in the presence of RBC, lysed RBC (which interestingly, showed enhancedgrowth), mononuclear cells or neutrophils. Plasma, however, inhibited thegrowth of H. pylori at all time points tested. No viable bacteria wererecovered from cultures incubated in the presence of plasma regardless ofthe plasma donor’s Hp antibody status.Conclusion Blood and plasma from Hp� as well as Hp� patients inhibitthe growth of Hp in liquid culture in an antibody-independent fashion, Thecomponent of plasma responsible however, remains to be determined.These data help to explain the unusual finding of the apparent low H. pyloriinfection rate in actively bleeding gastric and duodenal ulcer patients.

163

Associated lesions to gastric cancer: follow-up studyMario J Dinis-Ribeiro1, Costa-Pereira A2, Lopes C1, Lomba-Viana R1*and 1Instituto Portugues de Oncologia, Porto, Portugal; and 2Facultyof Medicine of Porto, Porto, Portugal.

Purpose: Adequate follow-up for some histopathological conditions andlesions, associated with gastric cancer, is not fully defined. Aim: Toevaluate progression and follow-up of atrophic gastritis (AG), intestinalmetaplasia (IM) and dysplasia (D).Methods: Seventy-seven patients clinical files retrospective analysis withmore than one endoscopy since January 1985, in whom biopsies revealedAG; complete (c) or incomplete (i ) IM; low-grade (LGD) or high-grade D(HGD).Results: Table: Median time and histology results for each type of pre-cancerous lesion in a once made endoscopyConclusions: Patients with AG or cIM may not need a follow-up endos-copy, at least every year. Instead non-invasive tests may be usefull for theirfollow-up (eg PI/PII). On the contrary, for patients with iIM or D (8–16%progressed to HGD and C) a intensive follow-up should be developed, withimprovement of endoscopy techniques (eg, magnification).

FOLLOW-UPTime (months) Histology

AG IM IM D D CBACKGROUND C I LGD HGD

AG 24 (6–264) 41% 10% 10% 39% 0 0IM-C 12 (6–48) 25% 63% 12% 0 0 0I 36 (6–60) 14% 33% 38% 5% 5% 5%LGD 24 (6–96) 36% 4% 18% 33% 5% 4%HGD 24 (6–72) 17% 0 42% 25% 8% 8%

164

Percutaneous endoscopic gastrostomy for decompression in patientswith malignant ascites and gastrointestinal obstructionCharles E Dye and Eli Ehrenpreis*. 1Gastroenterology, University ofChicago, Chicago, Illinois, United States; and 2Gastroenterology,University of Chicago, Chicago, Illinois, United States.

Purpose: The purpose of the study is to assess the safety and efficacy ofPercutaneuos Endoscopic Gastrostomy (PEG) for decompression of ob-struction in patients with malignant ascites.Methods: Eligible patients have permanent gastrointestinal obstruction andmoderate to large ascites due to terminal malignancy. Symptoms must berelieved by nasogastric tube (NGT) suction. After large volume paracen-tesis, PEG placement is performed and followed by placement of twogastropexy fastners to help assure adequate fixation during tract maturation.Large volume paracentesis is performed for moderate to large ascitesaccumulation until tract maturation occurs in 3–4 weeks. Subsequentparacentesis is performed only for palliation of abdominal pain.Results: Six patients were evaluated, five patients underwent endoscopywith consideration of PEG placement, and four patients had successfulPEG placement. PEG placement was not performed in one patient during

endoscopy due to epigastric tumor mass and failure of transcutaneousneedle localization of the gastric wall. The four patients who received PEGtubes for decompression had good relief of symptoms and no majorcomplications.Conclusions: PEG tubes can be safely placed in patients with malignantascites and gastrointestinal obstruction resulting in effective palliation ofnausea and vomiting, ability to comfortably swallow liquids, and improvedquality of life.

165

Expression of COX-2 in the colonic phenotype of gastric intestinalmetaplasia (GIM) with or without gastric adenocarcinomaImran Fayyaz, MD, Zafar K. Mirza, MD, Maria T. Lee, MD and KironM. Das, MD, FACG*. 1 Medicine, UMDNJ-Robert Wood JohnsonMedical School and Hospital (RWJUH), New Brunswick, New Jersey,United States.

Purpose: Some forms of gastric intestinal metaplasia (GIM) may beprecancerous. It is clinically important to determine the subtype of GIMthat can lead to gastric cancer. COX-2 expression in the GIM and itsrelation to GIM-phenotype is unknown. We have developed a monoclonalantibody (mAb Das-1) that specifically reacts with normal colonic andBarrett’s epithelium, but not with any other part of the gastrointestinal tract,including stomach and small intestine (Ann Int Med 120:753, 1994).Methods: Using anti-COX-2 antibody, by an immunoperoxidase assay, weexamined COX-2 expression in histologically confirmed GIM specimens(biopsy and surgical) with and without gastric cancer. Phenotype of GIMwas examined in parallel using mAb Das-1. Patients included, Group A:GIM without gastric carcinoma (n � 26), Group B: GIM away from gastriccancer area (n � 8).Results: COX-2 expression was present in 12 of the 26 (46%) specimensof GIM without cancer, and 5 out of 8 (62%) GIM specimens with cancer.mAb Das-1 reactivity was present in the GIM in 14/26 in Group A and 8/8in Group B patients. It is intriguing that COX-2 expression was noted onlyin the GIM reactive to mAb Das-1.Conclusions: COX-2 expression is present in GIM, more frequently incancer patients, and its expression is strongly associated with colonicphenotype of GIM.

166

Gastric intestinal metaplasia as detected by a novel biomarker ishighly associated with gastric adenocarcinomaImran Fayyaz, MD, Zafar K. Mirza, MD, Maria T. Lee, MD and KironM. Das, MD, FACG*. 1Medicine, UMDNJ-Robert Wood JohnsonMedical School and Hospital (RWJUH), New Brunswick, New Jersey,United States.

Purpose: Some forms of gastric intestinal metaplasia (GIM) may beprecancerous. However the cellular phenotype that predisposes to gastriccarcinogenesis is unknown. A monoclonal antibody (mAb Das-1, IgMisotype) specifically reacts with normal colonic and Barrett’s epithelium,but not with normal stomach esophagus and small intestine (Ann Int Med120:753, 1994). We examined if mAb Das-1 can identify sub-type of GIMassociated with gastric carcinoma.Methods: Using mAb Das-1, by a sensitive immunoperoxidase assay, weexamined histologically confirmed GIM specimens (biopsy and surgical-)from RWJUH. Patients included, Group A: GIM (without gastric carci-noma) (n � 26), Group B: GIM associated with gastric cancer, but awayfrom cancer area (n � 8).Results: In Group A, 14 of 26 (53.8%) samples, the glandular epitheliumin GIM clearly reacted with mAb Das-1. In Group B, all 8 samples (100%)of GIM areas away from gastric carcinoma reacted intensely with mAbDas-1 (p � 0.05). In addition, each of 8 gastric carcinoma tissue also

S53AJG – September, Suppl., 2001 Abstracts

reacted to mAb Das-1. The reactivity of mAb Das-1 was present in bothgoblet and non-goblet metaplastic cells in GIM and in cancer cells.Conclusions: Colonic phenotype of GIM, as identified by mAb Das-1, isassociated with gastric cancer. mAb Das-1 may identify “high risk” pa-tients for appropriate cost-effective surveillance.

167

Electrogastrography in children: What is normal?Barbara Fehling, M.D., Rita Steffen, M.D., FACG, Robert Wyllie, M.D.,FACG, Maha Barbar, M.D., Marilyn Goske, M.D., Janet Reid, M.D.,and Stuart Morrison, M.D. Cleveland Clinical Foundation, Cleveland,OH.

Background: Cutaneous electrogastrography (EGG) is a noninvasivemethod for assessing gastric electrical activity. Normal values have beendetermined in the adult population but little data is available in determiningthe spectrum of normal EGG values in children. The purpose of thisprospective study was to determine the range of EGG findings in a groupof healthy children with no gastrointestinal symptoms.Methods: Forty healthy subjects without any gastrointestinal complaintswere studied. The EGG was recorded using surface electrodes for 30minutes in the fasting state and 120 minutes after ingestion of a standardmeal. The postprandial change in dominant power, percentages of brady-gastria, normogastria and tachygastria and dominant frequency inhibitorycoefficient were recorded and analyzed comparing different ages andgenders.Results: Forty-one patients were enrolled. Forty completed the study (20males with a mean age of 10.6 years, 20 females with a mean age of 10.5years). Results were obtained for overall values and by age and gender.There were no statistically significant differences in the results in anycategory. The average time spent in normogastria was 65.3% which islower than the previously reported in adults and in studies of older children.The power ratio was much higher in children less than 12 years (26.9 vs3.14) and the p value approached statistical significance (P � 0.075).

168

Evaluation of acid suppresion following intravenous lansoprazoleand oral lansoprazoleJames W Freston, MD1*, Mitchell A Rosenberg, MD2, Janice S Griffin,RN, BSN3, Nancy L Lukasik, RN, BSN3 and Quang Wang, MS4.1Department of Medicine, University of Connecticut, Farmington, CT,United States; 2Parkway Research Center, Miami Beach, FL, UnitedStates; 3Research & Development, TAP Pharmaceutical Products, LakeForest, IL, United States; and 4Abbott Laboratories, Abbott Park, IL,United States.

Purpose: To compare the intragastric (IG) pH of lansoprazole (LAN) 30mg administered intravenously (IV) with that of LAN 30 mg orally.Methods: This was an open-label, crossover study in which thirty-sixhealthy male and female subjects were randomly divided into groups toreceive once-a-day 30 mg LAN orally and IV (30 minute infusion) for atotal of 5 days. 24-hour IG pH was recorded on Days 1 and 5 of eachcrossover period. Analyses of variance were performed to examine thedifferences between IV and oral doses.Results: During hours 0–1 and 2–5 post-dosing on Day 1, the mean IG pHand the percentage of time pH was � 3, 4, 5, and 6 (hour 0–1 only) weresignificantly greater with the IV regimen than with the oral regimen. Duringhour 0–1 post-dosing on Day 5, the mean IG pH and the percentage of timepH was � 3, 4, 5, and 6 were significantly greater in the IV regimencompared to the oral regimen.

Conclusions: The intravenous administration of lansoprazole raises themean intragastric pH higher within a period of one hour and maintains thepH above 4 longer than the oral administration. The mean pH over the 24hour post-dosing period does not differ between the two routes of admin-istration. Funded by TAP Pharmaceutical Products Inc.

Table Mean Intragastric pH Values with Oral and IV Lansoprazole*

Day 1Oral Lansoprazole

(30IV Lansoprazole

(30 mg/30

Total 24 4.75 4.86Hour 0–1 2.74 4.64�Hours 2–5 4.63 5.26�Day 5Total 24 5.25 5.36Hour 0–1 4.79 5.91�Hours 2–5 6.05 6.35

* Least squares mean estimate� Significantly (p � 0.05) higher than the oral lansoprazole regimen.

169

Pharmacokinetics of lansoprazole with multiple oral andintravenous dosesJames W Freston, MD1*, Mitchell A Roseberg, MD2, Janice S Griffin,RN, BSN3 Nancy L Lukasik, RN, BSN3 and Wei-jian Pan, PhD4.1Department of Medicine, University of Connecticut Health Center,Farmington, CT, United States; 2Parkway Research Center, MiamiBeach, FL, United States; 3Research & Development, TAPPharmaceutical Products, Lake Forest, IL, United States; and 4AbbottLaboratories, Abbott Park, IL, United States.

Purpose: To evaluate the pharmacokinetics (PK) and safety of multipleoral and intravenous (IV) doses of 30 mg lansoprazole (LAN).Methods: This was a randomized, open-label, crossover study. Thirty-sixhealthy male and female subjects (aged 20–42 years) were randomlydivided into groups to receive once-a-day, 30 mg LAN orally or IV (30minute infusion) for a total of 5 days. Plasma samples were collected onDays 1 and 5 and analyzed using LC/MS/MS for the assessment of (�) and(�) isomers, and total LAN PK. Mixed effects linear models were chosenfor statistical data analyses.Results: The PK of (�) and (�) isomers, and total LAN were the same.Half-lives were similar, and the differences observed between IV and oralvalues for Tmax, Cmax, and AUC were those expected of these routes ofadministration. The PK of LAN did not change significantly with time after5-day once-a-day repeated oral or IV administration of 30 mg LAN. Noclinically important changes were observed in the analyses of laboratory orvital sign results.Conclusions: Like the lansoprazole oral capsule formulation, the pharma-cokinetic profile of the lansoprazole 30 mg intravenous formulation doesnot change after repeated daily dosing and is not associated with changesin laboratory values or vital signs. Funded by TAP Pharmaceutical Prod-ucts Inc.

Table Mean PK Results for Lansoprazol Oral and IV Administration

30 mg QD Oral 30 mg/30 min QD

Day 1 Day 5 Day 1 Day 5

Cmax(ng/ml) 1027 1052 1814 1884Tmax(h) 1.7 1.5 0.5 0.5AUC24(ng-h/ml) 2876 3101 3463 3611t1/2(h)� 1.24 1.20 1.15 1.19MRT(h) -- -- 1.7 1.7CL(L/h) 13.0* 12.9* 10.2 9.7Vss(L) -- -- 16.7 16.6

� Harmonic Mean, * CL/F

S54 Abstracts AJG – Vol. 96, No. 9, Suppl., 2001