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Does baseline Hp status impact erosive esophagitis (EE) healing rates?
2438
Total 24-h Daytime Nighttime
Abstracts
AJG – Vol. 95, No. 9, 2000
O 20 day 28
O 20/R 75 day 7
O 20/R 75 day 28
P value
47.3% ⫾ 5.7% 57.3% ⫾ 7.1% 33.5% ⫾ 5.7%
61.7% ⫾ 7.0% 62.4% ⫾ 6.8% 60.6% ⫾ 8.4%
52.7% ⫾ 8.0% 53.4% ⫾ 8.1% 51.8% ⫾ 8.4%
p ⬎ 0.05 p ⬎ 0.05 p ⫽ 0.035
Summary: Adding ranitidine 75mg qhs to omeprazole 20mg qAM almost doubles the percent time of intragastric pH ⬎4 during nighttime but has no influence on the daytime and overall percent time of intragastric pH ⬎4. Tolerance to ranitidine did not occur by 28 days. Conclusion: These data suggest that addition of an H2-blocker at bedtime to once daily PPI may be useful for better nocturnal acid control.
Methods: Achalasia patients undergoing PD with Rigiflex balloons from 1992–1998 and those treated with laparoscopic myotomy from 1995–1999 were evaluated. Two PD patient groups were included: 1) patients with no prior achalasia treatment in whom the 3.0 cm Rigiflex balloon was the first balloon used (Group 1) and 2) those treated with different balloon sizes (3.0, 3.5, and 4.0 cm) (Group 2). All surgically treated patients had laparoscopic Heller myotomy (Group 3) by one experienced thoracic surgeon. Patients were divided into two sub-groups; age ⬍ 40 yrs and ⱖ 40 yrs. The primary study outcome was symptom relapse within first 12 months of tx.
94 Clinical findings and risk factors for candida esophagitis: A casecontrol study JA Underwood, MD, EJ Castillo, MD, JG Hentz, MS, RF Keate, MD. Division of Gastroenterology and Hepatology, and Section of Biostatistics, Mayo Clinic Scottsdale, Scottsdale, Arizona. Purpose: Candida esophagitis (CE) is well known to occur in immunocompromised hosts. When it is has been described in immunocompetent patients, predisposing medical conditions have often been identified. Our previous study (Am J Gastroenterol 1998:93:1628) retrospectively identified potential risk factors: the purpose of this study was to determine whether these risk factors were significantly associated with CE and to determine the magnitude of each risk factor. Methods: CE was defined by the presence of fungal mycelia on brush cytology. Fifty-two patients were identified from a report of esophageal brushings submitted for cytologic evaluation between July 1996 and December 1999; five additional patients with a previous positive brushing were added. A random sample of 114 control patients was generated from a list of all patients who underwent upper endoscopy with or without brushings and/or biopsy (CPT 43235, 43239) during the 3.5 year period. Both univariate and adjusted odds ratios were measured. Results: Each potential risk factor, except diabetes mellitus, was more common in the CE group. Statistically significant differences were noted in the use of acid suppressive therapy {70% CE vs. 54% control; p 0.048, odds ratio (OR) 2.04}, antibiotic use (30% vs. 10%; p 0.002, OR 3.98), underlying malignancy (26% vs 9%; p 0.005, OR 3.71), dysmotility (28% vs. 3%; p 0.000, OR 14.44), immunosuppression (40% vs. 16%; p 0.001, OR 3.61), prior esophageal or gastric surgery (28% vs. 1%; p 0.000, OR 44.10) and inhaled corticosteroids (16% vs. 10%; p 0.312, OR 1.76). No statistically significant differences were noted between the use of oral steroids, underlying connective tissue disease, diabetes mellitus, or the presence of a barrier injury. Conclusions: The strongest risk factors for CE in our study were esophageal or gastric surgery and dysmotility. Acid suppressive therapy, antibiotics, inhaled corticosteroids, malignancy and immunosuppression were moderately strong risk factors. Diabetes mellitus and barrier injuries were not strongly associated with CE. A larger sample size is needed to assess oral steroids and connective tissue disease. Low doses of oral corticosteroids, good control of diabetes mellitus, and the way we defined barrier injury, may have influenced the assessment of these factors. 95 Laparascopic myotomy may offer improved outcome in younger patients compared to pneumatic dilation (PD) Yaezi MF, Achkar E, Rice TW, Richter JE. Departments of Gastroenterology and Thoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Prior studies using older PD balloons suggest that achalasia patients ⬎ 40 yrs of age have more favorable outcome than those ⬍ 40 yrs. However, there are no studies comparing age response of laparoscopic surgery to PD.
Results: Group 1: 57 patients (30M/27F); Group 2: 48 patients (25M/23F); and Group 3: 47 patients (21M/26F). In those ⬍ 40 yrs, only 2/18 (11%) Group 1 patients still in symptomatic remission at one yr compared to 11/17 (65%) Group 2 and 11/14 (79%) Group 3 (p ⬍ 0.001). There was a higher symptomatic remission rate at one year for laparoscopically treated patients (Group 3) ⬍ 40 yrs of age (79%) compared to PD treated patients (Group 2) (65%), however, this did not reach statistical significance (p ⫽ 0.4). No significant difference (p ⫽ 0.8) among three groups in those ⬎ 40 yrs of age. Conclusions: 1) Patients younger than 40 yrs do not respond well to PD with 3.0 cm Rigiflex balloon. 2) In this group, initial therapy with either larger PD balloon sizes or laparoscopic myotomy improves outcome. 3) Surgical myotomy may be superior to PD in patients younger than 40 yrs; however, long-term clinical studies comparing the two modalities are needed.
96 Does baseline Hp status impact erosive esophagitis (EE) healing rates? N Vakil, MD. Univ. of Wisconsin Med. School, Milwaukee, WI. P Kahrilas, MD. Northwestern U, Chicago, IL. D Magner, MSHyg, W Skammer, BSN, J Levine, MD. AstraZeneca LA, Wayne, PA. Purpose: To examine the effect of Hp status at baseline of EE healing trials on healing rates after therapy with esomeprazole (NEXIUM™), the Sisomer of omeprazole, or with omeprazole. Methods: This pooled analysis includes data from 6708 EE patients (LA Classification grades A–D) who participated in 4 similarly designed US, double-blind, randomized, controlled studies. Due to evidence that Hp status may alter response to therapy, those who tested Hp⫹ during serological screening were excluded to eliminate a potentially confounding variable in assessing the efficacy of study medications. Those later found to be Hp⫹ (from histology testing) were allowed to remain in the study. Patients were treated with once-daily esomeprazole 40 mg (E40), 20 mg (E20), or omeprazole 20 mg (O20), the standard EE healing dose, for up to 8 weeks. Treatment comparison was made using log-rank test, controlling for the biopsy Hp status at baseline. Results: See table.
AJG – September, 2000
Abstracts
Table. Estimated EE Healing Rate, Week 8, ITT Analysis, by Hp Status Baseline Biopsy Status
E40 (95% CI) Nⴝ2446a
E20 (95% CI) Nⴝ1243a
O20 (95% CI) Nⴝ3019a
Hp Negative
93.2 (92.2, 94.4) (n⫽2224) 94.6 (91.4, 97.9) (n⫽207) 93.4 (92.4, 94.5)
89.9 (88.1, 91.7) (n⫽1127) 93.2 (88.0, 98.4) (n⫽111) 90.2 (88.5, 91.9)
86.6 (85.2, 87.9) (n⫽2726) 87.5 (83.4, 91.5) (n⫽280) 86.6 (85.4, 87.9)
Hp Positive Total a
Conclusions: The data in this pooled analysis indicate that baseline Hp status does not appear to affect EE healing rates at week 8. Overall, the healing rate increased as the dose of esomeprazole increased. E40 and E20 produced greater healing rates than O20 at week 8. This study was supported by a grant from AstraZeneca LP, Wayne, PA. 97 Does baseline severity of EE impact healing with esomeprazole? N Vakil, MD. Univ. of Wisconsin Medical School, Milwaukee, WI. J Richter, MD. Cleveland Clinic Foundation, Cleveland, OH. C Hwang, MS, V Marino, BSMT, J Levine, MD. AstraZeneca LP, Wayne, PA. Purpose: To examine the effect of baseline severity of erosive esophagitis (EE) on healing rates after therapy with either esomeprazole (E), the S-isomer of omeprazole, or with omeprazole (O). Methods: Data were pooled from 6708 patients with EE (LA Classification Grades A–D) from 4 similarly designed US multi-center, double-blind, randomized, controlled trials in which patients received once-daily doses of E40, E20, O20, the approved dose for EE, for up to 8 weeks. Treatment comparison was made using log-rank test while controlling for the LA severity at baseline. Results: See table. Table. Estimated Healing Rate at Wk 8 by Baseline EE Severity, ITT Analysis
A B C D Total
Purpose: To determine whether baseline severity of erosive esophagitis (EE), based on the LA Classification, affects EE maintenance rates after therapy with esomeprazole (NEXIUM™). Methods: Patients who participated in an 8-week healing trial, had endoscopy-proven healed EE (no erosions present), and were Hp negative (by histology) were randomized to esomeprazole 40 mg (E40), 20 mg (E20), 10 mg (E10), or placebo (P) for up to 6 months. Treatment comparison was made using log-rank test, controlling for LA severity at baseline. Results: (table) Table. Estimated Maintained Healing Rate by Baseline EE Severity, ITT Analysis
Patients with unknown Hp status were included.
Baseline Grade
2439
E40 (95% CI) (Nⴝ2446)
E20 (95% CI) (Nⴝ1243)
O20 (95% CI) (Nⴝ3019)
96.6 (95.3, 98.0) (n⫽849) 93.3 (91.7, 95.0) (n⫽923) 91.2 (88.7, 93.7) (n⫽520) 84.0 (77.9, 90.1) (n⫽152) 93.4 (92.4, 94.5)
97.5 (96.0, 99.0) (n⫽440) 89.7 (86.8, 92.5) (n⫽480) 83.5 (78.7, 88.3) (n⫽240) 74.0 (64.1, 83.9) (n⫽83) 90.2 (88.5, 91.9)
94.9 (93.4, 96.3) (n⫽990) 88.0 (86.1, 89.9) (n⫽1203) 76.0 (72.6, 79.5) (n⫽606) 72.4 (66.3, 78.6) (n⫽219) 86.6 (85.4, 87.9)
Conclusion: Healing was more consistent across all grades of esophagitis (A–D) with E40 than with E20 or O20. In contrast to O20, baseline severity of EE does not significantly impact healing rates with E40. All treatments effectively healed EE at week 8. Overall, E40 and E20 produced greater healing rates than O20 at week 8. This study was supported by a grant from AstraZeneca LP, Wayne, PA.
98 Effect of baseline grade of esophagitis on maintenance of healing rates N Vakil, MD. Univ. of Wisconsin Medical School, Milwaukee, WI. D Johnson, MD. Eastern VA School of Medicine, Norfolk, VA. C Hwang, MS, D D’Amico, MS, J Levine, MD. AstraZeneca LP, Wayne, PA.
Baseline Grade (n) A (52/62/43/64) B (74/81/74/69) C⫹D (48/37/51/38) A (52/62/43/64) B (74/81/74/69) C⫹D (48/37/51/38) Total
Month 1
E40 (%) Nⴝ174 100
E20 (%) Nⴝ180 100
E10 (%) Nⴝ168
P (%) Nⴝ171
90.7
64.1
1
98.6
95.1
81.1
47.8
1
97.9
97.3
76.5
26.3
6
91.9
86.8
67.2
34.5
6
93.3
83.5
57.1
36.9
6
85.7
88.5
45.3
7.5
6
90.5*
85.7*
55.7*
29.1
* p⫽0.0001 vs placebo (log rank test when controlling for baseline EE severity).
Conclusions: E40, E20, and E10 effectively maintained healing of EE at month 1 and 6. Baseline severity did not seem to affect maintenance of healing for E40 and E20. For E10, the greater the severity of baseline grade, the less effective the maintenance of healing. This study was support by a grant from AstraZeneca, LP, Wayne, PA.
99 Use of balloon inflation to decrease risk of airway compression from esophageal expandable metal stents (EMS) S Varadarajulu, MD, J Benson, MD. Univ. of Connecticut Health Center, Farmington, CT. Background: The incidence of tracheo-esophageal fistula is 5% in patients with esophageal cancer (EC). In these surgically unresectable patients, EMS have been used successfully to close tracheo-esopha-geal fistula (TEF). However, sudden death due to airway obstruction can occur after stent deployment. We report a patient with TEF managed with EMS using a novel approach. Technique: A 55 yr old man was referred for management of TEF secondary to squamous cell cancer of the esophagus. He had undergone right pneumonectomy 10 yrs ago for lung cancer. It was decided to manage the fistula by placement of EMS. To avoid the risk of tracheal compression during stent placement, we adopted the following approach: First, the proximal and distal margins of the tumor (30 –36cms) were marked with intra-mucosal injection of ethiodol. Second, a bronchoscopy was performed to evaluate the extent of airway involvement; the patient had a 30% narrowing of the tracheal lumen due to mechanical compression by tumor mass. Third, a Wilson-Cook Quantum TTC esophageal balloon dilatation catheter was passed through the endoscope and inflated in stages at the tumor site up to 54Fr (equivalent to the stent caliber) while the airways were monitored by bronchoscopy. After excluding further airway compression, a Wilson-Cook fully coated 10cm EMS was deployed in the standard fashion without complications. Complete occlusion of the fistula was obtained. The patient subsequently remained symptom free with no additional endoscopic intervention required at 3 months follow-up. Conclusion: In patients with EC complicated by airway compression, as may be seen with TEF, it is either impossible or very difficult to extract the EMS from the esophagus once airway obstruction occurs. Using the graded
Total 24-h Daytime Nighttime
Abstracts
AJG – Vol. 95, No. 9, 2000
O 20 day 28
O 20/R 75 day 7
O 20/R 75 day 28
P value
47.3% ⫾ 5.7% 57.3% ⫾ 7.1% 33.5% ⫾ 5.7%
61.7% ⫾ 7.0% 62.4% ⫾ 6.8% 60.6% ⫾ 8.4%
52.7% ⫾ 8.0% 53.4% ⫾ 8.1% 51.8% ⫾ 8.4%
p ⬎ 0.05 p ⬎ 0.05 p ⫽ 0.035
Summary: Adding ranitidine 75mg qhs to omeprazole 20mg qAM almost doubles the percent time of intragastric pH ⬎4 during nighttime but has no influence on the daytime and overall percent time of intragastric pH ⬎4. Tolerance to ranitidine did not occur by 28 days. Conclusion: These data suggest that addition of an H2-blocker at bedtime to once daily PPI may be useful for better nocturnal acid control.
Methods: Achalasia patients undergoing PD with Rigiflex balloons from 1992–1998 and those treated with laparoscopic myotomy from 1995–1999 were evaluated. Two PD patient groups were included: 1) patients with no prior achalasia treatment in whom the 3.0 cm Rigiflex balloon was the first balloon used (Group 1) and 2) those treated with different balloon sizes (3.0, 3.5, and 4.0 cm) (Group 2). All surgically treated patients had laparoscopic Heller myotomy (Group 3) by one experienced thoracic surgeon. Patients were divided into two sub-groups; age ⬍ 40 yrs and ⱖ 40 yrs. The primary study outcome was symptom relapse within first 12 months of tx.
94 Clinical findings and risk factors for candida esophagitis: A casecontrol study JA Underwood, MD, EJ Castillo, MD, JG Hentz, MS, RF Keate, MD. Division of Gastroenterology and Hepatology, and Section of Biostatistics, Mayo Clinic Scottsdale, Scottsdale, Arizona. Purpose: Candida esophagitis (CE) is well known to occur in immunocompromised hosts. When it is has been described in immunocompetent patients, predisposing medical conditions have often been identified. Our previous study (Am J Gastroenterol 1998:93:1628) retrospectively identified potential risk factors: the purpose of this study was to determine whether these risk factors were significantly associated with CE and to determine the magnitude of each risk factor. Methods: CE was defined by the presence of fungal mycelia on brush cytology. Fifty-two patients were identified from a report of esophageal brushings submitted for cytologic evaluation between July 1996 and December 1999; five additional patients with a previous positive brushing were added. A random sample of 114 control patients was generated from a list of all patients who underwent upper endoscopy with or without brushings and/or biopsy (CPT 43235, 43239) during the 3.5 year period. Both univariate and adjusted odds ratios were measured. Results: Each potential risk factor, except diabetes mellitus, was more common in the CE group. Statistically significant differences were noted in the use of acid suppressive therapy {70% CE vs. 54% control; p 0.048, odds ratio (OR) 2.04}, antibiotic use (30% vs. 10%; p 0.002, OR 3.98), underlying malignancy (26% vs 9%; p 0.005, OR 3.71), dysmotility (28% vs. 3%; p 0.000, OR 14.44), immunosuppression (40% vs. 16%; p 0.001, OR 3.61), prior esophageal or gastric surgery (28% vs. 1%; p 0.000, OR 44.10) and inhaled corticosteroids (16% vs. 10%; p 0.312, OR 1.76). No statistically significant differences were noted between the use of oral steroids, underlying connective tissue disease, diabetes mellitus, or the presence of a barrier injury. Conclusions: The strongest risk factors for CE in our study were esophageal or gastric surgery and dysmotility. Acid suppressive therapy, antibiotics, inhaled corticosteroids, malignancy and immunosuppression were moderately strong risk factors. Diabetes mellitus and barrier injuries were not strongly associated with CE. A larger sample size is needed to assess oral steroids and connective tissue disease. Low doses of oral corticosteroids, good control of diabetes mellitus, and the way we defined barrier injury, may have influenced the assessment of these factors. 95 Laparascopic myotomy may offer improved outcome in younger patients compared to pneumatic dilation (PD) Yaezi MF, Achkar E, Rice TW, Richter JE. Departments of Gastroenterology and Thoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Prior studies using older PD balloons suggest that achalasia patients ⬎ 40 yrs of age have more favorable outcome than those ⬍ 40 yrs. However, there are no studies comparing age response of laparoscopic surgery to PD.
Results: Group 1: 57 patients (30M/27F); Group 2: 48 patients (25M/23F); and Group 3: 47 patients (21M/26F). In those ⬍ 40 yrs, only 2/18 (11%) Group 1 patients still in symptomatic remission at one yr compared to 11/17 (65%) Group 2 and 11/14 (79%) Group 3 (p ⬍ 0.001). There was a higher symptomatic remission rate at one year for laparoscopically treated patients (Group 3) ⬍ 40 yrs of age (79%) compared to PD treated patients (Group 2) (65%), however, this did not reach statistical significance (p ⫽ 0.4). No significant difference (p ⫽ 0.8) among three groups in those ⬎ 40 yrs of age. Conclusions: 1) Patients younger than 40 yrs do not respond well to PD with 3.0 cm Rigiflex balloon. 2) In this group, initial therapy with either larger PD balloon sizes or laparoscopic myotomy improves outcome. 3) Surgical myotomy may be superior to PD in patients younger than 40 yrs; however, long-term clinical studies comparing the two modalities are needed.
96 Does baseline Hp status impact erosive esophagitis (EE) healing rates? N Vakil, MD. Univ. of Wisconsin Med. School, Milwaukee, WI. P Kahrilas, MD. Northwestern U, Chicago, IL. D Magner, MSHyg, W Skammer, BSN, J Levine, MD. AstraZeneca LA, Wayne, PA. Purpose: To examine the effect of Hp status at baseline of EE healing trials on healing rates after therapy with esomeprazole (NEXIUM™), the Sisomer of omeprazole, or with omeprazole. Methods: This pooled analysis includes data from 6708 EE patients (LA Classification grades A–D) who participated in 4 similarly designed US, double-blind, randomized, controlled studies. Due to evidence that Hp status may alter response to therapy, those who tested Hp⫹ during serological screening were excluded to eliminate a potentially confounding variable in assessing the efficacy of study medications. Those later found to be Hp⫹ (from histology testing) were allowed to remain in the study. Patients were treated with once-daily esomeprazole 40 mg (E40), 20 mg (E20), or omeprazole 20 mg (O20), the standard EE healing dose, for up to 8 weeks. Treatment comparison was made using log-rank test, controlling for the biopsy Hp status at baseline. Results: See table.
AJG – September, 2000
Abstracts
Table. Estimated EE Healing Rate, Week 8, ITT Analysis, by Hp Status Baseline Biopsy Status
E40 (95% CI) Nⴝ2446a
E20 (95% CI) Nⴝ1243a
O20 (95% CI) Nⴝ3019a
Hp Negative
93.2 (92.2, 94.4) (n⫽2224) 94.6 (91.4, 97.9) (n⫽207) 93.4 (92.4, 94.5)
89.9 (88.1, 91.7) (n⫽1127) 93.2 (88.0, 98.4) (n⫽111) 90.2 (88.5, 91.9)
86.6 (85.2, 87.9) (n⫽2726) 87.5 (83.4, 91.5) (n⫽280) 86.6 (85.4, 87.9)
Hp Positive Total a
Conclusions: The data in this pooled analysis indicate that baseline Hp status does not appear to affect EE healing rates at week 8. Overall, the healing rate increased as the dose of esomeprazole increased. E40 and E20 produced greater healing rates than O20 at week 8. This study was supported by a grant from AstraZeneca LP, Wayne, PA. 97 Does baseline severity of EE impact healing with esomeprazole? N Vakil, MD. Univ. of Wisconsin Medical School, Milwaukee, WI. J Richter, MD. Cleveland Clinic Foundation, Cleveland, OH. C Hwang, MS, V Marino, BSMT, J Levine, MD. AstraZeneca LP, Wayne, PA. Purpose: To examine the effect of baseline severity of erosive esophagitis (EE) on healing rates after therapy with either esomeprazole (E), the S-isomer of omeprazole, or with omeprazole (O). Methods: Data were pooled from 6708 patients with EE (LA Classification Grades A–D) from 4 similarly designed US multi-center, double-blind, randomized, controlled trials in which patients received once-daily doses of E40, E20, O20, the approved dose for EE, for up to 8 weeks. Treatment comparison was made using log-rank test while controlling for the LA severity at baseline. Results: See table. Table. Estimated Healing Rate at Wk 8 by Baseline EE Severity, ITT Analysis
A B C D Total
Purpose: To determine whether baseline severity of erosive esophagitis (EE), based on the LA Classification, affects EE maintenance rates after therapy with esomeprazole (NEXIUM™). Methods: Patients who participated in an 8-week healing trial, had endoscopy-proven healed EE (no erosions present), and were Hp negative (by histology) were randomized to esomeprazole 40 mg (E40), 20 mg (E20), 10 mg (E10), or placebo (P) for up to 6 months. Treatment comparison was made using log-rank test, controlling for LA severity at baseline. Results: (table) Table. Estimated Maintained Healing Rate by Baseline EE Severity, ITT Analysis
Patients with unknown Hp status were included.
Baseline Grade
2439
E40 (95% CI) (Nⴝ2446)
E20 (95% CI) (Nⴝ1243)
O20 (95% CI) (Nⴝ3019)
96.6 (95.3, 98.0) (n⫽849) 93.3 (91.7, 95.0) (n⫽923) 91.2 (88.7, 93.7) (n⫽520) 84.0 (77.9, 90.1) (n⫽152) 93.4 (92.4, 94.5)
97.5 (96.0, 99.0) (n⫽440) 89.7 (86.8, 92.5) (n⫽480) 83.5 (78.7, 88.3) (n⫽240) 74.0 (64.1, 83.9) (n⫽83) 90.2 (88.5, 91.9)
94.9 (93.4, 96.3) (n⫽990) 88.0 (86.1, 89.9) (n⫽1203) 76.0 (72.6, 79.5) (n⫽606) 72.4 (66.3, 78.6) (n⫽219) 86.6 (85.4, 87.9)
Conclusion: Healing was more consistent across all grades of esophagitis (A–D) with E40 than with E20 or O20. In contrast to O20, baseline severity of EE does not significantly impact healing rates with E40. All treatments effectively healed EE at week 8. Overall, E40 and E20 produced greater healing rates than O20 at week 8. This study was supported by a grant from AstraZeneca LP, Wayne, PA.
98 Effect of baseline grade of esophagitis on maintenance of healing rates N Vakil, MD. Univ. of Wisconsin Medical School, Milwaukee, WI. D Johnson, MD. Eastern VA School of Medicine, Norfolk, VA. C Hwang, MS, D D’Amico, MS, J Levine, MD. AstraZeneca LP, Wayne, PA.
Baseline Grade (n) A (52/62/43/64) B (74/81/74/69) C⫹D (48/37/51/38) A (52/62/43/64) B (74/81/74/69) C⫹D (48/37/51/38) Total
Month 1
E40 (%) Nⴝ174 100
E20 (%) Nⴝ180 100
E10 (%) Nⴝ168
P (%) Nⴝ171
90.7
64.1
1
98.6
95.1
81.1
47.8
1
97.9
97.3
76.5
26.3
6
91.9
86.8
67.2
34.5
6
93.3
83.5
57.1
36.9
6
85.7
88.5
45.3
7.5
6
90.5*
85.7*
55.7*
29.1
* p⫽0.0001 vs placebo (log rank test when controlling for baseline EE severity).
Conclusions: E40, E20, and E10 effectively maintained healing of EE at month 1 and 6. Baseline severity did not seem to affect maintenance of healing for E40 and E20. For E10, the greater the severity of baseline grade, the less effective the maintenance of healing. This study was support by a grant from AstraZeneca, LP, Wayne, PA.
99 Use of balloon inflation to decrease risk of airway compression from esophageal expandable metal stents (EMS) S Varadarajulu, MD, J Benson, MD. Univ. of Connecticut Health Center, Farmington, CT. Background: The incidence of tracheo-esophageal fistula is 5% in patients with esophageal cancer (EC). In these surgically unresectable patients, EMS have been used successfully to close tracheo-esopha-geal fistula (TEF). However, sudden death due to airway obstruction can occur after stent deployment. We report a patient with TEF managed with EMS using a novel approach. Technique: A 55 yr old man was referred for management of TEF secondary to squamous cell cancer of the esophagus. He had undergone right pneumonectomy 10 yrs ago for lung cancer. It was decided to manage the fistula by placement of EMS. To avoid the risk of tracheal compression during stent placement, we adopted the following approach: First, the proximal and distal margins of the tumor (30 –36cms) were marked with intra-mucosal injection of ethiodol. Second, a bronchoscopy was performed to evaluate the extent of airway involvement; the patient had a 30% narrowing of the tracheal lumen due to mechanical compression by tumor mass. Third, a Wilson-Cook Quantum TTC esophageal balloon dilatation catheter was passed through the endoscope and inflated in stages at the tumor site up to 54Fr (equivalent to the stent caliber) while the airways were monitored by bronchoscopy. After excluding further airway compression, a Wilson-Cook fully coated 10cm EMS was deployed in the standard fashion without complications. Complete occlusion of the fistula was obtained. The patient subsequently remained symptom free with no additional endoscopic intervention required at 3 months follow-up. Conclusion: In patients with EC complicated by airway compression, as may be seen with TEF, it is either impossible or very difficult to extract the EMS from the esophagus once airway obstruction occurs. Using the graded