Prospective multicenter trial of esophageal Z-stent placement for malignant dysphagia and tracheoesophageal fistula

Kozarek, Richard A.; Raltz, Shirley L.; Brugge, William R.; Schapiro, Robert H.; Waxman, Irving; Boyce, H. Worth; Baillie, John; Branch, Stanley; Stevens, Peter S.; Lightdale, Charles J.; Lehman, Glen A.; Benjamin, Stanley B.; Fleischer, David E.; Axelrad, Andrew M.; Kortan, Paul P.; Marcon, Norman E.

doi:10.1016/s0016-5107(96)70009-3

Cited by 132 publications

(44 citation statements)

References 19 publications

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“…An overdose of radiation was observed in the esophagus wall adjacent to the stent. These disturbances, caused by the presence of the SEMS, need to be recognized and studied further 17 .…”

Section: Discussionmentioning

confidence: 99%

Assesment of placement of the esophageal self-expandable metallic stent in esophageal cancer in patients with or without citorreduction therapy

Kamiyama

Sakai

Moura

et al. 2007

ABCD, arq. bras. cir. dig.

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BACKGROUND: Placement of self-expanding metallic esophageal stent in patients with advanced esophageal cancer offers excellent palliation of dysphagia and tracheo-esophageal fistulas. However, the safety of stent in patients undergoing radio and/or chemotherapy is controversial, in terms of the greater risk of complications in cases where these two treatments are used in conjunction. AIM: To assess the use of stent in patients with advanced cancer of the mid-thoracic esophagus, by comparing patients undergoing cytoreductive therapy with patients who have not undergone this treatment, in relation to improvement in the dysphagia, rate of complications, period of effectiveness and survival time. METHODS: Fifty seven patients were evaluated retrospectively (16 women and 41 men, with an average age 62 years) with advanced squamous cell carcinoma of the mid-thoracic esophagus who underwent placement of the Ultraflex™ self-expandable metallic coated stent, at the Gastrointestinal Endoscopy Unit of São Paulo University Medical School between October 1988 and October 2004. Out of the 57 patients, 24 patients received adjuvant cytoreductive therapy, and 33 patients were only treated with the stent placement. RESULTS: After stent placement, there was improvement in dysphagia in both groups; there were no differences in the rate of complications, such as migration, pain, fistula, obstruction and compression of the airways; the period of effectiveness was significantly higher in the group submitted to cytoreductive therapy (average 123 days compared to 63 days), as was the survival time (average of 210 days, compared with 120 days). CONCLUSIONS: Improvement in dysphagia was statistically significant in both groups, irrespective of whether the patient had undergone adjuvant cytoreductive therapy; there were no differences in the rate of complications between the two groups and both the period of effectiveness of the stent treatment and the survival time were higher in the group with adjuvant cytoreductive therapy.

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“…An overdose of radiation was observed in the esophagus wall adjacent to the stent. These disturbances, caused by the presence of the SEMS, need to be recognized and studied further 17 .…”

Section: Discussionmentioning

confidence: 99%

Assesment of placement of the esophageal self-expandable metallic stent in esophageal cancer in patients with or without citorreduction therapy

Kamiyama

Sakai

Moura

et al. 2007

ABCD, arq. bras. cir. dig.

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“…However, frequent tumor in-growth obstruction problems were encountered (7,(9)(10)(11). Covering the stent mesh reduced tumor in-growth, but increased SEMS migration rates (12)(13)(14). To address both the tumor in-growth problem and the migration problem, manufacturers pursued various design modifications to include covering only a portion of the SEMS body, increasing the SEMS BD, changing the shape of the SEMS body, or a combination of all three.…”

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confidence: 99%

Small caliber covered self expanding metal stents in the management of malignant dysphagia.

Kucera

Shridhar

Klapman

et al. 2016

JCO

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Background: Use of large caliber [≥18 mm body diameter (BD)] self-expanding metal stents (SEMS) for management of malignant dysphasia is associated with substantial adverse event (AE) and mortality rates (MRs). We sought to determine dysphagia response, stent migration rates, and AE and MRs, for small caliber covered SEMS (sccSEMS) with BDs between 10-16 mm in malignant dysphagia. Results: DS improved in 30 of 31 patients (97%). The median DS decreased from 3 to 2 (P<0.0001). The median effective duration of first sccSEMS placement was 116 (95% CI: days. Major and minor AE rates were 6.5% and 19.4% respectively. No stent related deaths were encountered. The overall migration rate was 36% (18/50). The anticipated migration rate was 45.7% (16/35) and the unanticipated migration rate was 13.3% (2/15) (P=0.052). Positive effective clinical outcome occurred in 93.5% (29/31) of cases. Conclusions:In malignant dysphagia, direct endoscopic sccSEMS placement provided acceptable dysphagia control and migration rates with substantial reductions in stent related AEs and MRs compared to those reported for large caliber SEMS. The median dysphagia score (DS) improved to 1 in both groups of patients. However, the rigid stent group experienced 14% procedure related mortality, whereas, the SEMS group experienced no procedure related mortality. Similar complication and MRs were observed by others (5-7). Uncovered SEMS rapidly replaced rigid stents for management of malignant dysphagia (8). However, frequent tumor in-growth obstruction problems were encountered (7,(9)(10)(11). Covering the stent mesh reduced tumor in-growth, but increased SEMS migration rates (12)(13)(14). To address both the tumor in-growth problem and the migration problem, manufacturers pursued various design modifications to include covering only a portion of the SEMS body, increasing the SEMS BD, changing the shape of the SEMS body, or a combination of all three.A randomized controlled trial by Siersema et al. (15) of partially covered and covered SEMS designs from three different manufacturers suggested that SEMS with BDs >20 mm were less likely to migrate when placed across distal esophagus and cardia malignant strictures. However, major stent related complications (perforation, bleeding, fever, pressure necrosis, severe pain) occurred in 18% to 36% of patients and overall 30-day mortality was 15%. In the multicenter randomized Dutch SIREC trial (16), 18 and 23 mm BD partially covered SEMS were compared to brachytherapy as palliation for inoperable esophageal adenocarcinoma. SEMS migration occurred in 17% and tumor in-or over-growth occurred in 15% of patients randomized to treatment with the partially covered SEMS. Major stent related complications occurred in 25% of patients. Stent related mortality was 9%.The available data from existing studies suggests that the major complication and MRs for covered or partially covered SEMS with BDs ≥18 mm are similar to those produced by the non-expandable rigid legacy stents that SEMS were designed to replace. Upon...

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“…In addition, brachytherapy as a sole treatment is frequently used in Western Europe, South Africa, Japan and to a lesser extent in the USA. Both stent placement and brachytherapy have been proven to be effective in relieving dysphagia with a low complication rate, but recurrent dysphagia due to various causes is seen in 30 -40% of patients (Brewster et al, 1995;Kozarek et al, 1996;Bartelsman et al, 2000;Siersema et al, 2001;Sur et al, 2002; Homs et al, 2003a).In order to comprehensively assess the relative merits of the different palliative treatments of malignant dysphagia, health economic aspects should be incorporated. Remarkably, the economic implications of both stent placement and brachytherapy have been evaluated only in a few studies (Adam et al, 1997;Farndon et al, 1998;Nicholson et al, 1999;Dallal et al, 2001;O'Donnell et al, 2002).…”

mentioning

confidence: 99%

mentioning

confidence: 99%

“…Most of these patients require palliative treatment to relieve progressive dysphagia (Sagar et al, 1994). Treatment options presently available for palliation of dysphagia include selfexpanding metal stent placement (Kozarek et al, 1996;Bartelsman et al, 2000;Siersema et al, 2001), laser therapy (Dallal et al, 2001), photodynamic therapy (PDT) (Luketich et al, 2000;Moghissi et al, 2000), external beam radiation in combination with brachytherapy (Taal et al, 1996;Schraube et al, 1997), brachytherapy as a sole treatment (Jager et al, 1995;Sur et al, 2002;Homs et al, 2003a) and dilatation (Lundell et al, 1989). A disadvantage of laser therapy is that repeated treatment sessions are required to achieve and maintain adequate palliation (Dallal et al, 2001;Spencer et al, 2002).…”

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confidence: 99%

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Cost study of metal stent placement vs single-dose brachytherapy in the palliative treatment of oesophageal cancer

2004

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Self-expanding metal stent placement and single-dose brachytherapy are commonly used for the palliation of oesophageal obstruction due to inoperable oesophagogastric cancer. We randomised 209 patients to the placement of an Ultraflex stent (n ¼ 108) or single-dose brachytherapy (12 Gy, n ¼ 101). Cost comparisons included comprehensive data of hospital costs, diagnostic interventions and extramural care. We acquired detailed information on health care consumption from a case record form and from monthly home visits by a specialised nurse. The initial costs of stent placement were higher than the costs of brachytherapy (h1500 vs h570; Po0.001). Total medical costs were, however, similar (stent h11 195 vs brachytherapy h10 078, P40.20). Total hospital stay during follow-up was 11.5 days after stent placement vs 12.4 days after brachytherapy, which was responsible for the high intramural costs in both treatment groups (stent h6512 vs brachytherapy h7982, P40.20). Costs for medical procedures during follow-up were higher after stent placement (stent h249 vs brachytherapy h168, P ¼ 0.002), while the costs of extramural care were similar (h1278 vs h1046, P40.20). In conclusion, there are only small differences between the total medical costs of both palliative treatment modalities, despite the fact that the initial costs of stent placement are much higher than those of brachytherapy. Therefore, cost considerations should not play an important role in decision making on the appropriate palliative treatment strategy for patients with malignant dysphagia. The incidence of oesophageal cancer has risen rapidly, due to a marked increase in the incidence of adenocarcinoma (Devesa et al, 1998;Botterweck et al, 2000). Oesophageal cancer is a disease with a high mortality, as reflected by a 5-year survival of 10 -15% (Pisani et al, 1999). Moreover, more than 50% of patients with oesophageal cancer have already inoperable disease at presentation. Most of these patients require palliative treatment to relieve progressive dysphagia (Sagar et al, 1994). Treatment options presently available for palliation of dysphagia include selfexpanding metal stent placement (Kozarek et al, 1996;Bartelsman et al, 2000;Siersema et al, 2001), laser therapy (Dallal et al, 2001), photodynamic therapy (PDT) (Luketich et al, 2000;Moghissi et al, 2000), external beam radiation in combination with brachytherapy (Taal et al, 1996;Schraube et al, 1997), brachytherapy as a sole treatment (Jager et al, 1995;Sur et al, 2002; Homs et al, 2003a) and dilatation (Lundell et al, 1989). A disadvantage of laser therapy is that repeated treatment sessions are required to achieve and maintain adequate palliation (Dallal et al, 2001;Spencer et al, 2002). A combined treatment of external beam radiation with brachytherapy is often too intensive for patients with inoperable disease due to metastases or a poor medical condition. Photodynamic therapy involves the local destruction of tumour tissue by light of a specific wavelength activating a previously administered photo...

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Prospective multicenter trial of esophageal Z-stent placement for malignant dysphagia and tracheoesophageal fistula

Cited by 132 publications

References 19 publications

Assesment of placement of the esophageal self-expandable metallic stent in esophageal cancer in patients with or without citorreduction therapy

Assesment of placement of the esophageal self-expandable metallic stent in esophageal cancer in patients with or without citorreduction therapy

Small caliber covered self expanding metal stents in the management of malignant dysphagia.

Cost study of metal stent placement vs single-dose brachytherapy in the palliative treatment of oesophageal cancer

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