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Cost-effectiveness of photodynamic therapy for high grade dysplasia in patients with Barrett's esophagus
ESOPHAGUS ~:209 COST-EFFECTIVENESS OF PHOTODYNAMIC THERAPY FOR HIGH GRADE DYSPLASIA IN PATIENTS WITH BARRETT'S ESOPHAGUS. TM Pasha, M WongKeeSong, KK Wang. Mayo Clinic, Rochester,
Minnesota. Management of patients with Barrett's and high grade dysplasia (HGD) is controversial. Photodynamic therapy (PDT) has been proposed as an alternative to surgical resection for HGD in patients with Barrett's esophagus. AIM: To assess the cost-effectiveness of PDT for Barrett's esophagus with HGD compared with surgical resection. METHODS: Clinical data from published literature on the risks and survival following esophagectomy and PDT in patients with Barrett's esophagus with HGD was used in a Markov model that simulates lifetime events. Where data was unavailable, expert opinion was used and assessed with sensitivity analysis. We took the perspective of a payer and included direct costs for PDT and surgery. Our final outcome measure was cost per quality adjusted life year ($/QALY). RESULTS: By varying the efficacy of PDT, our model predicts that for PDT to be more effective than surgery, it needs to achieve an efficacy of > 85%. With this level of efficacy, the $/QALY was $ 26,812 which compares favorably with other health care interventions. Sensitivity analysis confirmed the robustness of our results nn efficacy of PDT. Average cost per patient in the surgical strategy was consistently lower Efficacy of PDT 50% 75% 85% 100% Marginal Effectiveness (yr.) -3.54 -0.85 0.67 3.7 Quality Adjusted Life Expectancy (yr.) 14.69 17.38 18.91 21.93 Marginal Costs $22,400 $19,600 $18,000 $14,800 Total Costs/ pt. $42,700 $40,000 $38,400 $35,000 Cost Per Quality Surgery Surgery Adjusted Life Year more more $26,800 $4,000 effective effective than the PDT strategy. CONCLUSION: Our model suggests that PDT can be a viable alternative to surgical resection, if it can achieve an 85% or greater reduction in cancer risk. Clinical trials of PDT for Barrett's esophagus should be designod to determine long term cancer risk reduction.
210 ENDOSCOPIC DILATION OF ESOPHAGEAL STRICTURES: PROSPECTIVE ANALYSIS OF 990 PROCEDURES. ~ ILZ. Ramirez, A.C. Poy, C.A MarronL Department of Gastruenterelogy, Porto Alegre Medical School, Santa C m Hospital, Porto Alegre, BraziL Endoscopic dilation is the initial treatment of choice for most benign esophageal stenoses. The aim of this study is to report a prospective evaluation of the technique in a large cohort of patients. Methods: Between 5192 and 10/96 we prospectively analyzed 141 patients (93 males/48 females, mean ate: 54 years, range: 286) who underwent 990 endoscopic esophageal dilation procedures (7.02 sessions per patient). Stricture etiology was confirmed by biopsy or patient outcome. Eder-Puestow and Savury-Glllierd dilators were used according to endoscopist's discretion. Results: Stricture etiology was post-sorgicel in 80 patients (56.7%), peptic in 35 (24.8%), caustic in 14 (10%), web in 4 (2.8%) and other etiologies in 8 (5.6%). A good response to therapy (absence of dysphalia to meat) was observed in 102 patients (74%), a partial response (dysphalin to some solid foods) in 18 (13%) and treatment failure in 8 (5.8%). Ten patients abandoned treatment and so were lost to follow-up. Mean maximum dilation diameter employed was 42 French for patients with good response to treatment (51.33) and 34.5 French (39-29) in treatment failures (0<0.05 Mann-Whimey U test). The sole severe complication observed was esophageal perforation which occurred in 5 patients (0.5% of dilation procedures, but 3.5% of the patients), with I death and 4 patients treated surgically. Conclusion: Endoscopic esophageal dilation is a safe and effective tecnique in relieving dysphalia due to benign strictures, although it demands many sessions due to stricture recurrence.
VOLUME 45, NO. 4, 1997
J'211 SELF EXPANDING METAL ETENTS (SEMS) FOR MALIGNANT ESOPHAGEAL
OBSTRUCTION
GL Portwood,C Reed, RH Hawan,BJ Hofiman Division of Gselreanterologyand Hepatology, Digestive Disease Center, Division of Cardlcthor~ Surgery;MedEalUniversityof SonlhCarolina,Cherleston,Sou~ Carolina Backeround and Aims: Therape~ ol~tlansin the palliationof malignantesophageal obstruction have,been greatly improved~ the availability of SEMS. The aim of the study was to review our expedencewith 3 SEMS types. Consecotlvecase series of 40 paeonts-(33M 7F; mean age 64, range 40-87 years) ~ malignantesophageal ob61xuctionwere treated with MiorovasiveDIlraflex covered SEMS (25), MIcroves~eUllraflex uncoveredSEMS (9), or SchneiderWallstent SEM$ (14). Histologiesincluded34 esophagealand 9 lung carcinomas. EF~.stentswere placed In 40 patients including 14 with trachso-esophageal
~
UF Uncovered 7/9 (/9%)
Wallstent
Immediate 2/25 (8%) Complications deatNsepsis I (<48 hrs) fever/ sep~n I
0/9 (0%)
I114 (7%) hypotensinn
Delayed Complications
7/21 (33%) pts 11 noted
4/9 (44%)pte 6 coted
2/13 (15%) 2 noted
i ~ b r g i m ~ n (5) ro~h ~z/ rosy01(1) leed (1) .~.plration (1). M6dlsetinalalx:ese~ fist.la (1)
.TEF(1).... Lngro~ ~1) uysphagia (!) F ~ I im-pac~ (2) GI bleed (1)
GI bleed (2)
Food disiml~(5) SEMS (4 Balloonlo)ila~on(1)
F_o(Rl.=disimpa~on(2) EGDrI'x(2) ~euU (~ SEMS 2) Balloon~llatlon(3) PEG (~f.
Implant Success
Re-Interventions
UF Covered 24/25 (96%)
13/14(93%)
Total e.xpedencerevealed implantsuccess 44./48 (92%, incomplete expansion lq 4), meolate r rate 3/48 (6%), deisyco complicationrate 11/40.(28%),ann reintmvan6enrate 12/40(30%). AdditionalSEMS were requiredfor incompleteexpansion (2).tumor overgrowth (2), incompleteTEF seal (2) recurrent food Iml~r (2) and TEF/tumor i~_lr6wth(1). ' ' SEMS ' were.successfullydeployedin 92% of .p~er~. Dela~l ~plk3ations ana m-mm~naon ram. vmre28% and 30% ms. ; ~ . ~ / . ~ were highest in uncoveredstant group, use of covered SEMS only ann conenuedimprovementin me des~n of gEMS should decreasethe delayed complca~ and re-lntepmn6~nrates.
212 PLACEMENT OF METAL STENTS FOR MALIGNANT ESOPHAGEAL STRICTURES WITHOUT FLUOROSCOPY F,., Rahmani, D. Rex, G. Lehman, F. Cress, Division of Gastroenterology and Hepatology, Indiana University Medical Center, Indianapolis, IN BACKGROUND: Manufacturers recommend fluoroscopic guidance for placement of self-expanding metal stents (SEMS) in the esophagus. AIIM: Determine the feasibility and safety of SEMS placement with endoscopic guidance alone. METHOD: Prospective observational study of consecutive SEMS placement without fluoroscopy. Eleven consecutive patients with esophageal cancer had the following SEMS placed: Instent (C.R. Bard, Inc., Billerica MA) n = 7, Uhraflex (Microvasive, Watertown, MA); uncoated n = 2, coated n = 1, and Z-arena (Wilson-Cook, Winston-Salem, NC); n = 1. Fluoroscopy was used in 2 cases to confirm guidewire placement for dilation when the tumor could not be passed. Otherwise wires were placed with endoscopic guidance using pediatric scopes when necessary. Upper and lower edges of the tumor were measured endoscopically from the incisors and a distance was chosen for placement of the middle of the stent and marked on the delivery system. The system was positioned by distance and the endoscope was passed alongside to observe deployment. Proper system placement was confirmed by positioning the proximal end of stent at a predetermined distance from the incisors which accounted for any shortening of the stent and was monitored by endoscopy during deployment. RESULTS: All il SEMS were properly positioned aider deployment. Nine patients were discharged home the same day and 2 the following day. All had relief of dysphagia at follow up in I week. Three required narcotics for increased chest pain which improved spontaneously. No perforation or bleeding or migration occurred. CONCLUSION: Fluoroscopy is not necessary for routine SEMS placement for malignant esophageal strictures.
GASTROINTESTINAL ENDOSCOPY AB77
Minnesota. Management of patients with Barrett's and high grade dysplasia (HGD) is controversial. Photodynamic therapy (PDT) has been proposed as an alternative to surgical resection for HGD in patients with Barrett's esophagus. AIM: To assess the cost-effectiveness of PDT for Barrett's esophagus with HGD compared with surgical resection. METHODS: Clinical data from published literature on the risks and survival following esophagectomy and PDT in patients with Barrett's esophagus with HGD was used in a Markov model that simulates lifetime events. Where data was unavailable, expert opinion was used and assessed with sensitivity analysis. We took the perspective of a payer and included direct costs for PDT and surgery. Our final outcome measure was cost per quality adjusted life year ($/QALY). RESULTS: By varying the efficacy of PDT, our model predicts that for PDT to be more effective than surgery, it needs to achieve an efficacy of > 85%. With this level of efficacy, the $/QALY was $ 26,812 which compares favorably with other health care interventions. Sensitivity analysis confirmed the robustness of our results nn efficacy of PDT. Average cost per patient in the surgical strategy was consistently lower Efficacy of PDT 50% 75% 85% 100% Marginal Effectiveness (yr.) -3.54 -0.85 0.67 3.7 Quality Adjusted Life Expectancy (yr.) 14.69 17.38 18.91 21.93 Marginal Costs $22,400 $19,600 $18,000 $14,800 Total Costs/ pt. $42,700 $40,000 $38,400 $35,000 Cost Per Quality Surgery Surgery Adjusted Life Year more more $26,800 $4,000 effective effective than the PDT strategy. CONCLUSION: Our model suggests that PDT can be a viable alternative to surgical resection, if it can achieve an 85% or greater reduction in cancer risk. Clinical trials of PDT for Barrett's esophagus should be designod to determine long term cancer risk reduction.
210 ENDOSCOPIC DILATION OF ESOPHAGEAL STRICTURES: PROSPECTIVE ANALYSIS OF 990 PROCEDURES. ~ ILZ. Ramirez, A.C. Poy, C.A MarronL Department of Gastruenterelogy, Porto Alegre Medical School, Santa C m Hospital, Porto Alegre, BraziL Endoscopic dilation is the initial treatment of choice for most benign esophageal stenoses. The aim of this study is to report a prospective evaluation of the technique in a large cohort of patients. Methods: Between 5192 and 10/96 we prospectively analyzed 141 patients (93 males/48 females, mean ate: 54 years, range: 286) who underwent 990 endoscopic esophageal dilation procedures (7.02 sessions per patient). Stricture etiology was confirmed by biopsy or patient outcome. Eder-Puestow and Savury-Glllierd dilators were used according to endoscopist's discretion. Results: Stricture etiology was post-sorgicel in 80 patients (56.7%), peptic in 35 (24.8%), caustic in 14 (10%), web in 4 (2.8%) and other etiologies in 8 (5.6%). A good response to therapy (absence of dysphalia to meat) was observed in 102 patients (74%), a partial response (dysphalin to some solid foods) in 18 (13%) and treatment failure in 8 (5.8%). Ten patients abandoned treatment and so were lost to follow-up. Mean maximum dilation diameter employed was 42 French for patients with good response to treatment (51.33) and 34.5 French (39-29) in treatment failures (0<0.05 Mann-Whimey U test). The sole severe complication observed was esophageal perforation which occurred in 5 patients (0.5% of dilation procedures, but 3.5% of the patients), with I death and 4 patients treated surgically. Conclusion: Endoscopic esophageal dilation is a safe and effective tecnique in relieving dysphalia due to benign strictures, although it demands many sessions due to stricture recurrence.
VOLUME 45, NO. 4, 1997
J'211 SELF EXPANDING METAL ETENTS (SEMS) FOR MALIGNANT ESOPHAGEAL
OBSTRUCTION
GL Portwood,C Reed, RH Hawan,BJ Hofiman Division of Gselreanterologyand Hepatology, Digestive Disease Center, Division of Cardlcthor~ Surgery;MedEalUniversityof SonlhCarolina,Cherleston,Sou~ Carolina Backeround and Aims: Therape~ ol~tlansin the palliationof malignantesophageal obstruction have,been greatly improved~ the availability of SEMS. The aim of the study was to review our expedencewith 3 SEMS types. Consecotlvecase series of 40 paeonts-(33M 7F; mean age 64, range 40-87 years) ~ malignantesophageal ob61xuctionwere treated with MiorovasiveDIlraflex covered SEMS (25), MIcroves~eUllraflex uncoveredSEMS (9), or SchneiderWallstent SEM$ (14). Histologiesincluded34 esophagealand 9 lung carcinomas. EF~.stentswere placed In 40 patients including 14 with trachso-esophageal
~
UF Uncovered 7/9 (/9%)
Wallstent
Immediate 2/25 (8%) Complications deatNsepsis I (<48 hrs) fever/ sep~n I
0/9 (0%)
I114 (7%) hypotensinn
Delayed Complications
7/21 (33%) pts 11 noted
4/9 (44%)pte 6 coted
2/13 (15%) 2 noted
i ~ b r g i m ~ n (5) ro~h ~z/ rosy01(1) leed (1) .~.plration (1). M6dlsetinalalx:ese~ fist.la (1)
.TEF(1).... Lngro~ ~1) uysphagia (!) F ~ I im-pac~ (2) GI bleed (1)
GI bleed (2)
Food disiml~(5) SEMS (4 Balloonlo)ila~on(1)
F_o(Rl.=disimpa~on(2) EGDrI'x(2) ~euU (~ SEMS 2) Balloon~llatlon(3) PEG (~f.
Implant Success
Re-Interventions
UF Covered 24/25 (96%)
13/14(93%)
Total e.xpedencerevealed implantsuccess 44./48 (92%, incomplete expansion lq 4), meolate r rate 3/48 (6%), deisyco complicationrate 11/40.(28%),ann reintmvan6enrate 12/40(30%). AdditionalSEMS were requiredfor incompleteexpansion (2).tumor overgrowth (2), incompleteTEF seal (2) recurrent food Iml~r (2) and TEF/tumor i~_lr6wth(1). ' ' SEMS ' were.successfullydeployedin 92% of .p~er~. Dela~l ~plk3ations ana m-mm~naon ram. vmre28% and 30% ms. ; ~ . ~ / . ~ were highest in uncoveredstant group, use of covered SEMS only ann conenuedimprovementin me des~n of gEMS should decreasethe delayed complca~ and re-lntepmn6~nrates.
212 PLACEMENT OF METAL STENTS FOR MALIGNANT ESOPHAGEAL STRICTURES WITHOUT FLUOROSCOPY F,., Rahmani, D. Rex, G. Lehman, F. Cress, Division of Gastroenterology and Hepatology, Indiana University Medical Center, Indianapolis, IN BACKGROUND: Manufacturers recommend fluoroscopic guidance for placement of self-expanding metal stents (SEMS) in the esophagus. AIIM: Determine the feasibility and safety of SEMS placement with endoscopic guidance alone. METHOD: Prospective observational study of consecutive SEMS placement without fluoroscopy. Eleven consecutive patients with esophageal cancer had the following SEMS placed: Instent (C.R. Bard, Inc., Billerica MA) n = 7, Uhraflex (Microvasive, Watertown, MA); uncoated n = 2, coated n = 1, and Z-arena (Wilson-Cook, Winston-Salem, NC); n = 1. Fluoroscopy was used in 2 cases to confirm guidewire placement for dilation when the tumor could not be passed. Otherwise wires were placed with endoscopic guidance using pediatric scopes when necessary. Upper and lower edges of the tumor were measured endoscopically from the incisors and a distance was chosen for placement of the middle of the stent and marked on the delivery system. The system was positioned by distance and the endoscope was passed alongside to observe deployment. Proper system placement was confirmed by positioning the proximal end of stent at a predetermined distance from the incisors which accounted for any shortening of the stent and was monitored by endoscopy during deployment. RESULTS: All il SEMS were properly positioned aider deployment. Nine patients were discharged home the same day and 2 the following day. All had relief of dysphagia at follow up in I week. Three required narcotics for increased chest pain which improved spontaneously. No perforation or bleeding or migration occurred. CONCLUSION: Fluoroscopy is not necessary for routine SEMS placement for malignant esophageal strictures.
GASTROINTESTINAL ENDOSCOPY AB77