- Email: [email protected]
Palliation of malignant dysphagia and fistulae with coated expandable metal stents: experience with 101 patients
Palliation of malignant dysphagia and fistulae with coated expandable metal stents: experience with 101 patients Isaac Raijman, MD, Iqbal Siddique, MD, Jaffer Ajani, MD, Patrick Lynch, MD Houston, Texas
Background: Insertion of coated expandable esophageal stents is the preferred endoscopic palliative treatment for malignant dysphagia and digestiverespiratory fistulae. Methods: One hundred one patients with malignant dysphagia and digestiverespiratory fistulae, 83 due to esophageal cancer and 18 due to metastatic disease, underwent placement of a coated expandable metal stent. Thirteen patients had a digestive-respiratory fistula. The stricture location (99 patients) was proximal in 11, mid in 29, distal in 37, and at the gastroesophageal junction in 24. The endoscopic appearance was exophytic in 80, infiltrative in 19, single ulcer in 1, and normal in 1. The mean stricture length was 6.7 cm. Results: Initial stent placement was successful in 100 patients; a second stent was required in 1. The median dysphagia grade improved from 3.6 to 1.4 and sealing-off of the digestive-respiratory fistula was successful in all cases. The overall complication rate was 37.9%. Life-threatening complications occurred in 7.9%. There were no procedure-related deaths. During a mean follow-up of 201 days, 99 patients died—none from stent-related problems. Conclusions: This large series confirms the efficacy of the coated metal expandable stent in the palliation of malignant dysphagia and digestiverespiratory fistula with an acceptable complication rate. (Gastrointest Endosc 1998;48:172-9.)
Dysphagia is the most common and disabling symptom in the majority of patients with esophageal cancer. At presentation, over 60% of patients have unresectable tumors.1 The most realistic goal is to provide relief of dysphagia, which in turn may improve nutritional status, sensation of well being, and overall quality of life.2 This is clearly the case for patients with mediastinal metastatic disease and for those with digestive-respiratory fistulae. Of the different endoscopic and non-endoscopic methods of palliation for nonoperable malignant dysphagia and digestive-respiratory fistulae, expandable stents are Received July 23, 1997. For revision November 4, 1997. Accepted March 29, 1998. From the Division of Gastroenterology, M. D. Anderson Cancer Center, Houston, Texas. Presented as abstract and poster at the annual meeting of the American Society for Gastrointestinal Endoscopy, DDW, May 1720, 1997, New Orleans, Louisiana. (Gastrointest Endosc 1997;47:AB78). Reprints requests: Isaac Raijman, MD, 1200 Binz, Suite 480, Houston, TX 77004. Copyright © 1998 by the American Society for Gastrointestinal Endoscopy 0016-5107/98/$5.00 + 0 37/1/90684 172
GASTROINTESTINAL ENDOSCOPY
preferred. Expandable stents provide immediate relief of dysphagia, may be placed in an outpatient setting, require only one treatment session, and are cost effective compared with two plastic stents.3 We report our experience, the largest thus far published, in 101 patients using a single stent design placed endoscopically in patients with malignant dysphagia and digestive-respiratory fistulae. PATIENTS AND METHODS
Demographics and clinical presentation From November 1994 to November 1996, 101 patients with unresectable malignant dysphagia and digestiverespiratory fistulae were treated with the coated WallstentI (Schneider, Minneapolis, Minn.). There were 63 men and 38 women, with a mean age of 70.3 years (range 25 to 90 years). Clinical presentations and characteristics are given in Table 1. Of the 13 patients with digestive-respiratory fistula, two required mechanical ventilation for respiratory failure. The dysphagia median score was 3.6 and was graded as follows: grade 0, normal swallowing; grade 1, unable to swallow solids; grade 2, unable to swallow semisolids; grade 3, unable to swallow liquids; grade 4, unable to swallow own saliva.4 Previous therapy is outlined in Table 1. Patients with cervical malignancies with approximately 1 cm or more of normal esophageal mucosa distal to the VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Table 1. Demographics and clinical presentation in 101 patients with malignant dysphagia and digestiverespiratory fistulae Gender (M/F) Mean age (yr) (range) Esophageal cancer Metastatic cancer Dysphagia only Dysphagia + respiratory symptoms Respiratory symptoms only Median dysphagia score Previous therapy Chemoradiation Rx Surgery Nd-YAG laser Bougienage Other expandable stents
I Raijman, I Siddique, J Ajani, et al.
tion o f the
63/38 70.3 (range 25-90) 46 squamous, 37 adenocarcinoma 18 88 11 2 3.6 80* 27 22 80 5
*Ongoing in 11 patients at stent insertion.
Table 2. Endoscopic and radiographic findings in 101 patients with malignant dysphagia and digestiverespiratory fistulae Stricture Stricture location Proximal (cervical) Mid (mid-thoracic) Distal (distal thoracic) Gastroesophageal junction Mean stricture length (cm) (range) Digestive-respiratory fistulae Endoscopic characteristics Exophytic Infiltrative Ulcerative Normal Fistula
99 patients 11 29 37 24 6.9 (2-11) 13 80 19 1 1 13
upper esophageal sphincter were included. Exclusion criteria included moribund state, an expected survival of less than 3 months, tumor bleeding before stent placement, and extensive tumor involvement of the stomach. Because dysphagia reflects only one aspect of the multidimensionality of quality of life, which is composed of the multifaceted aspects of day-to-day living, we also assessed the quality of life according to The European Organization for Research and Treatment of Cancer (EORTC). 5 The EORTC questionnaire incorporates scales of general symptoms and functional, working, cognitive, emotional, and social ability, as well as measurements of financial strain and global quality of life. Endoscopic and radiographic findings Endoscopy was performed in all patients, and a preendoscopic barium swallow was performed in 87. The locaVOLUME 48, NO. 2, 1998
Figure 1. Delivery apparatus (left ) and Wallstent-I (right ); stent is shown with deployed configuration.
strictures, present in 99 patients, is given in Table 2. The mean length of the stricture was 6.9 cm (range 2 to 11 cm). The endoscopic characteristics of the lesion are also presented in Table 2. In all 13 patients with a digestive-respiratory fistulae, the lesion was identified at the time of endoscopy. Wallstent characteristics and placement The Wallstent-I is a two-layer stainless steel mesh with a polyurethane coating (Permalume) between the wires (Fig. 1). One centimeter on each end of the stent is not coated. The stent is constrained in a 38F delivery system and, after deployment, expands to 28 mm at each end and 22 mm over the greater length between the two ends. Approximately a 20% shortening of the stent can be expected after deployment. The stent was placed in all GASTROINTESTINAL ENDOSCOPY
173
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Figure 2. Sequential fluoroscopic view of placement of an esophageal Wallstent-I. A, Contrast injection at the tumor margins; B, advancement of guidewire through stricture; C, Wallstent-I being placed through stricture; D, full expansion of Wallstent-I after deployment. cases under intravenous sedation and with the head of the fluoroscopy table elevated to 30 degrees. Esophageal dilation was carried out to 42F in the initial 22 patients, to 38F to 39F in the next 22 patients, and either enough to advance the endoscope (27F) or not at all in the last 57 patients.6 All patients underwent injection of contrast at the tumor margins or 1 to 2 cm away from the lesion into normal mucosa with an x-ray contrast medium as previously described7 (Fig. 2A). In all patients with a fistula, contrast was also injected at the site of the fistula. In the patient with a fistula and a normal esophagus, only the site of the fistula was marked. In all patients with a cervical stricture, contrast was injected just distal to the upper esophageal sphincter in addition to the other mark174
GASTROINTESTINAL ENDOSCOPY
er points. Except for the initial 22 patients and according to the anatomic location (particularly cervical strictures), all stents were placed so as to extend at least 2 cm beyond the proximal and distal margins of the lesion. Of the 11 patients with a proximal stricture, the proximal tumor margin was located at approximately 1 cm from the upper esophageal sphincter in 5, 2 cm in 2, and more than 3 cm in 4. According to availability, we used either a 0.038-inch ultrastiff wire, a hydrophilic wire, or the Savary wire (Fig. 2B). Once the radioopaque bands of the stent were in correct position in reference to the injected contrast, the stent was deployed (Fig. 2C and D). In patients with a previously placed expandable stent, placement of the Wallstent-I was carried out in the same fashion (Fig. 3A VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
I Raijman, I Siddique, J Ajani, et al.
Table 3. Results after Wallstent-I placement in 101 patients with malignant dysphagia and digestive-respiratory fistulae Successful placement Initial misplacement Two stents Median dysphagia score Before After Improvement respiratory symptoms Fistulae closure Improvement of well being Mean follow up (days) (range) Other treatments after Wallstent-I Second stent Gastrostomy Nd-YAG laser Overall mortality
101 patients 1 1 3.6 p < 0.05 1.4 13 patients 13 patients 82 patients 201 (16-400) 13 patients 7 4 2 99 patients
}
and B). Stents were successfully placed and deployed in all patients. Early in our experience, in one patient the initial stent was placed too distal and could not be repositioned because of the angulation of the stricture at the gastroesophageal junction. A second stent was successfully placed during the same procedure. One patient required 2 stents to entirely bridge the stricture. Stent placement was difficult in 4 patients: because of cervical osteopathy in 3 and breakdown of the fluoroscopy machine in 1. In the latter, the stent was placed under endoscopic guidance by placing the endoscope alongside the stent delivery apparatus. Placement of the stent was difficult in patients with proximal cervical strictures (1 cm from the upper esophageal sphincter), in those with tight and angulated strictures irrespective of location, and in those with previous subtotal gastric resection. Injecting contrast just distal to the upper esophageal sphincter and advancing the guidewire into the small intestine facilitated stent placement in these latter patients. We did not encounter any episodes of tracheal or bronchial obstruction. Bronchoscopy was not performed in any of the patients. Eighty-two of the procedures were performed on an outpatient basis. All patients were allowed a liquid diet the same day of stent placement; this was advanced to semisolids/solids within the first week. Lansoprazole or omeprazole were given to all patients in whom the stent traversed the gastroesophageal junction along with instructions to elevate the head of the bed 6 inches. Patients were encouraged to drink one carbonated beverage daily. All patients were advised to use only non-narcotic analgesics if possible to control pain. Repeat endoscopy and/or barium swallow was performed within the first 2 weeks in the initial 23 patients and a barium swallow in all patients with a digestive-respiratory fistula. For subsequent patients, these studies were performed only if symptom recurrence occurred. The results were assessed as mean values. Significance was tested with the chi-square test. Values of p less than 0.05 were regarded VOLUME 48, NO. 2, 1998
Figure 3. A, Fluoroscopic view of the Wallstent-I delivery apparatus being advanced through a previously placed uncoated Ultraflex stent (Microvasive, Natick, Mass.). B, Fluoroscopic view of the Wallstent-I deployed inside a previously placed uncoated Ultraflex stent. as significant.
RESULTS Symptoms Outcomes for patients are shown in Table 3. The median dysphagia score improved from 3.6 to 1.4. The majority of patients were able to resume taking liquids by mouth within the first day and a semisolid diet within the first week. All fistulae were successfully obliterated as assessed radiographically and endoscopically (Fig. 4A and B). Respiratory symptoms and ventilatory compromise resolved in all patients. The sensation of overall well-being and quality of life improved in 82 patients (data to be published separately). Patients were followed for a mean of 201 days (range 16 to 400 days) by phone call, office visit, or review of the outpatient and/or inpatient records. We did not find a statistically sigGASTROINTESTINAL ENDOSCOPY
175
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Table 4. Complications after Wallstent-I placement in 101 patients with malignant dysphagia and digestiverespiratory fistulae Complication Minor Chest pain Foreign body sensation Gastric ulcer Esophageal ulcer Major Tumor overgrowth Tumor ingrowth Stent migration Life threatening Bleeding Esophageal tear Perforation Aspiration Total Mortality
N (%) 21 13
20.9 12.9
3 2 2 9 6 0 3 8 7 1 0.9 0 0 38 0
2.9 1.9 1.9 8.9 5.9 2.9 7.9 6.9 1
37.9
Early (within Late (after 1 week) 1 week) 13 3 2 2
1*
6 0 3 5
2
26
12
*One patient had continued foreign body sensation until his death.
Figure 4. A, Barium swallow showing opacification of the respiratory tree through a digestive-respiratory fistula. B, Fluoroscopic view of obliteration of the fistula by successfully placed Wallstent-I.
nificant difference in the response to the stent or in complications (described later) between patients who had or did not have chemotherapy. Direct contact was possible in 81 patients, by phone in 34, and by office visit in 47. No direct contact was possible in 20 patients who had come from outside the United States for one single treatment session. During the follow-up, 4 patients underwent percutaneous endoscopic gastrostomy for persistent dysphagia despite stent patency in all; 1 with digestive-respiratory fistula and respiratory insufficiency required longterm non-oral enteral nutrition. Seven patients needed a second stent, 4 for tumor overgrowth and 3 for stent migration. Nd-YAG laser was used for tumor overgrowth in 2 patients, only one session being necessary to establish stent patency in both. Ninety-nine patients died of tumor progression, and 2 were still alive at the time of this report. Complications Early clinical complications were defined as those occurring within the first week of the procedure, whereas delayed clinical complications were those occurring more than 1 week after the procedure. Life-threatening clinical complications were defined 176
GASTROINTESTINAL ENDOSCOPY
as esophageal tear or perforation, bleeding requiring blood transfusion or treatment to achieve hemostasis, or aspiration of gastric contents requiring admission to the hospital. Minor clinical complications were defined as those requiring minimal therapeutic intervention, such as chest pain, foreign body sensation, bloating, gastric ulceration, and esophageal ulceration. Major clinical complications were defined as those requiring more invasive therapeutic intervention, such as stent migration and tumor ingrowth or overgrowth. Early and delayed clinical complications classified by severity are given in Table 4. All bleeding episodes required blood transfusions, and 1 patient required external radiotherapy to achieve hemostasis after endoscopic methods had failed. There were no perforations or episodes of aspiration, and the procedure-related mortality was nil. Because neither endoscopy nor barium swallows were performed in all patients, it is possible that some complications such as tumor ingrowth or overgrowth, esophageal and/or gastric ulceration, or minimal movement of the stent may have been underestimated. However, their presence may not have been of clinical significance as they were not associated with a change to the initial positive response to the stent. We compared the complication rate between the group of patients without chemoradiation therapy (21 subjects) and those receiving chemoradiation therapy (80 subjects). Respectively, bleeding VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
occurred in 3 versus 4 (not significant [NS]), tumor overgrowth in 3 versus 3 (NS), gastric ulceration in 1 versus 1 (NS), chest pain in 3 versus 10 (NS), stent migration in 1 versus 2 (NS). There were no perforations or mortality in either group. The overall complication rate was 52.3% for those without chemotherapy and 28.4% for those with chemotherapy (p < 0.03). DISCUSSION Currently available endoscopic treatments for patients with inoperable malignant dysphagia include balloon dilation or bougienage, thermocoagulation, injection of alcohol and chemotherapeutic agents, photodynamic therapy, intracavitary irradiation, and placement of a prosthesis, either plastic or expandable.3,8-23 Laser ablation and stent placement are the most commonly used methods in Western countries. Expandable esophageal stents proved superior to plastic stents in a recent prospective randomized trial.3 Self-expanding metal stents of different designs have been shown to be highly effective in the palliation of malignant dysphagia.11-23 Self-expanding metal stents offer a number of advantages, including small delivery systems and large luminal diameter, flexible material, less operative sedation and pre-placement dilation, ease of insertion, immediate relief of obstructions, and long patency rates. They are well tolerated by patients and can be placed on an outpatient basis. Mortality related to stent placement has been minimal. Despite these favorable results, there are still a considerable number of immediate (bleeding, perforation, pain) and delayed (stent migration, tumor ingrowth and overgrowth) complications and additional therapy (gastrostomy, stent replacement) is needed in a relatively high proportion of patients. Coating of the stents, in addition to the added benefit for patients with fistula, prevents tumor ingrowth or tissue hyperplasia but may increase the risk of migration. However, some of these complications are technique- and operator-dependent and not necessarily related to stent dysfunction. Early in our experience, stent migration occurred in 3 patients, presumably related to excessive dilation.6 Tumor overgrowth occurred in 6 patients, likely due to initial placement of the stent too close to the tumor margins. By modifying our technique, tumor overgrowth, as well as stent migration, were eliminated. There have been no instances of stent migration since adopting the “no dilation if the endoscope can be advanced through the stricture” policy and no cases of tumor overgrowth since allowing, if possible, at least a 2 cm tumor-free margin at each end of VOLUME 48, NO. 2, 1998
I Raijman, I Siddique, J Ajani, et al.
the stent. Aspiration during the procedure has been completely eliminated by elevating the head of the fluoroscopy table by 30 degrees and by limiting water flushes during the procedure. Our series is the largest thus far published in which a single stent design was used. Most reports of palliation with the Wallstent have included the uncoated stent, different stent diameters, different endoscopic techniques, and a relatively small number of patients.20,23,24 Complications in our series were largely minor and self-limited. The overall clinical complication rate was 37.9%, 38 of 101 patients. Of these, 21 (20.9%) were minor, 9 (8.9%) were major, and 8 (7.9%) were life threatening (Table 4). It is likely that some of these complications, such as bleeding and chest pain, occur as a result of pressure necrosis from the stent, in a similar fashion as that which occurs with plastic stents.25 Although the expansile force of the expandable stent may produce similar pressure necrosis, it is difficult to distinguish with absolute certainty whether delayed bleeding is due to the stent, tumor progression, spontaneous tumor bleeding, or in some instances further chemotherapy or radiation. Our results compared favorably to those reported by other authors.19 Stent modifications, such as decreasing the expansile force, should decrease the rate of certain complications. Although it has been suggested that prior radiation or chemotherapy or esophageal surgery may increase the complication rate with insertion of the modified Z stent,26 we initially did not find a statistically significant difference.27 However, with a larger number of patients, a statistically significant difference was found. Of the 21 patients without prior chemoradiation therapy, there were 3 with bleeding, 3 with tumor overgrowth, 1 with gastric ulceration, 3 with chest pain, and 1 with stent migration. Of the 80 patients who received chemoradiation therapy, there were 4 patients with bleeding, 3 with tumor overgrowth, 1 with an esophageal tear, 2 with esophageal ulcers, 1 with gastric ulceration, 10 with chest pain, and 2 with stent migration. There were no perforations or mortality in either group. The overall complication rate was 52.3% for those with no prior chemotherapy and 28.4% for those who had undergone chemotherapy (p > 0.03); the incidence of serious and/or life-threatening complications was 14% and 6%, respectively (NS). Data from our first 60 patients disclosed life-threatening complications in 14.3% of patients without prior therapy compared with 8% with prior therapy (NS).27 These results differ from those of Kinsman et al.26 This may be related to the differences in technique and the stent used. Although we recognize the limitations of a GASTROINTESTINAL ENDOSCOPY
177
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
nonrandomized study such as ours, which may allow bias in the selection of patients, some complications potentially related to the stent itself, such as bleeding and fistula formation, may not necessarily be related to the initial decision to give chemoradiation therapy and may simply reflect the local interaction of the stent and the tumor. Digestive-respiratory fistulae occur in approximately 5% to 15% of patients with esophageal cancer and have a high mortality due to recurrent pulmonary complications.28-32 The currently available literature includes only a small number of patients with digestive-respiratory fistulae treated with various metallic expandable stents. The coated Wallstent had a 100% efficacy in sealing off the fistulous tract and relieving the respiratory symptoms in 13 patients in our series, when mechanical ventilation was required.34 Placement of expandable stents is easy, but it is important to recognize that there is an inherent and required learning curve. Factors that may increase the difficulty of placement and expansion of the stent include improperly placed markers indicating the edges of the stricture; a tortuous, hard, and acutely angulated stricture; previous subtotal gastric surgery; and proximal cervical strictures. Placement of the stent with minimal or no esophageal dilation (if possible), with the ends at least 2 cm from each tumor margin (if possible), as well as elevation of the patient’s head on the fluoroscopy table during the procedure can prevent complications. It is also important to properly select patients for expandable esophageal stenting. This will allow for best possible results, avoiding potential complications, unrealistic expectations, and incurring unnecessary use of resources and costs. Palliation of malignant dysphagia and digestiverespiratory fistula with the coated Wallstent-I is effective with a low morbidity and no mortality, including palliation for patients with previous or ongoing chemoradiation therapy. REFERENCES 1. DeMeester TR, Barlow AP. Surgery and current management for cancer of the esophagus and cardia: Part II. Curr Probl Surg 1988;25:540-605. 2. Angueira CE, Kadakia SC. Esophageal stents for inoperable esophageal cancer: Which to use? Am J Gastroenterol 1997;92:373-6. 3. Knyrim K, Wagner HJ, Bethge N, Keymling M, Vakil N. A controlled trial of expansile metal stent for palliation of esophageal obstruction due to inoperable cancer. N Engl J Med 1993;329:1302-7. 4. 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.
178
GASTROINTESTINAL ENDOSCOPY
5. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76. 6. Raijman I, Siddique I, Ajani J, Lynch P. How much dilation (if any) is necessary prior to placement of an esophageal Wallstent [abstract]? Gastrointest Endosc 1997;45:213. 7. Raijman I, Kortan P, Marcon N, Haber G. The use of contrast injection to identify tumor margins during expandable esophageal stent placement. Gastrointest Endosc 1994;40: 222-4. 8. Loizou LA, Grigg D, Atkinson M, Robertson C, Brown SG. A prospective comparison of laser therapy and intubation in endoscopic palliation for malignant dysphagia. Gastroenterology 1991;100:1303-10. 9. Sander R, Hagenmuller F, Sander C, Riess G, Classen M. Laser versus laser plus afterloading with iridium 192 in the palliative treatment of malignant stenosis of the esophagus: a prospective, randomized and controlled study. Gastrointest Endosc 1991;37:433-9. 10. Payne-James JJ, Spiller RC, Misiewicz JJ, Silk DB. Use of ethanol-induced tumor necrosis to palliate dysphagia in patients with esophagogastric cancer. Gastrointest Endosc 1990;36:43-6. 11. Wright RA, O’Conner KW. A pilot study of endoscopic injection chemo/sclerotherapy of esophageal carcinoma. Gastrointest Endosc 1990;36:47-8. 12. Heier SK, Rothman K, Heier LM, Rosenthal WS. Photodynamic therapy for obstructing esophageal tumors: efficacy, safety, light dosimetry and results of an ongoing randomized trial [abstract]. Gastrointest Endosc 1991;37:187. 13. Raijman I, Walden D, Kortan P, Haber GB, Fuchs E, Siemens M, et al. Expandable esophageal stents: initial experience with a new nitinol stent. Gastrointest Endosc 1994;40:614-21. 14. Schaer J, Katon RM, Ivancev K, Uchida B, J Rosch, Binmoeller KF. Treatment of malignant esophageal obstruction with silicone-coated metallic self-expanding stents. Gastrointest Endosc 1992;38;7-11. 15. Cwikiel W, Stridbeck H, Tranberg KG, von Holstein CS, Hambraeus G, Lillo-Gil R, et al. Malignant esophageal stricture: treatment with self-expanding nitinol stent. Radiology 1993:187:661-5. 16. Jones WF, Raijman I, Akerman P, Khandelwal M, Siemens M, Kandel G, et al. Endoscopic palliation of malignant obstruction with expandable esophageal stents (EES) [abstract]. Gastrointest Endosc 1994;40:246. 17. Parekh P, Lynch P, Sinicrope F, Raijman I. Coated expandable esophageal stents (CEES) in the treatment of malignant dysphagia [abstract]. Am J Gastroenterol 1995;90:56. 18. Kozarek RA. Expandable endoprostheses for gastrointestinal stenoses. Gastrointest Endosc Clin N Am 1994;4:279-95. 19. Vermeijden JR, Bartelsman JFWM, Fockens P, Meijer R, Tytgat G. Self-expanding metal stents for palliation of esophagocardial malignancies. Gastrointest Endosc 1995;41: 58-63. 20. Ell C, Hochberger J, May A, Wolfgang F, Eckhart H. Coated and uncoated self-expanding metal stents for malignant stenoses in the upper GI tract: preliminary clinical experiences with Wallstent. Am J Gastroenterol 1994;89:1496-500. 21. Hoepffner N, Foerster EC, Kautz G, Domschke W. Polyurethane-covered mesh stent for malignant esophageal stenosis with fistulas [abstract]. Gastrointest Endosc 1994;40:651. 22. Kozarek RA, Ball TJ, Brandabur JJ, Patterson DJ, Low D, Hill
VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
23.
24.
25.
26.
27.
L, et al. Expandable versus conventional esophageal prostheses: easier insertion may not preclude subsequent stentrelated problems. Gastrointest Endosc 1996;43:204-8. Neuhaus H, Hoffmann W, Dittler HJ, Niedermeyer HP, Classen M. Implantation of self-expanding esophageal metal stents for palliation of malignant dysphagia. Endoscopy 1992;24:405-10. Bethge N, Knyrim K, Wagner HJ, Starck E, Pausch J, Kleist DV. Self-expanding metal stents for palliation of malignant esophageal obstruction. A pilot study of eight patients. Endoscopy 1992;24:411-5. den Hartog Jager FCA, Bartelsman JFWM, Tytgat GN. Palliative treatment of obstructing esophageal malignancy by endoscopic positioning of a plastic prosthesis. Gastroenterology 1979;77:1008-14. Kinsman KJ, DeGregorio BT, Katon RM, Morrison K, Saxon RR, Keller FS, et al. Prior radiation and chemotherapy increase the risk of life-threatening complications after insertion of metallic stents for esophagogastric malignancy. Gastrointest Endosc 1996;43:196-203. Raijman I, Sinicrope F, Leveritt S, Naranjo K, Ahmed M, Glober G, et al. Does chemo-radiation therapy (ChXRT) increase the incidence of complications after self-expanding coated stents (cEES) in the management of malignant esophageal strictures
VOLUME 48, NO. 2, 1998
I Raijman, I Siddique, J Ajani, et al.
[abstract]? Gastrointest Endosc 1996;43:210. 28. Raijman I, Siddique I, Ajani J, Lynch P. Palliation of malignant dysphagia with chemoradiation therapy (CHXRT) does not increase the rate of serious complications with coated Wallstent [abstract]. Gastrointest Endosc 1997;45:216. 29. Martini N, Goodner JT, D’Angio GJ, Beattie EJ. Tracheoesophageal fistula due to cancer. J Thorac Cardiovasc Surg 1970;59:319-24. 30. Little AG, Ferguson MK, DeMeester TR, Hoffman PC, Skinner DB. Esophageal carcinoma with respiratory fistula. Cancer 1984;53:1322-8. 31. Duranceau A, Jamieson GG. Malignant tracheoesophageal fistula. Ann Thorac Surg 1984;37:346-54. 32. Symbas PN, McKeown PP, Hatcher CR, Vlasis SE. Tracheoesophageal fistula from carcinoma of the esophagus. Ann Thorac Surg 1984;38:382-6. 33. Burt M, Diehl W, Martini N, Bains MS, Ginsberg RJ, McCormack PM, et al. Malignant esophageal fistula: management options and survival. Ann Thorac Surg 1991;52: 1222-8. 34. Raijman I, Sinicrope F, Leveritt S, Naranjo K, Ahmed M, Glober G, et al. Management of digestive-respiratory fistulae (DRF) with coated expandable esophageal stents (cEES) [abstract]. Gastrointest Endosc 1996;43:211.
GASTROINTESTINAL ENDOSCOPY
179
Background: Insertion of coated expandable esophageal stents is the preferred endoscopic palliative treatment for malignant dysphagia and digestiverespiratory fistulae. Methods: One hundred one patients with malignant dysphagia and digestiverespiratory fistulae, 83 due to esophageal cancer and 18 due to metastatic disease, underwent placement of a coated expandable metal stent. Thirteen patients had a digestive-respiratory fistula. The stricture location (99 patients) was proximal in 11, mid in 29, distal in 37, and at the gastroesophageal junction in 24. The endoscopic appearance was exophytic in 80, infiltrative in 19, single ulcer in 1, and normal in 1. The mean stricture length was 6.7 cm. Results: Initial stent placement was successful in 100 patients; a second stent was required in 1. The median dysphagia grade improved from 3.6 to 1.4 and sealing-off of the digestive-respiratory fistula was successful in all cases. The overall complication rate was 37.9%. Life-threatening complications occurred in 7.9%. There were no procedure-related deaths. During a mean follow-up of 201 days, 99 patients died—none from stent-related problems. Conclusions: This large series confirms the efficacy of the coated metal expandable stent in the palliation of malignant dysphagia and digestiverespiratory fistula with an acceptable complication rate. (Gastrointest Endosc 1998;48:172-9.)
Dysphagia is the most common and disabling symptom in the majority of patients with esophageal cancer. At presentation, over 60% of patients have unresectable tumors.1 The most realistic goal is to provide relief of dysphagia, which in turn may improve nutritional status, sensation of well being, and overall quality of life.2 This is clearly the case for patients with mediastinal metastatic disease and for those with digestive-respiratory fistulae. Of the different endoscopic and non-endoscopic methods of palliation for nonoperable malignant dysphagia and digestive-respiratory fistulae, expandable stents are Received July 23, 1997. For revision November 4, 1997. Accepted March 29, 1998. From the Division of Gastroenterology, M. D. Anderson Cancer Center, Houston, Texas. Presented as abstract and poster at the annual meeting of the American Society for Gastrointestinal Endoscopy, DDW, May 1720, 1997, New Orleans, Louisiana. (Gastrointest Endosc 1997;47:AB78). Reprints requests: Isaac Raijman, MD, 1200 Binz, Suite 480, Houston, TX 77004. Copyright © 1998 by the American Society for Gastrointestinal Endoscopy 0016-5107/98/$5.00 + 0 37/1/90684 172
GASTROINTESTINAL ENDOSCOPY
preferred. Expandable stents provide immediate relief of dysphagia, may be placed in an outpatient setting, require only one treatment session, and are cost effective compared with two plastic stents.3 We report our experience, the largest thus far published, in 101 patients using a single stent design placed endoscopically in patients with malignant dysphagia and digestive-respiratory fistulae. PATIENTS AND METHODS
Demographics and clinical presentation From November 1994 to November 1996, 101 patients with unresectable malignant dysphagia and digestiverespiratory fistulae were treated with the coated WallstentI (Schneider, Minneapolis, Minn.). There were 63 men and 38 women, with a mean age of 70.3 years (range 25 to 90 years). Clinical presentations and characteristics are given in Table 1. Of the 13 patients with digestive-respiratory fistula, two required mechanical ventilation for respiratory failure. The dysphagia median score was 3.6 and was graded as follows: grade 0, normal swallowing; grade 1, unable to swallow solids; grade 2, unable to swallow semisolids; grade 3, unable to swallow liquids; grade 4, unable to swallow own saliva.4 Previous therapy is outlined in Table 1. Patients with cervical malignancies with approximately 1 cm or more of normal esophageal mucosa distal to the VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Table 1. Demographics and clinical presentation in 101 patients with malignant dysphagia and digestiverespiratory fistulae Gender (M/F) Mean age (yr) (range) Esophageal cancer Metastatic cancer Dysphagia only Dysphagia + respiratory symptoms Respiratory symptoms only Median dysphagia score Previous therapy Chemoradiation Rx Surgery Nd-YAG laser Bougienage Other expandable stents
I Raijman, I Siddique, J Ajani, et al.
tion o f the
63/38 70.3 (range 25-90) 46 squamous, 37 adenocarcinoma 18 88 11 2 3.6 80* 27 22 80 5
*Ongoing in 11 patients at stent insertion.
Table 2. Endoscopic and radiographic findings in 101 patients with malignant dysphagia and digestiverespiratory fistulae Stricture Stricture location Proximal (cervical) Mid (mid-thoracic) Distal (distal thoracic) Gastroesophageal junction Mean stricture length (cm) (range) Digestive-respiratory fistulae Endoscopic characteristics Exophytic Infiltrative Ulcerative Normal Fistula
99 patients 11 29 37 24 6.9 (2-11) 13 80 19 1 1 13
upper esophageal sphincter were included. Exclusion criteria included moribund state, an expected survival of less than 3 months, tumor bleeding before stent placement, and extensive tumor involvement of the stomach. Because dysphagia reflects only one aspect of the multidimensionality of quality of life, which is composed of the multifaceted aspects of day-to-day living, we also assessed the quality of life according to The European Organization for Research and Treatment of Cancer (EORTC). 5 The EORTC questionnaire incorporates scales of general symptoms and functional, working, cognitive, emotional, and social ability, as well as measurements of financial strain and global quality of life. Endoscopic and radiographic findings Endoscopy was performed in all patients, and a preendoscopic barium swallow was performed in 87. The locaVOLUME 48, NO. 2, 1998
Figure 1. Delivery apparatus (left ) and Wallstent-I (right ); stent is shown with deployed configuration.
strictures, present in 99 patients, is given in Table 2. The mean length of the stricture was 6.9 cm (range 2 to 11 cm). The endoscopic characteristics of the lesion are also presented in Table 2. In all 13 patients with a digestive-respiratory fistulae, the lesion was identified at the time of endoscopy. Wallstent characteristics and placement The Wallstent-I is a two-layer stainless steel mesh with a polyurethane coating (Permalume) between the wires (Fig. 1). One centimeter on each end of the stent is not coated. The stent is constrained in a 38F delivery system and, after deployment, expands to 28 mm at each end and 22 mm over the greater length between the two ends. Approximately a 20% shortening of the stent can be expected after deployment. The stent was placed in all GASTROINTESTINAL ENDOSCOPY
173
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Figure 2. Sequential fluoroscopic view of placement of an esophageal Wallstent-I. A, Contrast injection at the tumor margins; B, advancement of guidewire through stricture; C, Wallstent-I being placed through stricture; D, full expansion of Wallstent-I after deployment. cases under intravenous sedation and with the head of the fluoroscopy table elevated to 30 degrees. Esophageal dilation was carried out to 42F in the initial 22 patients, to 38F to 39F in the next 22 patients, and either enough to advance the endoscope (27F) or not at all in the last 57 patients.6 All patients underwent injection of contrast at the tumor margins or 1 to 2 cm away from the lesion into normal mucosa with an x-ray contrast medium as previously described7 (Fig. 2A). In all patients with a fistula, contrast was also injected at the site of the fistula. In the patient with a fistula and a normal esophagus, only the site of the fistula was marked. In all patients with a cervical stricture, contrast was injected just distal to the upper esophageal sphincter in addition to the other mark174
GASTROINTESTINAL ENDOSCOPY
er points. Except for the initial 22 patients and according to the anatomic location (particularly cervical strictures), all stents were placed so as to extend at least 2 cm beyond the proximal and distal margins of the lesion. Of the 11 patients with a proximal stricture, the proximal tumor margin was located at approximately 1 cm from the upper esophageal sphincter in 5, 2 cm in 2, and more than 3 cm in 4. According to availability, we used either a 0.038-inch ultrastiff wire, a hydrophilic wire, or the Savary wire (Fig. 2B). Once the radioopaque bands of the stent were in correct position in reference to the injected contrast, the stent was deployed (Fig. 2C and D). In patients with a previously placed expandable stent, placement of the Wallstent-I was carried out in the same fashion (Fig. 3A VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
I Raijman, I Siddique, J Ajani, et al.
Table 3. Results after Wallstent-I placement in 101 patients with malignant dysphagia and digestive-respiratory fistulae Successful placement Initial misplacement Two stents Median dysphagia score Before After Improvement respiratory symptoms Fistulae closure Improvement of well being Mean follow up (days) (range) Other treatments after Wallstent-I Second stent Gastrostomy Nd-YAG laser Overall mortality
101 patients 1 1 3.6 p < 0.05 1.4 13 patients 13 patients 82 patients 201 (16-400) 13 patients 7 4 2 99 patients
}
and B). Stents were successfully placed and deployed in all patients. Early in our experience, in one patient the initial stent was placed too distal and could not be repositioned because of the angulation of the stricture at the gastroesophageal junction. A second stent was successfully placed during the same procedure. One patient required 2 stents to entirely bridge the stricture. Stent placement was difficult in 4 patients: because of cervical osteopathy in 3 and breakdown of the fluoroscopy machine in 1. In the latter, the stent was placed under endoscopic guidance by placing the endoscope alongside the stent delivery apparatus. Placement of the stent was difficult in patients with proximal cervical strictures (1 cm from the upper esophageal sphincter), in those with tight and angulated strictures irrespective of location, and in those with previous subtotal gastric resection. Injecting contrast just distal to the upper esophageal sphincter and advancing the guidewire into the small intestine facilitated stent placement in these latter patients. We did not encounter any episodes of tracheal or bronchial obstruction. Bronchoscopy was not performed in any of the patients. Eighty-two of the procedures were performed on an outpatient basis. All patients were allowed a liquid diet the same day of stent placement; this was advanced to semisolids/solids within the first week. Lansoprazole or omeprazole were given to all patients in whom the stent traversed the gastroesophageal junction along with instructions to elevate the head of the bed 6 inches. Patients were encouraged to drink one carbonated beverage daily. All patients were advised to use only non-narcotic analgesics if possible to control pain. Repeat endoscopy and/or barium swallow was performed within the first 2 weeks in the initial 23 patients and a barium swallow in all patients with a digestive-respiratory fistula. For subsequent patients, these studies were performed only if symptom recurrence occurred. The results were assessed as mean values. Significance was tested with the chi-square test. Values of p less than 0.05 were regarded VOLUME 48, NO. 2, 1998
Figure 3. A, Fluoroscopic view of the Wallstent-I delivery apparatus being advanced through a previously placed uncoated Ultraflex stent (Microvasive, Natick, Mass.). B, Fluoroscopic view of the Wallstent-I deployed inside a previously placed uncoated Ultraflex stent. as significant.
RESULTS Symptoms Outcomes for patients are shown in Table 3. The median dysphagia score improved from 3.6 to 1.4. The majority of patients were able to resume taking liquids by mouth within the first day and a semisolid diet within the first week. All fistulae were successfully obliterated as assessed radiographically and endoscopically (Fig. 4A and B). Respiratory symptoms and ventilatory compromise resolved in all patients. The sensation of overall well-being and quality of life improved in 82 patients (data to be published separately). Patients were followed for a mean of 201 days (range 16 to 400 days) by phone call, office visit, or review of the outpatient and/or inpatient records. We did not find a statistically sigGASTROINTESTINAL ENDOSCOPY
175
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
Table 4. Complications after Wallstent-I placement in 101 patients with malignant dysphagia and digestiverespiratory fistulae Complication Minor Chest pain Foreign body sensation Gastric ulcer Esophageal ulcer Major Tumor overgrowth Tumor ingrowth Stent migration Life threatening Bleeding Esophageal tear Perforation Aspiration Total Mortality
N (%) 21 13
20.9 12.9
3 2 2 9 6 0 3 8 7 1 0.9 0 0 38 0
2.9 1.9 1.9 8.9 5.9 2.9 7.9 6.9 1
37.9
Early (within Late (after 1 week) 1 week) 13 3 2 2
1*
6 0 3 5
2
26
12
*One patient had continued foreign body sensation until his death.
Figure 4. A, Barium swallow showing opacification of the respiratory tree through a digestive-respiratory fistula. B, Fluoroscopic view of obliteration of the fistula by successfully placed Wallstent-I.
nificant difference in the response to the stent or in complications (described later) between patients who had or did not have chemotherapy. Direct contact was possible in 81 patients, by phone in 34, and by office visit in 47. No direct contact was possible in 20 patients who had come from outside the United States for one single treatment session. During the follow-up, 4 patients underwent percutaneous endoscopic gastrostomy for persistent dysphagia despite stent patency in all; 1 with digestive-respiratory fistula and respiratory insufficiency required longterm non-oral enteral nutrition. Seven patients needed a second stent, 4 for tumor overgrowth and 3 for stent migration. Nd-YAG laser was used for tumor overgrowth in 2 patients, only one session being necessary to establish stent patency in both. Ninety-nine patients died of tumor progression, and 2 were still alive at the time of this report. Complications Early clinical complications were defined as those occurring within the first week of the procedure, whereas delayed clinical complications were those occurring more than 1 week after the procedure. Life-threatening clinical complications were defined 176
GASTROINTESTINAL ENDOSCOPY
as esophageal tear or perforation, bleeding requiring blood transfusion or treatment to achieve hemostasis, or aspiration of gastric contents requiring admission to the hospital. Minor clinical complications were defined as those requiring minimal therapeutic intervention, such as chest pain, foreign body sensation, bloating, gastric ulceration, and esophageal ulceration. Major clinical complications were defined as those requiring more invasive therapeutic intervention, such as stent migration and tumor ingrowth or overgrowth. Early and delayed clinical complications classified by severity are given in Table 4. All bleeding episodes required blood transfusions, and 1 patient required external radiotherapy to achieve hemostasis after endoscopic methods had failed. There were no perforations or episodes of aspiration, and the procedure-related mortality was nil. Because neither endoscopy nor barium swallows were performed in all patients, it is possible that some complications such as tumor ingrowth or overgrowth, esophageal and/or gastric ulceration, or minimal movement of the stent may have been underestimated. However, their presence may not have been of clinical significance as they were not associated with a change to the initial positive response to the stent. We compared the complication rate between the group of patients without chemoradiation therapy (21 subjects) and those receiving chemoradiation therapy (80 subjects). Respectively, bleeding VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
occurred in 3 versus 4 (not significant [NS]), tumor overgrowth in 3 versus 3 (NS), gastric ulceration in 1 versus 1 (NS), chest pain in 3 versus 10 (NS), stent migration in 1 versus 2 (NS). There were no perforations or mortality in either group. The overall complication rate was 52.3% for those without chemotherapy and 28.4% for those with chemotherapy (p < 0.03). DISCUSSION Currently available endoscopic treatments for patients with inoperable malignant dysphagia include balloon dilation or bougienage, thermocoagulation, injection of alcohol and chemotherapeutic agents, photodynamic therapy, intracavitary irradiation, and placement of a prosthesis, either plastic or expandable.3,8-23 Laser ablation and stent placement are the most commonly used methods in Western countries. Expandable esophageal stents proved superior to plastic stents in a recent prospective randomized trial.3 Self-expanding metal stents of different designs have been shown to be highly effective in the palliation of malignant dysphagia.11-23 Self-expanding metal stents offer a number of advantages, including small delivery systems and large luminal diameter, flexible material, less operative sedation and pre-placement dilation, ease of insertion, immediate relief of obstructions, and long patency rates. They are well tolerated by patients and can be placed on an outpatient basis. Mortality related to stent placement has been minimal. Despite these favorable results, there are still a considerable number of immediate (bleeding, perforation, pain) and delayed (stent migration, tumor ingrowth and overgrowth) complications and additional therapy (gastrostomy, stent replacement) is needed in a relatively high proportion of patients. Coating of the stents, in addition to the added benefit for patients with fistula, prevents tumor ingrowth or tissue hyperplasia but may increase the risk of migration. However, some of these complications are technique- and operator-dependent and not necessarily related to stent dysfunction. Early in our experience, stent migration occurred in 3 patients, presumably related to excessive dilation.6 Tumor overgrowth occurred in 6 patients, likely due to initial placement of the stent too close to the tumor margins. By modifying our technique, tumor overgrowth, as well as stent migration, were eliminated. There have been no instances of stent migration since adopting the “no dilation if the endoscope can be advanced through the stricture” policy and no cases of tumor overgrowth since allowing, if possible, at least a 2 cm tumor-free margin at each end of VOLUME 48, NO. 2, 1998
I Raijman, I Siddique, J Ajani, et al.
the stent. Aspiration during the procedure has been completely eliminated by elevating the head of the fluoroscopy table by 30 degrees and by limiting water flushes during the procedure. Our series is the largest thus far published in which a single stent design was used. Most reports of palliation with the Wallstent have included the uncoated stent, different stent diameters, different endoscopic techniques, and a relatively small number of patients.20,23,24 Complications in our series were largely minor and self-limited. The overall clinical complication rate was 37.9%, 38 of 101 patients. Of these, 21 (20.9%) were minor, 9 (8.9%) were major, and 8 (7.9%) were life threatening (Table 4). It is likely that some of these complications, such as bleeding and chest pain, occur as a result of pressure necrosis from the stent, in a similar fashion as that which occurs with plastic stents.25 Although the expansile force of the expandable stent may produce similar pressure necrosis, it is difficult to distinguish with absolute certainty whether delayed bleeding is due to the stent, tumor progression, spontaneous tumor bleeding, or in some instances further chemotherapy or radiation. Our results compared favorably to those reported by other authors.19 Stent modifications, such as decreasing the expansile force, should decrease the rate of certain complications. Although it has been suggested that prior radiation or chemotherapy or esophageal surgery may increase the complication rate with insertion of the modified Z stent,26 we initially did not find a statistically significant difference.27 However, with a larger number of patients, a statistically significant difference was found. Of the 21 patients without prior chemoradiation therapy, there were 3 with bleeding, 3 with tumor overgrowth, 1 with gastric ulceration, 3 with chest pain, and 1 with stent migration. Of the 80 patients who received chemoradiation therapy, there were 4 patients with bleeding, 3 with tumor overgrowth, 1 with an esophageal tear, 2 with esophageal ulcers, 1 with gastric ulceration, 10 with chest pain, and 2 with stent migration. There were no perforations or mortality in either group. The overall complication rate was 52.3% for those with no prior chemotherapy and 28.4% for those who had undergone chemotherapy (p > 0.03); the incidence of serious and/or life-threatening complications was 14% and 6%, respectively (NS). Data from our first 60 patients disclosed life-threatening complications in 14.3% of patients without prior therapy compared with 8% with prior therapy (NS).27 These results differ from those of Kinsman et al.26 This may be related to the differences in technique and the stent used. Although we recognize the limitations of a GASTROINTESTINAL ENDOSCOPY
177
I Raijman, I Siddique, J Ajani, et al.
Malignant dysphagia and fistulae palliated with coated expandable metal stents
nonrandomized study such as ours, which may allow bias in the selection of patients, some complications potentially related to the stent itself, such as bleeding and fistula formation, may not necessarily be related to the initial decision to give chemoradiation therapy and may simply reflect the local interaction of the stent and the tumor. Digestive-respiratory fistulae occur in approximately 5% to 15% of patients with esophageal cancer and have a high mortality due to recurrent pulmonary complications.28-32 The currently available literature includes only a small number of patients with digestive-respiratory fistulae treated with various metallic expandable stents. The coated Wallstent had a 100% efficacy in sealing off the fistulous tract and relieving the respiratory symptoms in 13 patients in our series, when mechanical ventilation was required.34 Placement of expandable stents is easy, but it is important to recognize that there is an inherent and required learning curve. Factors that may increase the difficulty of placement and expansion of the stent include improperly placed markers indicating the edges of the stricture; a tortuous, hard, and acutely angulated stricture; previous subtotal gastric surgery; and proximal cervical strictures. Placement of the stent with minimal or no esophageal dilation (if possible), with the ends at least 2 cm from each tumor margin (if possible), as well as elevation of the patient’s head on the fluoroscopy table during the procedure can prevent complications. It is also important to properly select patients for expandable esophageal stenting. This will allow for best possible results, avoiding potential complications, unrealistic expectations, and incurring unnecessary use of resources and costs. Palliation of malignant dysphagia and digestiverespiratory fistula with the coated Wallstent-I is effective with a low morbidity and no mortality, including palliation for patients with previous or ongoing chemoradiation therapy. REFERENCES 1. DeMeester TR, Barlow AP. Surgery and current management for cancer of the esophagus and cardia: Part II. Curr Probl Surg 1988;25:540-605. 2. Angueira CE, Kadakia SC. Esophageal stents for inoperable esophageal cancer: Which to use? Am J Gastroenterol 1997;92:373-6. 3. Knyrim K, Wagner HJ, Bethge N, Keymling M, Vakil N. A controlled trial of expansile metal stent for palliation of esophageal obstruction due to inoperable cancer. N Engl J Med 1993;329:1302-7. 4. 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.
178
GASTROINTESTINAL ENDOSCOPY
5. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76. 6. Raijman I, Siddique I, Ajani J, Lynch P. How much dilation (if any) is necessary prior to placement of an esophageal Wallstent [abstract]? Gastrointest Endosc 1997;45:213. 7. Raijman I, Kortan P, Marcon N, Haber G. The use of contrast injection to identify tumor margins during expandable esophageal stent placement. Gastrointest Endosc 1994;40: 222-4. 8. Loizou LA, Grigg D, Atkinson M, Robertson C, Brown SG. A prospective comparison of laser therapy and intubation in endoscopic palliation for malignant dysphagia. Gastroenterology 1991;100:1303-10. 9. Sander R, Hagenmuller F, Sander C, Riess G, Classen M. Laser versus laser plus afterloading with iridium 192 in the palliative treatment of malignant stenosis of the esophagus: a prospective, randomized and controlled study. Gastrointest Endosc 1991;37:433-9. 10. Payne-James JJ, Spiller RC, Misiewicz JJ, Silk DB. Use of ethanol-induced tumor necrosis to palliate dysphagia in patients with esophagogastric cancer. Gastrointest Endosc 1990;36:43-6. 11. Wright RA, O’Conner KW. A pilot study of endoscopic injection chemo/sclerotherapy of esophageal carcinoma. Gastrointest Endosc 1990;36:47-8. 12. Heier SK, Rothman K, Heier LM, Rosenthal WS. Photodynamic therapy for obstructing esophageal tumors: efficacy, safety, light dosimetry and results of an ongoing randomized trial [abstract]. Gastrointest Endosc 1991;37:187. 13. Raijman I, Walden D, Kortan P, Haber GB, Fuchs E, Siemens M, et al. Expandable esophageal stents: initial experience with a new nitinol stent. Gastrointest Endosc 1994;40:614-21. 14. Schaer J, Katon RM, Ivancev K, Uchida B, J Rosch, Binmoeller KF. Treatment of malignant esophageal obstruction with silicone-coated metallic self-expanding stents. Gastrointest Endosc 1992;38;7-11. 15. Cwikiel W, Stridbeck H, Tranberg KG, von Holstein CS, Hambraeus G, Lillo-Gil R, et al. Malignant esophageal stricture: treatment with self-expanding nitinol stent. Radiology 1993:187:661-5. 16. Jones WF, Raijman I, Akerman P, Khandelwal M, Siemens M, Kandel G, et al. Endoscopic palliation of malignant obstruction with expandable esophageal stents (EES) [abstract]. Gastrointest Endosc 1994;40:246. 17. Parekh P, Lynch P, Sinicrope F, Raijman I. Coated expandable esophageal stents (CEES) in the treatment of malignant dysphagia [abstract]. Am J Gastroenterol 1995;90:56. 18. Kozarek RA. Expandable endoprostheses for gastrointestinal stenoses. Gastrointest Endosc Clin N Am 1994;4:279-95. 19. Vermeijden JR, Bartelsman JFWM, Fockens P, Meijer R, Tytgat G. Self-expanding metal stents for palliation of esophagocardial malignancies. Gastrointest Endosc 1995;41: 58-63. 20. Ell C, Hochberger J, May A, Wolfgang F, Eckhart H. Coated and uncoated self-expanding metal stents for malignant stenoses in the upper GI tract: preliminary clinical experiences with Wallstent. Am J Gastroenterol 1994;89:1496-500. 21. Hoepffner N, Foerster EC, Kautz G, Domschke W. Polyurethane-covered mesh stent for malignant esophageal stenosis with fistulas [abstract]. Gastrointest Endosc 1994;40:651. 22. Kozarek RA, Ball TJ, Brandabur JJ, Patterson DJ, Low D, Hill
VOLUME 48, NO. 2, 1998
Malignant dysphagia and fistulae palliated with coated expandable metal stents
23.
24.
25.
26.
27.
L, et al. Expandable versus conventional esophageal prostheses: easier insertion may not preclude subsequent stentrelated problems. Gastrointest Endosc 1996;43:204-8. Neuhaus H, Hoffmann W, Dittler HJ, Niedermeyer HP, Classen M. Implantation of self-expanding esophageal metal stents for palliation of malignant dysphagia. Endoscopy 1992;24:405-10. Bethge N, Knyrim K, Wagner HJ, Starck E, Pausch J, Kleist DV. Self-expanding metal stents for palliation of malignant esophageal obstruction. A pilot study of eight patients. Endoscopy 1992;24:411-5. den Hartog Jager FCA, Bartelsman JFWM, Tytgat GN. Palliative treatment of obstructing esophageal malignancy by endoscopic positioning of a plastic prosthesis. Gastroenterology 1979;77:1008-14. Kinsman KJ, DeGregorio BT, Katon RM, Morrison K, Saxon RR, Keller FS, et al. Prior radiation and chemotherapy increase the risk of life-threatening complications after insertion of metallic stents for esophagogastric malignancy. Gastrointest Endosc 1996;43:196-203. Raijman I, Sinicrope F, Leveritt S, Naranjo K, Ahmed M, Glober G, et al. Does chemo-radiation therapy (ChXRT) increase the incidence of complications after self-expanding coated stents (cEES) in the management of malignant esophageal strictures
VOLUME 48, NO. 2, 1998
I Raijman, I Siddique, J Ajani, et al.
[abstract]? Gastrointest Endosc 1996;43:210. 28. Raijman I, Siddique I, Ajani J, Lynch P. Palliation of malignant dysphagia with chemoradiation therapy (CHXRT) does not increase the rate of serious complications with coated Wallstent [abstract]. Gastrointest Endosc 1997;45:216. 29. Martini N, Goodner JT, D’Angio GJ, Beattie EJ. Tracheoesophageal fistula due to cancer. J Thorac Cardiovasc Surg 1970;59:319-24. 30. Little AG, Ferguson MK, DeMeester TR, Hoffman PC, Skinner DB. Esophageal carcinoma with respiratory fistula. Cancer 1984;53:1322-8. 31. Duranceau A, Jamieson GG. Malignant tracheoesophageal fistula. Ann Thorac Surg 1984;37:346-54. 32. Symbas PN, McKeown PP, Hatcher CR, Vlasis SE. Tracheoesophageal fistula from carcinoma of the esophagus. Ann Thorac Surg 1984;38:382-6. 33. Burt M, Diehl W, Martini N, Bains MS, Ginsberg RJ, McCormack PM, et al. Malignant esophageal fistula: management options and survival. Ann Thorac Surg 1991;52: 1222-8. 34. Raijman I, Sinicrope F, Leveritt S, Naranjo K, Ahmed M, Glober G, et al. Management of digestive-respiratory fistulae (DRF) with coated expandable esophageal stents (cEES) [abstract]. Gastrointest Endosc 1996;43:211.
GASTROINTESTINAL ENDOSCOPY
179