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Background. Almost 20% of patients with active Crohn's disease are refractory to conventional therapy. Infliximab is a treatment of proven efficacy in this group of patients and it is not clear which variables predict a good response. Aims. To evaluate the role of infliximab looking at the predictors of response in a large series of patients with Crohn's disease. Patients and methods. Five hundred and seventy-three patients with luminal refractory Crohn's disease (Crohn's Disease Activity Index (CDAI) > 220–400) (312 patients) or with fistulising disease (190 patients) or both of them (71 patients) were treated with a dose of 5 mg/kg in 12 Italian referral centres. The primary endpoints of the study were clinical response and clinical remission for luminal refractory and fistulising disease. We evaluated at univariable and multivariable analysis the following variables: number of infusions, sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, and type of fistulas. Results. Patients with luminal refractory disease: 322 patients (84.1%) had a clinical response and 228 (59.5%) reached clinical remission. Patients with fistulising disease: 187 patients (72%) had a reduction of 50% of the number of fistulas and in 107 (41%) a total closure of fistulas was observed. For luminal disease, single infusion (OR 0.49, 95% CI 0.28–0.86) and previous surgery (OR 0.53, 95% CI 0.30–0.93) predicted a worse response for fistulising disease. Other fistulas responded worse than perianal fistulas (OR 0.57, 95% CI 0.303–1.097). Conclusion. In Crohn's disease infliximab is effective in luminal refractory and in fistulising disease. A single infusion and previous surgery predicted a worse response in luminal disease whereas perianal fistulas predicted a better response than other type of fistulas.

In recent years, self-expandable metallic stents (SEMSs) have emerged as a promising treatment alternative for the bridging and sealing of esophageal perforations and extensive anastomotic leaks after esophageal resection or total gastrectomy. A 56-year-old woman underwent a total gastrectomy with Roux-en-Y end-to-side esophagojejunostomy for a gastric signet ring cell carcinoma. Ten days later, esophagogastroduodenoscopy showed a 2 cm fistula in the distal end of the Roux limb of the anastomosis. This was confirmed by gastrografin esophagography. The patient was started on total parenteral nutrition. Having deemed clipping treatment for this fistula unfeasible, we decided to insert a partially silicone-coated SEMS (Evolution Controlled Release Esophageal Stent System, Cook Medical, Winston-Salem, N.C., USA). The stent was removed after ten days. Gastrografin esophagography showed no further contrast extravasation, and esophagogastroduodenoscopy showed closure of the fistula. No clinical complications were observed, and the patient was able to start normal per os nutrition. In conclusion, the treatment of symptomatic leaks in patients who have undergone esophagojejunostomy is challenging, and leakage from the jejunal stump can be a potentially serious complication. In the treatment of leakage after total gastrectomy, plastic stents (which are either too light or exercise too little radial force) and totally covered metallic stents may not adhere sufficiently to the esophagojeujunal walls and, as a result, migrate beyond the anastomosis. The promising results of this report suggest that early stenting, using a partially silicone-coated SEMS, is a feasible alternative to surgical treatment in this category of patients.

Summary Background Remission and response are the main outcomes to evaluate the efficacy of new treatments for Crohn’s disease (CD). Aim To explain variation of remission and response rates in active luminal CD. Methods We studied control patients from trials of biological therapies through articles retrieved by MEDLINE search (from 1997 to 2007) and by bibliography review. Thousand nine hundred and thirteen control patients from 28 trials were identified; data were extracted by three independent observers and pooled by DerSimonian and Laird random effect model; factors influencing remission and clinical response were explored by metaregression for aggregated data. Results The pooled control rates of remission and response were 17% and 33%, respectively, both with significant heterogeneity among studies (P

BACKGROUND AND AIMS: The widespread use of anti-tumour necrosis factor alpha antibody (Infliximab) in Crohn's disease (CD) raises concerns about a possible cancer risk in the long term. In a matched pair study, we assessed whether Infliximab is associated with an increased risk of neoplasia. METHODS: In a multicentre matched pair study, 404 CD patients treated with Infliximab (CD-IFX) were matched with 404 CD patients who had never received Infliximab (CD-C). Cases and controls were matched for sex, age (+/-5 years), site of CD, age at diagnosis (+/-5 years), immunosuppressant use, and follow up. New diagnoses of neoplasia from April 1999 to October 2004 were recorded. RESULTS: Among the 404 CD-IFX, neoplasia was diagnosed in nine patients (2.22%) while among the 404 CD-C, seven patients developed neoplasia (1.73%) (odds ratio 1.33 (95% confidence interval 0.46-3.84); p=0.40). The survival curve adjusted for patient year of follow up showed no differences between CD-IFX and CD-C (p=0.90; log rank test). In the CD-IFX group, there was one cholangiocarcinoma, three breast cancers, one skin cancer, one leukaemia, one laryngeal cancer, and two anal carcinomas. Among the 7/404 (1.73%) CD-C, there were three intestinal adenocarcinomas (two caecum, one rectum), one basalioma, one spinalioma, one non-Hodgkin's lymphoma, and one breast cancer. Age at diagnosis of neoplasia did not differ between groups (CD-IFX v CD-C: median 50 (range 40-70 years) v 45 (27-72); p=0.50). CONCLUSION: In our multicentre matched pair study, the frequency of a new diagnosis of neoplasia in CD patients treated with Infliximab was comparable with CD patients who had never received Infliximab.

1. Aliment Pharmacol Ther. 2008 Jun;27(12):1210-23. Epub 2008 Mar 14. Meta-analysis: remission and response from control arms of randomized trials of biological therapies for active luminal Crohn's disease. Tinè F, Rossi F, Sferrazza A, Orlando A, Mocciaro F, Scimeca D, Olivo M, Cottone M. Divisione di Gastroenterologia, Azienda Ospedaliera V. Cervello, Palermo, Italy. fabiotinemd@virgilio.it BACKGROUND: Remission and response are the main outcomes to evaluate the efficacy of new treatments for Crohn's disease (CD). AIM: To explain variation of remission and response rates in active luminal CD. METHODS: We studied control patients from trials of biological therapies through articles retrieved by MEDLINE search (from 1997 to 2007) and by bibliography review. Thousand nine hundred and thirteen control patients from 28 trials were identified; data were extracted by three independent observers and pooled by DerSimonian and Laird random effect model; factors influencing remission and clinical response were explored by metaregression for aggregated data. RESULTS: The pooled control rates of remission and response were 17% and 33%, respectively, both with significant heterogeneity among studies (P < 0.0001). At metaregression, the time of primary outcome evaluation was associated with remission, whereas the trial's criteria for defining response and publication year were predictors of response. CDAI score, CRP levels or other clinical variables related with disease activity or concomitant medications were not significant factors. CONCLUSIONS: Populations used as 'add-on' treatment comparator in trials of biological therapies for active luminal CD are poorly characterized and outcomes are heterogeneous. Planning of future trials will require better description of patients and concomitant therapies, blinding of outcome assessors and homogeneous criteria of outcome definition.

Leiomyosarcoma of the colon is a rare tumor (330 reported cases [1]) which can mimic an adenocarcinoma [2]. Contrastenhanced computed tomography (CT) is the imaging method of choice in the diagnostic work-up, though magnetic resonance imaging may be useful. Endoscopy and endoscopic ultrasonography (EUS) are also useful for further characterizing the lesion, and are helpful in distinguishing a benign lesion from a malignant one [3]. Positron emission tomography can be used to monitor the response to therapy or detect local recurrence [2]. The management of leiomyosarcomas involving the gastrointestinal tract depends on the confidence in the preoperative diagnosis, and the treatment of choice is radical surgical excision [4]. No data are available on endoscopic treatment in patients who cannot undergo surgery. A 64-year-old man affected with hepatitis C virus-related decompensated cirrhosis was admitted to our hospital because of rectal bleeding. At colonoscopy a large sigmoid polyp (diameter 2.5cm) was found (●" Fig.1a). At EUS with a 20-mHz miniprobe the polyp was seen as rising from the second and third layers (●" Fig.1b). At histopathology the diagnosis was true leiomyosarcoma. CT scan was negative for metastatic lesions. Taking into account the severe liver disease, and in agreement with the surgeon, an endoscopic mucosectomy was performed after injection with saline, epinephrine, and dilute methylene blue into the base, obtaining a complete lift. The polyp was resected en bloc with a snare, using coagulation current followed by Endo Cut current. At the end, clips were placed at the mucosectomy site to prevent delayed bleeding (●" Fig.1c). The histopathology of the resected specimen confirmed the diagnosis (●" Fig.1d). At 6-month distal endoscopy there was no local recurrence (●" Fig.1e), and PET scan was negative. Although surgery is the treatment of choice in operable patients affected with leiomyosarcoma, this report shows that in selected inoperable patients with no metastatic disease, endoscopic excision of leiomyosarcoma can be an effective and safe nonsurgical approach.

Faecal calprotectin is predictive of clinical relapse in inflammatory bowel disease and ultrasound is sensitive in detecting its post-surgical recurrence. However, no data regarding the role of calprotectin in predicting post-surgical recurrence in asymptomatic Crohn's disease are available. The aim of this study was to prospectively evaluate the role of calprotectin as a predictive marker for one year post-surgical endoscopic recurrence in comparison with ultrasound in patients with asymptomatic Crohn's disease.We consecutively enlisted 50 patients who had undergone a resection for Crohn's disease. Faecal calprotectin was analysed and ultrasound were performed at the third month, and a colonoscopy after one year. The sensitivity and specificity of these two techniques were evaluated using endoscopic findings as a golden standard. A Receiver Operator Curve (ROC) curve was plotted, in order to identify the best-cut off value for calprotectin.39 out of 50 patients were evaluated by performing a colonoscopy after one year; 19 patients had an endoscopic recurrence after one year. Calprotectin sensitivity and specificity were calculated for 5 different cut-off values; the best cut-off value for calprotectin sensitivity (63%) and specificity (75%) was200 mg/L. The US sensitivity and specificity at the third month were 26% and 90% respectively.When performed three months after surgery ultrasound is more specific than calprotectin in predicting endoscopic recurrence. Faecal calprotectin at a dosage200 mg/L seems to have a better sensitivity than ultrasound. Values of calprotectin200 mg can be an indication to colonoscopy in the group of patients with negative ultrasound in order to detect early recurrence.

DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study L. Biancone1 *, C. Petruzziello1, A. Armuzzi2, M.L. Scribano3, R. D’Inca4, C. Papi5, L. Spina6, L. Guidi2, A. Kohn3, E. Calabrese1, G. Condino1, S. Onali1, F. Mocciaro7, R. Monterubbianesi3, P. Alvisi8, W. Fries9, G. Riegler10, F. Castiglione11, I. Frankovic4, G. Margagnoni5, R. Di Mitri7, G. Meucci12, F. Rogai13, S. Ardizzone14, A. Orlando15, F. Pallone1. 1Universita di Roma Tor Vergata, Medicina dei sistemi, cattedra di Gastroenterologia, Roma, Italy, 2Universita Cattolica, CIC, Roma, Italy, 3A.O.San Camillo Forlanini, Gastroenterology Unit, Rome, Italy, 4University of Padova, Gastroenterology Department, Padova, Italy, 5AO S. Filippo Neri, UOC GE/Hep, Roma, Italy, 6Universita S. Donato, Gastroenterologia, Milano, Italy, 7ARNAS Civico-Di Cristina-Benfratelli Hospital, Gastroenterology and Endoscopy Unit, Palermo, Italy, 8Ospedale Maggiore, Pediatria, Bologna, Italy, 9Universita di Messina, Medicina Interna, Messina, Italy, 10Seconda Universita Napoli, SUN, Napoli, Italy, 11Universita “Federico II” di Napoli, Gastroenterologia, Napoli, Italy, 12S. Giuseppe Hospital, Gastroenterology, Milano, Italy, 13AOU Careggi, Largo Brambilla, Gastroenterologia, Firenze, Italy, 14Luigi Sacco University Hospital, Gastroenterology Department, Milano, Italy, 15Ospedale Cervello, Medicina Interna, Palermo, Italy