Severity of gastroesophageal reflux disease (GERD) symptoms and erosive esophagitis (EE) as a...
2
The objective of this study is to compare the performance of CT, FDG-PET and EUS in the preoperative evaluation of potentially operable ECA patients. Methods: All patients underwent preoperative staging with CT, FDG-PET and EUS. When non-peritumoral lymph nodes (LN) were identified by EUS, fine needle aspiration was performed. All patients were evaluated by one thoracic surgeon and underwent EUS by a single experienced en- dosonographer. Staging was reported according to the 1997 AJCC classi- fication. Results: Forty-three patients were evaluated. Ninety one percent were males and 88% were Caucasian. Sixty seven percent of the patients had esophageal adenocarcinoma. EUS T stage for the patients was as follows: T1 (12%), T2 (12%), T3 (72%), T4 (4%). EUS detected overall more peritumoral, perigastric or mediastinal ade- nopathy compared to both PET and CT (P0.03). EUS was superior to Both PET and CT for the detection of celiac adenopathy (p0.01). EUS- FNA documented LN involvement in 25 % of patients. PET was superior to EUS in the detection of distant metastasis to liver and lung (p 0.002). Conclusions: EUS is superior to both PET and CT in the determination of loco-regional disease and celiac axis LN involvement in patients with ECA. PET and EUS are complementary for complete staging and prognostication of patients with ECA at the time of presentation. 16 SATISFACTION SURVEY OF PATIENTS WITH GERD WITH DIFFERENT PROTON PUMP INHIBITOR Khondker K. Islam, M.D.*, Kashyap N. Katawala, M.D., Steeve Creech, Moneera Haque, Sohrab Mobarhan, M.D. Loyola University Medical Center, Maywood, IL. Purpose: Gastroesophageal reflux disease (GERD) is notable for its prev- alence, variety of clinical presentations and underrecognized morbidity. Currently there are various over the counter H2 blockers and proton pump inhibitors that are used by the patients and physicians to treat this condition. This satisfaction survey was carried out to identify preferences for different acid suppressor medications, response to symptom relief and endoscopic findings. Methods: Eighty-six patients were selected who had completed the survey before having EGD for GERD related symptoms. All statistical analyses were performed using SPSS for Windows (SPSS 10.1, SPSS Inc., Chicago, IL). Descriptive statistics are reported for all variables. Results: Fifteen patients were on Esomeprazole, 10 patients were on Omeprazole, 7 patients were on Pantoprazole, 6 patients were on Rabe- prazole, 18 patients were on Lansoprazole, 9 patients were on H2 blocker and 13 of them were using over the counter medications. Upon EGD, 10 % of patients with Omeprazole and 11% of patients with Lansoprazole were found to have gastric or duodenal ulcers. Esophagitis was noted in 13% of patients on Esomeprazole, 17% patients on Rabeprazole and 7% of patients on Lansoprazole. Gastritis was noted in 10 % of patients on Omeprazole, 17% of patients on Rabeprazole, 6% of patients on Lansoprazole and 11% of patients on H2 blocker. Out of 86 patients, 7 (8%) were found to have H. pylori infection. Complete symptoms relief occurred in 26% of patients on Esomeprazole, 20% on Omeprazole, and 14% on Pantoprazole group. Sleep disturbance with GERD related symptoms was variable in different proton pump inhibitor groups. Forty four percent of patients with H2 blocker woke up in the night with GERD symptoms compared to 27% in Esomeprazole, 29% in Pantoprazole and 60% in Omeprazole group. The best response to night time GERD was seen in the Rabeprazole group. Only 17 % in the Rabeprazole group had night time GERD symptoms. Conclusions: GERD symptoms were seen more commonly in female patients. Most of the patients seen by gastroenterologysts have symptom duration more than one year (49%). The patient population seen by gas- troenterologysts have more frequent symptoms. Lansoprazole is a com- monly prescribed medication in this group (20%). All patients with gastric or duodenal ulcer had a hiatal hernia. Complete relief of symptoms was more common in the Esomeprazole group (27%). Night time symptom relief was more commonly seen in the Rabeprazole group (83%). 17 COMMUNITY EXPERIENCE WITH ENTERYX,A MINIMALLY INVASIVE THERAPY FOR THE TREATMENT OF GERD Robert A. Ganz, M.D.*. Minnesota Gastroenterology, P.A., Minneapolis, MN. Background: Enteryx is an inert biocompatible polymer recently FDA approved for the treatment of GERD. Enteryx is injected into the muscle layer of the esophagus at the gastroesophageal junction, in order to favor- ably affect LES barrier function. Purpose: 12 month follow-up data from a large multi-center trial suggest that the method is effective and safe, however the experience of a single community center has not previously been presented. Methods: Subgroup analysis of a single community center (Minnesota Gastroenterology, Minneapolis, MN), participating in the 12 month En- teryx multicenter trial, was performed. Patient inclusion and exclusion criteria, specifics of the endoscopic technique, and outcomes for the entire cohort have previously been published (AJG, 2003). All patients were PPI dependent, and all had abnormal pH monitoring scores prior to entry into the study. Enteryx was injected at the z-line in a circumferential distribu- tion, under fluoroscopic guidance, as previously described. A single en- doscopist performed all procedures. Results: 24 patients have been treated to date with 14 patients evaluable at the time of abstract submission. 64% of the patients were male. The mean age was 46 (range 24 –70) and the mean BMI was 28.0 (range 17.6 –36.4). The Velanovich GERD-HRQL symptom scores improved by an average of 71% at the end of 12 months. 78.6% of patients were completely off all meds at 12 months, and an additional 7.1% decreased PPI use by at least 50%. 14.3% of patients had no change in PPI use. There was no change in LES resting pressure (baseline 10.3 mm Hg; 12 month 9.5 mm Hg). Ambulatory pH monitoring data showed a significant improvement of 40% in overall DeMeester scores. There were no significant adverse events in any of the patients studied. Conclusions: These data suggest that Enteryx treatment of GERD is safe and effective, and can be performed in the community setting with endo- scopic and fluoroscopic resources. Optimum location and amount of En- teryx material to be injected warrants further study. 18 SEVERITY OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS AND EROSIVE ESOPHAGITIS (EE) AS A FUNCTION OF AGE Malcolm Robinson, M.D., FACG*, Lian Mao, M.S., Luella Engelhart, M.S., Reshmi Siddique, Ph.D., Leonard Jokubaitis, M.D. Oklahoma Foundation for Digestive Research, University of Oklahoma Health Center, Oklahoma City, OK and Janssen Pharmaceutica Inc., Titusville, NJ. Purpose: GERD prevalence and severity may differ in older patients relative to younger ones. To assess GERD severity in the elderly, we conducted a survey of age-related GERD symptoms. Results were com- pared with age-specific findings from a separate large-scale clinical trial. Methods: 9035 adults aged 18 years, including 1726 aged 65 years, participated in a random-sample telephone survey of US households. In- terview questions elicited self-reports on the occurrence, frequency, and timing of GERD symptoms (heartburn [HB] and regurgitation) over the past 3 months. Symptomatic GERD (sGERD) cases (HB or regurgitation 1 time/week in 3 months) were further stratified as nocturnal GERD (sGERD with 1 nocturnal symptom 1 time/week) and nonnocturnal GERD. Symptoms occurring 2 times/week were arbitrarily defined as severe. We also analyzed age-specific data on symptoms and EE grade S6 Abstracts AJG – Vol. 98, No. 9, Suppl., 2003
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Transcript of Severity of gastroesophageal reflux disease (GERD) symptoms and erosive esophagitis (EE) as a...
The objective of this study is to compare the performance of CT,FDG-PET and EUS in the preoperative evaluation of potentially operableECA patients.Methods: All patients underwent preoperative staging with CT, FDG-PETand EUS. When non-peritumoral lymph nodes (LN) were identified byEUS, fine needle aspiration was performed. All patients were evaluated byone thoracic surgeon and underwent EUS by a single experienced en-dosonographer. Staging was reported according to the 1997 AJCC classi-fication.Results: Forty-three patients were evaluated. Ninety one percent weremales and 88% were Caucasian. Sixty seven percent of the patients hadesophageal adenocarcinoma.
EUS T stage for the patients was as follows: T1 (12%), T2 (12%), T3(72%), T4 (4%).
EUS detected overall more peritumoral, perigastric or mediastinal ade-nopathy compared to both PET and CT (P�0.03). EUS was superior toBoth PET and CT for the detection of celiac adenopathy (p�0.01). EUS-FNA documented LN involvement in 25 % of patients. PET was superiorto EUS in the detection of distant metastasis to liver and lung (p �0.002).Conclusions: EUS is superior to both PET and CT in the determination ofloco-regional disease and celiac axis LN involvement in patients with ECA.PET and EUS are complementary for complete staging and prognosticationof patients with ECA at the time of presentation.
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SATISFACTION SURVEY OF PATIENTS WITH GERD WITHDIFFERENT PROTON PUMP INHIBITORKhondker K. Islam, M.D.*, Kashyap N. Katawala, M.D., Steeve Creech,Moneera Haque, Sohrab Mobarhan, M.D. Loyola University MedicalCenter, Maywood, IL.
Purpose: Gastroesophageal reflux disease (GERD) is notable for its prev-alence, variety of clinical presentations and underrecognized morbidity.Currently there are various over the counter H2 blockers and proton pumpinhibitors that are used by the patients and physicians to treat this condition.This satisfaction survey was carried out to identify preferences for differentacid suppressor medications, response to symptom relief and endoscopicfindings.Methods: Eighty-six patients were selected who had completed the surveybefore having EGD for GERD related symptoms. All statistical analyseswere performed using SPSS for Windows (SPSS 10.1, SPSS Inc., Chicago,IL). Descriptive statistics are reported for all variables.Results: Fifteen patients were on Esomeprazole, 10 patients were onOmeprazole, 7 patients were on Pantoprazole, 6 patients were on Rabe-prazole, 18 patients were on Lansoprazole, 9 patients were on H2 blockerand 13 of them were using over the counter medications. Upon EGD, 10 %of patients with Omeprazole and 11% of patients with Lansoprazole werefound to have gastric or duodenal ulcers. Esophagitis was noted in 13% ofpatients on Esomeprazole, 17% patients on Rabeprazole and 7% of patientson Lansoprazole. Gastritis was noted in 10 % of patients on Omeprazole,17% of patients on Rabeprazole, 6% of patients on Lansoprazole and 11%of patients on H2 blocker. Out of 86 patients, 7 (8%) were found to haveH. pylori infection. Complete symptoms relief occurred in 26% of patientson Esomeprazole, 20% on Omeprazole, and 14% on Pantoprazole group.Sleep disturbance with GERD related symptoms was variable in differentproton pump inhibitor groups. Forty four percent of patients with H2blocker woke up in the night with GERD symptoms compared to 27% inEsomeprazole, 29% in Pantoprazole and 60% in Omeprazole group. Thebest response to night time GERD was seen in the Rabeprazole group. Only17 % in the Rabeprazole group had night time GERD symptoms.Conclusions: GERD symptoms were seen more commonly in femalepatients. Most of the patients seen by gastroenterologysts have symptomduration more than one year (49%). The patient population seen by gas-troenterologysts have more frequent symptoms. Lansoprazole is a com-monly prescribed medication in this group (20%). All patients with gastricor duodenal ulcer had a hiatal hernia. Complete relief of symptoms was
more common in the Esomeprazole group (27%). Night time symptomrelief was more commonly seen in the Rabeprazole group (83%).
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COMMUNITY EXPERIENCE WITH ENTERYX�, AMINIMALLY INVASIVE THERAPY FOR THE TREATMENT OFGERDRobert A. Ganz, M.D.*. Minnesota Gastroenterology, P.A.,Minneapolis, MN.
Background: Enteryx is an inert biocompatible polymer recently FDAapproved for the treatment of GERD. Enteryx is injected into the musclelayer of the esophagus at the gastroesophageal junction, in order to favor-ably affect LES barrier function.Purpose: 12 month follow-up data from a large multi-center trial suggestthat the method is effective and safe, however the experience of a singlecommunity center has not previously been presented.Methods: Subgroup analysis of a single community center (MinnesotaGastroenterology, Minneapolis, MN), participating in the 12 month En-teryx multicenter trial, was performed. Patient inclusion and exclusioncriteria, specifics of the endoscopic technique, and outcomes for the entirecohort have previously been published (AJG, 2003). All patients were PPIdependent, and all had abnormal pH monitoring scores prior to entry intothe study. Enteryx was injected at the z-line in a circumferential distribu-tion, under fluoroscopic guidance, as previously described. A single en-doscopist performed all procedures.Results: 24 patients have been treated to date with 14 patients evaluable atthe time of abstract submission. 64% of the patients were male. The meanage was 46 (range 24–70) and the mean BMI was 28.0 (range 17.6–36.4).The Velanovich GERD-HRQL symptom scores improved by an average of71% at the end of 12 months. 78.6% of patients were completely off allmeds at 12 months, and an additional 7.1% decreased PPI use by at least50%. 14.3% of patients had no change in PPI use. There was no change inLES resting pressure (baseline 10.3 mm Hg; 12 month 9.5 mm Hg).Ambulatory pH monitoring data showed a significant improvement of 40%in overall DeMeester scores. There were no significant adverse events inany of the patients studied.Conclusions: These data suggest that Enteryx treatment of GERD is safeand effective, and can be performed in the community setting with endo-scopic and fluoroscopic resources. Optimum location and amount of En-teryx material to be injected warrants further study.
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SEVERITY OF GASTROESOPHAGEAL REFLUX DISEASE(GERD) SYMPTOMS AND EROSIVE ESOPHAGITIS (EE) AS AFUNCTION OF AGEMalcolm Robinson, M.D., FACG*, Lian Mao, M.S.,Luella Engelhart, M.S., Reshmi Siddique, Ph.D.,Leonard Jokubaitis, M.D. Oklahoma Foundation for DigestiveResearch, University of Oklahoma Health Center, Oklahoma City, OKand Janssen Pharmaceutica Inc., Titusville, NJ.
Purpose: GERD prevalence and severity may differ in older patientsrelative to younger ones. To assess GERD severity in the elderly, weconducted a survey of age-related GERD symptoms. Results were com-pared with age-specific findings from a separate large-scale clinical trial.Methods: 9035 adults aged �18 years, including 1726 aged �65 years,participated in a random-sample telephone survey of US households. In-terview questions elicited self-reports on the occurrence, frequency, andtiming of GERD symptoms (heartburn [HB] and regurgitation) over thepast 3 months. Symptomatic GERD (sGERD) cases (HB or regurgitation�1 time/week in 3 months) were further stratified as nocturnal GERD(sGERD with �1 nocturnal symptom �1 time/week) and nonnocturnalGERD. Symptoms occurring �2 times/week were arbitrarily defined assevere. We also analyzed age-specific data on symptoms and EE grade
S6 Abstracts AJG – Vol. 98, No. 9, Suppl., 2003
from 2449 patients in an open-label, multicenter study of rabeprazole inGERD, the Future of Acid Suppression Therapy (FAST) trial.Results: Prevalence and severity of sGERD were significantly lower inelderly than in younger survey respondents—prevalence: 9.9% vs 14.9%,respectively (P �0.0001); severity: 74% vs 87%, respectively (P �0.05).Nocturnal GERD was less prevalent in elderly than younger people (2.4%vs 4.5%, respectively; P �0.0001). FAST trial results indicated stableprevalence of severe HB (score � 3 on a 0–3 scale) in EE patients �50years (�40%). Severe HB symptoms steadily declined to 24.2% of patientsaged �70 years. This age-related decline was consistent for both day andnight HB. Despite decreased HB severity with age, the FAST trial indicatedan age-associated increase in high-grade EE (modified Hetzel-Dent grades3 and 4). Rabeprazole treatment showed similar efficacy in patients aged�65 years compared with younger patients, despite worse EE in the olderpatients.Conclusions: An inverse relationship was observed between patient ageand GERD symptom severity in both a population survey and clinical trial.Although high-grade EE increased with age, therapeutic response was goodin all age groups. Research supported by Eisai Inc., Teaneck, NJ, andJanssen Pharmaceutica Inc., Titusville, NJ.
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RABEPRAZOLE (RAB) PROVIDES FAST SYMPTOM RELIEFIN GASTROESOPHAGEAL REFLUX DISEASE (GERD)PATIENTS WITH LOW PRETREATMENT HEALTH-RELATEDQUALITY OF LIFE (HRQOL)Malcolm Robinson, M.D., FACG*, Lian Mao, M.S.,Reshmi Siddique, Ph.D., Leonard Jokubaitis, M.D. OklahomaFoundation for Digestive Research, University of Oklahoma HealthCenter, Oklahoma City, OK and Janssen Pharmaceutica Inc., Titusville,NJ.
Purpose: GERD symptoms (eg, heartburn [HB], regurgitation) are knownto significantly impair HRQOL. However, there is little information cor-relating severity of HRQOL impairment with treatment response. Thisstudy evaluated symptom and HRQOL response in the subgroup of RAB-treated erosive esophagitis (EE) patients with low baseline HRQOL in acommunity-based trial.Methods: 2449 patients with endoscopy-confirmed EE were enrolled in anopen-label, multicenter trial. Patients received RAB 20 mg once daily for8 weeks and reported GERD symptoms using a 4-point severity scale(0�none, 3�severe) at baseline, and days 1, 7, and 28 of therapy. Com-plete relief (CR) was defined as a patient with a baseline symptom score �0achieving a score of 0 with treatment. Satisfactory relief (SR) was definedas a change from moderate or severe baseline symptoms (score �1) to ascore of 0 or 1 (none or mild) during therapy. Patients completed anHRQOL Short Form (SF)-36 health survey at baseline. The physicalcomponent summary (PCS) and mental component summary (MCS) scoresof the SF-36 were ranked, and the lowest quartile assessed for CR and SRof day and night HB and regurgitation.Results: Mean baseline SF-36 PCS and MCS were 43.9 and 48.1, respec-tively, with 50 representing the mean in the general population. Patients inthe lowest quartile (n�599) had mean baseline SF-36 PCS of 28.9 (range,10.5–36.8) and MCS of 31.8 (range, 9.3–41.3). In patients with the lowestbaseline HRQOL, most achieved CR and SR of HB with RAB 20 mg(Tables 1 and 2). Similar results were seen with regurgitation over the 4weeks of RAB treatment.
Symptom Relief in Patients With Low Baseline HRQOL PCS
Day HB Night HB
CR SR CR SR
Baseline N 503 387 474 385Day 1 (%) 56.3 70.6 56.9 69.2Day 7 (%) 72.9 81.7 76.6 84.8Day 28 (%) 83.5 92.2 88.8 94.1
Symptom Relief in Patients With Low Baseline HRQOL MCS
Day HB Night HB
CR SR CR SR
Baseline N 505 401 475 388Day 1 (%) 57.5 72.5 61.5 72.3Day 7 (%) 74.5 85.8 77.8 86.3Day 28 (%) 82.5 91.2 85.8 92.7
Conclusions: GERD patients whose symptoms had resulted in the mostsevere impact on HRQOL achieved substantial symptom relief beginningwith the first dose of RAB. Research supported by Eisai Inc., Teaneck, NJ,and Janssen Pharmaceutica Inc., Titusville, NJ.
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IS ESOPHAGECTOMY REALLY A CURE FOR BARRETT’SDYSPLASIA AND CANCER?Herbert C. Wolfsen, M.D., Lois L. Hemminger, A.R.N.P.,Kenneth R. DeVault, M.D.*. Mayo Clinic, Jacksonville, FL.
Purpose: Esophagectomy is considered standard therapy for high-gradedysplastic Barrett’s (BE�HGD) and localized carcinoma (ACA) of thelower esophagus. Traditionally, patients are considered cured after resec-tion of the metaplasia, dysplasia and neoplasia. Although BE has beenreported in patients after esophageal resection it is unclear whether thisrepresents newly formed BE or insufficient resection of all glandularmucosa. The aim of this study was to determine if BE recurs in esopha-gectomy patients after documented, complete BE resection.Methods: After IRB approval, the electronic database was searched forpatients who had undergone esophagectomy for cure at our institution andtheir records were reviewed for endoscopic, histologic and surgical find-ings.Results: Since 1995, 50 patients have undergone esophagectomy forBE�HGD or ACA. Endoscopy was performed in our lab after surgery in38 patients including 7 patients (18%) with recurrent Barrett’s metaplasiaor neoplasia after curative resection (see Table).
Pre-op DiagnosisAge
(years) SexFollow UpDiagnosis
Time toFollow Up Treatment
Barrett’s T3 N0ACA
58 F Barrett’s T2 N1 7 months Surgery
Barrett’s T3 N0ACA
64 F Barrett’s LGD 36 months Observation
BE�HGD 64 M Barrett’s LGD 41 months ObservationBarrett’s T3 N0
ACA69 M Barrett’s T1 N0 18 months Surgery
BE�HGD 72 M Barrett’smetaplasia
84 months Observation
Barrett’s T2 N0ACA
78 M Barrett’smetaplasia
11 months Observation
Barrett’s T2 N0ACA
80 M BE�HGD 88 months Photodynamictherapy
Conclusions: 1) Barrett’s metaplasia, dysplasia or cancer after curativeesophagectomy was common in our patients who underwent at least oneendoscopy after surgery. This appears to represent the development ofmetachronous disease after complete resection of esophageal disease. 2)Several of these patients (3/7) have required intervention–either furthersurgery or PDT. 3) These results support formalized studies to establish theutility of screening endoscopy after “curative” esophagectomy for Barrett’sdysplasia or cancer.
S7AJG – September, Suppl., 2003 Abstracts
