Results: The majority of responders were hospital-based and 59% of theunits performed over 3000 procedures per year. After use the endoscopewas hand-carried or transported in a dry container (97%) to a separatecleaning room (85%) for HLD by technicians (40%). Wide variationsexisted in manual step procedures including use of disposable (50%)brushes and number of times channel brushed: once (21%), twice (35%),3–5 times (37%). Soaking duration in disinfectant (gluteraldehyde 70%)was �10min (8%), 10–20 min (35%), 20–30 min (38%), 30–40 min (7%)and �40 min (3%). 67% had an active unit infection control (IC) serviceand 98% had a QA program. Monitoring of cleaning effectiveness was byvisual inspection (50%) and culturing endoscopes (17%). Culturing wasdone weekly (1%) and biannually (6.5%) and performed by swab of theendoscope end (5%) or rinsing the biopsy channel (8%). If culture positive,most would remove the instrument from clinical use and reevaluate pro-tocol and personnel for technique lapses. Two respondents were aware ofa procedure related infection (bronchoscope in one).Conclusions: Wide practice variations were noted in manual cleaning andin soaking time during automated HLD in this community. Less variationswere noted in cleaning personnel and training, location and methods ofcleaning, presence of IC services and QA programs. Endoscope culturingwas infrequently done and positive cultures were rare. While most unitsclaim to have ongoing quality assurance programs, few use objectivecriteria to monitor effective disinfection or lapses in technique. Iatrogenicinfection is uncommonly recognized following GI endoscope procedures.

870

SAFETY AND LAXATIVE EFFECTS OF VISICOL TABLETS(SODIUM PHOSPHATE) IN HEALTHY VOLUNTEERSMartin Rose, M.D.*, Nancy Ettinger, Jeffrey Arcara,William G. Kramer, Ph.D. InKine Pharmaceutical Co., Inc., Blue Bell,PA and Kramer Consulting, LLC, North Potomac, MD.

Purpose: This study was intended to assess the safety and laxative effectsof one week of therapy with sodium phosphate (NaP) tablets. Miralax(polyethylene glycol (PEG)) was used as a comparator.Methods: After a 7 day screening period, 31 healthy volunteers wererandomized to receive either 8 NaP tablets (1.5 g/tablet), 12 NaP tabletsdaily, or PEG 17 g (the dose recommended for constipation). Study drugswere given each morning for 7 days. NaP tablets were taken 4 at a timeevery 15 minutes with 8 oz of any beverage. PEG was dissolved in 8 ozwater. Subjects ate their usual diets. Laxatives other than stable doses offiber supplements were prohibited. Patients kept a diary of their bowelmovements (time, consistency and ease of passage of each BM) and GIsymptoms (cramps, flatus, and rectal irritation). Subjects who met definedcriteria for excess laxative effects had mandatory reductions in their doseof study drug. Serum electrolytes (Na, K, Cl, HCO3, Ca, P, Mg) weremeasured at baseline and 4 times during treatment.Results: Each dose level of NaP was associated with a significantly greaterincrease in mean daily bowel movements than Miralax after one day ofdosing and after the last dosing day for each patient (Table 1). Changes inthe stool consistency score were significantly greater with NaP after thefirst and last dosing day. Every subject randomized to either NaP doserequired at least one dose reduction, compared to none of the subjectstaking PEG (p�0.01). The time to the first soft or liquid BM was signif-icantly shorter with NaP than with PEG. No subject was discontinued foran adverse event, but one subject in the PEG group was lost to follow-upafter vomiting on the second day of dosing. Changes from baseline inelectrolytes did not differ significantly among the treatment groups follow-ing completion of dosing.

Change from Baseline in Bowel Movements per Day (Mean � SD)

NaP 8 tabs NaP 12 tabs PEG

Day 1 1.97 � 1.53† 3.29 � 2.40† -0.18 � 0.68Last treatment day 1.15 � 0.76† 1.56 � 0.96† 0.13 � 0.44

† p�0.05 compared to PEG

Conclusions: NaP tablets taken for one week were well tolerated byvolunteers, and produced significantly greater and more prompt laxativeeffects than PEG. Changes from baseline in electrolytes did not differsignificantly among the treatment groups at the end of dosing. NaP tabletsshow promise as a treatment for constipation, and further studies in patientswith constipation are planned.

871

A PROSEPECTIVE STUDY ASSESSING THE COMPLICATIONSASSOCIATED WITH THE USE OF WIRELESS-CAPSULEENDOSCOPY (WCE)Daryl S. Hutchinson, M.D., Mohammed Barawi, M.D.*,Fernando Bermudez, M.D., Teri Taggart, C.N.M.T., Valiya Ravi, M.D.St. John Hospital and Medical Center, Detroit, MI.

Purpose: Wireless-Capsule Endoscopy (WCE) has emerged as a noveltechnology for gastroenterologists. It has been designed primarily for theworkup of occult gastrointestinal bleeding and investigating suspicioussmall bowel pathology. The purpose of our study was to prospectivelyassess the potential complications associated with the use of capsuleendoscopy in 200 patients seen through a large, single specialty grouppractice.Methods: Two hundred patients (112M. 88F; mean age 52; range 18-73)were evaluated in an outpatient setting. Indications for capsule endoscopyincluded anemia (n� 171), evaluation of inflammatory bowel disease(n�16) and evaluation for malabsorption (n�13). Patients underwent cap-sule endoscopy using the Given Imaging M2A endocapsule.Results: Most patients (n� 194) tolerated the procedure well withoutcomplications. Images were viewed through the small bowel and patientsspontaneously passed the capsule. Six complications were documented inour study. One patient was unable to swallow the capsule secondary to itssize and oropharyngeal dysphagia (subsequent diagnosis). Two cases re-viewed showed camera battery failure at 2 and 4 hours respectively. Imageswere not retrievable after shutdown. One patient inadvertently aspirated theendocapsule into the trachea and coughed it out without further conse-quences. One patient with diabetic gastroparesis was unable to pass thecapsule into the duodenum. Two cases of small bowel obstruction withfailure of camera passage were encountered. One patient had a history ofpelvic irradiation and the other had chronic NSAID use with formation ofdiaphragm strictures and bowel ulcerations. Capsule ingestion producedsymptoms of small bowel obstruction. Both patients underwent laporotomyfor removal.Conclusions: Wireless-Capsule Endoscopy (WCE) is a new tool in thearmamentarium of gastroenterologists for diagnosing obscure intestinalpathology. In general, it is a safe, painless and efficacious outpatientprocedure with a high diagnostic yield. Adverse events and complicationsmay occur. Patients with swallowing and motility disorders should bescreened for candidacy prior to introducing the endocapsule. The mostserious complication encountered in our patient population was bowelobstruction. Physicians should screen patients for bowel obstruction riskfactors including history of pelvic radiation exposure and chronic NSAIDuse prior to performing this procedure in their clinical practice.

872

A PROSPECTIVE CONTROLLED STUDY OF THE RISK OFBACTEREMIA IN BANDING VERSUS SCLEROTHERAPY OFESOPHAGEAL VARICESMarc Zuckerman, M.D., FACG*, Hoi Ho, M.D., Hemal Amin, M.D.,Jesus Hernandez, M.D., Venkateswara Kolli, M.D., Arturo Norte, M.D.,Nancy Casner, M.S., Gavin Gregory, Ph.D. Texas Tech UniversityHealth Sciences Center and The University of Texas, El Paso, TX.

Purpose: Esophageal variceal banding may be less likely to cause bacte-remia than sclerotherapy. A prospective randomized study was conductedto determine the frequency of bacteremia after endoscopy with esophagealvariceal banding compared with esophageal variceal sclerotherapy.

S290 Abstracts AJG – Vol. 98, No. 9, Suppl., 2003