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AIM Low anterior resection syndrome (LARS) following sphincter-preserving surgery for rectal cancer has a high prevalence, with an impact on long-term bowel dysfunction and quality of life. We designed the bowel rehabilitation programme (BOREAL) as a proactive strategy to assess and treat patients with LARS. The BOREAL programme consists of a stepwise approach of escalating treatments: medical management (steps 0-1), pelvic floor physiotherapy, biofeedback and transanal irrigation (step 2), sacral nerve neuromodulation (step 3), percutaneous endoscopic caecostomy and anterograde enema (step 4) and definitive colostomy (step 5). METHODS A pilot study was undertaken to assess the feasibility of collecting LARS data routinely with the parallel implementation of the BOREAL programme. All patients who underwent total mesorectal excision for rectal cancer between February 2017 and March 2019 were included. LARS was assessed using the LARS score and the Wexner Faecal Incontinence score at 30 days and 3, 6, 9 and 12 months postoperatively. A good functional result was considered to be a combined LARS score

Background Local excision (LE) after chemoradiotherapy is a new option in low rectal cancer, but morbidity has never been compared prospectively with total mesorectal excision (TME). Early and late morbidity were compared in patients treated either by LE or TME after neoadjuvant chemoradiotherapy for rectal cancer. Method This was a post-hoc analysis from a randomized trial. Patients with clinical T2/T3 low rectal cancer with good response to the chemoradiotherapy and having either LE, LE with eventual completion TME, or TME were considered. Early (1 month) and late (2 years) morbidities were compared between the three groups. Results There were no deaths following surgery in any of the three groups. Early surgical morbidity (20 per cent LE versus 36 per cent TME versus 43 per cent completion TME, P = 0.025) and late surgical morbidity (4 per cent versus 33 per cent versus 57 per cent, P Conclusion The rate of surgical complications after neoadjuvant chemoradiotherapy in the LE group was half that of TME group at 1 month and 10 times lower at 2 years. LE is a safe approach for organ preservation and should be considered as an alternative to watch-and-wait in complete clinical responders and to TME in subcomplete responders.

The pathological nodal stage, determination of which requires examination of ≥ 12 lymph nodes, is one of the main prognostic factors in rectal cancer. Neoadjuvant chemoradiotherapy (CRT) may reduce the number of both lymph nodes retrieved and positive lymph nodes. Induction chemotherapy before CRT aimed at reducing the rate of distant metastases. However, the impact of this new treatment on number of lymph nodes retrieved and positive lymph nodes is unknown. This study was performed to evaluate the effects of neoadjuvant chemotherapy on lymph nodes in locally advanced rectal cancer treated by CRT. We retrospectively included patients with T2 – 4 Nx M0 rectal cancer and compared those receiving neoadjuvant chemotherapy plus CRT with those receiving CRT alone. From 2012 to 2019, 85 patients were treated with neoadjuvant chemotherapy + CRT and 189 with CRT alone. The number of lymph nodes retrieved (19 vs. 17, respectively, P = 0.434), the rate of specimens with ≥ 12 lymph nodes (92% vs. 88%, respectively, P = 0.397), and the median number of positive lymph nodes (1 vs. 2, respectively, P = 0.878) were similar between the two groups. However, the rate of pN0 was higher after neoadjuvant chemotherapy + CRT compared to CRT (75% vs. 62%, respectively, P = 0.030). Neoadjuvant chemotherapy before CRT for locally advanced rectal cancer did not modify the number of lymph nodes retrieved or the number of positive lymph nodes compared to CRT alone. However, it significantly increased the rate of tumors without any positive lymph nodes (ypN0).

A raised C-reactive protein level should be used to prompt early detection of anastomotic leakage before development of clinical symptoms. Early biochemical diagnosis of anastomotic leakage and intervention mitigates the negative impact of leakage on oncological outcomes in patients with rectal cancer.

Background Laparoscopy, by its minimally invasive nature, has revolutionized digestive and particularly colorectal surgery by decreasing post-operative pain, morbidity, and length of hospital stay. In this trial, we aim to assess whether low pressure in laparoscopic colonic surgery (7 mm Hg instead of 12 mm Hg) could further reduce pain, analgesic consumption, and morbidity, resulting in a shorter hospital stay. Methods and analysis The PAROS trial is a phase III, double-blind, randomized controlled trial. We aim to recruit 138 patients undergoing laparoscopic colectomy. Participants will be randomly assigned to either a low-pressure group (7 mm Hg) or a standard-pressure group (12 mm Hg). The primary outcome will be a comparison of length of hospital stay between the two groups. Secondary outcomes will compare post-operative pain, consumption of analgesics, morbidity within 30 days, technical and oncological quality of the surgical procedure, time to passage of flatus and stool, and ambulation. All adverse events will be recorded. Analysis will be performed on an intention-to-treat basis. Trial registration This research received the approval from the Committee for the Protection of Persons and was the subject of information to the ANSM. This search is saved in the ID-RCB database under registration number 2018-A03028–47. This research is retrospectively registered January 23, 2019, at http://clinicaltrials.gov/ed under the name “LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)”. This trial is ongoing.

Introduction et but de l’etude La radiotherapie neoadjuvante rectale peut etre delivree en technique conformationnelle tridimensionnelle ou avec modulation d’intensite. Les etudes retrospectives montrent une reduction de la toxicite aigue pendant la chimioradiotherapie delivree avec modulation d’intensite mais aucune etude ne s’est interessee a l’impact de ce type de technique sur la morbidite postoperatoire. L’objectif de l’etude etait d’evaluer la morbidite chirurgicale severe en fonction de la technique de radiotherapie. Les objectifs secondaires etaient l’evaluation de la toxicite aigue pendant la chimioradiotherapie et les sequelles digestives. Materiel et methodes Tous les patients pris en charge par chimioradiotherapie puis chirurgie au CHU de Bordeaux entre 2012 et 2019 pour un cancer rectal ont ete inclus. Le critere de jugement principal etait la morbidite chirurgicale severe qui etait renseignee de maniere prospective par le chirurgien et definie comme tout evenement de grade III-IV selon la classification Dindo-Clavien survenant jusqu’a 30 jours de la chirurgie. Les sequelles digestives etaient evaluees selon le score LARS. Resultats et analyse statistique Cent-cinquante-cinq patients ont ete inclus : 79 dans le bras recevant la radiotherapie conformationnelle tridimensionnelle (soit 51 %) et 75 dans le bras recevant la radiotherapie conformationnelle avec modulation d’intensite (soit 49 %). La dose mediane etait de 50 Gy (intervalle : 25–60 Gy). Une resection rectale anterieure a ete realisee pour 107 patients (soit 69 %), une tumorectomie pour 25 (soit 16 %) et une chirurgie plus lourde pour 23 (soit 15 %). Il n’y a eu aucun deces et 86 patients n’ont pas presente de complications postoperatoires (soit 56 %). Une morbidite chirurgicale severe est survenue chez 37 patients (soit 24 %), sans difference significative selon la technique de radiotherapie : 16 patients recevant la radiotherapie conformationnelle avec modulation d’intensite (soit 21 %), contre 21 patients recevant la radiotherapie conformationnelle tridimensionnelle (soit 27 %) (p = 0,628). Il y a eu plus de toxicite gastro-intestinale aigue de grade superieur a 2 dans le groupe recevant la radiotherapie conformationnelle tridimensionnelle : dix patients (soit 13 %) contre un patient (soit 1 %) recevant la radiotherapie conformationnelle avec modulation d’intensite (p = 0,006). Le benefice de la radiotherapie conformationnelle avec modulation d’intensite concernait essentiellement les diarrhees de grade superieur a 2 et cette difference etait encore plus prononcee pour les 60 patients ayant recu une chimiotherapie d’induction, puisqu’un seul patient a eu des diarrhees grade superieur a 2 avec la technique avec modulation d’intensite (soit 3 %) contre sept patients avec la technique tridimensionnelle (soit 24 %) (p = 0,017). Parmi les patients ayant eu une resection rectale anterieure, 52 scores de LARS ont ete collectes avec un intervalle median apres la chirurgie de 1,5 an dans le groupe pris en charge par technique avec modulation d’intensite contre 5 ans dans le groupe pris en charge par la technique tridimensionnelle. Dix-huit patients ont rapporte un LARS majeur (soit 35 %) : six recevant la radiotherapie conformationnelle avec modulation d’intensite (27 %) et 12 recevant la radiotherapie conformationnelle tridimensionnelle (soit 40 %), sans difference significative. Conclusion Cette etude retrospective comparative confirme que la technique avec modulation d’intensite diminue significativement la toxicite digestive en cours de chimioradiotherapie en comparaison a la technique tridimensionnelle, sans impact sur la morbidite chirurgicale severe, ni sur les sequelles tardives. Le benefice de la radiotherapie conformationnelle avec modulation d’intensite sur les diarrhees aigues a ete d’autant plus important en cas de chimiotherapie d’induction et la place ainsi comme une technique indispensable a l’heure ou la chimiotherapie d’induction devrait etre plus largement prescrite.

International audience; The quality of pathologic assessment of rectal cancer specimens is crucial for treatment efficiency and survival. The Royal College of Pathologists (RCP) recommends evaluating the quality of the pathology report in routine practice using three quality indicators (QIs): the number of lymph nodes (LNs) analyzed (≥ 12), the rate of venous invasion (VI ≥ 30%), and peritoneal involvement (pT4a ≥ 10%). In this study, we evaluated the three QIs of the French national pathology reports and compared them with British guidelines and assessed the influence of neoadjuvant radiochemotherapy on QIs. From January 1 to December 31, 2016, all pathology reports for rectal adenocarcinoma were collected from French departments. Neoadjuvant radiochemotherapy included long-course radiotherapy with concomitant 5-FU-based chemotherapy. A total of 983 rectal cancer pathology reports were evaluated. A median of 15 LNs were analyzed and 81% of centers had ≥ 12 LNs. The rate of VI was 30% and 41% of centers had ≥ 30% VI. The rate of pT4a was 4% and 18% of centers reported ≥ 10% pT4a. None of the centers reached the threshold for the three QIs. All three QIs were lower after radiochemotherapy compared to surgery alone. In conclusion, in French routine practice, the values of two of the three QIs (LNs analyzed and VI) were globally in line with RCP guidelines. However, the rate of pT4a was very low, particularly after radiochemotherapy, suggesting its low value in rectal cancer.

Objectifs Les cancers du rectum peuvent etre diagnostiques a un stade localement avance avec atteinte des organes de voisinage. Sur le plan urologique, les ureteres, la vessie et la prostate peuvent etre concernes. Un groupe multidisciplinaire a ete constitue au sein de notre etablissement pour envisager ces chirurgies complexes avec un objectif de conservation d’organes et des fonctions urinaires et digestives. Methodes Cette video chirurgicale propose l’exerese monobloc d’une tumeur rectale envahissant la prostate. Il s’agissait d’un patient âge de 50 ans ayant eu une premiere chirurgie rectale pour une GIST de 4 cm. Une recidive locale precoce a ete mise en evidence apres 12 mois et traitee par Imatinib sans reponse significative. La tumeur etait situee sur la paroi anterieure du rectum et infiltrait la partie posterieure de la prostate pouvant justifier d’une indication de pelvectomie totale avec double derivation, urinaire et digestive. Une approche conservatrice a ete proposee en combinant un abord cœlioscopique trans-anal et un abord cœlioscopique abdominal robot-assiste. Resultats En fin d’intervention, une anastomose vesico-uretrale est realisee, puis la piece est extraite par voie trans-anale avant confection d’une anastomose colo-anale differee. Le patient quitte le bloc operatoire apres 4h30 d’intervention sans stomie ni incision abdominale. L’analyse anatomopathologique a confirme la presence d’une GIST rectale de 4 cm envahissant la prostate avec resection en marge saine et le patient est reste hospitalise pendant 13 jours. Avec un recul de 18 mois, le patient n’a pas presente de recidive et a recupere une continence complete sur le plan urinaire et fecal. Depuis 2017, nous avons propose ce type d’approche conservatrice a 10 patients presentant une tumeur rectale envahissant la prostate. Les taux de marges positives etaient de 20 % et la survie specifique de 90 % avec un recul median de 13,3 mois. Conclusion Ce type d’approche conservatrice a egalement ete proposee pour des tumeurs envahissant la face posterieure de la vessie ou la region du trigone mettant en evidence l’interet de ces collaborations multidisciplinaires dans les prises en charges oncologiques modernes.

Background and Aim: Anti-tumour necrosis factor [TNF] agents have dramatically improved the prognosis of inflammatory bowel disease [IBD]. However, despite their good safety profile, use of these agents may lead to paradoxical manifestations involving skin or joints. Pathogenesis of such side effects is poorly understood and may involve anti-TNF pharmacokinetics. The aim of the present study was to look for an association between infliximab trough levels [ITL] and cutaneous [CPM] or rheumatological [RPM] paradoxical manifestations. Methods: IBD patients receiving infliximab as maintenance therapy were included in a cross-sectional prospective monocentre study. At inclusion, patients had an ITL measurement [LISA-TRACKER®, Biomedical Diagnostics BMD] and were assessed for paradoxical manifestations: a CPM was defined by new onset or exacerbation of pre-existing psoriasis lesions during IFX therapy, and an RPM by new onset of severe poly-arthralgia during IFX therapy. Results: Among the 121 patients included [69 female; median age: 38.9 years; 92 with Crohn’s disease], 7% had CPM and 8% RPM. Median ITL values were 5.87 [range: 0.52–19.53] µg/ml in patients with CPM and 1.90 [0.00–13.5] µg/ml in those with RPM, as compared respectively with 5.12 [0.00–49.12] µg/ml in patients without CPM [ p = 0.56] and 5.57 [0.00–49.12] µg/ml in those without RPM [ p = 0.058]. No prognostic factor was associated with CPM. The single factor associated with RPM was elevated antinuclear antibodies. Conclusion: ITL were not elevated in IBD patients developing cutaneous or rheumatological paradoxical manifestations when receiving IFX as maintenance therapy. As suggested by the high level of antinuclear antibodies, RPM could be related to an induced autoimmune disorder.

BACKGROUND Urogenital dysfunctions after rectal cancer treatment are well recognized, although incidence and evolution over time are less well known. OBJECTIVE We aimed to assess the evolution of urogenital functions over time after the treatment for rectal cancer. DESIGN This is a prospective, longitudinal cohort study. SETTINGS This study was conducted at a quaternary referral center for colorectal surgery. PATIENTS A total of 250 consecutive patients treated for rectal cancer were prospectively enrolled for urogenital assessment. MAIN OUTCOME MEASURES End points were the International Prostatic Symptom Score, the International Index of Erectile Function, and the Female Sexual Index obtained by questionnaires before (baseline status) and after preoperative radiotherapy and 3, 6, and 12 months after surgery. RESULTS Overall, 169 patients (68%) responded to the questionnaires. The urinary function decreased temporary after irradiation in men (International Prostatic Symptom Score: 7.8 vs 4.9; p < 0.001). Sexual activity decreased significantly in women after radiotherapy (p = 0.02), and in all patients after surgery (p < 0.001). At 12 months, sexual activity in women declined from 59% before treatment to 36% (p = 0.02). In men, sexual activity (82% vs 57%), erectile function (71% vs 24%), and ejaculatory function (78% vs 32%) decreased from baseline (p < 0.001). Stage T3T4 tumors (OR = 5.72 (95% CI, 1.24-26.36)) and low rectal tumors (OR = 17.86 (95% CI, 1.58-20.00)) were independent factors of worse sexual function. LIMITATIONS This study was limited by the proportion of uncompleted questionnaires, especially in women, and by its monocentric feature. CONCLUSIONS Most patients experienced sexual dysfunction at 12 months after surgery for rectal cancer, and predictive factors for this dysfunction were related to characteristics of the tumor.

Background: Rectal cancer involving at least one adjacent organ (mrT4b) requires multi-visceral resection to achieve clear resection margin (RO). Performing pelvic compartment preservation according to the tumour response has not been considered. This study assesses the impact of changing the surgical strategy according to tumour response in rectal cancer mrT4b. Methods: Patients with non-metastatic T4b rectal cancer at two tertiary referral centres between 2008 and 2013 were grouped as "Responders" ypTO-3abNx versus "Non-responders" ypT3cd-4Nx and divided into three surgical procedures: total mesorectal excision (TME), extended-TME (eTME) and beyond-TME (b-TME). End-points were circumferential resection margin, postoperative morbidity, definitive stoma formation, 3-years local recurrence (3y-LR) and 3-years disease-free survival (3y-DFS) according to both tumours' response and surgical procedures. Results: Among 883 patients with rectal cancer, 101 were included. Responders had a higher rate of induction chemotherapy (59.7% vs. 38.2%; p = 0.04). Morbidity and definitive stoma formation were significantly higher in Non-responders. RO was not impacted by either the tumour response or the surgical procedures. The 3y-LR was lower in Responders (14%) compared to Non Responders (32%) (HR 1.6; 95% CI: 1.02-2.59; p = 0.041), and was two-fold higher in e-TME compared to b-TME in Non-responders, whereas no difference was found in Responders. The 3y-DFS was higher in Responders irrespective to the surgery (71% vs. 47%; p = 0.07). Conclusion: In Responders, TME or e-TME are technically and oncollogically feasible and should be considered in preferrence to b-TME. In Non-responders, allowing for high rates of morbidity and local recurrence in patients with e-TME, b-TME procedures should be preferred. (C) 2016 Elsevier Ltd, BASO - The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Introduction Cyclosporine (CsA) is an effective agent for treating patients with acute steroid-refractory ulcerative colitis (UC). The aim was to assess endoscopic and histologic responses to CsA and to determine their predictive value on UC outcome. Patients and methods Consecutive UC patients who received intravenous CsA for an acute refractory UC were included when they had endoscopic assessments with biopsies at entry and, at CsA interruption in responders. Mucosal healing (MH) was defined by Mayo endoscopic subscore ≤1 and, histologic response (HR) by the absence of basal plasmocytosis or a Geboes score Results Among 21 patients who responded to CsA, MH was achieved in 81%. Survival rates without relapse at 2 years were 79% and 25% in patients with MH and without MH, respectively (p = 0.04). HR was observed in 84% of patients according to basal plasmocytosis and in 68% according to Geboes score. Multivariate analysis revealed that a Mayo endoscopic subscore of 0 was the only prognostic factor associated with absence of relapse (RR = 12; 95%CI: 1.05–136.79). Conclusion CsA provides MH and HR in most of UC patients responding to this drug. As suggested with other UC treatments, a complete MH with CsA has a good prognostic value.

Objective Approximately 30% of patients with gastro-oesophageal reflux disease (GORD) do not achieve adequate symptom control with proton pump inhibitors (PPIs). The aim of this study was to determine whether any symptom profile or reflux pattern was associated with refractoriness to PPI therapy. Design Patients with typical GORD symptoms (heartburn and/or regurgitation) were included and had 24 h pH-impedance monitoring off therapy. Patients were considered to be responders if they had fewer than 2 days of mild symptoms per week while receiving a standard or double dose of PPI treatment for at least 4 weeks. Both clinical and reflux parameters were taken into account for multivariate analysis (logistic regression). Results One hundred patients were included (median age 50 years, 42 male), 43 responders and 57 non-responders. Overall, multivariate analysis showed that the factors associated with the absence of response were absence of oesophagitis (p=0.050), body mass index (BMI) ≤25 kg/m 2 (p=0.002) and functional dyspepsia (FD) (p=0.001). In patients who reported symptoms during the recording (n=85), the factors associated with PPI failure were BMI ≤25 kg/m 2 (p=0.004), FD (p=0.009) and irritable bowel syndrome (p=0.045). In patients with documented GORD (n=67), the factors associated with PPI failure were absence of oesophagitis (p=0.040), FD (p=0.003), irritable bowel syndrome (p=0.012) and BMI ≤25 kg/m 2 (p=0.029). Conclusion No reflux pattern demonstrated by 24 h pH-impedance monitoring is associated with response to PPIs in patients with GORD symptoms. In contrast, absence of oesophagitis, presence of functional digestive disorders and BMI ≤25 kg/m 2 are strongly associated with PPI failure.

Restoration of bowel continuity is a major goal after surgical treatment of rectal cancer. Intersphincteric resection allows sphincter preservation in low rectal cancer but may have poor functional results, including frequent bowel movements, urgency, and incontinence.This study aimed to evaluate long-term functional outcome after intersphincteric resection to identify factors predictive of good continence.Descriptive observational study.Follow-up of surgery in tertiary care university hospital.Eligible patients were without recurrence 1 year or more after surgery for low rectal cancer.Intersphincteric resection.: Bowel function was assessed with a standardized questionnaire sent to patients. Functional outcome was considered as good if the Wexner score was 10 or less. Univariable and multivariable regression analyses were used to evaluate impact of age, gender, body mass index, tumor stage, tumor location, distance of the tumor from the anal verge and from the anal ring, type of surgery, colonic pouch, height of the anastomosis, pelvic sepsis, and preoperative radiotherapy on functional outcome.Of 125 eligible patients, 101 responded to the questionnaire. Median follow-up was 51 (range, 13-167) months. In multivariate analyses, the only independent predictors of good continence were distance of the tumor greater than 1 cm from the anal ring (OR, 5.88; 95% CI, 1.75-19.80; P = .004) and anastomoses higher than 2 cm above the anal verge (OR, 6.59; 95% CI, 1.12-38.67; P = .037).The study is limited by its retrospective, observational design and potential bias due to possible differences between those who responded to the questionnaire and those who did not.Patient characteristics do not appear to influence functional outcome at long-term follow-up after intersphincteric resection. The risk of fecal incontinence depends mainly on tumor level and height of the anastomosis.

Aliment Pharmacol Ther 2011; 34: 462–469 Summary Background Faecal calprotectin is a reliable tool for predicting Crohn’s disease (CD) relapse in patients with sustained remission. Prediction of relapse with faecal calprotectin has been less studied in patients with severe CD treated with anti-TNF. Aim To identify an association between faecal calprotectin concentration and CD clinical relapse in patients achieving remission with infliximab (IFX). Methods From February 2007 to October 2008, consecutive patients with refractory luminal CD were prospectively included when they received three IFX infusions (5 mg/kg at weeks 0, 2 and 6) followed by maintenance with an immunomodulator alone. Faecal calprotectin and C-reactive protein (CRP) were measured at entry and at week 14 (w14). Results Sixty-five patients (43W; median age: 30.4 years) were included, and 50 (77%) were in clinical remission off steroids at w14; twenty-three of fifty (46%) experienced CD clinical relapse during the first year of follow-up. Median faecal calprotectin level at w14 was similar in patients with and without CD clinical relapse (200 and 150 μg/g respectively). When considering two suggested faecal calprotectin cut-offs to predict CD relapse, sensitivities and specificities were 61% and 48% for 130 μg/g, respectively, and 43% and 57% for 250 μg/g. Neither faecal calprotectin nor CRP at baseline and at w14 could predict relapse even when CD location subgroup analysis was considered. Conclusion In patients responding to an infliximab induction regimen, faecal calprotectin measurement at w14 cannot predict Crohn’s disease clinical relapse at 1 year.

Aliment Pharmacol Ther 2011; 33: 714–721 Summary Background Mucosal healing has become a new therapeutic goal in Crohn’s disease and can be achieved with azathioprine (AZA) or biologics. Methotrexate (MTX) is an effective drug for both the induction and maintenance of remission in Crohn’s disease. However, mucosal healing with MTX has been poorly investigated. Aim To assess the mucosal healing rate in patients with Crohn’s disease with clinical response to MTX as compared with AZA or infliximab (IFX). Methods From October 2007 to May 2009, consecutive patients with Crohn’s disease were prospectively enrolled into a single-centre study when they met the following criteria: previous identification of mucosal ulcerations with ileo-colonoscopy, clinical remission within at least 3 months with MTX, AZA or IFX monotherapy, usual indication for colonoscopy in Crohn’s disease (dysplasia/cancer screening, suspected stenosis) excluding assessment for mucosal healing. Mucosal healing was defined as absence of mucosal ulceration in all segments. Results Fifty-one patients with Crohn’s disease (38 female; median age: 42 years) were included: 18 receiving MTX, 18 AZA and 15 IFX. Mucosal healing was achieved in 2/18 (11%) with MTX, in 9/18 (50%) with AZA (P = 0.011 vs. MTX) and in 9/15 (60%) with IFX (P = 0.008 vs. MTX). Conclusion In patients with Crohn’s disease in sustained clinical remission, mucosal healing is less frequently achieved with MTX as compared with AZA or IFX.

Background: Infliximab is the only medical therapy that has been proven to be effective in fistulizing Crohn's disease (CD), but the recurrence rate of fistulas is high despite maintenance therapy. The aim of this prospective study was to evaluate the short- and long-term efficacy of a combined schedule with infliximab, methotrexate, and sphincter-sparing surgery in patients with severe fistulizing anoperineal CD. Methods: From January 2006 to November 2007, all consecutive patients in three referral centers with severe fistulizing anoperineal CD were prospectively included after primary drainage. At inclusion, patients received three infliximab infusions at weeks 0, 2, and 6, and maintenance therapy with methotrexate. A second optimized surgical step consisting of at least removal of setons was performed between the second and the third infliximab infusions. Results: Thirty-four CD patients (26 women; median age 38.5 years) with complex anoperineal fistula were enrolled (including 9 with recto-vaginal fistulas, and 10 with anorectal stenosis). At week 14 the response rate was 85% with 74% complete responders. At 1 year, 50% were still responders; luminal CD worsening was the major cause of relapse. Median Perineal Disease Activity Index (PDAI) and magnetic resonance imaging (MRI) scores significantly decreased from baseline to week 50. Conclusions: A combined approach with infliximab induction, two surgical sphincter-sparing steps and methotrexate is effective in achieving short-term response in severe fistulizing anoperineal CD. The best maintenance regimen remains to be determined. (Inflamm Bowel Dis 2011;)

In locally advanced rectal adenocarcinoma, preoperative radiochemotherapy induces tumor response. The impact of pathologic tumor response on survival is still debated because of the numerous distinct tumor-response gradings available in the literature and the lack of standardized pathologic approach. The objective of this work was to study the impact of tumor response on survival, according to the 4 main tumor-response gradings available in the literature in locally advanced rectal adenocarcinoma after preoperative radiochemotherapy. From 1995 to 2004, 292 consecutive patients with cT3-T4 and/or N + rectal adenocarcinoma were enrolled. Tumor response was evaluated according to ypTN-response gradings (downstaging: ypT0-2 N0 and complete pathologic response: ypT0 N0) and cellular-response gradings (ie, Mandard et al's and Rodel et al's gradings). The impact of tumor-response gradings and of different clinicopathologic variables on 5-year disease-free and overall survival were studied by univariate and multivariate analyses. We found that all tumor-response gradings were associated with survival. However, multivariate analysis showed that downstaging was the only tumor-response grading that influenced survival independently. In the subgroup of stage II patients (n = 99), we also observed no difference on both 5-year disease-free and overall survival between low and high responders according to cellular response. In conclusion, in our experience, downstaging is the only tumor-response grading that influenced survival independently in locally advanced rectal adenocarcinomas. Cellular-response gradings had no impact on survival even in stage II patients.

Resume Objectif Il n’y a pas de consensus quant au traitement de la tumeur rectale primitive en situation metastatique. L’interet de la radiotherapie rectale est discute au cas par cas. Patients et methodes Trente-sept patients atteints de tumeur rectale d’emblee metastatique ont ete traites par irradiation premiere entre septembre 1994 et decembre 2004. Nous avons analyse l’interet d’une (chimio)radiotherapie premiere en termes de tolerance du traitement, de controle local, de resecabilite et de survie globale. Resultats La duree mediane de suivi etait de 30 mois. Vingt-quatre tumeurs etaient resequables au moment du diagnostic tant pour le site primitif que les metastases (groupe potentiellement curable). Treize patients n’etaient pas resequables d’emblee (groupe traite a visee palliative). Trente-trois patients ont recu une chimioradiotherapie concomitante, dix une radiotherapie seule, 67,5 % des patients ont presente des effets secondaires de grade 1 ou 2 (echelle soma LENT). Au total, 86,5 % des patients ne presentaient plus de symptomes pelviens six semaines apres l’arret de la radiotherapie. Six tumeurs ont progresse pendant la radiotherapie. Apres la radiotherapie, vingt et un patients ont pu etre operes de la tumeur rectale. L’exerese des metastases a ete possible chez 12 patients du groupe traite a visee curative mais pour aucun patient du groupe traite a visee palliative. Conclusion Deux groupes de patients atteints de tumeur rectale metastatique peuvent etre individualises en fonction du pronostic de la maladie : certains sont operables d’emblee, d’autres sont en situation palliative des le diagnostic. Dans notre serie, la (chimio)radiotherapie apparait un traitement faisable en pratique malgre des effets secondaires digestifs ou urinaires de grades 1 a 2 frequents. Cependant, en l’absence de traitement chirurgical, le controle des symptomes locaux reste limite dans le temps.

Approximately 20% of patients have persistent symptoms of gastro-oesophageal reflux despite proton pump inhibitor (PPI) therapy. The aim of this study was to assess the determinants of reflux perception in patients on PPI therapy.20 patients with typical gastro-oesophageal reflux symptoms (heartburn and/or regurgitation) despite double-dose PPIs (twice daily) were included in this study. Ambulatory 24 h pH-impedance studies were performed in all patients. The characteristics of symptomatic and asymptomatic reflux episodes were compared. Symptoms were considered globally and separately for heartburn and regurgitation.A total of 1273 reflux episodes were detected including 243 (19.1%) acidic, 1018 (80.0%) weakly acidic and 12 (0.9%) weakly alkaline reflux episodes. Overall, 312 (24.5%) reflux episodes were symptomatic. The only factor associated with reflux perception was high proximal extent (p = 0.037). Compared with regurgitation, reflux episodes associated with heartburn were more frequently pure liquid (p = 0.009) and acidic (p = 0.027), had a lower nadir pH (p0.001), were more frequently preceded by acid reflux episodes (p0.001) and had a longer reflux bolus clearance time (p0.001).High proximal extent of the refluxate is the only factor associated with reflux perception in patients on double-dose PPI. However, compared with regurgitation, composition of the refluxate, sensitisation of the oesophagus by preceding acid exposure and delayed bolus clearance appear to play a role in heartburn perception.

There is a significant worldwide variation in practice regarding the criteria for operative intervention and overall management in patients with locally recurrent rectal cancer (LRRC). A survival benefit has been described for patients with clear resection margins in patients undergoing surgery for LRRC which is seen as an important surgical quality indicator.A prospective French national database was established in 2008 which recorded procedures undertaken for locally recurrent rectal cancer (LRRC). Overall and Disease-Free Survival (OS, DFS) were assessed retrospectively. We report the variability and the heterogeneity of LRRC management in France as well as 5-year oncological outcomes.In this national report, 104 questionnaires were completed at 29 French surgical centres with a high variability of cases-loaded. Patients had preoperative treatment in 86% of cases. Surgical procedures included APER (36%), LAR (25%), Hartmann's procedure (21%) and pelvic exenterations (15.5%). Four patients had a low sacrectomy (S4/S5). There were no postoperative deaths and overall morbidity was 41%. R0 was achieved in 60%, R1 and R2 in 29% and 11%, respectively. R0 resection resulted in a 5-year OS of 35% compared to 12% and 0% for respectively R1 and R2 (OR = 2.04; 95% CI: 1.4-2.98; p0.001). OS was similar between R2 and non-resected patients (OR = 1.47; 95% CI: 0.58-3.76; p = 0.418).Our data is in accordance with the literature except the rate of extended resection procedures. This underlines the selective character of operative indications for LRRC in France as well as the care variability and the absence of optimal clinical pathway regarding these patients.

Background The incidence of hepatocellular carcinoma (HCC) in cirrhotic and noncirrhotic liver is increasing in the world, probably because of the high prevalence of infections by hepatitis B and C viruses. Despite numerous publications on hepatic resection, prognostic factors for intrahepatic recurrence and survival are not well known for patients with HCC without cirrhosis. Study design One hundred eight consecutive patients with HCC in noncirrhotic liver have been treated by hepatic resection in the past 18 years in our center. Clinical, biologic, and histopathologic parameters of these patients were collected. Risk factors for intrahepatic recurrence and prognostic factors for survival were evaluated by univariate and multivariate analyses. Results Postoperative morbidity and mortality rates were 23% and 6.5%, respectively. The 3- and 5-year disease-free and overall survival rates were 55% and 43%, and 43% and 29%, respectively. Blood transfusion, absence of tumor capsule, and daughter nodules were independently associated with overall survival. But the only risk factors for recurrence were blood transfusion, absence of tumor capsule, daughter nodules, and margin resection Conclusions In the treatment of HCC without cirrhosis, hepatectomy remains a safe and legitimate treatment, but longterm results are impaired by a high rate of early recurrence likely related to metastatic dissemination. Only histopathologic factors related to the tumor are predictive of recurrence and overall survival.

Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) is a recent method for non-invasive assessment of steatosis. Its usefulness in clinical practice is unknown. We prospectively investigated the determinants of CAP failure and the relationships between CAP and clinical or biological parameters in a large cohort of consecutive patients.All CAP examinations performed in adult patients with suspected chronic liver disease were included. CAP failure was defined as zero valid shot. The following factors were analyzed for their influence on CAP value and the relationships between CAP and clinico-biological parameters: age, gender, body mass index, waist circumference, hypertension, diabetes, metabolic syndrome, alcohol use, liver stiffness measurement, indication, and different biological parameters.CAP failure occurred in 7.7% of 5323 examinations. By multivariate analysis, factors independently associated with CAP measurement failure were female gender, BMI, and metabolic syndrome. By multivariate analysis, factors significantly associated with elevated CAP were BMI [25-30]kg/m(2), BMI30kg/m(2), metabolic syndrome, alcohol14 drink/week and liver stiffness6kPa. CAP increased with the number of parameters of metabolic syndrome, BMI, waist circumference, the presence of diabetes or hypertension, and the cause of the disease. In the 440 patients with liver biopsy, for the diagnosis of steatosis10%, steatosis33%, and steatosis66%, AUROCs of CAP were 0.79 (95% CI 0.74-0.84, p0.001), 0.84 (95% CI 0.80-0.88, p0.001), 0.84 (95% CI 0.80-0.88, p0.001), respectively.CAP provides an immediate assessment of steatosis simultaneously with liver stiffness measurement. The strong association of CAP with the metabolic syndrome and alcohol use could be of interest for the follow-up of NAFLD or alcoholic patients.

Summary Background Mucosal healing can be achieved with infliximab (IFX). Aim To assess the impact of mucosal healing on long-term outcomes in patients with ulcerative colitis (UC) when treated with infliximab (IFX) beyond 1 year. Methods All consecutive adult patients with refractory UC receiving maintenance treatment with IFX in five French referral centres were analysed retrospectively. Only patients who had endoscopic evaluation between 6 and 52 weeks following IFX initiation were included. According to their Mayo endoscopic sub-score, patients were categorised into mucosal healing (sub-score: 0–1) and no mucosal healing (2–3). Outcome measures were colectomy and IFX failure defined by drug withdrawal due to secondary failure among primary responders. Results Of the 63 patients (30 women; median age: 38 years), 30 (48%) achieved mucosal healing. The median follow-up duration was 27 (3–79) months. Colectomy-free survival rates at 12, 24 and 36 months were, respectively, 100%, 96% and 96% in patients with mucosal healing. The corresponding figures were, respectively, 80%, 65% and 65% in patients without mucosal healing (P = 0.004). By multivariate analysis, mucosal healing was the only factor associated with colectomy-free survival, with an odds ratio of 18.01 (95%CI: 1.58–204.92). IFX failure-free survival rates at 12, 24 and 36 months were, respectively, 76%, 69% and 64% in patients with mucosal healing, and 44%, 25% and 21% in those without mucosal healing (P = 0.003). Conclusion Patients with refractory UC who achieved mucosal healing after IFX initiation had better long-term outcomes, with significantly less colectomy and less IFX failure.

Objectives The aim of this study was to assess oncological outcomes in patients treated with pancreaticoduodenectomy for advanced pancreatic head adenocarcinoma after preoperative chemoradiotherapy and to compare these with outcomes in patients treated with surgery alone. Methods From 2004 to 2009, patients treated with pancreaticoduodenectomy for pancreatic head adenocarcinoma were included in a retrospective comparative study. Patients with locally advanced adenocarcinoma were treated with preoperative chemoradiotherapy (CRT group) and were compared with those treated with surgery alone (SURG group). Results A total of 111 patients were included; these comprised 72 patients in the SURG group and 39 patients in the CRT group. The median follow‐up was 21 months. Patients in the CRT group presented with a more advanced tumoral status. Microscopic resection rates were similar in both groups, but nodal status and vascular or lymphatic emboli were lower in the CRT group. At 3 years, the SURG and CRT groups exhibited similar overall (36% and 51%, respectively) and disease‐free (35% and 37%, respectively) survival ( P = 0.10). Conclusions In patients with advanced pancreatic head adenocarcinoma, a good response after preoperative chemoradiotherapy results in a survival rate similar to that in patients treated with surgery alone in whom the initial prognosis is better.

Faecal calprotectin is a reliable tool for predicting Crohn's disease (CD) relapse in patients with sustained remission. Prediction of relapse with faecal calprotectin has been less studied in patients with severe CD treated with anti-TNF.To identify an association between faecal calprotectin concentration and CD clinical relapse in patients achieving remission with infliximab (IFX).From February 2007 to October 2008, consecutive patients with refractory luminal CD were prospectively included when they received three IFX infusions (5mg/kg at weeks 0, 2 and 6) followed by maintenance with an immunomodulator alone. Faecal calprotectin and C-reactive protein (CRP) were measured at entry and at week 14 (w14). Sixty-five patients (43W; median age: 30.4years) were included, and 50 (77%) were in clinical remission off steroids at w14; twenty-three of fifty (46%) experienced CD clinical relapse during the first year of follow-up. Median faecal calprotectin level at w14 was similar in patients with and without CD clinical relapse (200 and 150μg/g respectively). When considering two suggested faecal calprotectin cut-offs to predict CD relapse, sensitivities and specificities were 61% and 48% for 130μg/g, respectively, and 43% and 57% for 250μg/g. Neither faecal calprotectin nor CRP at baseline and at w14 could predict relapse even when CD location subgroup analysis was considered.In patients responding to an infliximab induction regimen, faecal calprotectin measurement at w14 cannot predict Crohn's disease clinical relapse at 1year.

Mucosal healing has become a new therapeutic goal in Crohn's disease and can be achieved with azathioprine (AZA) or biologics. Methotrexate (MTX) is an effective drug for both the induction and maintenance of remission in Crohn's disease. However, mucosal healing with MTX has been poorly investigated.To assess the mucosal healing rate in patients with Crohn's disease with clinical response to MTX as compared with AZA or infliximab (IFX).From October 2007 to May 2009, consecutive patients with Crohn's disease were prospectively enrolled into a single-centre study when they met the following criteria: previous identification of mucosal ulcerations with ileo-colonoscopy, clinical remission within at least 3 months with MTX, AZA or IFX monotherapy, usual indication for colonoscopy in Crohn's disease (dysplasia/cancer screening, suspected stenosis) excluding assessment for mucosal healing. Mucosal healing was defined as absence of mucosal ulceration in all segments.Fifty-one patients with Crohn's disease (38 female; median age: 42 years) were included: 18 receiving MTX, 18 AZA and 15 IFX. Mucosal healing was achieved in 2/18 (11%) with MTX, in 9/18 (50%) with AZA (P =0.011 vs. MTX) and in 9/15 (60%) with IFX (P=0.008 vs. MTX).In patients with Crohn's disease in sustained clinical remission, mucosal healing is less frequently achieved with MTX as compared with AZA or IFX.

Background No long-term advantage of the laparoscopic approach has been demonstrated in colorectal surgery. This study compared the risk of incisional hernia between laparoscopic and open surgery for rectal cancer. Methods Between 1994 and 2004, patients who had restorative mesorectal excision for rectal cancer by laparoscopy were compared with those treated by open surgery. Follow-up was prospective, and incisional hernia was considered to be any abdominal wound dehiscence occurring at the midline, extraction, trocar or ileostomy site. Cumulative risks of hernia were evaluated by the Kaplan–Meier method and compared with the log rank test. Results Some 155 patients had a laparoscopic and 165 an open procedure. The two groups were similar in terms of age, sex, body mass index, tumour stage, loop ileostomy and morbidity. The conversion rate was 20·6 per cent. The rate of incisional hernia in all patients was 11·4 per cent at 1 year, 21·1 per cent at 2 years and 23·7 per cent at 5 years. The rate of hernia at 5 years was significantly lower in the laparoscopic than in the open group (13·0 versus 33·0 per cent; P < 0·001). The rate of hernia due specifically to the laparoscopic procedure (extraction and trocar sites) was ten times less than that after a primary or secondary open procedure (2·1 versus 16·1–33·1 per cent; P < 0·001). Conclusion The laparoscopic approach decreases the risk of long-term incisional hernia following restorative mesorectal excision for rectal cancer. The benefit is most apparent in patients without conversion or postoperative complication.

The number and status of lymph nodes examined is crucial for tumor staging. Impact of preoperative chemoradiotherapy on lymph nodes status and survival is still controversial in rectal carcinoma. The aim of this study was (i) to define the impact of preoperative chemoradiotherapy on the number of both retrieved and positive lymph nodes in rectal cancer specimen, (ii) to evaluate the influence of the number of lymph nodes retrieved on survival in patients treated by preoperative chemoradiotherapy. From 1994 to 2004, 495 patients underwent rectal excision for cancer, of which 332 received long course preoperative radiotherapy. Surgery and pathologic assessment were standardized. Multivariate analysis evaluated the influence of clinical and pathologic variables on the number of both retrieved and positive lymph nodes. Kaplan-Meier method and log-rank test assessed the relation between survival and the number of lymph nodes retrieved in patients treated by preoperative chemoradiotherapy. Compared with surgery alone, preoperative chemoradiotherapy decreased both the mean number of lymph nodes retrieved (17 vs. 13; P0.001) and the mean number of positive lymph nodes (2.3 vs. 1.2; P=0.001). Multivariate analysis confirmed the independent impact of preoperative chemoradiotherapy on retrieved and positive lymph nodes. In patients treated by preoperative chemoradiotherapy, the 5-year overall (71%) and disease-free (60%) survival was not associated with the number of lymph nodes retrieved. Although long course preoperative chemoradiotherapy decreases by 24%, the mean number of lymph nodes retrieved and by 48% the mean number of positive lymph nodes, survival was not influenced by the number of lymph nodes retrieved in irradiated rectal specimen.

There is no consensus about the treatment of rectal tumour when there are synchronous metastases. The interest of radiotherapy is debated.Thirty-seven patients with rectal tumour and synchronous metastases were treated with radiotherapy first between September 1994 and December 2004. We analysed the tolerance, local control, resecability, overall survival of such a therapeutic strategy.The mean follow-up was 30 months. Twenty-four tumors were resecable for both the primary site and the metastases. Thirteen were unresecable at the time of diagnosis. Thirty-three patients were treated with radiochemotherapy, ten with radiotherapy alone. Eighty-six decimal five percent of them had no pelvic symptom six weeks after the treatment. Twenty-one rectal tumours were finally resected. The disease progressed in six cases during the radiotherapy. Surgery of the metastases was possible for 12 patients with tumour initially resecable.Radiochemotherapy is a "tolerable" treatment, in spite of more frequent urinary or digestive side-effects. But, if there is no surgery, palliative effect of radiotherapy is limited.

To determine the presence of Helicobacter species DNA in the liver of chronic hepatitis C (CHC) patients with and without cirrhosis as compared to controls, and to identify the bacterial species involved.Seventy-nine consecutive patients (HBV and HIV negative) with a liver sample obtained after liver biopsy or hepatic resection were studied: 41 with CHC without cirrhosis, 12 with CHC and cirrhosis, and 26 controls (HCV negative). Polymerase chain reactions (PCRs) targeting Helicobacter 16S rDNA and species-specific were performed on DNA extracted from the liver. A gastric infection with H pylori was determined by serology and confirmed by 13C-urea breath test.Overall, Helicobacter 16S rDNA was found in 16 patients (20.2%). Although positive cases tended to be higher in CHC patients with cirrhosis (41.6%) than in those without cirrhosis (17.0%) or in controls (15.4%), the difference was not statistically significant (P = 0.08). H pylori-like DNA was identified in 12 cases and H. pullorum DNA in 2, while 2 cases remained unidentified. Gastric infection with H pylori was found in only 2 of these patients.Our results do not confirm the association of Helicobacter species DNA in the liver of CHC patients with advanced liver disease. The lack of correlation between positive H pylori serology and the presence of H pylori-like DNA in the liver may indicate the presence of a variant of this species.

of calcium homeostasis and inflammatory parameters in subjects with either active or inactive IBD. In the linear regression model, calprotectin was the strongest predictor of the disease activity, as expected [beta coefficient 0.75 (P< 0.001) in men and 0.42 (P< 0.05) in women, respectively], when adjusted for age and TNF-alpha inhibitor treatment. Ionized calcium and serum PTH did not demonstrate any significant associations with disease activity in the same regression model. Conclusions: IBD patients have an altered calcium homeostasis and ionized calcium levels are significantly lower in the active disease state. That may indicate that IBD patients with frequent relapses may suffer from underestimated calcium losses and could be at higher risk of osteoporosis.

Background: The natural history of CD of the pouch has not been characterized. Methods: All eligible patients with CD of the pouch were identified and included from our subspecialty Pouchitis Clinic between 2002 and 2009. Demographic & clinical variables were collected from a prospectively maintained database. Results: 206 pts with CD of the pouch consisted of 49 inflammatory, 40 fibrostenotic, and 117 fistulizing types. Pts with fistulizing CD were younger than those with fibrostenotic CD. The interval from IBD diagnosis and pouch construction was shorter in the fistulizing CD group. More pts with fistulizing CD had postoperative use of biologics (25.6% vs. 10.2% and 12.5%, p=0.028). More patients with fistulizing CD were hospitalized for pouch-related condition (21.4% vs. 15.0% and 2.0%, p=0.007). Progression of phenotypes and pouch survival are shown in Figures. Conclusions: Clinical phenotypes of Crohn's pouch can change over time. These phenotypes of CD were associated with different natural history and risk for pouch failure.

But L’infliximab est le traitement de reference des fistules ano-perineales de la maladie de Crohn (MC) [1,2]. Cependant, son effet semble suspensif et les trajets fistuleux persistent en IRM. Le but de cette etude prospective etait d’evaluer, au cours des fistules ano-perineales complexes de MC, l’efficacite a court et a long terme d’un traitement associant infliximab en induction, methotrexate en traitement de fond, et chirurgie proctologique optimale. Patients et Methodes Entre janvier 2006 et novembre 2007, tous les malades avec fistules ano-perineales complexes de MC ont ete inclus prospectivement et consecutivement apres le drainage initial de la suppuration. A l’inclusion, tous recevaient un traitement par methotrexate (25 mg/semaine pendant toute la duree de l’etude) et trois perfusions d’infliximab (5 mg/kg aux semaines 0, 2 et 6). Lors du deuxieme temps chirurgical proctologique, realise a la semaine 4, les setons etaient retires et une procedure optimale etait realisee. L’infliximab etait interrompu apres l’induction et le methotrexate etait poursuivi en entretien. La reponse clinique initiale etait definie par une diminution d’au moins 50 % du nombre des ecoulements fistuleux lors d’au moins deux visites consecutives. L’objectif principal de l’etude etait la reponse clinique a la semaine 14. Les objectifs secondaires etudies etaient : 1) le delai median de perte de reponse chez les repondeurs a la semaine 14 ; 2) l’evolution du Perineal Disease Activity Index (PDAI) et du score IRM de Van Assche ; 3) la tolerance du traitement. Resultats Trente-quatre malades (26 femmes, âge median : 38,5 ans) atteints de fistules ano-perineales fistules complexes ont ete inclus : 29 % avaient une stenose ano-rectale et 26 % une fistule recto-vaginale ; 62 % etaient cortico-dependants ou cortico-resistants, 62 % avaient deja recu de l’azathioprine et 26 % de l’infliximab. Le deuxieme temps chirurgical proctologique a consiste en une ablation simple de seton (n = 7), une fistulotomie (4), une application de colle biologique (10), un lambeau (11), une intervention de Musset (2). A la semaine 14, 85 % des malades etaient repondeurs dont 73,5 % de reponse complete. Le delai median de perte de reponse etait de 69 semaines. Aux semaines 0, 14 et 50, le PDAI median etait respectivement de 11, 3 puis 0 (p Conclusion Un traitement associant infliximab en induction et chirurgie proctologique optimisee permet d’obtenir une reponse clinique rapide en cas de fistules ano-perineales complexes de MC. Le traitement d’entretien par le methotrexate en monotherapie permet ensuite de maintenir cette reponse clinique et anatomique (IRM) pendant plus d’un an. Le methotrexate pourrait etre compare a l’infliximab en traitement d’entretien de la MC ano-perineale fistulisante.

Background: Treatment with infliximab (IFX) can result in immunogenicity through the formation of human anti-chimeric antibodies (HACAs). These antibodies are associated with a decreased duration of response, whereas therapeutic levels of IFX are associated with durable clinical response. We evaluated the clinical utility of measuring serum IFX and HACA levels. Methods: We retrospectively reviewed charts of patients with inflammatory bowel disease who had IFX drug and HACA levels measured over a three-year period from 2005-2008. The clinical utility of these tests was assessed by determining whether the result affected clinical management. The management and subsequent clinical response to therapeutic changes based on test results was evaluated. Fisher's exact test and log-rank test for discontinuation were used for statistical analysis. Results: One hundred and fifty-five patients underwent IFX level and HACA status testing. The median time to initial testing after IFX initiation was 50 weeks (IQR: 22.7-120). The main indications for testing were: loss of response to IFX (50.3%), partial response after initiation of IFX (22.6%) and possible autoimmune/delayed hypersensitivity reaction (14.8%). HACAs were identified in 35 patients (22.6%) and therapeutic IFX levels were found in 51 (32.9%). Of 177 total tests assessed, the results impacted treatment decisions in 73.4% (95% CI: 66-80%). In those with positive HACAs, change to another anti-TNF was associated with a complete or partial response in 91.6% of patients whereas increasing the dose had a response of 16.7% (p