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 endosonographer. Staging was reported according to the 1997 AJCC classification. 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 adenopathy compared to both PET and CT (P⫽0.03). EUS was superior to Both PET and CT for the detection of celiac adenopathy (p⫽0.01). EUSFNA 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 prevalence, 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 Rabeprazole, 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 gastroenterologysts have more frequent symptoms. Lansoprazole is a commonly prescribed medication in this group (20%). All patients with gastric or duodenal ulcer had a hiatal hernia. Complete relief of symptoms was
AJG – Vol. 98, No. 9, Suppl., 2003
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威, 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 favorably 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 Enteryx 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 distribution, under fluoroscopic guidance, as previously described. A single endoscopist 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 endoscopic and fluoroscopic resources. Optimum location and amount of Enteryx 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 compared with age-specific findings from a separate large-scale clinical trial. Methods: 9035 adults aged ⱖ18 years, including 1726 aged ⱖ65 years, participated in a random-sample telephone survey of US households. Interview 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 ⱖ1 time/week in 3 months) were further stratified as nocturnal GERD (sGERD with ⱖ1 nocturnal symptom ⱖ1 time/week) and nonnocturnal GERD. Symptoms occurring ⱖ2 times/week were arbitrarily defined as severe. We also analyzed age-specific data on symptoms and EE grade
AJG – September, Suppl., 2003
from 2449 patients in an open-label, multicenter study of rabeprazole in GERD, the Future of Acid Suppression Therapy (FAST) trial. Results: Prevalence and severity of sGERD were significantly lower in elderly 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 stable prevalence of severe HB (score ⫽ 3 on a 0 –3 scale) in EE patients ⱕ50 years (⬇40%). Severe HB symptoms steadily declined to 24.2% of patients aged ⬎70 years. This age-related decline was consistent for both day and night HB. Despite decreased HB severity with age, the FAST trial indicated an age-associated increase in high-grade EE (modified Hetzel-Dent grades 3 and 4). Rabeprazole treatment showed similar efficacy in patients aged ⱖ65 years compared with younger patients, despite worse EE in the older patients. Conclusions: An inverse relationship was observed between patient age and GERD symptom severity in both a population survey and clinical trial. Although high-grade EE increased with age, therapeutic response was good in all age groups. Research supported by Eisai Inc., Teaneck, NJ, and Janssen Pharmaceutica Inc., Titusville, NJ.
19 RABEPRAZOLE (RAB) PROVIDES FAST SYMPTOM RELIEF IN GASTROESOPHAGEAL REFLUX DISEASE (GERD) PATIENTS WITH LOW PRETREATMENT HEALTH-RELATED QUALITY OF LIFE (HRQOL) Malcolm Robinson, M.D., FACG*, Lian Mao, 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 symptoms (eg, heartburn [HB], regurgitation) are known to significantly impair HRQOL. However, there is little information correlating severity of HRQOL impairment with treatment response. This study evaluated symptom and HRQOL response in the subgroup of RABtreated erosive esophagitis (EE) patients with low baseline HRQOL in a community-based trial. Methods: 2449 patients with endoscopy-confirmed EE were enrolled in an open-label, multicenter trial. Patients received RAB 20 mg once daily for 8 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. Complete relief (CR) was defined as a patient with a baseline symptom score ⬎0 achieving a score of 0 with treatment. Satisfactory relief (SR) was defined as a change from moderate or severe baseline symptoms (score ⬎1) to a score of 0 or 1 (none or mild) during therapy. Patients completed an HRQOL Short Form (SF)-36 health survey at baseline. The physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 were ranked, and the lowest quartile assessed for CR and SR of day and night HB and regurgitation. Results: Mean baseline SF-36 PCS and MCS were 43.9 and 48.1, respectively, with 50 representing the mean in the general population. Patients in the 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 lowest baseline HRQOL, most achieved CR and SR of HB with RAB 20 mg (Tables 1 and 2). Similar results were seen with regurgitation over the 4 weeks of RAB treatment. Symptom Relief in Patients With Low Baseline HRQOL PCS Day HB
Baseline N Day 1 (%) Day 7 (%) Day 28 (%)
503 56.3 72.9 83.5
387 70.6 81.7 92.2
474 56.9 76.6 88.8
385 69.2 84.8 94.1
Symptom Relief in Patients With Low Baseline HRQOL MCS Day HB
Baseline N Day 1 (%) Day 7 (%) Day 28 (%)
505 57.5 74.5 82.5
401 72.5 85.8 91.2
475 61.5 77.8 85.8
388 72.3 86.3 92.7
Conclusions: GERD patients whose symptoms had resulted in the most severe impact on HRQOL achieved substantial symptom relief beginning with the first dose of RAB. Research supported by Eisai Inc., Teaneck, NJ, and Janssen Pharmaceutica Inc., Titusville, NJ.
20 IS ESOPHAGECTOMY REALLY A CURE FOR BARRETT’S DYSPLASIA 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-grade dysplastic Barrett’s (BE⫹HGD) and localized carcinoma (ACA) of the lower esophagus. Traditionally, patients are considered cured after resection of the metaplasia, dysplasia and neoplasia. Although BE has been reported in patients after esophageal resection it is unclear whether this represents newly formed BE or insufficient resection of all glandular mucosa. The aim of this study was to determine if BE recurs in esophagectomy patients after documented, complete BE resection. Methods: After IRB approval, the electronic database was searched for patients who had undergone esophagectomy for cure at our institution and their records were reviewed for endoscopic, histologic and surgical findings. Results: Since 1995, 50 patients have undergone esophagectomy for BE⫹HGD or ACA. Endoscopy was performed in our lab after surgery in 38 patients including 7 patients (18%) with recurrent Barrett’s metaplasia or neoplasia after curative resection (see Table). Age Pre-op Diagnosis (years) Sex Barrett’s T3 N0 ACA Barrett’s T3 N0 ACA BE⫹HGD Barrett’s T3 N0 ACA BE⫹HGD Barrett’s T2 N0 ACA Barrett’s T2 N0 ACA
Follow Up Diagnosis
Time to Follow Up
Barrett’s T2 N1
Barrett’s LGD Barrett’s T1 N0
41 months 18 months
Barrett’s metaplasia Barrett’s metaplasia BE⫹HGD
Conclusions: 1) Barrett’s metaplasia, dysplasia or cancer after curative esophagectomy was common in our patients who underwent at least one endoscopy after surgery. This appears to represent the development of metachronous disease after complete resection of esophageal disease. 2) Several of these patients (3/7) have required intervention– either further surgery or PDT. 3) These results support formalized studies to establish the utility of screening endoscopy after “curative” esophagectomy for Barrett’s dysplasia or cancer.