed in the supine position. Stents were deployed in the standard manner over guidewires and with the aid of fluoroscopy. Dilation to facilitate either the EUS examination or stent placement (to accommodate the 12-mm-wide stent delivery catheter) was performed if it was thought to be warranted by the endoscopist. The stents were placed by the same physician who performed the EUS examination. All 3 endoscopists had extensive experience with Polyflex stents. Stents were sized based on the location and size of the tumor, the length and severity of the stricture, and the
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PATIENTS AND METHODS Patients
Placement of stents in patients with esophageal cancer
diameter of the proximal and distal esophagus. Endoscopic and fluoroscopic confirmation of an adequate stent position was obtained. The patients were advised to use over-the-counter proton pump inhibitors as needed after stent placement.
Postprocedure evaluation and follow-up Patients were prospectively assessed for dysphagia by telephone calls at 1-week intervals for 1 month and then at monthly intervals until stent removal (endoscopic or surgical) or death. Data on the dysphagia score, immediate and early complications after the procedure (up to 1 week), and late complications (occurring O1 week after stent placement) were collected. Patients were weighed before stent placement. Dysphagia scores were obtained via telephone. Patients were reevaluated by endoscopy and/or chest radiographs, as needed, to evaluate the position and patency of the stent.
Statistical analysis Dysphagia scores were analyzed as nonparametric data by using the Wilcoxon signed rank test. A P value!.05 was considered significant.
Adler et al
TABLE 1. Patient demographics Parameter Mean age (y) Men, no. (%)
Result 63.3 (range 45-83) 13 (100)
Type, no. (%) Adenocarcinoma Squamous cell
11 (85) 2 (15)
Location, no. (%) Middle
1 (8)
Middle-lower
3 (23)
Lower
9 (69)
Mean length (cm) Mean serum albumin (mg/dL)
7.3 (range 5-15) 3.9 (3.3-4.5)
Balloon dilation at time of endoscopy, no. (%) No
7 (54)
Yes
6 (46)
Mean dysphagia score
3 (range 2-5)
RESULTS During the study period, 31 patients were referred for evaluation of esophageal cancer. Patients with disease that was unresectable at presentation were not offered enrollment in the study. All patients who were potential surgical candidates and in whom neoadjuvant therapy was planned were offered enrollment, and this constituted the 13 patients who met entry criteria and were enrolled in the study. All patients were men, with a mean (SD) age of 63.3 12.3 years (range 45-83 years). Eleven patients had a diagnosis of adenocarcinoma (85%), and 2 patients (15%) had squamous-cell cancer. The mean tumor length was 7.3 cm (range 5-15 cm). Tumors were located in the mid esophagus in 1 patient, the mid to distal esophagus in 3 patients, and the distal esophagus in 9 patients. Eight patients had circumferential tumors; the other patients had tumors that were partially circumferential. Seven patients (54%) required balloon dilation (range 12-16.5 mm, although only one patient underwent dilation to 16.5 mm) to allow passage of the EGD scope and/or the echoendoscope or to facilitate stenting. Six patients required no dilation at all. Endoscopy was performed with the patient under conscious sedation (by using either a combination of intravenous midazolam and fentanyl, or propofol and fentanyl) in 9 of 13 patients (69%) and under general anesthesia in 4 of 13 patients (31%). These data are summarized in Table 1. Nine of 13 patients had their disease staged as uT3N1, one patient’s disease was staged as uT3N0, one patient’s disease was staged as uT2N1. Two patients had their disease staged as uT4N1.
These 2 patients had borderline aortic involvement and were thought to be candidates for neoadjuvant therapy per institutional protocol. All 13 patients underwent stent placement. Stents lengths used were either 9 or 15 cm long, and stent widths ranged from 16 to 20 mm and 21 to 25 mm (the center diameter and the proximal stent diameter, respectively). All stents were inserted via a 12-mm delivery catheter. In 2 patients, the position of the stent after placement was thought to be suboptimal, and the stent was removed and redeployed in proper position at the same procedure. In the remaining 11 patients, initial stent deployment was successful, with good positioning on the first attempt. There were no perforations and no episodes of bleeding. Immediate complications included some degree of chest discomfort after stent placement in 12 of 13 patients. Chest pain severity did not correlate with the size or location of stents. Chest discomfort was generally mild to moderate, although 1 patient complained of severe discomfort after the procedure and required admission for observation. This patient had severe pain, despite narcotic analgesic medications, and the stent was removed 2 days later because of patient intolerance, which resulted in relief of pain. One patient experienced stent migration 2 days after initial placement and underwent removal of the stent, with subsequent placement of a new Polyflex stent, without difficulty. Twelve of 13 patients were discharged to home the same day. All patients were given a prescription for oral narcotic analgesics. With
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the exception of the aforementioned patient with intractable pain, all patients had resolution of chest pain within 7 days. All patients were offered neoadjuvant therapy, with chemotherapy combined with radiation therapy. Neoadjuvant therapy was typically started 2 weeks after stent placement. Twelve of 13 patients elected to proceed with neoadjuvant therapy. One patient opted for palliation only and declined neoadjuvant therapy. The Polyflex stent in this patient was left in place as a palliative measure. Stents remained in place for a mean of 65.9 days (range 2-180 days). The mean dysphagia score at the time of stent placement was 3. Mean dysphagia scores obtained at 1, 2, 3, and 4 weeks after stent placement were 1.1 (P Z .005), 0.8 (P Z .01), 0.9 (P Z .02), and 1.0 (P Z .008), respectively. All the dysphagia scores were significantly improved when compared with baseline. Afterward, the dysphagia scores were obtained on a monthly basis until stent removal or patient death, although patients started to exit the study because of surgery or death after the 1-month time point, which limited analysis because of few data points. Stent migration occurred at some point in 6 of 13 patients (46%). Five of these patients underwent stent removal at a mean of 6.4 weeks (range 2-48 days). Three of the 6 patients (50%) with migrated stents underwent esophagectomy at a mean of 8.5 weeks after stent placement. One of 6 migrated stents was removed from the stomach during esophagectomy; 5 of 6 were removed via EGD. Two patients (15%) required PEG tubes during follow-up for supplemental caloric intake. In one of these patients, his stent had migrated, and there was a patent esophageal lumen, but the oncology service thought that supplemental nutrition was required. Two patients died with stents in place. One patient developed neutropenic fever with a rash and hypokalemia during neoadjuvant therapy, which was managed medically and thought to be unrelated to the stent. These data are summarized in Table 2.
Placement of stents in patients with esophageal cancer
TABLE 2. Outcomes after stent placement Mean (%)
Range
65.9
2-180
Wk 1 (n Z 11)
1.1
0-4
.005
Wk 2 (n Z 9)
0.8
0-3
.01
Wk 3 (n Z 8)
0.9
0-3
.02
Wk 4 (n Z 9)
1
0-4
.008
Parameter Days of follow-up with stent in situ (n Z 13)
P value
Dysphagia scores
Final outcomes (n Z 13) Migrations
6 (46)
Tumor overgrowth
1 (8)
Esophagectomy
3 (23)
PEG tubes placed with stent in situ
2 (15)
Chemoradiation therapy
12 (93)
Death with stent in situ
2 (15)
Most patients with locally advanced esophageal cancer have malignant dysphagia, and the current standard of care in the United States is to offer these patients neoadjuvant therapy.7,8 The goal of such therapy is to decrease tumor burden and to eradicate malignant lymphadenopathy.9 Neoadjuvant therapy can improve dysphagia symptoms via decreasing tumor size and increasing the esophageal luminal diameter, but this can take time. In addition, some patients will experience a worsening of their dysphagia because of mucositis, and these patients often require enteral feeding.10 Nasogastric tubes, gastrostomy (PEG) tubes, gastrojejunostomy (PEG-jejunostomy [PEG-J] tubes, and direct jejunostomy tubes are all effective options for delivering both hydration and nutrition, but none allow
oral feeding.11-14 Although some investigators have stated that PEG or PEG-J tubes are safe in these patients, this is a controversial issue, with some concerns regarding whether or not a prior PEG or PEG-J leads to worse operative outcomes.15 The Polyflex stent is a self-expanding plastic stent and is established to be useful in a variety of esophageal diseases, both benign and malignant. These include treatment of malignant dysphagia, benign esophageal strictures, and esophageal leaks and fistulas.16-21 As of this writing, the Polyflex stent is the only U.S. Food and Drug Administration–approved and commercially available self-expanding plastic esophageal stent in the United States. Early studies of this device demonstrated relief of dysphagia that was thought to be roughly comparable with that seen with SEMSs, although the rate of migration with these devices is relatively high (4.5%-37%),1,3,22 Drawbacks to this device include a relatively thick and rigid delivery catheter, which typically requires esophageal dilation before deployment, and a complicated delivery system.23 The current study aimed to provide immediate relief of malignant dysphagia and to ameliorate nutritional deterioration via the placement of Polyflex stents as soon as patients with esophageal cancer were thought to be candidates for neoadjuvant therapy. This study was novel in that it was the first study to prospectively evaluate this device in this specific context. This study was also novel in another respect, because the stents were placed
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DISCUSSION
Placement of stents in patients with esophageal cancer
at the same time that EUS staging was performed, thus saving the patients a second procedure and allowing oral intake to resume as quickly as possible. Although the investigators recognize that the Polyflex stent may not be the ideal esophageal stent for all clinical situations, we thought that, in this setting, this device was the best one to undergo formal study in this context, given its removability, metal-free design, and lack of interference with standard imaging modalities (which would be more prominent with metal stents and would have complicated subsequent restaging evaluations). In this study, stents were successfully placed in all patients. Perforations during EUS and stent placement in patients in esophageal cancer have been reported but did not occur in this study.24 Immediate complications were limited to chest pain, which was severe in one patient and required stent removal. Migration was a common problem and occurred in just under half of all patients at some point. Some of these migrations were likely a consequence of the stent design, whereas others were likely a sign that the patients were responding to neoadjuvant therapy (because of a decrease in the severity of the malignant esophageal stricture, which allowed the stent to anchor in place). Migration of the stent did not necessarily trigger an automatic stent replacement, because often the lumen was thought to be adequate for at least a liquid diet (comparable with what could be introduced via a PEG tube). Dysphagia scores improved compared with baseline in a statistically significant manner at all time points during the first month after stent placement. Dysphagia scores continued to stay low thereafter, but, as patients started to exit the study via surgery or death, there were inadequate data points for further statistical analysis. Polyflex stents were previously evaluated in a similar context in a limited manner in 2 smaller retrospective studies. Siddiqui et al25 published a retrospective study of 6 patients with malignant dysphagia who underwent Polyflex stent placement before neoadjuvant therapy. Stents were placed at some point after an esophageal-cancer diagnosis. Stent placement was successful in 5 of 6 patients. Patients had a statistically significant improvement in dysphagia after the procedure, although scores were only tracked before the procedure, 1 week after the procedure, and at the time of surgery. Another retrospective study that looked at a mixed group of presurgical and postsurgical patients with esophageal cancer included 5 patients in whom Polyflex stents were placed in preparation for neoadjuvant therapy. There was good technical and clinical success in these patients, with oral fluid and nutrition goals met. The stent migration rate in this study was 20%.26 Our study showed good outcomes with regard to improvement in dysphagia scores and a lack of serious complications, although our migration rate was higher than previously reported. No patients were harmed by placement of stents, and patients voiced appreciation for having 2 endoscopic procedures performed in one setting. Patients also were eager to return to oral feed618 GASTROINTESTINAL ENDOSCOPY Volume 70, No. 4 : 2009
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ing and avoid a nasogastric, PEG, or jejunostomy tube during neoadjuvant therapy for a more normal day-to-day life. Although this study has closed, the practice of simultaneous EUS staging and stent placement has been incorporated into clinical practice at our institution. The high migration rate may have been from a variety of factors, including the diameter of the endoscopes used during staging, the frequent need for dilation during placement, and the high rate of patients undergoing neoadjuvant therapy. Only one patient underwent dilation to 16.5 mm. All other patients who required dilation only received dilation to 12 to 15 mm. We believe that neoadjuvant therapy likely played a major role in stent migration, although we acknowledge that dilation could have contributed as well. Neoadjuvant chemoradiation therapy probably played a key role in decreasing tumor size overall, which led to a decrease in the severity of the malignant esophageal stricture and, thus, stent migration. In conclusion, placement of Polyflex stents in patients with locally advanced esophageal cancer at the time of EUS staging to allow oral nutrition and hydration during neoadjuvant therapy appears safe and relatively effective. These stents were chosen because of their lack of interference with subsequent reimaging studies and their removability. Our study is limited by a small number of patients. Patients may be able to avoid nasogastric, PEG, or jejunostomy tube feedings. In this study, stent migration was relatively common in this patient subset. Not all patients with a migrated stent will require stent replacement because the stent migration may be a sign of tumor response to neoadjuvant therapy. Patients who do not proceed to surgery can have the stent left in place as a palliative measure.
REFERENCES 1. Radecke K, Gerken G, Treichel U. Impact of a self-expanding, plastic esophageal stent on various esophageal stenoses, fistulas, and leakages: a single-center experience in 39 patients. Gastrointest Endosc 2005;61:812-8. 2. Conigliaro R, Battaglia G, Repici A, et al. Polyflex stents for malignant oesophageal and oesophagogastric stricture: a prospective, multicentric study. Eur J Gastroenterol Hepatol 2007;19:195-203. 3. Dormann AJ, Eisendrath P, Wigginghaus B, et al. Palliation of esophageal carcinoma with a new self-expanding plastic stent. Endoscopy 2003;35:207-11. 4. Szegedi L, Ga´l I, Ko´sa I, et al. Palliative treatment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol 2006;18:1197-201. 5. Pennathur A, Chang AC, McGrath KM, et al. Polyflex expandable stents in the treatment of esophageal disease: initial experience. Ann Thorac Surg 2008;85:1968-72, discussion 1973. 6. Mellow MH, Pinkas H. Endoscopic laser therapy for malignancies affecting the esophagus and gastroesophageal junction. Analysis of technical and functional efficacy. Arch Intern Med 1985;145:1443-6. 7. Siersema PD, van Hillegersberg R. Treatment of locally advanced esophageal cancer with surgery and chemoradiation. Curr Opin Gastroenterol 2008;24:535-40. 8. Ku GY, Ilson DH. Preoperative therapy in esophageal cancer. Clin Adv Hematol Oncol 2008;6:371-9.
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9. Mougey A, Adler DG. Esophageal stenting for the palliation of malignant dysphagia. J Support Oncol 2008;6:267-73. 10. Stockeld D, Tennvall J, Wagenius G, et al. A Swedish study of chemoradiation in squamous cell carcinoma of the esophagus. Acta Oncol 2001;40:566-73. 11. Stockeld D, Fagerberg J, Granstro¨m L, et al. Percutaneous endoscopic gastrostomy for nutrition in patients with oesophageal cancer. Eur J Surg 2001;167:839-44. 12. Kight CE. Nutrition considerations in esophagectomy patients. Nutr Clin Pract 2008;23:521-8. 13. Sparrow P, David E, Pugash R. Direct percutaneous jejunostomy: an underutilized interventional technique? Cardiovasc Intervent Radiol 2008;31:336-41. 14. Lin CH, Liu NJ, Lee CS, et al. Nasogastric feeding tube placement in patients with esophageal cancer: application of ultrathin transnasal endoscopy. Gastrointest Endosc 2006;64:104-7. 15. Margolis M, Alexander P, Trachiotis GD, et al. Percutaneous endoscopic gastrostomy before multimodality therapy in patients with esophageal cancer. Ann Thorac Surg 2003;76:1694-7; discussion 1697-8. 16. Conio M, Repici A, Battaglia G, et al. A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia. Am J Gastroenterol 2007;102:2667-77. 17. Adler DG, Pleskow DK. Closure of a benign tracheoesophageal fistula by using a coated, self-expanding plastic stent in a patient with a history of esophageal atresia. Gastrointest Endosc 2005;61:765-8. 18. Gelbmann CM, Ratiu NL, Rath HC, et al. Use of self-expandable plastic stents for the treatment of esophageal perforations and symptomatic anastomotic leaks. Endoscopy 2004;36:695-9. 19. Langer FB, Wenzl E, Prager G, et al. Management of postoperative esophageal leaks with the Polyflex self-expanding covered plastic stent. Ann Thorac Surg 2005;79:398-403; discussion 404.
20. Schubert D, Scheidbach H, Kuhn R, et al. Endoscopic treatment of thoracic esophageal anastomotic leaks by using silicone-covered, self-expanding polyester stents. Gastrointest Endosc 2005;61:891-6. 21. Freeman RK, Ascioti AJ, Wozniak TC. Postoperative esophageal leak management with the Polyflex esophageal stent. J Thorac Cardiovasc Surg 2007;133:333-8. 22. Szegedi L, Ga´l I, Ko´sa I, et al. Palliative treatment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol 2006;18:1197-201. 23. Radecke K, Gerken G, Treichel U. Impact of a self-expanding, plastic esophageal stent on various esophageal stenoses, fistulas, and leakages: a single-center experience in 39 patients. Gastrointest Endosc 2005;61:812-8. 24. American Society for Gastrointestinal Endoscopy, Adler DG, Jacobson BC, et al. Complications of EUS. Gastrointest Endosc 2005;61:8-12. 25. Siddiqui AA, Loren D, Dudnick R, et al. Expandable polyester siliconcovered stent for malignant esophageal strictures before neoadjuvant chemoradiation: a pilot study. Dig Dis Sci 2007;52:823-9. 26. Martin R, Duvall R, Ellis S, et al. The use of self-expanding silicone stents in esophageal cancer care: optimal pre-, peri-, and postoperative care. Surg Endosc 2009;23:615-21.
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Received December 8, 2008. Accepted January 15, 2009. Current affiliations: Division of Gastroenterology and Hepatology, Huntsman Cancer Center, University of Utah School of Medicine, Salt Lake City, Utah, USA. Reprint requests: Douglas G. Adler, MD, Gastroenterology and Hepatology, 30N 1900E 4R118, University of Utah, Salt Lake City, UT 84132. If you would like to chat with an author of this article, you may contact him at [email protected]; [email protected].