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44 Patients With Crohn's Disease Treated With Certolizumab Pegol Experienced Long-Term Remission Regardless of Prior TNF-α Inhibitor Exposure (PRECiSE 4 Study)
extent of intra-abdominal CD complications in patients with CD. METHODS AND PATIENTS. Within a long-term prospective follow-up study of CD in a inflammatory bowel disease referral center, 43 patients (23 M , mean age 40 yrs; range 12-71 yrs) underwent resective bowel surgery and were included in this study. SICUS was performed preoperatively after the ingestion of 375 ml of macrogol oral solution. The accuracy of SICUS to detect strictures, intra-abdominal fistulas, and abscesses was compared with surgical and pathological findings by kappa-statistics. RESULTS. SICUS was able to identify: 1) at least 1 stricture in 24/25 and to exclude it in 16/18 (96% sensitivity, 89% specificity, k=0.85); 2) two or more strictures in 6/8 (75%) k=0.75. The extension of strictures (N= 22) was 5.6±3.4 cm at surgery, 5.7±4.1 cm at SICUS (n.s). Fistulas were correctly identified in 18/19 patients and excluded in 23/24 patients (95% sensitivity, 96% specificity , k=0.86). Intra-abdominal abscesses were correctly detected in 8/8 patients and excluded in 35/35 patients (100% sensitivity, 100% specificity). The concordance index (k-statistics) between surgery and SICUS in identifying proximal location and number of complications was 0.93. CONCLUSIONS. SICUS is an accurate method for the detection of intestinal complications in Crohn's disease. Non invasive SICUS can be thus indicated as a primary investigative method for evaluating and planning surgical treatment in patients with severe Crohn's disease of the small bowel. 1) Pallotta N et al. Lancet 1999; 2) Pallotta N et al IBD 2005.
Impact of Psychiatric Disorders on Patients With Crohn's Disease: An Analysis Based on a Healthcare Claims Database Chenglong Han, Ning Zhao, Marion Blank, Christopher Gasink Objectives: To evaluate the risk of psychiatric disorders and the associated healthcare expenditures among patients with Crohn's disease (CD) using data from a United States healthcare claims database. Methods: Adult patients with CD (N=13655) were identified from the PharMetrics healthcare claims database using the ICD-9 code of 555.x. Patients had to be continuously diagnosed with CD in both years 2003 and 2004, and treated with systemic therapies including aminosalicylates, corticosteroids, immunomodulators, antibiotics, and biologic therapy (infliximab and adalimumab). Controls (N=54620) without CD were matched with CD cases in a 4:1 ratio by gender, age, region, and previous time-in-plan. Prevalence of psychiatric disorders and anti-psychiatric drug therapies in year 2004 were identified using ICD-9 codes or therapeutic class and Odds Ratios (OR) were estimated using the Mantel-Haenzel methods. The total annual (2004) healthcare expenditures including inpatient and outpatient visits, prescription drug and all other costs were accumulated and compared using an ANOVA on the van der Waerden normal transformed scores adjusted for age and gender. Results: 57.8% of CD patients were females, the mean age was 44.7 years, and 10% received biologic therapy. Compared with controls, patients with CD had a statistically significantly higher prevalence (p<0.001) of anxiety (9.0% vs. 4.8%, OR=1.9), depression (11.4% vs. 5.7%, OR=2.1), and delirium (0.5% vs. 0.1%, OR=4.6) and bipolar disorder (1.1% vs. 0.6, OR=1.8). There was no difference between CD patients and controls in the prevalence of dementia and schizophrenia (p>0.05). Compared with controls, a greater proportion of CD patients had been treated with antidepressants (2.4% vs. 0.90%, OR= 2.7), anxiolytics (1.9% vs. 0.8%, OR=2.6) or anti-psychotics (2.3% vs. 0.9%, OR=2.7). Patients with CD had higher total health care expenditures ($15,767) than controls ($4,046, p<0.001). Among the CD patients, those with any psychiatric disorders had a total healthcare expenditure of $26,244, as compared with $13,696 for those without psychiatric disorders (p<0.001). Conclusion: Patients with CD have a significantly higher prevalence of psychiatric disorders as compared with patients without CD. CD patients with psychiatric disorders have significantly higher healthcare care expenditures than those without such disorders.
46 A Phase 2a Randomized Placebo-Controlled Double-Blind Multi-Center Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Patients With Moderately Active Ulcerative Colitis Severine Vermeire, Paul J. Rutgeerts, Geert R. D'Haens, Martine De Vos, Brian Bressler, Annegret Van der Aa, Bernard Coulie, Cindy J. Wong, Brian G. Feagan We conducted a randomized, double-blind placebo-controlled, multi-centre dose escalation study that assessed the safety and tolerability of AG011, a genetically modified L. lactis bacteria secreting human interleukin-10 (hIL-10), in patients with moderately active ulcerative colitis (UC). METHODS Eligible patients had a minimum disease extent of 15 cm from the anal verge, with a minimum of Grade 2 modified Baron score changes on sigmoidoscopy, and a minimum Mayo Clinic Disease Activity Score of 5 with a score of at least 1 on both the stool frequency and rectal bleeding components. Patients were assigned to one of three escalating dose levels of AG011 administered orally BID and by enema at HS: (Group 1) AG011 2.4 x 1010 colony forming units (CFU) PO plus AG011 enema (2.4 x 1010 CFU); (Group 2) AG011 2.4 x 1011 (CFU) PO plus AG011 enema (2.4 x 1011 CFU); (Group 3) AG011 7.2 x 1011 (CFU) PO plus AG011 enema (1.2 x 1012 CFU) or (Group 4) identically appearing placebo preparations for 29 days. Adverse events were classified according to the MedDRA dictionary. The Wilcoxon rank-sum statistic was used to evaluate differences in modified Baron scores between the pooled AG011 treatment group and those assigned to placebo. RESULTS Ten, 10, 20, and 20 patients were assigned to Groups 1, 2, 3 and 4 respectively. 31 (77.5%) AG011 patients and 18 (90.0%) placebo patients reported at least one adverse event. The most frequently reported event was worsening of UC, reported in 15 (37.5%) AG011 and 3 (15.0%) placebo patients and was the reason for early study termination of 13 AG011 patients and 2 placebo patients. Three AG011 patients in Group 3 experienced serious worsening of UC. Among 2 placebo patients experiencing serious adverse events, one had worsening of UC with secondary anemia. No difference was observed between the pooled AG011 groups and placebo group in the distribution of the modified Baron score at Day 29 (p=0.280). Remission, defined as a modified Baron score of 0 or 1 with no rectal bleeding was present in 2 (5.0%) AG011 treated patients and 4 (20.0%) of those who received placebo, (p=0.075). CONCLUSIONS AG011 was well-tolerated and safe in patients with moderate active UC. However there was no significant improvement of mucosal inflammation, as measured by the modified Baron score, or clinical symptoms in patients receiving active product compared with placebo. Insufficient exposure to viable bacteria and/or the active molecule (hIL-10) may be factors responsible for the observed lack of clinical benefit.
44 Patients With Crohn's Disease Treated With Certolizumab Pegol Experienced Long-Term Remission Regardless of Prior TNF-α Inhibitor Exposure (PRECiSE 4 Study) William J. Sandborn, Stefan Schreiber, Stephen B. Hanauer, Jean-Frederic Colombel, Ralph Bloomfield, Gary Lichtenstein BACKGROUND: Maintenance of remission in patients with Crohn's disease correlates with continuous long-term anti-TNF therapy. OBJECTIVE: The study evaluated long-term certolizumab pegol (CZP) remission rates in patients with and without previous TNF-α inhibitor exposure who received CZP for 4 years in PRECiSE 4 (P4; NCT00160706). MATERIALS AND METHODS: In PRECiSE 2 (P2; NCT00152425), patients responding to CZP induction therapy at Week 6 were randomized to continuous therapy with CZP or placebo for Weeks 6-26. Patients from either arm with exacerbation of symptoms before Week 26 (increase in Crohn's Disease Activity Index [CDAI] score ≥70 points from Week 6) could enter P4 (an open-label extension) for re-induction with CZP 400 mg (1 extra dose at Week 2 in P2active arm patients and doses at Weeks 0, 2, and 4 in P2-placebo patients) and as maintenance therapy every 4 weeks thereafter. The Harvey-Bradshaw Index was used to measure disease activity (remission = score of ≤4). Remission rates were analyzed in patients enrolled in P4 (P2-active + P2-placebo) and in a subset of these patients having no previous infliximab (IFX) exposure. Remission rates were calculated using nonresponder imputation (NRI), observed case (OC), and last observation carried forward (LOCF) analyses. RESULTS: Of 124 patients entering P4, 84 (67.8%) were IFX-naïve. At the start of P4, 4.8% of both the P2active + P2-placebo population (6/124) and IFX-naïve population (4/84) were in remission. Remission rates after 1, 2, 3, and 4 years from the start of P4 (LOCF analysis) were 45.2% (56/124), 44.4% (55/124), 42.7% (53/124), and 41.1% (51/124), respectively, for the P2active + P2-placebo population, and 50.0% (42/84), 48.8% (41/84), 45.2% (38/84), and 46.4% (39/84), respectively, for the IFX-naïve population. For patients completing assessments at 1, 2, 3, and 4 years in P4 (OC analysis), remission rates were 62.7% (42/67), 70.0% (32/46), 63.3% (19/30), and 57.7% (15/26),respectively, for the P2-active + P2placebo population, and 68.0% (34/50), 71.4% (25/35), 60.0% (12/20), and 62.5% (10/ 16), respectively, for the IFX-naïve population. Remission rates after 1, 2, 3, and 4 years among patients in remission at the start of P4 (NRI analysis) were 33.9% (42/124), 25.8% (32/124), 14.5% (18/124), and 11.3% (14/124), respectively, for the P2-active + P2-placebo population and 40.5% (34/84), 29.8% (25/84), 13.1% (11/84), and 11.9% (10/84) for the IFX-naïve population. CONCLUSION: Continuous CZP therapy provided long-term remission over 4 years; comparable long-term remission rates were observed in the P2active + P2-placebo population, and in those with no previous exposure to infliximab.
47 Prevalence of Elevated Serum Immunoglobulin G4 in a Population Based Cohort of Primary Sclerosing Cholangitis Maria Benito de Valle, Einar Bjornsson, Björn Lindkvist Background: Immunoglobulin G4-associated cholangitis (IAC) is a recently identified clinical entity characterized by a clinical picture similar to primary sclerosing cholangitis (PSC) but with infiltration of immunoblobulin (Ig) G4-positive plasma cells in bile ducts, elevated IgG4-levels in serum and, in some cases, other organ manifestations (e.g. autoimmune pancreatitis). As opposed to PSC, IAC respond to steroid treatment. Previous studies on IgG4 levels in PSC cohorts originating from tertiary referral centers have indicated that approximately 10% of all patients have IgG4 elevations. We aimed to investigate IgG4 levels in serum in a population based cohort of PSC-patients and to compare the clinical picture of IgG4 positive and negative subjects. Methods: All patients in a regional health care unit in Sweden (population: 1.5 million inhabitants) fulfilling Mayo criteria for PSC have been identified in a previous study. Cases with prevalent PSC not subjected to liver transplantation by the end of 2005 (n=190) were invited to participate in the study, 103 (54%) out of these accepted. Another 8 patients diagnosed after 2005 were also included in the study yielding a cohort of 111 patients. Clinical characteristics were extracted from case files. Serum IgG4 was measured by a nephelometric method (normal value <130 mg/dL). Results: Seven (6.3%) out of 111 patients presented IgG4 levels above the upper normal limit. Three out of these had signs of other organ involvement (two autoimmune pancreatitis and one sialadenitis) suggesting IgG4 related systemic disease. Patients with elevated serum IgG4 had a significantly higher frequency of combined involvement of both intra and extrahepatic bileducts on colangiography (86 vs 38%, two-sided p = 0.02) and jaundice at diagnosis (57 vs 13%, p = 0.01). There was no significant difference in sex distribution (100% vs 63% male, p = NS), age at diagnosis (42 vs 38 years, p = NS) prevalence of IBD (57 vs 73%, p = NS) or prevalence of other symptoms at diagnosis (i.e. cholangitis, pruritus and abdominal pain) in IgG4 positive vs negative patients. Conclusion: Elevated serum IgG4 was a relatively infrequent finding in this population based cohort of PSC patients, present in 6% of all patients. Jaundice
45 Small Intestine Contrast Ultrasonography (SICUS) for the Detection of Intestinal Complications in Crohn's Disease: A Prospective Comparative Study Versus Intraoperative Findings Nadia Pallotta, Giuseppina Vincoli, Erminia Romeo, Barbara Ciccantelli, Chiara Montesani, Piero Chirletti, Anna Maria Pronio, Luigi Dall'Oglio, Naima Abdulkadir Hassan, Enrico Corazziari In patients with Crohn's disease (CD) small intestine contrast ultrasonography (SICUS) (1) compared to radiological and surgical findings (2), has been proven to be a useful tool in the assessment of the presence, number, extension, and sites of CD small bowel involvement even in patients with undiagnosed small bowel (SB) diseases. It is not known its diagnostic role, if any, in the assessment of intra-abdominal CD complications, namely strictures, abscesses, fistulas. AIM. To test the value of SICUS to assess presence, number, site, and
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Impact of Psychiatric Disorders on Patients With Crohn's Disease: An Analysis Based on a Healthcare Claims Database Chenglong Han, Ning Zhao, Marion Blank, Christopher Gasink Objectives: To evaluate the risk of psychiatric disorders and the associated healthcare expenditures among patients with Crohn's disease (CD) using data from a United States healthcare claims database. Methods: Adult patients with CD (N=13655) were identified from the PharMetrics healthcare claims database using the ICD-9 code of 555.x. Patients had to be continuously diagnosed with CD in both years 2003 and 2004, and treated with systemic therapies including aminosalicylates, corticosteroids, immunomodulators, antibiotics, and biologic therapy (infliximab and adalimumab). Controls (N=54620) without CD were matched with CD cases in a 4:1 ratio by gender, age, region, and previous time-in-plan. Prevalence of psychiatric disorders and anti-psychiatric drug therapies in year 2004 were identified using ICD-9 codes or therapeutic class and Odds Ratios (OR) were estimated using the Mantel-Haenzel methods. The total annual (2004) healthcare expenditures including inpatient and outpatient visits, prescription drug and all other costs were accumulated and compared using an ANOVA on the van der Waerden normal transformed scores adjusted for age and gender. Results: 57.8% of CD patients were females, the mean age was 44.7 years, and 10% received biologic therapy. Compared with controls, patients with CD had a statistically significantly higher prevalence (p<0.001) of anxiety (9.0% vs. 4.8%, OR=1.9), depression (11.4% vs. 5.7%, OR=2.1), and delirium (0.5% vs. 0.1%, OR=4.6) and bipolar disorder (1.1% vs. 0.6, OR=1.8). There was no difference between CD patients and controls in the prevalence of dementia and schizophrenia (p>0.05). Compared with controls, a greater proportion of CD patients had been treated with antidepressants (2.4% vs. 0.90%, OR= 2.7), anxiolytics (1.9% vs. 0.8%, OR=2.6) or anti-psychotics (2.3% vs. 0.9%, OR=2.7). Patients with CD had higher total health care expenditures ($15,767) than controls ($4,046, p<0.001). Among the CD patients, those with any psychiatric disorders had a total healthcare expenditure of $26,244, as compared with $13,696 for those without psychiatric disorders (p<0.001). Conclusion: Patients with CD have a significantly higher prevalence of psychiatric disorders as compared with patients without CD. CD patients with psychiatric disorders have significantly higher healthcare care expenditures than those without such disorders.
46 A Phase 2a Randomized Placebo-Controlled Double-Blind Multi-Center Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Patients With Moderately Active Ulcerative Colitis Severine Vermeire, Paul J. Rutgeerts, Geert R. D'Haens, Martine De Vos, Brian Bressler, Annegret Van der Aa, Bernard Coulie, Cindy J. Wong, Brian G. Feagan We conducted a randomized, double-blind placebo-controlled, multi-centre dose escalation study that assessed the safety and tolerability of AG011, a genetically modified L. lactis bacteria secreting human interleukin-10 (hIL-10), in patients with moderately active ulcerative colitis (UC). METHODS Eligible patients had a minimum disease extent of 15 cm from the anal verge, with a minimum of Grade 2 modified Baron score changes on sigmoidoscopy, and a minimum Mayo Clinic Disease Activity Score of 5 with a score of at least 1 on both the stool frequency and rectal bleeding components. Patients were assigned to one of three escalating dose levels of AG011 administered orally BID and by enema at HS: (Group 1) AG011 2.4 x 1010 colony forming units (CFU) PO plus AG011 enema (2.4 x 1010 CFU); (Group 2) AG011 2.4 x 1011 (CFU) PO plus AG011 enema (2.4 x 1011 CFU); (Group 3) AG011 7.2 x 1011 (CFU) PO plus AG011 enema (1.2 x 1012 CFU) or (Group 4) identically appearing placebo preparations for 29 days. Adverse events were classified according to the MedDRA dictionary. The Wilcoxon rank-sum statistic was used to evaluate differences in modified Baron scores between the pooled AG011 treatment group and those assigned to placebo. RESULTS Ten, 10, 20, and 20 patients were assigned to Groups 1, 2, 3 and 4 respectively. 31 (77.5%) AG011 patients and 18 (90.0%) placebo patients reported at least one adverse event. The most frequently reported event was worsening of UC, reported in 15 (37.5%) AG011 and 3 (15.0%) placebo patients and was the reason for early study termination of 13 AG011 patients and 2 placebo patients. Three AG011 patients in Group 3 experienced serious worsening of UC. Among 2 placebo patients experiencing serious adverse events, one had worsening of UC with secondary anemia. No difference was observed between the pooled AG011 groups and placebo group in the distribution of the modified Baron score at Day 29 (p=0.280). Remission, defined as a modified Baron score of 0 or 1 with no rectal bleeding was present in 2 (5.0%) AG011 treated patients and 4 (20.0%) of those who received placebo, (p=0.075). CONCLUSIONS AG011 was well-tolerated and safe in patients with moderate active UC. However there was no significant improvement of mucosal inflammation, as measured by the modified Baron score, or clinical symptoms in patients receiving active product compared with placebo. Insufficient exposure to viable bacteria and/or the active molecule (hIL-10) may be factors responsible for the observed lack of clinical benefit.
44 Patients With Crohn's Disease Treated With Certolizumab Pegol Experienced Long-Term Remission Regardless of Prior TNF-α Inhibitor Exposure (PRECiSE 4 Study) William J. Sandborn, Stefan Schreiber, Stephen B. Hanauer, Jean-Frederic Colombel, Ralph Bloomfield, Gary Lichtenstein BACKGROUND: Maintenance of remission in patients with Crohn's disease correlates with continuous long-term anti-TNF therapy. OBJECTIVE: The study evaluated long-term certolizumab pegol (CZP) remission rates in patients with and without previous TNF-α inhibitor exposure who received CZP for 4 years in PRECiSE 4 (P4; NCT00160706). MATERIALS AND METHODS: In PRECiSE 2 (P2; NCT00152425), patients responding to CZP induction therapy at Week 6 were randomized to continuous therapy with CZP or placebo for Weeks 6-26. Patients from either arm with exacerbation of symptoms before Week 26 (increase in Crohn's Disease Activity Index [CDAI] score ≥70 points from Week 6) could enter P4 (an open-label extension) for re-induction with CZP 400 mg (1 extra dose at Week 2 in P2active arm patients and doses at Weeks 0, 2, and 4 in P2-placebo patients) and as maintenance therapy every 4 weeks thereafter. The Harvey-Bradshaw Index was used to measure disease activity (remission = score of ≤4). Remission rates were analyzed in patients enrolled in P4 (P2-active + P2-placebo) and in a subset of these patients having no previous infliximab (IFX) exposure. Remission rates were calculated using nonresponder imputation (NRI), observed case (OC), and last observation carried forward (LOCF) analyses. RESULTS: Of 124 patients entering P4, 84 (67.8%) were IFX-naïve. At the start of P4, 4.8% of both the P2active + P2-placebo population (6/124) and IFX-naïve population (4/84) were in remission. Remission rates after 1, 2, 3, and 4 years from the start of P4 (LOCF analysis) were 45.2% (56/124), 44.4% (55/124), 42.7% (53/124), and 41.1% (51/124), respectively, for the P2active + P2-placebo population, and 50.0% (42/84), 48.8% (41/84), 45.2% (38/84), and 46.4% (39/84), respectively, for the IFX-naïve population. For patients completing assessments at 1, 2, 3, and 4 years in P4 (OC analysis), remission rates were 62.7% (42/67), 70.0% (32/46), 63.3% (19/30), and 57.7% (15/26),respectively, for the P2-active + P2placebo population, and 68.0% (34/50), 71.4% (25/35), 60.0% (12/20), and 62.5% (10/ 16), respectively, for the IFX-naïve population. Remission rates after 1, 2, 3, and 4 years among patients in remission at the start of P4 (NRI analysis) were 33.9% (42/124), 25.8% (32/124), 14.5% (18/124), and 11.3% (14/124), respectively, for the P2-active + P2-placebo population and 40.5% (34/84), 29.8% (25/84), 13.1% (11/84), and 11.9% (10/84) for the IFX-naïve population. CONCLUSION: Continuous CZP therapy provided long-term remission over 4 years; comparable long-term remission rates were observed in the P2active + P2-placebo population, and in those with no previous exposure to infliximab.
47 Prevalence of Elevated Serum Immunoglobulin G4 in a Population Based Cohort of Primary Sclerosing Cholangitis Maria Benito de Valle, Einar Bjornsson, Björn Lindkvist Background: Immunoglobulin G4-associated cholangitis (IAC) is a recently identified clinical entity characterized by a clinical picture similar to primary sclerosing cholangitis (PSC) but with infiltration of immunoblobulin (Ig) G4-positive plasma cells in bile ducts, elevated IgG4-levels in serum and, in some cases, other organ manifestations (e.g. autoimmune pancreatitis). As opposed to PSC, IAC respond to steroid treatment. Previous studies on IgG4 levels in PSC cohorts originating from tertiary referral centers have indicated that approximately 10% of all patients have IgG4 elevations. We aimed to investigate IgG4 levels in serum in a population based cohort of PSC-patients and to compare the clinical picture of IgG4 positive and negative subjects. Methods: All patients in a regional health care unit in Sweden (population: 1.5 million inhabitants) fulfilling Mayo criteria for PSC have been identified in a previous study. Cases with prevalent PSC not subjected to liver transplantation by the end of 2005 (n=190) were invited to participate in the study, 103 (54%) out of these accepted. Another 8 patients diagnosed after 2005 were also included in the study yielding a cohort of 111 patients. Clinical characteristics were extracted from case files. Serum IgG4 was measured by a nephelometric method (normal value <130 mg/dL). Results: Seven (6.3%) out of 111 patients presented IgG4 levels above the upper normal limit. Three out of these had signs of other organ involvement (two autoimmune pancreatitis and one sialadenitis) suggesting IgG4 related systemic disease. Patients with elevated serum IgG4 had a significantly higher frequency of combined involvement of both intra and extrahepatic bileducts on colangiography (86 vs 38%, two-sided p = 0.02) and jaundice at diagnosis (57 vs 13%, p = 0.01). There was no significant difference in sex distribution (100% vs 63% male, p = NS), age at diagnosis (42 vs 38 years, p = NS) prevalence of IBD (57 vs 73%, p = NS) or prevalence of other symptoms at diagnosis (i.e. cholangitis, pruritus and abdominal pain) in IgG4 positive vs negative patients. Conclusion: Elevated serum IgG4 was a relatively infrequent finding in this population based cohort of PSC patients, present in 6% of all patients. Jaundice
45 Small Intestine Contrast Ultrasonography (SICUS) for the Detection of Intestinal Complications in Crohn's Disease: A Prospective Comparative Study Versus Intraoperative Findings Nadia Pallotta, Giuseppina Vincoli, Erminia Romeo, Barbara Ciccantelli, Chiara Montesani, Piero Chirletti, Anna Maria Pronio, Luigi Dall'Oglio, Naima Abdulkadir Hassan, Enrico Corazziari In patients with Crohn's disease (CD) small intestine contrast ultrasonography (SICUS) (1) compared to radiological and surgical findings (2), has been proven to be a useful tool in the assessment of the presence, number, extension, and sites of CD small bowel involvement even in patients with undiagnosed small bowel (SB) diseases. It is not known its diagnostic role, if any, in the assessment of intra-abdominal CD complications, namely strictures, abscesses, fistulas. AIM. To test the value of SICUS to assess presence, number, site, and
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