Capsule endoscopy at the University of Florida: initial experience and a cost-benefit analysis

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Aims: Compare peak CCK stimulated lipase concentrations between healthy subjects and patients with chronic abdominal pain and equivocal/ minimal changes on pancreatogram. Methods: Healthy subjects (HS) and MCP pts studied. All MCP pts had ERCP independently scored by three therapeutic endoscopists. MCP defined as equivocal / minimal changes on pancreatogram by 2 of 3 therapeutic endoscopists. All pts underwent CCK stimulated ePFT protocol: 1) upper endoscopy 2) IV CCK 40 ng/kg/hr 3) duodenal fluid aspiration via endoscope at 30, 40, 50, and 60 minutes after infusion 4) fluid analysis for lipase concentration on lab autoanalyzer. (Normal cutpoint: Lipase conc ⬎810,000 IU/L,, sens/spec of 92/95%). Results: 20 HS and 8 MCP pts studied. Mean peak lipase (SD) for HS and MCP were 1,612,500 (566,152) and 1,116,925 (346,730) IU/L, respectively. All MCP pts had peak lipase values within 2 SD of the mean HS value. 7/8 (87.5%) of the MCP pts had lipase values above the cutpoint. No difference in enzyme secretion between MCP and HS. No episodes of acute pancreatitis or complications associated with the ePFT. Conclusions: 1)Enzyme secretion (acinar cell function) appears to be preserved in pts with MCP. 2)Further investigations of ductal cell physiology are needed in MCP to assess for bicarbonate secretory dysfunction. 3)The ePFT can help determine the clinical significance of equivocal changes seen on imaging studies. Clinical Implication: Pain in patients with MCP does not appear to be CCK mediated from acinar cell dysfunction.

202 EFFICACY OF MANOMETRY BASED ENDOSCOPIC SPHINCTEROTOMY IN SPHINCTER OF ODDI DYSFUNCTION: A META-ANALYSIS OF CONTROLLED TRIALS Deepak Agrawal, M.D., Pankaj Singh, M.D., Ananya Das, M.D., Gerard Isenberg, M.D., Richard C.K. Wong, M.D., Michael V. Sivak, M.D., Amitabh Chak, M.D.*. University Hospitals of Cleveland, Cleveland, OH. Purpose: The clinical utility of endoscopic sphincterotomy for biliary-type pain due to sphincter of Oddi dysfunction (SOD) remains controversial. Studies have suggested that abnormal manometry of sphincter (pressure ⬎ 40 mm Hg) can predict the response to sphincterotomy. The aim of this study was to evaluate the effects of sphincterotomy in patients with SOD with abnormal biliary manometry. Methods: We reviewed the literature systematically, for prospective controlled trials of endoscopic sphincterotomy for biliary type pain due to SOD. Study cohort included patients with confirmed SOD. Only randomized studies were included where diagnosis of SOD was confirmed by manometric studies and follow up was for at least 12 months. Primary endpoints included the symptomatic improvement in abdominal pain. Association was measured with the odds ratio in this meta-analysis. The Breslow-Day method was used to treat for homogeneity under the null hypothesis that the odds ratio was consistent across the studies and the corrected Mantel Haenszel Chi-square test was used to test whether odds ratio differed systematically from a value of 1. Quality methodological scoring was conducted for individual studies. Results: Four controlled trials with 92 subjects with confirmed SOD were identified for the meta-analysis. 57 of these patients underwent endoscopic sphincterotomy and 35 patients did not undergo sphincterotomy. 44 of the 57 patients showed symptomatic improvement as compared to 14 of the 35 patients who did not undergo sphincterotomy. Using fixed effect model there was trend towards significant improvement in the sphincterotomy group (p⫽0.06). However, using random effect model there was no statistical significance (p⫽0.24). Methodological quality scoring showed that all the studies were randomized, controlled unblinded trials. Conclusions: Endoscopic sphincterotomy is an ineffective treatment for symptomatic improvement in SOD with abnormal manometry results.

AJG – Vol. 98, No. 9, Suppl., 2003

203 PANCREATIC HEAD MASSES ON CT SCAN: ARE THEY ALL MALIGNANT? Amaar H. Ghazale, M.D., Qiang Cai, M.D.*. Emory University School of Medicine, Atlanta, GA. Purpose: Pancreatic head masses diagnosed by CT scan are an increasingly prevalent clinical problem. They are found either incidentally or in workup of symptoms or signs of biliary obstruction. In review of medical literature, there is no data indicating the percentage of pancreatic cancer in this patient population. The objective of this study is to find the percentage of patients with pancreatic head masses that will eventually have a diagnosis of pancreatic cancer and to evaluate the clinical and CT characteristics in patients with benign vs. malignant lesions. Methods: We performed a retrospective review of all patients that presented with pancreatic head masses on CT scan from 1998 –2003 in our institution. Patients with established diagnoses on presentation were excluded. The patients files were reviewed for information including diagnosis, CT characteristics of masses, suspicion of metastasis and comorbid conditions namely diabetes mellitus and pancreatitis. We then compared these characteristics in malignant vs. benign masses. Results: 72 patients were identified in this study period. The mean age of the patients was 62 years with 38 (53%) male and 34 (47%) female. Of all patients, approximately 80 percent had malignant lesions. 20% had benign lesions, such as inflammatory masses and pseudocysts. 47 patients (65% of the total) were diagnosed with pancreatic adenocarcinoma. Other malignant lesions included neuroendocrine tumors, lymphoma, and metastatic tumors. On CT scan, the overwhelming majority of hypodense lesions were malignant. However half of the cystic lesions were also malignant. Conclusions: Of all patients with pancreatic masses on CT scan, 20% of patients had benign masses on final diagnosis. The density of the lesion was helpful in assessing whether the mass was malignant, however a cystic appearance was not helpful in differentiating benign from malignant masses in our study. Chronic pancreatitis was present significantly more in patients with benign masses. Our conclusion is that a significant percentage of pancreatic head masses are benign and that it is very difficult to differentiate benign vs. malignant lesions for patients with a pancreatic mass on CT based only on the characteristics of the mass on CT scan. A comprehensive evaluation of these patients, including patient history, clinical presentation and more invasive pursuit of a diagnosis are necessary.

SMALL INTESTINE/UNCLASSIFIED 204 CAPSULE ENDOSCOPY AT THE UNIVERSITY OF FLORIDA: INITIAL EXPERIENCE AND A COST-BENEFIT ANALYSIS John M. Petersen, D.O., FACG*. University of Florida, Gainesville, FL. Purpose: Wireless capsule endoscopy (CE) has opened up the small bowel to diagnosis and treatment. This report summarizes the initial Univ. of Florida (UF) experience, and examines avg. annualized cost savings as a result of a diagnostic capsule study with subsequent intra-operative enteroscopy (IOE) and curative surgery. Methods: 54 pts. referred to UF, 8/02–5/03, for unexplained anemia, obscure bleeding, abd. pain, and/or obstructive symptoms not diagnosed on SB enteroclysis. 30 males, 24 females, avg. age 68, underwent CE (M2A, Given Imaging, Ltd.) without comp. and there were no GI retentions. Pre-CE Transfusion requirements avg. 18 U.CE was indicated for anemia/ obscure GI bleeding in 40, suspected Crohn’s in 5, abd. pain in 6, suspected malignancy in 3. 50/54 had non-diagnostic SB enteroclysis prior to CE. Results: CE diagnostic in 30/54 (56%). MD reading time avg.42 mts. SB transit time avg: 200 mts. CE revealed: 22 avm’s (multiple), 2 leiomyomas, 2 Crohn’s, 2 diverticuli, 2 NSAID bleeding ulcers. 9/30 pos. CE underwent IOE and surgery, inc. 6 mult. Avm’s, 1 Dieulafoy, 2 leiomyomas. LOS avg. 8 days. No intra-op. or post-op. complications. The 9 pts. are 35–200 days

AJG – September, Suppl., 2003

post-op without any further bleeding. 21/30 were observed or refused surg., with 3 recurrent major bleeds (2 controlled angiographically, 1 surgically), 1 death, when followed for 25–130 days. Avg. annual cost savings incurred amongst each of the 9 pts.with curative surgery include: RBC: 10 U. (type, screen, cross) $10,800; Hosp: 2 admisions/yr. avg 3 day stays each: $4,300; MD off. visits: 6/yr. $700; Labs: $255; repeat endoscopy with persistent bleeds: $2,500; Radio.: Angios: $2,800; Nuc Med RBC $1490. Data does not include potential work days missed, medication, referrals. TOTALS: $22,845. Cost of lap., oversew/resection/cautery, with IOE, 6 day stay (avg.): $12,875. Conclusions: CE is a novel, safe, well-tolerated, non-invasive method of examining the entire SB with excellent diagnostic yield, that surpasses that of SB radiography and SB enteroscopy combined. This technology, which will only improve in years to come, has major pt. care and cost-benefit impact, and has enhanced our ability to evaluate the small bowel mucosa in adults and children. The initial UF experience has shown that diagnostic CE, followed by IOE and curative surgery can result in tremendous healthcare cost savings. CE has the potential to become the initial investigation for SB disease including obscure bleeding, malabsorption, IBD, neoplasia, preceding radiography or endoscopy. 205 GIVENS M2A CAPSULE IMAGING OF THE SMALL INTESTINE Gregg A. Valenzuela, M.D.*, Linda Baldwin, R.N. HCA Doctors Hospital, Richmond, VA. Purpose: The Givens M2A capsule is a new technology involving the wireless radio transmission of color images that is now available for evaluating small bowel bleeding and causes for occult anemia. As in our patients, it is used in cases where endoscopic and/or radiographic studies have been nondiagnostic. Methods: We studied 35 patients, 14 male, mean age 64 years. Twenty nine were anemic. Thirteen patients were given metoclopramide 20 mg po before the study(Met⫹) to speed transit of the capsule, 23 patients were not, (Met⫺). Findings and transit times are reviewed. Results: Five had gastric bleeding, 1 with an ulcer, the others with gastritis. One had gastric telangiectasia. Four had active small bowel bleeding. Eight had small bowel inflamation; 5 patients were found to have evidence of unsuspected crohns disease, one with stricturing not seen on barium study; the others had nonspecific erosions or aphthous ulceration. Fourteen had small bowel telangiectasias. One had a small bowel neoplasm. Met⫹ patients had similar gastric transit times 63⫾ 29 SE versus 61 ⫾21 minutes for Met⫺, however 1 of the Met⫺ patients failed to pass the capsule out of the stomach whereas all of the Met ⫹ patients did. Mouth to cecum transit times were faster in the Met⫹ patients 216 ⫾ 26SE versus Met⫺ 277 ⫾23 minutes, p⫽0.04. More Met⫹ patients passed the capsule to the cecum for a complete study 13/13 versus only 16/23 of the Met⫺ patients, p⫽ 0.005. Conclusions: M2A capsule imaging of the gastrointestinal tract is an effective way of diagnosing etiologies for occult bleeding and anemia. Potentially significant new diagnoses were made including crohns disease and neoplasm. Other less serious diagnoses were important for patient management and establishing long term prognoses. Metoclopramide significantly speeds transit of the capsule and helps ensure the successful completion of the study. The small added cost of the medication is greatly offset by eliminating the need of repeating the study. 206 EXTRAMEDULLARY PLASMACYTOMA OF THE DUODENUM Daryl S. Hutchinson, M.D., Mohammed Barawi, M.D.*. St. John Hospital and Medical Center, Detroit, MI. Introduction: Extramedullary plasmacytomas are infrequent neoplasms that have an even rarer predilection for the gastrointestinal system. Diffuse or localized infiltration of tissue by plasma cells is the basis for this

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disorder. Localized plasmacytoma of the gastrointestinal tract is uncommon and constitutes less than 10% of all extramedullary plasmacytomas. Absence or presence of coexisting serum immunoglobulins have been reported in cases spanning greater than seventy years. Case: Our patient was a fifty year-old African American with the chief complaint of abdominal discomfort, nausea and vomiting. She subsequently underwent both upper endoscopy and colonoscopy for further evaluation. In the postbulbar region of the duodenum, a 1.5 centimeter sessile polyp was visualized. No other upper endoscopic visualized abnormalities. Colonoscopy was within normal limits. Histopathology from the biopsied duodenal polyp showed plasmacytosis of the lamina propria with IgM Lambda monoclonal restriction based on immunoperoxidase staining. Serum protein electrophoresis was within normal limits. Bone marrow biopsy was read as normocellular with only 2% plasma cells and no further morphologic appearance of myeloma. Patient refused further workup or treatment options. Discussion: Solitary extramedullary plasmacytoma of the gastrointestinal tract is noted in only 3–7% of reported cases with common sites being the small bowel, stomach and rarely the colon and esophagus. Our patient presented with duodenal pathology sans confirmation of underlying hematologic disease with a negative serum protein electrophoresis and a nondiagnostic bone marrow specimen. Continued observation has shown that many will develop the stigmata of multiple myeloma or other plasma cell dyscrasias with marrow infiltration, protein abnormalities and osseous lesions. Immunoperoxidase staining for immunoglobulins on our pathological specimen proved our diagnosis. If systemic disease is suspected, one may consider the highly sensitive immunofixation electrophoresis which was developed to detect small amounts of monoclonal protein in serum. Radiotherapy and chemotherapeutics have had minimal response in gastrointestinal plasmacytomas. Prognosis is usually unfavorable in gastric plasmacytomas with a high recurrence or systemic disease progression rate and death occurring in most cases within 5 years.

207 EFFECT OF ACTIVATED CHARCOAL ON LACTULOSE INDUCED BREATH HYDROGEN IN PATIENTS WITH COMPLAINT OF EXCESSIVE GAS Nirmal S. Mann, M.D.*, Eddie C. Cheung, M.D. U.C. Davis and VAMC Martinez, Martinez, CA. Purpose: To evaluate the effect of oral activated charcoal on lactulose induced breath hydrogen, number of passage of flatus, and bloating score in patients with complaints of excessive gas and to compare these parameters in healthy male controls. Methods: Five male healthy controls who had no G.I. symptoms fasted overnight. They ingested lactulose 20 gm. Before lactulose ingestion fasting breath hydrogen was measured using an EC 60 gastrolyzer (Bedfont Scientific; Medford, NJ). Thereafter breath hydrogen was measured every 15 minutes for the next 8 hours. Number of passage of flatus passed over 8 hours was recorded as also a bloating score (on a scale of 1–10). Cumulative hydrogen in parts per million (ppm) was calculated by evaluating the area under the curve (AUC). After some weeks, the test was repeated and the subjects ingested 6 capsules of activated charcoal (total amount of activated charcoal 1560 mg), with lactulose. Six male patients who had severe problem with abdominal gas underwent the test exactly as was done with healthy controls. The data are reported as mean ⫾ standard error of the mean. The means were compared using t-test; a p value of ⬍ 0.05 was considered significant. Results: The mean age of patients 48.1 (range 42–55) years was similar to controls 50.2 (range 32– 66) years. The number of flatus passed by patients with lactulose alone 24.0 ⫾ 3.2 (range 19 –30) was significantly higher compared to controls 19.6 ⫾ 2.8 (range 11–36). The bloating score in patients with lactulose alone 7.6 ⫾ 1.2 (range 6 –9) was higher compared to controls 7.0 ⫾ 1.4 (range 6 – 8). Cumulative hydrogen in ppm (AUC) in 8 hours in patients on lactulose alone 3485 ⫾ 27 ppm (range 2357–5404) was higher than in controls 2018 ⫾ 19 ppm (range 1236 –2456). Activated