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Abstracts
AJG – Vol. 98, No. 9, Suppl., 2003
healing rates in response to esomeprazole or lansoprazole in patients with EE and hiatus hernia. Methods: 5240 patients with EE participated in a randomized, doubleblind, multicenter US trial that compared esomeprazole 40 mg (n ⫽ 2624) with lansoprazole 30 mg (n ⫽ 2616) once daily for healing of EE after 4 or 8 weeks of treatment. The severity of EE (LA classification) and the presence or absence of hiatus hernia was documented during baseline EGD. The risk of hiatus hernia among patients with severe EE (LA grade C or D) was determined using odds ratios (OR) with 95% CI. Healing was confirmed by EGD at the final post-baseline visit, and life-table estimates with 95% CI were used to assess healing rates in each treatment group in this retrospective analysis. Results: 3350 (63.9%) of 5240 patients had hiatus hernia. At baseline, patients with hiatus hernia were twice as likely to have severe disease (OR 2.00, 95% CI ⫽ 1.73–2.30). Esomeprazole demonstrated significantly higher healing rates (92.9%; 95% CI ⫽ 91.6 –94.1%) than lansoprazole (87.8%; 95% CI ⫽ 86.2– 89.4%) in patients with hiatus hernia. Healing rates among patients treated with esomeprazole did not differ between patients with or without hiatus hernia (92.9% vs 92.1%, respectively).
Hiatus hernia, n (%) No hiatus hernia, n (%)
Overall (nⴝ5240)
Grade A/B (nⴝ3954)
Grade C/D (nⴝ1286)
3350 (63.9) 1890 (36.1)
2383 (60.3) 1571 (39.7)
967 (75.2) 319 (24.8)
Conclusions: Hiatus hernia is a risk factor for severe disease in patients with EE. Esomeprazole 40 mg is more effective than lansoprazole 30 mg for healing EE in patients with hiatus hernia. With esomeprazole, EE healing rates remain high regardless of the presence or absence of hiatus hernia. 50 LONG-TERM FOLLOW-UP OF REVERSAL OF BARRETT’S ESOPHAGUS COMBINING ENDOSCOPIC ABLATIVE THERAPY WITH ACID SUPPRESSION Adam Lowe, M.D., Douglas Faigel, M.D., M. Brian Fennerty, M.D., Wilfred M. Weinstein, M.D., Richard Sampliner, M.D.*. Southern Arizona VA Health Care System, Tucson, AZ; Arizona Health Sciences Center, Tucson, AZ; Oregon Health Sciences University and VAMC, Portland, OR and UCLA School of Medicine, Los Angeles, CA. Purpose: Safe and effective reversal of nondysplastic Barrett’s esophagus (BE) using endoscopic ablative therapy has been described. Only limited long-term results have been reported. A prospective endoscopic and histologic long-term follow-up study of patients with documented reversal of BE was performed to assess the recurrent/residual intestinal metaplasia (IM). Methods: Patients with BE who previously underwent endoscopic ablation with either multipolar electrocoagulation or argon plasma coagulation combined with high dose PPI therapy were maintained on acid suppression to control reflux symptoms. These patients were followed with regular interval endoscopy. Four quadrant large-capacity biopsies were taken every 2 cm of the former Barrett’s and of apparent columnar lined esophagus (CLE) to assess for remaining IM. Results: Forty-eight patients were followed up for at least 2 years with surveillance endoscopy after ablative therapy. The mean duration of follow up was 32 months (range 2–7 years). 42 of the patients were male; the mean age was 56 years. 46 patients received multipolar electrocoagulation. The mean initial length of BE was 3.1 cm (range 2–9 cm). Only 1 patient had IM one month post-ablation. At last endoscopy only 3 patients had measurable CLE. Nine additional patients had focal CLE (⬍ 5mm). Of the 12 patients with CLE only 2 had IM. 75% of patients had no visible CLE. 65% had both endoscopic and histologic reversal. Seven patients had histologic IM, none with dysplasia. 85% of patients had no IM. Conclusions: The majority of patients treated with combination therapy continue to remain free of endoscopic and histological BE on surveillance endoscopy. 85% lack IM, the premalignant eptithelium. The long-term
durability of new squamous epithelium is established, however, the risk for progression to neoplasia remains unknown. Surveillance endoscopy with biopsy should still be performed even after reversal treatment. 51 ESOMEPRAZOLE COMPARED WITH LANSOPRAZOLE FOR MAINTAINING HEALED EROSIVE ESOPHAGITIS IN PATIENTS WITH HIATUS HERNIA Karsten Lauritsen, M.D., Ph.D.*, Ola Junghard, Ph.D., Douglas Levine, M.D., FACG. Odense University Hospital, Odense, Denmark; AstraZeneca R&D, Molndal, Sweden and AstraZeneca LP, Wilmington, DE. Purpose: Hiatus hernia is a risk factor for gastroesophageal reflux disease. Patients with erosive esophagitis and hiatus hernia are more likely to present with more severe disease (Scand J Gastroenterol 2002;37:899). Long-term proton pump inhibitor therapy is recommended to prevent relapse in patients following healing of severe erosive esophagitis. We evaluated the efficacy of esomeprazole versus lansoprazole for maintenance therapy of patients with hiatus hernia and healed erosive esophagitis in a retrospective analysis. Methods: In a randomized, controlled, multicenter, clinical trial, 1224 patients with healed erosive esophagitis and resolution of heartburn after 4 or 8 weeks of therapy with esomeprazole 40 mg once daily were treated with either esomeprazole 20 mg or lansoprazole 15 mg once daily for up to 6 months as maintenance therapy. The presence of hiatus hernia was evaluated prior to healing of erosive esophagitis during baseline EGD. Repeat EGD was performed at 3 and 6 months after healing while on maintenance therapy. The presence or absence of symptoms during the final 7 days of maintenance treatment was assessed by each investigator. Maintenance of healing was evaluated using life table methods and compared between treatment groups with the log rank test. Results: Overall, hiatus hernia was present in 625 patients (51%). Esomeprazole maintained healing in a significantly higher percentage of patients with hiatus hernia following the 6-month course of treatment compared with lansoprazole (table, P ⬍0.005). In patients with hiatus hernia, resolution of heartburn, acid regurgitation and epigastric pain was observed in 71.2% of patients treated with esomeprazole versus 64.9% treated with lansoprazole.
Patients with/without hiatus hernia at baseline, n Maintenance of healing with hiatus hernia, n (%) Maintenance of healing, no hiatus hernia, n (%)
Esomeprazole 20 mg (nⴝ615)
Lansoprazole 15 mg (nⴝ609)
309/306
316/293
244 (79)*
224 (71)
266 (87)
226 (77)
* P ⬍0.005 versus lansoprazole
Conclusions: Six months of treatment with esomeprazole 20 mg is more effective than lansoprazole 15 mg for maintenance of healing of erosive esophagitis in patients with hiatus hernia. 52 ENDOSCOPIC FULL-THICKNESS PLICATION FOR GERD: 12MONTH MULTI-CENTER STUDY RESULTS Douglas K. Pleskow, M.D.*, Richard I. Rothstein, M.D., Simon K. Lo, M.D., Robert H. Hawes, M.D., Richard A. Kozarek, M.D., Gregory B. Haber, M.D., Christopher J. Gostout, M.D., Anthony J. Lembo, M.D. Beth Israel Deaconess Medical Center, Boston, MA; Dartmouth Hitchcock Medical Center, Lebanon, NH; Cedars-Sinai Medical Center, Los Angeles, CA; Medical University of South Carolina, Charleston, SC; Virginia Mason Medical Center, Seattle, WA; St. Michael’s Hospital, Toronto, ON, Canada and Mayo Clinic, Rochester, MN.
AJG – September, Suppl., 2003
Purpose: A novel full-thickness plication device (Plicator, NDO Surgical, Inc., Mansfield, MA) has been designed to inhibit gastroesophageal reflux by placing a transmural plication near the gastroesophageal (GE) junction under direct endoscopic visualization. The resulting serosa-to-serosa tissue union appears to accentuate and restore the valvular mechanism of the gastroesophageal junction. The purpose of this study was to asses the safety and efficacy of a novel endoscopic full-thickness plication device for the treatment of patients with symptomatic GERD. Methods: Patients with chronic heartburn and pathologic reflux requiring maintenance anti-secretory therapy were recruited. Patients with large hiatal hernias (⬎ 2cm), grades III and IV esophagitis, and Barrett’s esophagus were excluded. The following were assessed at baseline (on and off-meds) and 1-year post-plication: GERD-HRQL, GSRS, SF-36 questionnaires, and medication use. Additionally, 24-hr pH-metry and manometry were measured at baseline, three-months (pH/manometry) and sixmonths (pH only) post-plication. All patients received a single, endoscopic full-thickness plication in the gastric cardia within 2cm of the GE junction. Results: Sixty-four patients (mean age 46.3, range 23–71) underwent endoscopic full-thickness plication (mean procedure time ⫽ 17.2 min). No re-treatments were performed. One year post-plication (n ⫽ 56), median off-meds GERD-HRQL scores improved 65% (19.0 vs. 6.0) and were superior when compared to patients’ baseline on-meds HRQL scores (13.0 vs. 6.0). In 24-hour pH-metry studies conducted at six-months post-procedure (n ⫽ 35), median % time pH ⬍ 4 decreased 31% with 30% of patients experiencing a normalization of pH at 6-months. No significant change in esophageal manometry was noted. Upon entry, 59/64 patients required daily proton-pump inhibitor therapy. At one-year post-procedure, 37/53 patients (70%) remained off daily PPI therapy. The most common adverse event was sore throat (41%), spontaneously resolving within several days post-procedure. A complete adverse event profile will be discussed. Conclusions: In this study, a single full-thickness plication placed at the GE junction reduced symptoms, medication use and esophageal acid exposure associated with GERD.
53 VERRUCOUS CARCINOMA OF THE ESOPHAGUS: A WOLF IN SHEEP’S CLOTHING Harvey G. Phillips, M.D., Luis A. Balart, M.D.*, William A. Ferrante, M.D. LSU, New Orleans, LA. Purpose: Fifteen cases of verrucous carcinoma of the esophagus have been reported in the English literature. It is a slow growing epidermoid neoplasm that is most commonly found in the oral cavity, larynx, and genitalia. It is indolent and associated with a high mortality. Discrepancy between its clinical and histologic character often leads to delayed diagnosis. We present a typical case to emphasize that a high index of suspicion is the key to proper diagnosis and treatment. A fourty-three year old man presented to the ER with two months of solid food dysphagia, heartburn, and a twenty pound weight loss. He drank a six-pack of beer daily and had a 40 pack/year tobacco habit. No significant physical findings were noted. HIV serology was negative. A barium esophagram demonstrated a markedly abnormal mucosa in the distal third, consistent with an inflammatory process. When he finally presented to the GI clinic, three months later, the dysphagia had progressed such that any solid food per os was forcibly regurgitated. At endoscopy, the distal third of the esophagus appeared circumferentially encrusted with a shaggy, whitish plaque extending to the GEJ. The pathology report showed only mild acute and chronic inflammation. The patient was lost to follow-up. Seven months following his initial presentation, his dysphagia had marginally improved. He underwent endoscopy with brush biopsy. There was no endoscopic improvement and the histology was notable only for poorlypreserved and highly atypical squamous cells. The discrepancy between the histologic findings and the clinical signs was debated and ultimately led to a third EGD. The pathology from the third investigation was more distinc-
Abstracts
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tive showing hyperkeratotic verrucous squamous mucosa suggestive of squamous papilloma (spike form) with pseudoepitheliomatous hyperplasia. The abruptly more redolent histologic description suggested sampling error. The pathology related to the fourth endoscopy, in the 11th month, was similarly benign. Nonetheless, the patient was referred to surgery and received a complete esophagectomy which showed well-differentiated, invasive carcinoma. Routine endoscopic biopsy is frequently inadequate to make the diagnosis of verrucous carcinoma of the esophagus due to its benign appearance and well differentiated histology. A high index of suspicion and close clinical follow-up are vital for making an early diagnosis. EUS is likely to contribute substantially to making the diagnosis earlier and perhaps will have impact on survival.
54 ESOPHAGEAL FUNCTION TESTING USING BOTH LIQUID AND VISCOUS SUBSTANCES: PROVIDES GREATER POTENTIAL TO DETECT ABNORMALITIES Radu Tutuian, M.D., Donald O. Castell, M.D., M.A.C.G.*. Medical University of South Carolina, Charleston, SC. Purpose: Traditional esophageal function testing includes esophageal manometry using liquid (water) swallows. Adding viscous (semisolid) swallows as part of esophageal manometry may provide additional information similar to the “modified” barium swallow. Methods: We have prospectively performed esophageal function testing using 10 liquid and 10 viscous swallows (5ml each) in 341 consecutive patients referred to our laboratory. Studies were reported manometrically normal for either liquid or viscous test substances if there were no more than 20% ineffective and 10% simultaneous swallows, the lower esophageal sphincter (LES) had normal residual pressure during relaxations and distal esophageal amplitude did not exceed 180 mmHg. Results: 217 patients had an abnormal test result for liquid swallows. Similarly, 242 had abnormal viscous swallows. However, disparate results were found in 53 studies. From the 124 normal studies for liquid swallows 85 (69%) satisfied normality criteria for viscous swallows. From the remaining studies 21 were classified as showing ineffective esophageal motility (IEM), 10 as poorly relaxing LES, 7 distal esophageal spasm and one nutcracker esophagus for viscous swallows. On the other hand 14 abnormal studies for liquid swallows (6 IEM, 4 nutcracker esophagus, 1 DES, 3 poorly relaxing LES) fulfilled normality criteria for viscous swallows.
normal viscous abnormal viscous Total
Normal liquid
abnormal liquid
total
85 39 124
14 203 217
99 242 341
Conclusions: Adding viscous swallows to traditional water swallows may increase the sensitivity of manometry to detect abnormal esophageal motility. Outcome studies are required to assess the value of the additional information provided by viscous swallows.
55 SALIVARY PROTECTIVE POTENTIAL IS SIGNIFICANTLY ENHANCED BY STIMULATION INDUCED BOTH BY MASTICATION AND ESOPHAGO-SALIVARY REFLEX: ITS CLINICAL SIGNIFICANCE Tomasz Skoczylas, M.D., Cezary Poplawski, M.D., Marek Marcinkiewicz, M.D., Tomasz Zbroch, M.D., Zbigniew Namiot, M.D., Richard W. McCallum, M.D., Jerzy Sarosiek, M.D.*. Kansas University Medical Center, Kansas City, KS.