Nine patients with malignant esophageal obstruction were treated with non-covered or covered Ultraflex stents. All patients achieved palliation, six of nine patients showed improvement of at least one dysphagia grade, and five patients could tolerate a normal or near-normal diet. Major (massive bleeding) and minor complications (ingrowth, overgrowth, stent migration, and bleeding) were encountered during follow-up in 2 and 4 patients, respectively. Ultraflex stents for esophageal cancer offer effective palliative treatment and quickly improve dysphagia. However, care should be exercised particularly of potentially serious life-threatening complications such as massive bleeding

Furusu Hisashi

Haraguchi Masuho

Ikeda Koki

Inoue Kenichiro

Isomoto Hajime

Kohno Shigeru

Kubo Keigo

Mizuta Yohei

Murase Kunihiko

Ofukuji Megumi

Omagari Katsuhisa

Onita Ken

Onizuka Yasunori

Osabe Masayuki

Takeshima Fumitoshi

Yamao Takushi

Yamasaki Kazufumi

Nagasaki University's Academic Output SITE: NAOSITE

Acta Med. Nagasaki 43:67-71Ultraflex Stent Placement for Palliation of Esophageal CancerKunihiko MURASE1), Hisashi FURUSU1), Takushi YAMAO1), Ken ONITA1), Koki IKEDA1), Megumi OFUKUJI1), Kenichiro INOUE2), Kazufumi YAMASAKI3), Keigo KUBO4), Yasunori ONIZUKA5), Masayuki OSABE6), Masuho HARAGUCHI7), Hajime ISOMOTO1), Fumitoshi TAKESHIMA1), Katsuhisa OMAGARI1), Yohei MIZUTA1), Shigeru KOHNO1)1) Second Department of Internal Medicine, Nagasaki University School of Medicine 2) Department of Internal Medicine, Inoue Hospital 3) Department of Internal Medicine, Nagasaki Municipal Medical Center 4) Department of Internal Medicine, Kubo Naika Hospital 5) Department of Internal Medicine, Hokusho Central Hospital 6) Department of Internal Medicine, Omura Municipal Hospital 7) Department of Internal Medicine, Sasebo Municipal Hospital Nine patients with malignant esophageal obstruction were treated with non-covered or covered Ultraflex stents. All patients achieved palliation, six of nine patients showed im-provement of at least one dysphagia grade, and five patients could tolerate a normal or near-normal diet. Major (massive bleeding) and minor complications (ingrowth, overgrowth, stent migration, and bleeding) were encountered during follow-up in 2 and 4 patients, respectively. Ultraflex stents for esophageal cancer offer effective palliative treatment and quickly improve dysphagia. However, care should be exercised particularly of potentially serious life-threatening complications such as massive bleeding.Key words: ultraflex stent, esophageal cancer, palliative therapyIntroduction  Most patients with carcinoma of the esophagus present with progressive, unrelenting dysphagia, malnutrition, and weight loss (1). Palliative therapy is the primary form of treatment, since these patients are not candidates for curative surgical resection (2). Laser surgery, radio-therapy and conventional plastic prostheses are well-established modes of treatment, and highly effective methods of palliation for the dysphagia that usuallyaccompanies esophageal cancer (3-5). Laser therapy is not suitable for tumors causing extrinsic compression or long stenosis (6), while radiotherapy requires a long course extending at least for two months (7). Further-more, the use of rigid plastic endoprotheses is plagued by high complication rates (8, 9).  Recently, self-expanding metal stents have provided a new option for the palliative treatment of malignant stenotic esophageal tumors (10-13). These stents have proved to be effective in reducing morbidity and mor-tality (10, 11). Several studies have examined the thera-peutic benefits of various self-expanding metal esophag-eal stents for esophageal neoplasia, but few have com-pared different self-expanding metal stents (12, 13).  The aim of the present study was to evaluate the effectiveness and complications of non-covered and/or covered Ultraflex stents for palliation of dysphagia due obstructive esophageal cancer.Address Correspondence : Kunihiko Murase, M.D. The Second Department of Internal Medicine, 7-1 Sakamoto 1-Chome Nagasaki 852-8501, JapanPatients and Methods Patients  From January 1995 to December 1997, nine patients with malignant dysphagia due to esophageal carcino-mas were treated with non-covered or covered Ultraflex stents (Boston Scientific Corporation, Watertown, MA, USA) after informed consent. The mean age was 65 years (range, 46 to 85 years) and patients included four men and five women. All nine patients had esophag-eal squamous carcinomas. The tumor was located in the upper, middle and lower esophagus in 1, 6, and 2patients, respectively. Chemotherapy was performed in 3 patients, radiotherapy in 2 patients, and both in 1 patient (Table 1).Table 1. Patient demographics Cases Age Sex Location Prior treatment 1 60 M Middle Chemotherapy 2 62 M Middle Chemotherapy 3 70 M Middle Chemotherapy 4 72 F Lower None 5 46 M Lower None 6 56 F Upper Chemotherapy and radiation 7 74 F Middle Radiation 8 85 F Lower None 9 85 F Lower RadiationStents placement technique  After guidewire insertion (Jegwire; 0.035 inch: Boston Scientific Corporation)esophageal dilation was performed twice each for 2 min using 8-10 atm Endoscopy Dilators (diameter 8 mm, length 50 mm, Boston Scientific Corpo-ration). The stent was then pushed out of the delivery catheter and delivered. Five non-covered and six cov-ered Ultraflex stents were implanted in these patients. The body of the stent ranged in length from 10 to 15 cm (Fig. 1 A and B). The stents were placed fluoroscopic-ally under local anesthesia. Patients underwent a follow-up endoscopic examination immediately, 3 days, 1 week and 4 weeks later, and as needed thereafter.Severity of dysphagia and complications  The severity of dysphagia was quantified with a 0 to 4 dysphagia scale as follow: grade 0, normal, no dysphagia; grade 1, unable to swallow solid food; grade 2, unable to swallow semi-solids; grade 3, unable to swal-low liquids; grade 4 unable to swallow own saliva. All nine patients had severe grade 3 or 4 dysphagia, and none were suitable candidates for operative surgery.  The major stent-related complications were defined as life-threatening complications, such as bleeding requiring blood transfusion, while minor complications were de-fined as non-life-threatening complications, such as tumor ingrowth, overgrowth, stent migration, and bleeding without requiring blood transfusion.Results  Stent placement was successful in all nine patients, however two patients required a second stent because of migration, and tumor ingrowth or overgrowth. After one week of stenting, all five patients with non-covered stent and five of six patients with covered stent showedFig 1. Ultraflex stents. A; non-covered type, B; covered type improvement of at least one dysphagia grade. After one month, three patients with non-covered stent and three patients with covered stent became able to swallow a normal or near-normal diet. There was no difference in improvement of grades of dysphagia between non-covered and covered Ultraflex stents.  Five patients were discharged from the hospital after 2 to 4 weeks, however all nine patients died during the follow-up period; the mean survival after the procedure was 12 weeks (range 1 to 56 weeks). Severe complica-tions, such as massive bleeding occurred in two pa-tients who received non-covered and covered Ultraflex stents. Both (Case 3; non-covered and Case 9; covered) died due to massive esophageal bleeding, one and three months later, respectively. Three types of minor prob-lems were encountered: ingrowth and overgrowth (1 patient; non-covered type), stent migration (1 patient; covered type), and bleeding (2 patients; non-covered type). One patient (Case 8) underwent an additional non-covered Ultraflex stent because of stent migration 10 days after stenting of the covered type. Anotherpatient (Case 2) had recurrent dysphagia due to tumor ingrowth and overgrowth, one after 2 months. In this patient, an additional overlapping covered Ultraflex stent was successfully placed.  Fig. 2 represents a 70-year old man with squamous cellFig 2. Endoscopic photographs. A; Nodular tumors with near-total obstruction. B; Proximal view of non-covered Ultraflex stent with massive fibrin exudate after 3 days of insertion. C; View of non-covered Ultraflex stent with full expansion after 7 days of application.carcinoma of esophagus and thoracic aortic aneurysm (Case 3, Tables 1 and 2). Dysphagia was of grade 3. The patient was treated palliatively with Ultraflex stent. After stenting, the severity of dysphagia improved and the patient was able to swallow a semi-solid diet. Improve-ment was sustained for 1 month but he suddenly died because of a massive hematemesis probably due to rupture of an aortic aneurysm. Unfortunately, autopsy was not performed.Discussion  A variety of esophageal endoprosthesis ranging from rigid plastic devices to the newer self-expandable me-tallic stents (e.g., Z-stent, Wall-stent, Ultraflex-stent) have been used (4, 8-33). Despite the good results, complica-tions are common, and further therapeutic interventions are necessary in a considerable number of patients. Thus, the ideal stent is not yet available. Self-expanding me-tallic stents offer a number of advantages, including small delivery systems and large lumen diameter, less operative sedation, ease of insertion, immediate relief of obstruction, and long patency rates (14, 15). Despite these favorable results, there are still considerable num-ber of complications including stent migration, tumor ingrowth and overgrowth, and bleeding. The rate of complications is reported at 31-49% in patients treated with Z-stent and/or Wall stent (16-18).  Recent reports have indicated the long-term effective-ness of Ultraflex stents and that these stents provide a safe method of palliative therapy for patients with ob-structive esophageal neoplasms (12, 19). Ultraflex stents seem to offer a lower force of expansion (20), and Ell et al. (21) reported that the expansile force of Ultraflex stent is sufficient even for very firm strictures. However, in our experience, one of nine patients showed an in-sufficient degree of spontaneous expansion.  The most common cause of recurrent dysphagia is ingrowth or overgrowth of non-covered stents by the tumor tissue (22, 23). Knyrim et al. (24) indicated that non-covered stent are associated with fewer complica-tions. Non-covered stents are associated with tumor in-growth and overgrowth which may further reduce the size of the available lumen, and sometimes require a second stent (stent in stent) or laser therapy (15, 25). Covered metallic stents offer effective treatment for per-forations and fistulas in patients with esophageal ma-lignancies (26,27), and might prevent tumor ingrowth allowing treatment of digestive-respiratory fistulas (28). However, preliminary studies indicate that migration of stent or disruption of the membrane by tumor ingrowth may occur even in these stents (29, 30). We presentedtwo cases of tumor overgrowth after stenting in pa-tients with inoperable esophageal cancers that were managed by placement of a second stent. The frequency of distal migration of covered stents (5-25 %) is rela-tively higher than that of non-covered stents (0-1%) (12, 21, 31-33). In our series, one case treated with covered stent later showed stent migration.  den Hartog et al. (34) and Kinsman et al. (35) reported that chemoradiotherapy increased the incidence of stent-related complications in the management of malignant esophageal strictures. However, Raijman et al. (5) re-ported that the same therapy was not associated with increased risk of life threatening complications. In our series, chemotherapy and/or irradiation before stent application were not associated with increased risk of complications (Table 2).  Issues related to the palliative therapy for esophageal cancer are complex. Whereas the tendency is to focus on technical aspects of therapy and the relief of dysphagia,broader aspects related to quality of life cannot be ig-nored (23). In our departments, patients were actively encouraged to take optimal oral nutrition, before and after discharge from hospital. Prolonged cachexia re-duces appetite and restoration of a normal diet may require more than simply the restoration of the eso-phageal lumen.  Further investigation in a large series of patients treated by stent insertion have to be performed before a general conclusion can be drawn regarding the clini-cal efficacy of Ultraflex stents for endoscopic palliation of esophageal carcinoma.  In summery, Ultraflex stents for esophageal cancer offer a quick improvement of dysphagia in patients with non-operable esophageal tumors. Tumor ingrowth and overgrowth are problems associated with noncovered stent. Covered stent are associated with markedly less tumor ingrowth and overgrowth, but stent migration of covered stent is inferior to that of non-covered stents.Table 2. Results and complications of Ultraflex stent Cases Stent Dysphagia grade complications Follow up        type Pre-stent Post(1w) Post(Imo) 1 N 4 3 3 Bleeding Died(2mo) 2 N 4 2 1 Ingrowth, Overgrowth Died(13mo)        C 3 1 1 3 N 3 1 1 Massive bleeding Died(lmo) 4 N 4 3 3 Bleeding Died(4mo) 5 C 4 3 None Died(3w) 6 C 4 4 None Died(lw) 7 C 3 3 1 None Died(9mo) 8 C 4 2 Stent migration Died(5mo)        N 2 1 1 9 C 3 3 2 Massive bleeding Died(4mo)         N : non-covered type, C : covered typeAcknowledgement  We gratefully acknowledge the skillful technical as-sistant of Mr. Kawazoe. References 1) Schottenfeld D. Epidemiology of cancer of the esophagus. Semin    Oncol 11-92-100, 1984 2) Earlarm HW, Canha-Melo JR. Oesophageal squamous cell carci-   noma; A critical review of surgery. 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Ultraflex Stent Placement for Palliation of Esophageal Cancer

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Ultraflex Stent Placement for Palliation of Esophageal Cancer

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