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Several advanced therapies (biologic therapies and small molecules) have been approved for the treatment of moderate-to-severe ulcerative colitis. The registration trials for these agents typically excluded patients with isolated proctitis, leaving an evidence gap. We evaluated efficacy and safety of advanced therapies in patients with ulcerative proctitis (UP). This multicenter retrospective cohort study included consecutive patients with active UP (Mayo endoscopy subscore of ≥2, rectal inflammation up to 15 cm) initiating advanced therapy, after failing conventional therapy. The primary end point was short-term steroid-free clinical remission (total Mayo score ≤2 with no individual subscore >1). In addition, drug persistence and relapse-free and colectomy-free survival were assessed. Both binary logistic and Cox regression analyses were performed. In total, 167 consecutive patients (52.0% female; median age 41.0 years; 82.0% bionaive) underwent 223 courses of therapy for UP (38 adalimumab, 14 golimumab, 54 infliximab, 9 ustekinumab, 99 vedolizumab, 9 tofacitinib). The primary end point was achieved with 36.3% of the treatment courses, and based on multivariate analysis, more commonly attained in bionaive patients (P =.001), patients treated with vedolizumab (P =.001), patients with moderate endoscopic disease activity (P =.002), and a body mass index <25 kg/m2 (P =.018). Drug persistence was significantly higher in patients treated with vedolizumab (P <.001) and patients with a shorter disease duration (P =.006). No new safety signals were observed. Advanced therapies are also efficacious and safe in patients with ulcerative colitis limited to the rectum. Therefore, the inclusion of patients with UP in future randomized-controlled trials should be considered. [ABSTRACT FROM AUTHOR]

Fatigue is highly prevalent among patients with inflammatory bowel disease (IBD), and only limited treatment options are available. Based on the hypothetical link between low serum tryptophan concentrations and fatigue, we determined the effect of 5-hydroxytryptophan supplementation on fatigue in patients with inactive IBD. A multicenter randomized controlled trial was performed at 13 Belgian hospitals, including 166 patients with IBD in remission but experiencing fatigue, defined by a fatigue visual analog scale (fVAS) score of ≥5. Patients were treated in a crossover manner with 100 mg oral 5-hydroxytryptophan or placebo twice daily for 2 consecutive periods of 8 weeks. The primary end point was the proportion of patients reaching a ≥20% reduction in fVAS after 8 weeks of intervention. Secondary outcomes included changes in serum tryptophan metabolites, Functional Assessment of Chronic Illness Therapy Fatigue scale, and scores for depression, anxiety, and stress. The effect of the intervention on the outcomes was evaluated by linear mixed modeling. During 5-hydroxytryptophan treatment, a significant increase in serum 5-hydroxytryptophan (estimated mean difference, 52.66 ng/mL; 95% confidence interval [CI], 39.34–65.98 ng/mL; P <.001) and serotonin (3.0 ng/mL; 95 CI, 1.97–4.03 ng/mL; P <.001) levels was observed compared with placebo. The proportion of patients reaching ≥20% reduction in fVAS was similar in placebo- (37.6%) and 5-hydroxytryptophan (35.6%)-treated patients (P =.830). The fVAS reduction (−0.18; 95% CI, −0.81 to 0.46; P =.581) and Functional Assessment of Chronic Illness Therapy Fatigue scale increase (0.68; 95% CI, −2.37 to 3.73; P =.660) were both comparable between 5-hydroxytryptophan and placebo treatment as well as changes in depression, anxiety, and stress scores. Despite a significant increase in serum 5-hydroxytryptophan and serotonin levels, oral 5-hydroxytryptophan did not modulate IBD-related fatigue better than placebo. (Trial Registration: Belgian Federal Agency for Medication and Health Products, EudraCT number: 2017-005059-10 and ClinicalTrials.gov: NCT03574948 , https://clinicaltrials.gov/ct2/show/NCT03574948.) [Display omitted] This multicentered study shows that oral intake of 5-hydroxytryptophan is not better than placebo in the treatment of fatigue in patients with inflammatory bowel diseases. [ABSTRACT FROM AUTHOR]

Abstract: Peutz-Jeghers syndrome (PJS) is a rare, autosomal dominant inherited disease. It is clinically characterized by the development of gastrointestinal hamartomas, mainly located in the small bowel. These hamartomas are prone to complications such as intussusceptions, abdominal complaints and anaemia. Furthermore, patients are at increased risk for developing small bowel cancer. Therefore, regular surveillance of the small bowel is indicated. However, the optimal strategy for surveillance has not been determined yet. This review gives an overview of the different techniques that have been described to examine the small bowel of PJS patients. First, a number of radiologic and endoscopic imaging modalities with diagnostic value are discussed. Secondly, recently developed advanced endoscopy techniques are described that can serve both as a diagnostic and therapeutic tool in the surveillance of the small bowel. Finally, a recommendation is given how to apply these individual techniques for small bowel surveillance in a step-up approach. [Copyright &y& Elsevier]

Background and Study Aim: The ESGE curriculum guideline on training in ESD advises an extensive experience in animal models before commencing ESD training on humans. However, the evidence on which this recommendation is based, is rather limited. In this study we evaluate the performance of novices in ESD during their one-year training period; with continuous supervision of an endoscopist with extensive experience in ESD., Patients and Methods: During a 6.5 years period, all ESD procedures performed by an expert endoscopist (eESD) or by one of the 3 novices (sESD), in a single non-academic center, were retrospectively collected. Primary outcome parameters were rate of en-bloc resection and clinically relevant adverse events. The secondary outcome was R0 resection, recurrence rate and delayed adverse events., Results: In total 210 ESD procedures were included. Of these 97 sESD (46.2%), were performed by a novice endoscopist under supervision and 113 eESD (53,8%) by an expert. En-bloc resection rate was 99.1% vs 99% (p = ns), R0 resection rate was 80.5 % vs 79.4 % (p=ns). Clinically relevant complications 14.2% vs 6.2 % (p = 0.04) and severe complications 4.4% vs 2.1% (p=ns). Perforation was the most frequent reported serious complication. Three patients in the eESD group versus one in the other group needed additionally surgery due to a complication (p=ns). Recurrence rate was 2.2% for eESD and 1.3 % for sESD (p=ns)., Conclusion: This retrospective analysis demonstrates that learning ESD in humans without extensive prior animal model training is safe and feasible, on the condition that continuous supervision by an expert is provided., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

Background: This study evaluated the safety and efficacy of salvage endoscopic submucosal dissection (ESD) for Barrett's neoplasia recurrence after radiofrequency ablation (RFA)., Methods: Data from patients at 16 centers were collected for a multicenter retrospective study. Patients who underwent at least one RFA treatment for Barrett's esophagus and thereafter underwent further esophageal ESD for neoplasia recurrence were included., Results: Data from 56 patients who underwent salvage ESD between April 2014 and November 2022 were collected. Immediate complications included one muscular tear (1.8%) treated with stent (Agree classification: grade IIIa). Two transmural perforations (3.6%; treated with clips) and five muscular tears (8.9%; two treated with clips) had no clinical impact and were not considered as adverse events. Seven patients (12.5%) developed strictures (grade IIIa), which were treated with balloon dilation. Histological analysis showed 36 adenocarcinoma, 17 high grade dysplasia, and 3 low grade dysplasia. En bloc and R0 resection rates were 89.3% and 66.1%, respectively. Resections were curative in 33 patients (58.9%), and noncurative in 22 patients (39.3%), including 11 "local risk" (19.6%) and 11 "high risk" (19.6%) resections. At the end of follow-up with a median time of 14 (0-75) months after salvage ESD, and with further endoscopic treatment if necessary (RFA, argon plasma coagulation, endoscopic mucosal resection, ESD), neoplasia remission ratio was 37/53 (69.8%) and the median remission time was 13 (1-75) months., Conclusion: In expert hands, salvage ESD was a safe and effective treatment for recurrence of Barrett's neoplasia after RFA treatment., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Introduction: Acute and chronic anal fissures are common proctological problems that lead to relatively high morbidity and frequent contacts with health care professionals. Multiple treatment options, both topical and surgical, are available, therefore evidence-based guidance is preferred., Methods: A Delphi consensus process was used to review the literature and create relevant statements on the treatment of anal fissures. These statements were discussed and modulated until sufficient agreement was reached. These guidelines were based on the published literature up to January 2023., Results: Anal fissures occur equally in both sexes, mostly between the second and fourth decades of life. Diagnosis can be made based on cardinal symptoms and clinical examination. In case of insufficient relief with conservative treatment options, pharmacological sphincter relaxation is preferred. After 6-8 weeks of topical treatment, surgical options can be explored. Both lateral internal sphincterotomy as well as fissurectomy are well-established surgical techniques, both with specific benefits and risks., Conclusions: The current guidelines for the management of anal fissures include recommendations for the clinical evaluation of anal fissures, and their conservative, topical and surgical management., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

The importance to reach the target to be carbon net zero by 2050, as presented by the European Commission in the European Green Deal, cannot be overestimated. In a current endoscopy world, where single use has found its place and techniques are constantly evolving, it will be a challenge to reach these goals. How can we reconcile this evolution to a carbon neutral status by 2050 without compromising patients care, clinical standards and training needs? The European Society of Gastrointestinal Endoscopy (ESGE) together with the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) recently published a position statement (1) whereas in the UK there is the work from the green endoscopy group (2) in line with the strategy of the British Society of Gastroenterology (BSG) on sustainability (3). In Flanders, a project called "greendeal in duurzame zorg" had its kick off in March 2023 (4) so it is about time that we in Belgium, as gastroenterologists, start with tangible actions to a more sustainable daily practice. We wrote this position statement in cooperation with the Vlaamse Vereniging voor Gastro-Enterologie (VVGE), the Société royale belge de Gastro-entérologie (SRBGE) and the Belgian Society of Gastrointestinal Endoscopy (BSGIE). We will also work together in the coming years to continue to motivate our members to work on these initiatives and to co-opt new projects within the framework of the greendeal., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

Competing Interests: The authors declare that they have no conflict of interest

Background and Study Aims: Prospective data are lacking on evolution of trough levels, effectiveness, acceptance rate and patient satisfaction after switch from the adalimumab originator to a biosimilar in patients with inflammatory bowel disease., Patients and Methods: Patients in clinical remission or stable response and treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, prospective trial in which patients were switched to adalimumab biosimilar SB5. The primary outcome was the description of adalimumab trough levels over time. Secondary outcomes were secondary loss of response, disease activity, patient satisfaction score and drug persistence over 12 months., Results: The study included 110 patients. Mean baseline adalimumab trough level was 9.21 μg/ml. Concentration remained within the therapeutic range over time. No changes were observed in disease activity scores nor in biochemical parameters over time. The acceptance rate of switch was 84.6%. By month 12, 74.5% was still treated with SB5. The most frequent reason for discontinuation was occurrence of adverse events. 50% of these adverse events were injection site pain. The local discomfort was only significant the first 30 minutes after injection. Satisfaction with the decision to switch to SB5 was high and remained stable over time., Conclusions: After being well informed the great majority of patients treated with the adalimumab originator is willing to switch to biosimilar SB5. In our study, there was a persistence rate of 75% over one year. The trough levels remained within the therapeutic range and no change in disease activity was seen over time., (© Acta Gastro-Enterologica Belgica.)

Background: The loss of response to infliximab is a challenge for clinicians in the management of inflammatory bowel disease (IBD). Mounting evidence suggests that therapeutic drug monitoring at induction may predict remission during maintenance. The aim of the study was to improve predictive models of remission by exploring new peak and intermediate infliximab measurements during induction., Methods: This was a prospective multicenter study evaluating the pharmacokinetics of infliximab during induction in a pioneer cohort of 63 patients with IBD. Pharmacokinetics data including peak, intermediate, and trough levels were combined with clinical and biological parameters and were subsequently fed into tailored logistic regression and tree-based techniques to predict remission at week 30., Results: Infliximab peak levels at week 2, intermediate levels at week 3, and trough levels at week 6 were correlated with remission at week 30. Predictive models exhibited an increased accuracy over the successive timepoints of the induction with key inputs such as albumin, C-reactive protein, eosinophils, neutrophils, lymphocytes, intermediate level at week 3, trough level at week 6, and age at diagnosis. Our predictive model of remission at week 30 was obtained with an area under the receiver operating characteristic curve of 0.9 ± 0.12, a sensitivity of 89%, and a specificity of 75%., Conclusions: This study showed the clinical relevance of measuring new infliximab levels to predict remission in patients with IBD. These findings lay the foundation for a personalized medicine in which biotherapies could be monitored at an early stage, thereby improving patients' clinical management., (© 2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

In this case report we present a family cluster of amoebiasis in a nonendemic region. A 46-year-old women, diagnosed with Crohn's disease for which she received no maintenance therapy, was evaluated for the suspicion of a flare. At colonoscopy however, atypical findings for Crohn's disease were seen. Histopathologic examination revealed micro-organisms compatible with amoebiasis. Interestingly, 4 years before this event she started a new relationship with a 38-year-old man who was diagnosed with liver-amoebiasis 3 months after the start of their relationship. On top of this, her 18-year-old daughter was diagnosed with amoebiasis 2 years after her diagnosis. The source of the infection remains unknown, but we speculate that the infection was transmitted feco-orally between the different members of this family. These cases illustrate that we should be aware of parasitological causes of colitis, especially in patients with atypical endoscopic images or when a close "relative" is diagnosed with amoebiasis., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

Introduction: Hemorrhoidal disease is a common problem that arises when hemorrhoidal structures become engorged and/or prolapse through the anal canal. Both conservative and invasive treatment options are diverse and guidance to their implementation is lacking., Methods: A Delphi consensus process was used to review current literature and draft relevant statements. These were reconciliated until sufficient agreement was reached. The grade of evidence was determined. These guidelines were based on the published literature up to June 2020., Results: Hemorrhoids are normal structures within the anorectal region. When they become engorged or slide down the anal canal, symptoms can arise. Every treatment for symptomatic hemorrhoids should be tailored to patient profile and expectations. For low-grade hemorrhoids, conservative treatment should consist of fiber supplements and can include a short course of venotropics. Instrumental treatment can be added case by case : infrared coagulation or rubber band ligation when prolapse is more prominent. For prolapsing hemorrhoids, surgery can be indicated for refractory cases. Conventional hemorrhoidectomy is the most efficacious intervention for all grades of hemorrhoids and is the only choice for non-reducible prolapsing hemorrhoids., Conclusions: The current guidelines for the management of hemorrhoidal disease include recommendations for the clinical evaluation of hemorrhoidal disorders, and their conservative, instrumental and surgical management., (© Acta Gastro-Enterologica Belgica.)

Mycoplasma pneumoniae infection can present with a plethora of symptoms and result in a systemic vasculitis by activating a cascade of autoimmune reactions. In this case report, a young man without relevant past medical history was admitted to the hospital with diarrhea, abdominal pain and spiking fever. A CT-scan showed terminal ileitis. A 5-day broad spectrum antibiotic treatment (ciprofloxacin/clindamycin) did not result in any clinical improvement. On the contrary, the patient developed a cholestatic hepatitis, bilateral anterior uveitis and a dry cough. Extensive serological testing finally led to the diagnosis of a M . pneumoniae infection by paired serology (≥4-fold rise in IgG titer). In the diagnostic work-up, a PET-CT was performed and showed increased tracer uptake in the carotids and vertebral arteries, suggesting the diagnosis of vasculitis. After start of azithromycin and low-dose corticosteroids (0.5 mg/kg/day), a gradual clinical and biochemical improvement was observed. But subsequently, the patients relapsed and presented with an acute coronary syndrome. Coronary angiography revealed aneurysmatic deformation of the three coronary arteries, leading to the assumption of coronary vasculitis. Clinical improvement was achieved with high-dose corticosteroids (1 mg/kg/day). This case shows that M . pneumoniae is not merely a pulmonary infection, but that its primary symptoms can be diverse and misleading. All clinicians should be aware of its extrapulmonary manifestations.

Background and Aims: With the first wave of the COVID-19 pandemic declining, activities in the gastrointestinal clinic are being recommenced after a period of stringent measures. Since a second COVID-19 wave is not entirely ruled out health care professionals might remain faced with the need to perform endoscopic procedures in patients with a confirmed positive or unknown COVID-19 status. With this report we aim to provide a practical relevant overview of preparation and protective measures for gastroenterologists based on the currently available guidelines and our local experience and results of a national Belgian survey, to guarantee a fast recall of an adequate infection prevention if COVID-19 reoccurs., Methods: From the 23rd of March 2020 and the 13th of May 2020 we performed a Pubmed, Embase and Medline search, resulting in 37 papers on COVID-19 and endoscopy. Additionally, we combined these data with data acquired from the national BSGIE survey amongst Belgian gastroenterologists., Results: Based on 72 completed surveys in both university and non-university hospitals, the results show (1) a dramatic (<20%) or substantial (<50%) decrease of normal daily endoscopy in 74% and 22% of the units respectively, (2) a difference in screening and protective measures between university and non-university hospitals. These findings were subsequently compared with the current guidelines., Conclusion: Based on new data from the BSGIE survey and current guidelines we tried to realistically represent the current COVID-19 trends in protective measures, screening and indications for endoscopy and to provide a practical overview as preparation for a possible second wave., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

We report the case of a 58 year old man with occult obscure gastro-intestinal bleeding (OGIB) without other significant symptoms, in which systemic localisation of follicular B-cell non-Hodgkin lymphoma was discovered trough capsule endoscopy. This case reflects the clinical significance of performing capsule endoscopy in patients with OGIB., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

There is a need for well-organized comprehensive strategies to achieve good training in ESD. In this context, the European Society of Gastrointestinal Endoscopy (ESGE) have developed a European core curriculum for ESD practice across Europe with the aim of high quality ESD training.Advanced endoscopy diagnostic practice is advised before initiating ESD training. Proficiency in endoscopic mucosal resection (EMR) and adverse event management is recommended before starting ESD trainingESGE discourages the starting of initial ESD training in humans. Practice on animal and/or ex vivo models is useful to gain the basic ESD skills. ESGE recommends performing at least 20 ESD procedures in these models before human practice, with the goal of at least eight en bloc complete resections in the last 10 training cases, with no perforation. ESGE recommends observation of experts performing ESD in tertiary referral centers. Performance of ESD in humans should start on carefully selected lesions, ideally small ( < 30 mm), located in the antrum or in the rectum for the first 20 procedures. Beginning human practice in the colon is not recommended. ESGE recommends that at least the first 10 human ESD procedures should be done under the supervision of an ESD-proficient endoscopist.Endoscopists performing ESD should be able to correctly estimate the probability of performing a curative resection based on the characteristics of the lesion and should know the benefit/risk relationship of ESD when compared with other therapeutic alternatives. Endoscopists performing ESD should know how to interpret the histopathology findings of the ESD specimen, namely the criteria for low risk resection ("curative"), local risk resection, and high risk resection ("non-curative"), as well as their implications. ESD should be performed only in a setting where early and delayed complications can be managed adequately, namely with the possibility of admitting patients to a ward, and access to appropriate emergency surgical teams for the organ being treated with ESD., Competing Interests: F. Berr has received financial support from Ethical MedTech (Olympus, Fujifilm, ERBE, and others) to organize medical education courses and live endoscopy events (2009 – 2019), and speaker’s fees from Olympus (2015 – 2018). R. Bisschops has received research support from Cook and Medtronic, and financial support for symposium organization from Cook, Boston Scientific, Olympus, and Erbe (2009 – 2019), and speaker's fees from Boston Scientific and Medtronic (2009 – 2019). E. Dekker has received speaker’s fees from Olympus, Roche, and GI Supply, has provided consultancy to FujiFilm, Olympus, Tillots, GI Supply, and CPP-FAP, and is a member of the supervisory board of eNose; she receives a research grant from FujiFilm (2017 to present). P. Deprez has provided consultancy to Olympus, Erbe, and Boston Scientific (2015 – 2019). M. Dinis-Ribeiro is co-editor in-chief of Endoscopy. J. E. East received speaker’s fees from Olympus and Falk (2018) and is on the clinical advisory boards of Boston Scientific and Lumendi (2016 to present). G. Johnson has served on advisory boards for Boston Scientific and Olympus (2017) and Medtronic (2018), and has been a faculty member for annual training courses supported by Olympus (2014 to present) and Boston Scientific (2017 to present). B. L. A. M. Weusten received financial support for clinical and preclinical research from Pentax Medical Nature (2018 to 2019). E. Albéniz, M. Arvanitakis, P. Dewint, A. Ebigbo, A Haji, A. Panarese, P. Pimentel-Nunes, M. Pioche, T. Ponchon, and D. S. Sanders have no competing interests., (© Georg Thieme Verlag KG Stuttgart · New York.)

The field of rectal cancer treatment is a dynamic and changing field, due to better understanding of the pathology and new medical treatment options, but perhaps mostly due to innovations in the surgical approach. Surgery is the cornerstone for rectal cancer treatment. Currently, Total Mesorectal Excision is the gold standard. After evolution towards laparoscopic TME, improving technology has led to the development of platforms that allow transanal TME and robotic TME. In addition, local excision can be performed safer and more accurately by means of Transanal Endoscopic Microsurgery (TEM), TransAnal Minimally Invasive Surgery or Endoscopic Submucosal Dissection (ESD), possibly avoiding TME. The aim of this review is to summarize the different surgical techniques and approaches for rectal cancer in function of tumor stage and describe the specifics of the technique., (© Acta Gastro-Enterologica Belgica.)

Background: Adalimumab (ADM) has been shown efficacious in ulcerative colitis (UC). In randomized controlled trials, dose escalation from 40 mg ADM every other week to 40 mg every week was required in 20%-25% of patients within 1 year. Real-life data suggest higher escalation rates. Attempts for dose de-escalation have not been studied yet. We assessed the need for, outcome of, and predictors of dose escalation and de-escalation in a large retrospective cohort of UC patients treated with ADM., Methods: We included 231 consecutive patients from 10 Belgian centers initiating ADM treatment for active UC before September 1, 2015 (follow-up ≥1 year in each patient). We performed detailed chart review to identify variables associated with short-term clinical benefit (based on physician global assessment and absence of rectal bleeding at week 10), success of dose escalation, and dose de-escalation. Backward Cox regression and Wald Logistic regression were used to identify predictive variables., Results: Short-term clinical benefit was achieved in 101 patients (44%) and was less frequent in infliximab failures [37% vs 50%, Odds ratio 0.57 (95% CI 0.34-0.97), P = 0.038]. After a median of 2.8 (1.7-5.1) months, 164 patients (71%) needed ADM discontinuation (n = 35, 15%) or dose escalation (n = 129, 56%). Dose escalation was successful in 77/129 (60%). Dose de-escalation was attempted in 71% (55/77) after a median of 4.3 (2.9-7.2) months and was successful in 80% (43/54)., Conclusions: In this cohort, 56% of patients with UC required ADM dose escalation with a 60% success rate. Of note, most patients could be successfully de-escalated later on.

Lessons Learned: Motivating patients to enroll in chemopreventive studies is challenging.Chemoprevention with toxic drugs is not feasible., Background: LKB1 mutations are the underlying genetic abnormality causing Peutz-Jeghers syndrome (PJS) and are a potential target for everolimus. In this phase II study, the efficacy of everolimus on polyp and tumor growth in PJS patients was investigated., Methods: Adult patients with a proven LKB1 mutation and who were suitable for everolimus treatment were included in two different PJS cohorts: (a) patients with unresectable malignancies and (b) patients with high-risk polyps. Treatment in both groups was oral everolimus, 10 mg daily. Response rates were primary endpoints for both cohorts., Results: Between October 2011 and April 2016, only two patients were enrolled, one in each cohort. A 49-year-old patient with advanced pancreatic cancer in cohort 1 was progressive after 2 months. A 52-year-old male patient in cohort 2 experienced severe toxicity and refused treatment after 4 months, even though endoscopy suggested stabilization of polyps. Adverse events included dental inflammations, mucositis, and rash. In 2016, the trial was aborted for lack of accrual, despite extensive accrual efforts in an area where PJS is highly prevalent and care is highly centralized., Conclusion: Due to accrual problems, no conclusions can be drawn about the value of everolimus in PJS treatment, questioning the feasibility of this agent for chemoprevention., (©AlphaMed Press; the data published online to support this summary is the property of the authors.)

Background: Patients with inflammatory bowel disease (IBD) are at increased risk to develop malignant melanoma and this risk may increase with use of anti-tumor necrosis factor (TNF) therapy. Impaired survival of immunosuppressed melanoma patients is reported in transplant and rheumatology patients. This study aims to (1) identify risk factors for melanoma development in patients with IBD, (2) compare clinical characteristics of melanoma in patients with IBD to the general population, and (3) assess the influence of immunosuppressive medication on survival., Methods: We retrospectively searched the Dutch Pathology Database to identify all Dutch patients with IBD with cutaneous melanoma between January 1991 and December 2011. We then performed 2 case-control studies. To identify risk factors for melanoma development in IBD, we compared patients with IBD with melanoma to the general IBD population. To compare outcome and survival after melanoma diagnosis, we compared cases with non-IBD melanoma patients., Results: We included 304 patients with IBD with melanoma, 1800 IBD controls, and 8177 melanoma controls. IBD cases had more extensive IBD (ulcerative colitis: pancolitis: cases 44.5% versus IBD controls without melanoma 28.1%; P < 0.01; Crohn's disease: ileal and colonic disease: cases 57.9% versus controls 48.9%; P = 0.02). Despite a lower Nodes (N)-stage in patients with IBD (N1+ 8.3% versus 18.2%; P < 0.01) with comparable Tumor (T) and Metastasis (M) stages, survival was similar between groups, regardless of immunosuppressive or anti-TNF therapy., Conclusions: This study showed that IBD extent is a risk factor for melanoma development. Despite the lower N-stage in patients with IBD, we could not confirm impaired survival after melanoma in patients with IBD, regardless of anti-TNF and/or thiopurine use.