Publications by authors named "Fernando Rizzello"

93 Publications

COVID-19 in IBD: The experience of a single tertiary IBD center.

Dig Liver Dis 2021 03 26;53(3):271-276. Epub 2020 Dec 26.

Centro di Riferimento Regionale Malattie Infiammatorie Croniche Intestinali, DIMEC Azienda Ospedaliero-Universitaria Policlinico Sant'Orsola-Malpighi, Bologna, Italy. Electronic address:

Background: Italy has been one of the most affected countries in the world by COVID-19. There has been increasing concern regarding the impact of COVID-19 on patients with inflammatory bowel disease (IBD), particularly in patients treated with immunosuppressants or biologics. The aim of our study is to understand the incidence of COVID-19 in a large cohort of patients with IBD. Furthermore, we analyzed possible risk factors for infection and severity of COVID-19.

Methods: This was an observational study evaluating the impact of COVID-19 on IBD patients in a single tertiary center. A 23 multiple-choice-question anonymous survey was administered to 1200 patients with IBD between March 10th and June 10th 2020.

Results: 1158 questionnaires were analyzed. The majority of patients had Crohn's disease (CD) (60%) and most of them were in clinical remission. Among the 26 patients (2.2%) who tested positive for COVID-19, only 5 (3CD) were on biological treatment and none required hospitalization. Two patients died and were on treatment with mesalazine only. Of the 1158 patients, 521 were on biological therapy, which was discontinued in 85 (16.3%) and delayed in 195 patients (37.4%). A worsening of IBD symptoms was observed in 200 patients on biological therapy (38.4%). Most of these patients, 189 (94.5%), had stopped or delayed biological treatment, while 11 (5.5%) had continued their therapy regularly (p<0.001).

Conclusions: Our data are in line with the current literature and confirm a higher incidence compared to the general population. Biological therapy for IBD seems to not be a risk factor for infection and should not be discontinued in order to avoid IBD relapse.
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http://dx.doi.org/10.1016/j.dld.2020.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764386PMC
March 2021

Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study.

United European Gastroenterol J 2020 Nov 17:2050640620974308. Epub 2020 Nov 17.

CEMAD - IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background: Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response.

Objective: This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.

Methods: Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy.

Results: A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio (OR) = 3.02, 95% confidence interval (CI) 1.44-6.29,  = 0.003) and being able to discontinue steroids at week 8 (OR = 3.32, 95% CI 1.34-8.30,  = 0.010) and week 14 (OR = 2.94, 95% CI 1.08-8.02,  = 0.036) were associated with longer persistence on therapy. At week 54, 65/124 (52.4%) post-induction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy ( < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients.

Conclusions: Biological-naïve status and not requiring steroids at weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.
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http://dx.doi.org/10.1177/2050640620974308DOI Listing
November 2020

Prognostic Role of Mismatch Repair Status, Histotype and High-Risk Pathologic Features in Stage II Small Bowel Adenocarcinomas.

Ann Surg Oncol 2021 Feb 5;28(2):1167-1177. Epub 2020 Aug 5.

Department of Internal Medicine, University of Pavia and Fondazione IRCCS San Matteo Hospital, Pavia, Italy.

Background: Small bowel adenocarcinoma is a relatively rare cancer, often diagnosed in an advanced stage. In localized and resectable disease, surgery alone or in combination with adjuvant chemotherapy is the mainstay of treatment. In the recently published National Comprehensive Cancer Network Clinical Practice guidelines, criteria for selecting patients with stage II small bowel adenocarcinoma to receive adjuvant chemotherapy are provided, and they are mainly extrapolated from studies on colorectal cancer.

Patients And Methods: In the present study, we aimed to verify whether mismatch repair deficiency phenotype, high-risk pathologic features (including T4, positive resection margins and a low number of lymph nodes harvested), as well as tumor histologic subtype, were associated with cancer-specific survival in 66 stage II non-ampullary small bowel adenocarcinoma patients, collected through the Small Bowel Cancer Italian Consortium. A central histopathology review was performed. Mismatch repair deficiency was tested by immunohistochemistry for MLH1, MSH2, MSH6 and PMS2, and confirmed by polymerase chain reaction for microsatellite instability.

Results: We identified mismatch repair deficiency, glandular/medullary histologic subtype, and celiac disease as significant predictors of favorable cancer-specific survival using univariable analysis with retained significance in bivariable models adjusted for pT stage. Among the high-risk features, only T4 showed a significant association with an increased risk of death; however, its prognostic value was not independent of mismatch repair status.

Conclusions: Mismatch repair protein expression, histologic subtype, association with celiac disease, and, in the mismatch repair proficient subset only, T stage, may help identify patients who may benefit from adjuvant chemotherapy.
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http://dx.doi.org/10.1245/s10434-020-08926-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801310PMC
February 2021

Ustekinumab for treating ulcerative colitis: an expert opinion.

Expert Opin Biol Ther 2020 11 24;20(11):1321-1329. Epub 2020 Jul 24.

IBD UNIT AO, "Villa Sofia-Cervello" Hospital , Palermo, Italy.

Introduction: Biologic agents have revolutionized the therapeutic management of ulcerative colitis. Anti-tumor necrosis factor agents were the first biologic drugs used to induce and maintain remission in this inflammatory bowel disease. Recently, another biologic option, ustekinumab, has become available for the treatment of moderate-to-severe ulcerative colitis.

Areas Covered: In this article, the authors review the literature on the efficacy and safety of ustekinumab in the context of current biologic agents used for the management of this disease. The potential role of ustekinumab in the treatment paradigm of the disease is also discussed. : The UNIFI trial has demonstrated the efficacy and safety of ustekinumab in induction and maintenance phases of treatment for ulcerative colitis. Ustekinumab may provide clinical benefit in a range of settings in patients with ulcerative colitis, even for those with multiple treatment failures, which are relatively common in daily clinical practice. Future clinical trials should compare the efficacy of ustekinumab with existing biologic agents in the management of ulcerative colitis.
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http://dx.doi.org/10.1080/14712598.2020.1792882DOI Listing
November 2020

Long term remission after ileorectal anastomosis in Crohn's colitis.

Dig Liver Dis 2020 Jun 29. Epub 2020 Jun 29.

IBD Unit, Department of Medical and Surgical Science, Sant'Orsola-Malpighi Hospital -University of Bologna, via Massarenti 9, 40138 Bologna, Italy. Electronic address:

Background: Crohn's disease represents a heterogeneous entity, but its location tends to be relatively stable overtime. For extensive refractory Crohn's colitis, ileorectal anastomosis after colectomy is an engaging option, since the necessity of a permanent ileostomy is avoided.

Aims: In our study, the long-term outcome of two groups of patients with Crohn's colitis who underwent colectomy and ileorectal anastomosis was compared. The first group had isolated colonic Crohn's disease without rectal involvement and perianal disease, while the second group included patients who had rectal and/or ileal involvement, with or without perianal disease.

Methods: Between 1996 and 2016, in a single IBD tertiary center, 80 patients with a history of colectomy and ileorectal anastomosis for refractory Crohn's colitis were retrospectively identified.

Results: Recurrence of disease was diagnosed in 57/64 of patients with Crohn's colitis with rectal and/or ileal and/or perianal involvement compared with 1/16 of patients with isolated Crohn's colitis without rectal and perianal disease in a median time of recurrence of 2 years (IQR 1-6 years, minimum to maximum, 1-18 years, p < 0.001). Only 6 patients (7,5%) underwent definitive end ileostomy without proctectomy (1 in the noIRP group and 5 in the IRP group).

Conclusion: Our data suggest that colectomy with ileorectal anastomosis may represent a curative option in patients with refractory isolated colitis without rectal and perianal involvement.
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http://dx.doi.org/10.1016/j.dld.2020.06.021DOI Listing
June 2020

Usefulness of panoramic 344°-viewing in Crohn's disease capsule endoscopy: a proof of concept pilot study with the novel PillCam™ Crohn's system.

BMC Gastroenterol 2020 Apr 7;20(1):97. Epub 2020 Apr 7.

IBD Unit, Department of Medical and Surgical Sciences (DIMEC), Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.

Background: A new capsule endoscopy (CE) system featuring two advanced optics for 344°-viewing and a prolonged operative time has been recently developed for Crohn's disease (CD) patients. Hence, we evaluated, for the first time, the performance of this novel CE and the add-on value of the 344°-viewing in a multi-center real-life setting.

Methods: Consecutive patients with suspected or established CD received the PillCam™ Crohn's System as supplementary diagnostic work-up focused on the small-bowel between June 2017 and June 2018. Technical and clinical data, including the panenteric CE diagnostic yield, the Lewis score and the impact of small-bowel findings on clinical management during a 6-months follow-up (new diagnosis, staging or treatment upgrade) were collected, thereby evaluating the added value of the 344° panoramic-view (lesions detected by camera A and B) over the standard 172°-view (lesions detected by one camera only).

Results: Among 41 patients (aged 43 ± 20 years), 73% underwent CE for suspected CD and 27% for established CD. The rate of complete enteroscopy was 90%. No technical failure or retention occurred. Compared to the standard 172° view, the panoramic 344°-view revealed a greater number of patients with a relevant lesion (56.1% vs. 39.0%; P = 0.023), resulting in higher Lewis score (222,8 vs. 185.7; P = 0.031), and improved clinical management (48.8% vs. 31.7%, P = 0.023).

Conclusions: The panoramic 344°-view increases small-bowel CE accuracy, thereby improving the clinical management of CD patients with mild small-bowel active disease. This system should be regarded as a new standard for both small-bowel diagnosis and monitoring in inflammatory bowel diseases.
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http://dx.doi.org/10.1186/s12876-020-01231-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7140388PMC
April 2020

Correction: PD-L1 in small bowel adenocarcinoma is associated with etiology and tumor-infiltrating lymphocytes, in addition to microsatellite instability.

Mod Pathol 2020 07;33(7):1453

Department of Internal Medicine, University of Pavia and Fondazione IRCCS San Matteo Hospital, Pavia, Italy.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41379-020-0512-5DOI Listing
July 2020

PD-L1 in small bowel adenocarcinoma is associated with etiology and tumor-infiltrating lymphocytes, in addition to microsatellite instability.

Mod Pathol 2020 07 17;33(7):1398-1409. Epub 2020 Feb 17.

Department of Internal Medicine, University of Pavia and Fondazione IRCCS San Matteo Hospital, Pavia, Italy.

Small bowel adenocarcinomas (SBAs) are often associated with poor prognosis and have limited therapeutic options. Programmed cell death protein-1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway blockade is an effective treatment in many microsatellite instability-high (MSI-H) solid tumors. We aimed at investigating PD-L1 and PD-1 expression in non-hereditary, non-ampullary SBAs, associated with celiac disease (CeD), Crohn's disease (CrD), or sporadic, recruited through the Small Bowel Cancer Italian Consortium. We assessed PD-L1 and PD-1 by immunohistochemistry in a series of 121 surgically resected SBAs, including 34 CeD-SBAs, 49 CrD-SBAs, and 38 sporadic SBAs. PD-L1 and PD-1 expression was correlated with several clinico-pathological features, such as the etiology, microsatellite instability status, and tumor-infiltrating lymphocyte (TIL) density. The prevalence of PD-L1 positivity according to combined positive score (CPS) was 26% in the whole cohort of SBAs, with significantly (p = 0.001) higher percentage (35%) in both CeD-SBAs and CrD-SBAs in comparison with sporadic SBAs (5%). CPS ≥ 1 SBAs were significantly (p = 0.013) more frequent in MSI-H cases (41%) than in non-MSI-H ones (18%); however, 15 CPS ≥ 1 microsatellite stable SBAs were also identified. CPS ≥ 1 SBAs showed higher TIL and PD-1 immune cell density, more frequently medullary histotype, as well as a better outcome in comparison with CPS < 1 cases. This study demonstrates an increased proportion of PD-L1 cases in both CeD-SBAs and CrD-SBAs in comparison with sporadic SBAs. In addition, the identification of a subset of PD-L1 microsatellite stable SBAs supports the need to ascertain additional biomarkers of response to immune checkpoint inhibitors along with MSI-H.
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http://dx.doi.org/10.1038/s41379-020-0497-0DOI Listing
July 2020

Ultrasonographic and clinical assessment of peripheral enthesitis and arthritis in an Italian cohort of inflammatory bowel disease patients.

Semin Arthritis Rheum 2020 06 11;50(3):436-443. Epub 2020 Jan 11.

Reumatologia, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; Reumatologia e, Azienda Ospedaliero-Unversitaria di Modena e Università di Modena e Reggio Emilia, Modena, Italy. Electronic address:

Aims: To evaluate the prevalence of clinical and ultrasonographic musculoskeletal involvement in Italian patients with inflammatory bowel disease (IBD).

Methods: In this cross-sectional multicenter study, 148 consecutive patients with IBD were evaluated by a gastroenterologist and a rheumatologist. All patients underwent a B-mode and power Doppler ultrasonographic examination of 6 pairs of entheses and of knee and ankle joints.

Results: A positive history for at least one musculoskeletal manifestation was reported by 40.5% of patients, more frequently in ulcerative colitis (UC) (p = 0.033). Inflammatory back pain was reported by 13.5% of patients, and a past history of peripheral arthritis by 14.9%, entheseal inflammation by 14.2% and dactylitis by 2.7%. At clinical examination, arthritis was observed in 19.6% of patients and enthesitis in 33%. Oligoarthritis and enthesitis at clinical examination were more frequently observed in UC than in Crohn disease (CD). 37.8% of total IBD patients fulfilled ASAS classification criteria for axial and/or peripheral spondyloarthritis, 8.1% ASAS classification criteria for axial spondyloarthritis, and 29.7% ASAS classification criteria for peripheral spondyloarthritis. With ultrasonographic examination, signs of entheseal involvement were observed in 87.8% of patients, while at power Doppler, ≥1 abnormality was observed in 27.1%. ASAS+ patients compared to those ASAS- had a significantly higher frequency at ultrasonography of acute entheseal abnormalities, power Doppler entheseal positivity and joint involvement. These abnormalities at ultrasonography were also observed in 34%, 13% and 12% of ASAS- patients.

Conclusions: Musculoskeletal manifestations occur frequently in patients with IBD. Ultrasonographic entheseal and joint involvement were also observed in asymptomatic patients.
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http://dx.doi.org/10.1016/j.semarthrit.2020.01.001DOI Listing
June 2020

Management of patients with complex perianal fistulas in Crohn's disease: Optimal patient flow in the Italian clinical reality.

Dig Liver Dis 2020 05 31;52(5):506-515. Epub 2019 Dec 31.

Digestive Surgery Department, S. Orsola-Malpighi University Hospital, Bologna, Italy.

Perianal fistulizing Crohn's disease (PFCD) is a common, disabling and aggressive phenotype that negatively impacts on the quality of life of affected patients. Its successful treatment is still a struggle for both physicians and patients. Significant advances in the management of this condition have occurred in the last two decades holding promise for a better future. This culminated into the concept of a collaborative multidisciplinary approach using the latest medical therapies combined with modern surgical and endoscopic techniques. Despite this, PFCD management and treatment have not been standardized yet. Thus the gastroenterologist and surgeon have to be familiar with several approaches and/or techniques. The positioning of each therapeutic option will certainly evolve with new data, but for the time being it should be driven by patient's characteristics, physician's preference and/or experience, costs and availability in local practice. Additionally, patient's perception of benefits and risks of treatment may differ from those of physicians and recognition of this difference is a starting point for difficult clinical decision-making. In this paper, a multidisciplinary group of Italian IBD experts explore and discuss current medical and surgical therapeutic options, highlighting areas of unmet needs in PFCD, with particular focus on the optimal patient flow within the Italian clinical reality.
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http://dx.doi.org/10.1016/j.dld.2019.11.016DOI Listing
May 2020

Are we choosing wisely for inflammatory bowel disease care? The IG-IBD choosing wisely campaign.

Dig Liver Dis 2020 01 21;52(1):44-50. Epub 2019 Oct 21.

First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.

Background: The "Choosing Wisely" campaigns have the aim of promoting a better clinician-patient relationship.

Aims: The Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) conducted a choosing wisely campaign for IBD.

Methods: Ten IG-IBD panellists conducted the campaign through a modified Delphi process. All IG-IBD members were asked to submit five statements starting with "Do not…" addressing any IBD-related procedure or treatment the necessity of which should be questioned. All recommendations were evaluated by the panellists who prioritised each item. The top ten recommendations were prioritised again by IG-IBD members, and the top five recommendations were identified.

Results: 110 members (mean age 42 ± 12; 62 males) participated in the campaign. The top five recommendations were as follow: 1. Do not use corticosteroids for maintenance therapy, or without a clear indication; 2. Do not forget venous thromboembolism prophylaxis in hospitalised patients with active disease; 3. Do not treat perianal Crohn's disease with biologics without prior surgical evaluation; 4. Do not discontinue IBD-related medications during pregnancy unless specifically indicated; 5. Do not delay surgery.

Conclusion: The IG-IBD promoted a campaign with a bottom-up approach, identifying five recommendations that could be useful for providing a better IBD care, especially among non-IBD experts.
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http://dx.doi.org/10.1016/j.dld.2019.09.019DOI Listing
January 2020

Unmet Medical Needs in the Management of Ulcerative Colitis: Results of an Italian Delphi Consensus.

Gastroenterol Res Pract 2019 2;2019:3108025. Epub 2019 Sep 2.

IBD Unit, Department of Medicine and Surgery (DIMEC), University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.

Background: The lifelong and remitting nature of ulcerative colitis results in considerable disability and a substantial negative impact on quality of life. The major goal of the therapy of ulcerative colitis is considered to be the modification of the course of the disease, so that the patient's quality of life can be improved while minimising disease-related disability. Although considerable progress in understanding the molecular pathways involved in ulcerative colitis has led to improved treatment options, there is currently no definitive cure for ulcerative colitis, there remain considerable unmet needs in terms of long-term efficacy and safety, and there are many patients who continue to be burdened by physical and psychological symptoms. Defining unmet needs can help to increase the awareness of the shortcomings of current therapeutic management and highlight the need to achieve not only a control of clinical symptoms but also control of mucosal healing, in order to attain the best possible long-term outcomes.

Methods: With the aim of providing a better understanding of the unmet needs of patients towards improving overall care, a Delphi process was used to obtain consensus among a group of Italian ulcerative colitis experts. The consensus group met with a major focus of delineating the unmet needs of current treatment strategies and overall management of ulcerative colitis, while also focusing on quality of life and patient care.

Results: Three main areas were identified: (i) treatment, (ii) monitoring and risk management, and (iii) patient-related issues. A high level of consensus was reached on all but one of the statements identified.

Conclusions: The findings arising from the Delphi process provide valuable insights into the unmet needs in the management of moderate-to-severe ulcerative colitis from the clinician's perspective, while emphasising the benefits of therapeutic individualization and suggesting areas that need additional study with the aim of optimising the treatment of patients with ulcerative colitis.
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http://dx.doi.org/10.1155/2019/3108025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6745180PMC
September 2019

Separation of Low- Versus High-grade Crohn's Disease-associated Small Bowel Carcinomas is Improved by Invasive Front Prognostic Marker Analysis.

J Crohns Colitis 2020 Mar;14(3):295-302

Unit of Anatomic Pathology, Department of Molecular Medicine, University of Pavia, and Fondazione IRCCS San Matteo Hospital, Pavia, Italy.

Background And Aims: Crohn's disease-associated small bowel carcinoma is a rare event, usually reported to have a severe prognosis. However, in previous investigations we have found a minority of cases displaying a relatively favourable behaviour, thus outlining the need to improve the histopathological prediction of Crohn's disease-associated small bowel carcinoma prognosis.

Methods: As in recent studies on colorectal cancer, a substantial improvement in prognostic evaluations has been provided by the histological analysis of the tumour invasive front; we therefore systematically analysed the tumour budding and poorly differentiated clusters in the invasive front of 47 Crohn's disease-associated small bowel carcinomas collected through the Small Bowel Cancer Italian Consortium.

Results: Both tumour budding and poorly differentiated cluster analyses proved highly effective in prognostic evaluation of Crohn's disease-associated small bowel carcinomas. In addition, they retained prognostic value when combined with two other parameters, i.e. glandular histology and stage I/II, both known to predict a relatively favourable small bowel carcinoma behaviour. In particular, association of tumour budding and poorly differentiated clusters in a combined invasive front score allowed identification of a minor subset of cancers [12/47, 25%] characterised by combined invasive front low grade coupled with a glandular histology and a low stage [I or II] and showing no cancer-related death during a median follow-up of 73.5 months.

Conclusions: The improved distinction of lower- from higher-grade Crohn's disease-associated small bowel carcinomas provided by invasive front analysis should be of potential help in choosing appropriate therapy for these rare and frequently ominous neoplasms.
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http://dx.doi.org/10.1093/ecco-jcc/jjz140DOI Listing
March 2020

Refractory Complex Crohn's Perianal Fistulas: A Role for Autologous Microfragmented Adipose Tissue Injection.

Inflamm Bowel Dis 2020 01;26(2):321-330

Surgery of the Alimentary Tract, S. Orsola-Malpighi Hospital and Department of Medical and Surgical Sciences University of Bologna, Bologna, Italy.

Background: Complex perianal fistulas represent one of the most challenging manifestations of Crohn's disease. Combined surgical and medical therapy with biologic drugs today represent the first-line treatment option, but its efficacy does not exceed 60%. Recently, new therapeutic approaches, such as the use of mesenchymal stromal cells, have shown promising results. The adipose tissue is an abundant and easy to access source. The effectiveness, safety, and feasibility of local injections of microfragmented adipose tissue in patients with refractory complex fistulizing perianal Crohn's disease (PCD) were evaluated.

Methods: Fifteen patients with persistent complex fistulizing PCD after biosurgical approach and subsequent surgical "rescue" repair were treated in S. Orsola-Malpighi Hospital with a single-local administration of microfragmented adipose tissue prepared using a minimal manipulation technique (Lipogems) in a closed system. Clinical outcomes were determined at 24-week follow-ups assessing success rate, defined as combined clinical and radiological remission.

Results: Upon clinical examination at 24 weeks, 10 patients had combined remission (clinical and radiographic), 4 patients showed improvements, and 1 patient failed. The results were confirmed in all patients by pelvic MRI. No relevant postoperative complications nor adverse events were reported.

Conclusion: These results suggest that the local injection of autologous microfragmented adipose tissue is a safe and promising "rescue therapy" for patients with multiresistant complex fistulizing PCD. This approach might be proposed as routine because it is affordable, is minimally invasive, has no risk of sphincteric damage, and can be carried out in a day-surgery setting.
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http://dx.doi.org/10.1093/ibd/izz051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943693PMC
January 2020

Budesonide MMX: efficacy and safety profile in the treatment of ulcerative colitis.

Expert Rev Gastroenterol Hepatol 2019 Jul 30;13(7):607-613. Epub 2019 May 30.

a IBD unit, Department of Internal Medicine and Gastroenterology , University of Bologna , Bologna , Italy.

: Ulcerative colitis is an idiopathic, chronic inflammatory disease of the colonic mucosa. Its clinical course is unpredictable, marked by alternating periods of exacerbation and remission. Traditional oral corticosteroids are still the mainstay treatment for the induction of ulcerative colitis remission in patients failing or intolerant to aminosalicylates, but the risk of side effects and complications limits their usefulness. Based on these considerations, new steroids with low systemic bioavailability, such as Beclomethasone dipropionate and Budesonide, have been developed. : We reviewed the current literature about the efficacy, safety and the role of budesonide MMX in the treatment of ulcerative colitis. The evidence reviewed in this article is a summation of relevant scientific publications, expert opinion statements, and current practice guidelines. : Budesonide MMX is a novel formulation that uses a Multi-Matrix System (MMX) technology to facilitate the release of high concentrations of active drug into the colon. Budesonide MMX at the dose of 9 mg/day for 8 weeks is effective and safe in inducing clinical and endoscopic remission in patients with mild to moderate UC, who had an inadequate response or were intolerant to either first line conventional therapy with topical and oral 5-aminosalicylic acid.
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http://dx.doi.org/10.1080/17474124.2019.1621745DOI Listing
July 2019

Implications of the Westernized Diet in the Onset and Progression of IBD.

Nutrients 2019 May 8;11(5). Epub 2019 May 8.

Department of Medical and Surgical Sciences, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy.

Inflammatory bowel diseases (IBD) are currently considered multifactorial pathologies in which various combined environmental factors act on a genetic background, giving rise to a chronic inflammation of the gastrointestinal tract. Among the various environmental factors, it now seems clear that the diet plays the major role in IBD onset and progression. Several clinical studies have attempted to understand the impact of diet in the development and progression of these diseases in order to establish useful guidelines for their management. However, the modest and sometimes contradictory results did not lead to the definition of shared dietary suggestions. On the other hand, food fads and recommendations based on anecdotal episodes are often followed by IBD patients to improve their diet. This review provides a critical overview of existing data on the role of diet as a risk factor for IBD. The methodology used was that of analyzing the results of clinical studies conducted on diet and IBD over the last 12 years through PubMed, as well as analyzing the most relevant studies on nutrients and their possible roles in IBD through the knowledge of the mechanisms by which they can modulate the microbiota or the intestinal physiology.
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http://dx.doi.org/10.3390/nu11051033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6566788PMC
May 2019

A current overview of corticosteroid use in active ulcerative colitis.

Expert Rev Gastroenterol Hepatol 2019 Jun 22;13(6):557-561. Epub 2019 Apr 22.

a Department of Internal Medicine and Gastroenterology , University of Bologna , Bologna , Italy.

Introduction: Ulcerative colitis (UC) is a chronic inflammatory condition that causes continuous mucosal inflammation of the colon. New biological drugs have been developed in order to avoid colectomy, but corticosteroids still play a crucial role in management of active UC. Areas covered: We reviewed the current literature about the importance of corticosteroid use in the treatment of ulcerative colitis. The evidence reviewed in this article is a summation of relevant scientific publications, expert opinion statements, and current practice guidelines. This review is a summary of expert opinion in the field without a formal systematic review of evidence. Expert opinion: Corticosteroids represent the mainstay of treatment in patients with severe UC and are very effective in inducing remission in mild to moderate flares not responding to combined oral and topical mesalazine. A valid alternative to systemic corticosteroids is represented by poorly absorbed steroids, such as Beclomethasone dipropionate and Budesonide MMX. In mild-moderate distal disease topical administration of corticosteroids (both systemic and BDP) is an effective alternative to topical mesalazine. However, corticosteroids do not represent a therapeutic option as a maintenance treatment since they are associated with multiple adverse effects.
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http://dx.doi.org/10.1080/17474124.2019.1604219DOI Listing
June 2019

Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

Dig Liver Dis 2019 05 19;51(5):632-639. Epub 2019 Feb 19.

IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address:

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars.
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http://dx.doi.org/10.1016/j.dld.2019.02.004DOI Listing
May 2019

Hepatocellular carcinoma tumor thrombus entering the inferior vena cava treated with percutaneous RF ablation: a case report.

J Ultrasound 2019 Sep 12;22(3):363-370. Epub 2019 Mar 12.

Internal Medicine Division, Ostuni Hospital, Ostuni, BR, Italy.

Purpose: Hepatocellular carcinoma (HCC) is the most common form of liver cancer. In advanced cancer stages (metastatic disease and/or vascular invasion), the generally accepted standard of care is systemic therapy using sorafenib as first-line treatment and, recently, regorafenib and nivolumab as second-line treatment, but the quality of life and the prognosis of patients remain very poor. Our paper reports a case of US-guided radiofrequency ablation (RFA) of both intraparenchymal HCC and inferior vena cava tumor thrombus.

Methods: We treated a patient with HCC associated with tumor thrombus extending into vena cava after failure of sorafenib therapy using US-guided radiofrequency ablation (RFA).

Results: A good radiological and clinical response was observed in association with excellent tolerability. The patient has been followed up for 15 months from the ablation, is alive, and is in a good clinical condition without evidence of tumor recurrence.

Conclusion: This is the first case in which this minimally invasive percutaneous procedure has been successfully used to treat an HCC thrombus entering the vena cava.
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http://dx.doi.org/10.1007/s40477-019-00361-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6704268PMC
September 2019

Epidemiological features and disease-related concerns of a large cohort of Italian patients with active Crohn's disease.

Dig Liver Dis 2019 06 3;51(6):804-811. Epub 2019 Jan 3.

IBD Unit, University of Bologna, Emilia-Romagna Region IBD Reference Center, S. Orsola-Malpighi Hospital, Bologna, Italy.

Background-aims: The SOLE study was conducted on a large cohort of Italian patients with moderate-severe Crohn's disease (CD) to assess epidemiological and disease characteristics and their correlation with disease-related worries, treatment satisfaction and adherence, workability.

Methods: The following tools were used over 12 months to assess: Results were correlated with demographic and clinical variables with linear regression models.

Results: 552 patients with active CD (51% men) were recruited. Higher worries were having an ostomy bag and undergoing surgery. Variables associated with a higher RFIPC score included female sex, higher disease activity, lower treatment adherence (p < 0.001), previous surgical treatments (p = 0.003). 60% of patients claimed difficulties with activities of daily living. Lower VAS scores were reported by patients with disease duration >6years; treatment satisfaction/adherence was higher with anti-TNF-α treatment. Decreased hospitalizations during follow-up and improved workability/daily activities occurred with adalimumab, infliximab, azathioprine (p < 0.001).

Conclusion: Worries included having an ostomy bag, undergoing surgery, developing cancer: conditions significantly associated with worsened disease activity and low treatment adherence. Higher treatment adherence scores/greater workability improvements were observed in patients treated with anti-TNF-α agents.
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http://dx.doi.org/10.1016/j.dld.2018.12.019DOI Listing
June 2019

Predictors of early recurrence after strictureplasty for Crohn's disease of the small bowel during the years of biologics.

Dig Liver Dis 2019 05 8;51(5):663-668. Epub 2018 Dec 8.

Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background: The identification of patients prone to early recurrence of Crohn's disease at the site of a strictureplasty is fundamental in the clinical practice.

Aims: Aim of the study is to detect the risk factors for early reoperation for recurrence after primary strictureplasty.

Methods: From 2000, patients undergoing a primary strictureplasty and a subsequent reoperation for recurrence of Crohn's disease at the site of a strictureplasty were included. Univariate and multivariable linear regression models were performed to analyse the relationship between the time to recurrence and independent variables.

Results: Fifty-nine patients were included. Median time to recurrence was 4.5 years (0.7-12.6). At the multivariate linear regression, early relapse was significantly associated with use of biologics before primary surgery (-2.69, p < 0.0001) and location of disease in the ileum (-1.61, p 0.017). The use of biologics after surgery was similar between groups (40.7 vs 37.5%, p 0.79).

Conclusions: The location of Crohn's disease in the ileum and the use of biologics before surgery are strong predictors of early site-specific recurrence after strictureplasty. In this group of patients, a tailored follow-up and aggressive postoperative treatment should be considered.
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http://dx.doi.org/10.1016/j.dld.2018.11.027DOI Listing
May 2019

Dietary geraniol ameliorates intestinal dysbiosis and relieves symptoms in irritable bowel syndrome patients: a pilot study.

BMC Complement Altern Med 2018 Dec 19;18(1):338. Epub 2018 Dec 19.

Department of Biological, Geological and Environmental Sciences, Biology Unit, University of Bologna, Via Selmi 3, 40126, Bologna, Italy.

Background: (Trans)-3,7-Dimethyl-2,6-octadien-1-ol, commonly called geraniol (Ge-OH), is an acyclic monoterpene alcohol with well-known anti-inflammatory and antimicrobial properties. Ge-OH is a non-toxic compound classified as Generally Recognized As Safe (GRAS) by the US Food and Drug Administration and the European Food Security Agency.

Methods: Ge-OH was orally administered at a maximum daily dose of 8 mg kg body weight for four weeks in a delayed release formulation capable of reaching the colon. Fecal microbiota and blood cytokines were analyzed before and after Ge-OH treatment, as well as IBS symptomatology by using Visual Analogue Scale (VAS-IBS).

Results: The results show that orally administered Ge-OH is a powerful modulator of the intestinal microbial ecosystem, capable of leading to increased relative abundances of Collinsella and especially Faecalibacterium, a well-known health-promoting butyrate producer consistently found to be decreased in IBS patients. Moreover, Ge-OH strongly improved the clinical symptoms of colitis by significantly reducing the score recorded by the VAS-IBS questionnaire. Clinical improvement was associated with a significant reduction in the circulating MIP-1β, a chemokine found to be increased in several IBS patients.

Conclusion: Ge-OH could be a powerful component for food supplement targeted to the treatment of IBS patients.

Trial Registration: ISRCTN47041881 , retrospectively registered on 19th July 2018.
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http://dx.doi.org/10.1186/s12906-018-2403-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6299992PMC
December 2018

Unmet needs of Italian physicians managing patients with inflammatory bowel disease.

Dig Liver Dis 2019 02 9;51(2):212-217. Epub 2018 Aug 9.

Gastroenterology Unit, ASST Rhodense, Rho Hospital, Rho, Italy. Electronic address:

Background: Little is known about the unmet needs of physicians caring for patients with inflammatory bowel disease (IBD).

Aims: This study explored the practical difficulties and needs for professional updating of Italian IBD physicians.

Methods: A questionnaire was distributed to 600 physicians attending IG-IBD meetings.

Results: 280 physicians completed the questionnaire (46.7%). On a 5-point Likert scale (from 1, strongly disagree to 5, strongly agree), they identified the most problematic issues in managing IBD patients as increasing bureaucracy (3.9), lack of extra-gastroenterological IBD expertise (3.4), lack of diagnostic techniques (3.1) and budget limitations (2.9). The most lacking techniques, ranked from 1 (greatest need) to 9 (lowest need), were: anti-drug antibody and trough level assays (2.7), device-assisted enteroscopy (3.1), exploration under anaesthesia (3.2), MR enterography (3.2), and bowel ultrasonography (3.3). About professional updating, respondents indicated (on a 5-point Likert scale) that helpful topics were practical medicine (4.3), managing difficult patients (4.1), and guidelines (4.0). The most desired modality for updating was residential courses on clinical practice (4.3).

Conclusion: Several factors potentially limit the best management of IBD patients in Italy. Satisfying these unmet needs could improve care for IBD patients.
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http://dx.doi.org/10.1016/j.dld.2018.07.041DOI Listing
February 2019

The safety of beclomethasone dipropionate in the treatment of ulcerative colitis.

Expert Opin Drug Saf 2018 Sep 21;17(9):963-969. Epub 2018 Aug 21.

a Department of Medicine and Surgery (DIMEC), IBD unit, S. Orsola-Malpighi Hospital , University of Bologna , Bologna , Italy.

Introduction: Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that uses novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of BDP compared with other conventional corticosteroids. Areas covered: We reviewed the mechanism of action, efficacy, and safety of BDP in the treatment of UC. The positioning of BDP in management algorithms is also discussed. Expert opinion: The highly selective mechanism of action of BDP restricts the steroid-related side effects. BDP is efficacious in the treatment of active UC. Topical formulation is the first choice in distal UC, while oral formulation is used in patients with an extensive involvement of the colon. The rates of adverse events (AE), serious AEs, and steroid-related side-effects are similar to placebo and mesalamine and slightly inferior to traditional corticosteroids.
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http://dx.doi.org/10.1080/14740338.2018.1510914DOI Listing
September 2018

How clinicians and pathologists interact concerning inflammatory bowel disease in Italy: An IG-IBD survey.

Dig Liver Dis 2018 07 21;50(7):734-736. Epub 2018 Mar 21.

Department of Medical and Surgical Sciences (DIMEC), Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.1016/j.dld.2018.03.020DOI Listing
July 2018

Ustekinumab in the management of Crohn's disease: Expert opinion.

Dig Liver Dis 2018 07 11;50(7):653-660. Epub 2018 Mar 11.

Gastroenterology Unit, Mauriziano Hospital, Turin, Italy.

This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.
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http://dx.doi.org/10.1016/j.dld.2018.02.017DOI Listing
July 2018

Multidisciplinary Management of Spondyloarthritis-Related Immune-Mediated Inflammatory Disease.

Adv Ther 2018 04 7;35(4):545-562. Epub 2018 Mar 7.

Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.

Introduction: Immune-mediated inflammatory diseases (IMIDs) are chronic autoimmune conditions that share common pathophysiologic mechanisms. The optimal management of patients with IMIDs remains challenging because the coexistence of different conditions requires the intervention of several specialists. The aim of this study was to develop a series of statements defining overarching principles that guide the implementation of a multidisciplinary approach for the management of spondyloarthritis (SpA)-related IMIDs including SpA, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and uveitis.

Methods: A Delphi consensus-based approach was used to identify a core set of statements. The process included development of initial questions by a steering committee, an exhaustive search of the literature using complementary approaches to identify potential statements and two Delphi voting rounds for finalization of the statements.

Results: Consensus was achieved on the related nature of IMIDs, the existence of a high prevalence of multiple IMIDs in a single patient and the fact that a multidisciplinary approach can result in a more extensive evaluation and comprehensive approach to treatment. The goals of a multidisciplinary team should be to increase diagnosis of concomitant IMIDs, improve the decision-making process, and increase patient satisfaction and adherence. Early referral and diagnosis, early recognition of concomitant IMIDs and optimizing treatment to improve patient quality of life are some of the advantages of using multidisciplinary teams. To be effective, a multidisciplinary team should be equipped with the appropriate tools for diagnosis and follow-up, and at a minimum the multidisciplinary team should include a dermatologist, gastroenterologist and rheumatologist; providing psychologic support via a psychologist and involving an ophthalmologist, general practitioners and nurses in multidisciplinary care is also important.

Conclusion: The present Delphi consensus identified a set of overarching principles that may be useful for implementation of a multidisciplinary approach for the management of SpA-related IMIDs.

Funding: Aristea and Hippocrates.
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http://dx.doi.org/10.1007/s12325-018-0672-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5910456PMC
April 2018

Prepouch Ileitis After Ileal Pouch-anal Anastomosis: Patterns of Presentation and Risk Factors for Failure of Treatment.

J Crohns Colitis 2018 Feb;12(3):273-279

Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background And Aims: There is a lack in the literature about prepouch ileitis [PI], in particular regarding risk factors associated with failure of the medical treatment. Aim of the study is to analyse the characteristics of PI patients and to compare those who required surgery with those who were successfully treated with conservative therapy.

Methods: All cases presenting a diagnosis of PI were included and analysed. Patients eventually requiring surgery were compared with those who were managed conservatively, for symptoms of presentation, endoscopic characteristics, and rate of response to medical treatment. A sub-analysis of outcomes based on the final histology was performed.

Results: The overall incidence of PI among 1286 patients was 4.4% [57], after a median of 6.8 years from pouch surgery. Symptoms included increased frequency [26.4%], outlet obstruction [21%], and bleeding [15.8%]. Afferent limb stenosis affected 49.1% of patients. The comparison showed that patients requiring surgery had a higher rate of Crohn's disease and indeterminate colitis [42.1 vs 0% and 15.8 vs 2.6%, p < 0.0001], outlet obstruction as main symptom [47.4 vs 7.9%, p = 0.0023], and afferent limb stenosis [73.7 vs 36.8%, p = 0.008] at endoscopy. Rate of failure of medical treatment at 5 years was 8.2% in patients with ulcerative colitis and 75% in the presence of both indeterminate colitis and Crohn's disease [p < 0.0001].

Conclusions: Crohn's disease, indeterminate colitis, and stenosis with outlet obstruction are risk factors for failure of treatment after diagnosis of PI. Early aggressive therapy and surgery should be considered in these cases.
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http://dx.doi.org/10.1093/ecco-jcc/jjx140DOI Listing
February 2018

Transabdominal salvage surgery after pouch failure in a tertiary center: A case-matched study.

Dig Liver Dis 2018 May 26;50(5):446-451. Epub 2017 Nov 26.

Surgery of the Alimentary Tract - Digestive Disease Department, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background: Salvage surgery after failure of ileal pouch-anal anastomosis (IPAA) could be offered to selected patients. However, the results vary widely in different centers.

Aims: To assess the outcomes of salvage surgery by comparison with a control group matched for confounding variables.

Methods: From a prospective database of 1286 IPAA, patients undergoing transabdominal salvage surgery were compared for perioperative and functional outcomes and quality of life (QOL) to a 1:3 control group of primary IPAA cases.

Results: Salvage surgery patients (30) had a higher rate of hand-sewn anastomoses (80 vs 20%, p <0.0001) and reoperations (10 vs 2.2%, p 0.02) than control group (90). A higher number of daytime and nighttime bowel movements (7.4 vs 4.1, p <0.0001, and 2.6 vs 1.8, p=0.002), a lower median CGQL score (0.7 vs 0.8, p=0.0001) and a higher rate of pouch fistulae (13.3 vs 1.1%, p=0.003) were reported after salvage surgery. Pouch failure rate after salvage surgery was 10.1%, 18.7% and 26.8% at 1, 5 and 10 years (vs 0%, 3.5% and 8.4% in control group, p=0.0085).

Conclusions: Although worse functional outcomes and decreased QOL have to be expected, salvage surgery after pouch failure is associated with acceptable outcomes when performed in a referral center.
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http://dx.doi.org/10.1016/j.dld.2017.11.011DOI Listing
May 2018

Real-time elastography for the detection of fibrotic and inflammatory tissue in patients with stricturing Crohn's disease.

J Ultrasound 2017 Dec 26;20(4):273-284. Epub 2017 Oct 26.

Department of Medical and Surgical Sciences (DIMEC), Alma Mater Studiorum-University of Bologna, Sant'Orsola-Malpighi Hospital, Via Massarenti 9, 40138 Bologna, Italy.

Purpose: The distinction between active inflammation and fibrosis of the bowel wall is essential for therapeutic decisions in stricturing Crohn's disease. We aimed to assess whether real-time elastography (RTE) with strain ratio measurement could be useful in differentiating fibrotic from inflamed bowel strictures and to evaluate the possible relationship between US techniques and the histology of the stenotic bowel wall.

Materials And Methods: Bowel ultrasonography (including RTE, color-Doppler and CEUS examination) was prospectively evaluated in 26 patients with symptomatic stricturing Crohn's disease, before surgery. RTE was adopted to evaluate bowel stiffness: five loops of 20 RTE frames were recorded for each stenotic segment and the mean strain ratio (MSR) was obtained. Histology scoring systems both for inflammation and fibrosis were established for surgical specimens.

Results: No significant correlation was found between MSR and fibrosis score ( = 0.877). Color-Doppler score was significantly related to gut wall and submucosal thicknesses ( = 0.006 and  = 0.032, respectively). There was no significant correlation between the number of vessels counted at histology and color-Doppler and CEUS examinations ( = 0.170 and  = 0.302, respectively).

Conclusion: MSR detection was not able to distinguish fibrotic from inflammatory tissue in our selected population. This result could be influenced by the presence of the superimposed inflammation. Larger cohort of patients, further analysis with shear wave elastography, and validated histopathology classification systems for fibrosis and inflammation are necessary to assess if intestinal fibrosis could be reliably detected on the basis of bowel elastic properties.
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http://dx.doi.org/10.1007/s40477-017-0265-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698189PMC
December 2017