Abstract Background Over half of patients with Crohn’s disease (CD) develop intestinal strictures that often require surgical resection. Endoscopic balloon dilatation (EBD) can be a potential alternative therapeutic option. Methods This retrospective cohort study included adult patients with CD (≥18 years) who underwent EBD between January 2016 and September 2024 at two Canadian hospitals. The primary outcome was technical success. Secondary outcomes were clinical success at 6 and 12 months, hospitalization due to obstruction, and CD-related surgery. Cox proportional hazards models assessed predictors of outcomes. Results A total of 234 patients (age: 47.6 years, males: 47.4%) were included with mean disease duration of 17.7 years and median follow-up of 61 months. A majority of the strictures (226/234) were dilated under ileocolonoscopy guidance, and 79.4% had symptoms at baseline. Most strictures were of de novo type (62.5%) and the median number of stricture dilatations was 3 (IQR: 2). Technical success was achieved in 81% (150/185). Clinical success was noted in 47.7% at 6 months. The cumulative probabilities of being hospitalization-free were 96.9% (95% CI 94.7-99.2]) at 1 year, 91.3% (95% CI 87.5-95.2) at 3 years, and 85.0% (95% CI 79.8-90.5) at 5 years. The cumulative probabilities of being surgery-free were 91.1% (95% CI 87.5-94.9) at 1 year, 81.7% (95% CI 76.5-87.2) at 3 years, and 78.1% (95% CI 72.4-84.3) at 5 years. Multiple strictures were associated with an increased risk of surgery while anastomotic strictures and maximum balloon diameter were associated with lower risk. No patients experienced procedure-related complications. Conclusions EBD is effective and safe in de novo and anastomotic strictures with the majority of patients achieving technical success and being free of surgery within 5 years.
Abstract Background and Aims A significant number of patients with inflammatory bowel disease (IBD) undergo stoma-forming surgery. For many, an ostomy is not curative, and disease exacerbations requiring ongoing therapy may be required. Despite this, IBD patients with stomas are frequently excluded from clinical trials due to the heterogeneity in outcomes and the absence of validated measurement tools. The TOAST-IBD project aimed to develop a Core Outcome Set (COS) for IBD patients with stomas undergoing interventional trials to address this issue. Methods Candidate outcomes were identified through a systematic literature review and patient focus groups. These were refined using a two-round online Delphi process, with scoring based on the importance of each outcome in determining treatment success. Participants were recruited internationally and grouped into four stakeholder panels: patients, specialist and research nurses, colorectal surgeons, and gastroenterologists. Feedback was provided after each round to allow score refinement. A final consensus meeting determined the COS. Results A total of 81 outcomes were identified and categorized into five themes. In total, 76 stakeholders (73.1% response rate) from 17 countries participated in the Delphi process, carrying 37 outcomes forward. At the final consensus meeting, 37 experts and patients agreed on a six-domain COS: maintenance of hydration and volume status, maintenance of nutritional status, symptom-based clinical activity, objective marker-based disease activity, and two quality-of-life domains (IBD-related and stoma-specific). Conclusion An IBD Stoma COS has been produced by all key stakeholders. This COS will standardize outcome reporting and support creation of validated measurement instruments, facilitating the inclusion of this underserved group in future clinical trials. Registration This study has been registered with the COMET Initiative as study 2855 (https://www.comet-initiative.org/Studies/Details/2855) and followed its recommended methodological procedures. The systematic review has been registered with the PROSPERO database (PROSPERO-ID: CRD42023442388).
Abstract Background Patients with inflammatory bowel disease (IBD) undergo colonoscopy for diagnosis, disease assessment, and colorectal cancer surveillance. We used the UK National Endoscopy Database (NED) to evaluate the quality of IBD surveillance and identify factors associated with procedural quality. Design All colonoscopies uploaded to NED between January 1 and December 31, 2024 were analyzed. IBD procedures were identified from recorded indications and classified as assessment or surveillance. Key performance indicators (KPIs) were assessed against national guidance. Case-mix-adjusted impacts of endoscopist- and service-level factors were evaluated using multilevel mixed-effects logistic regression. Results Of 588 841 colonoscopies, 2.7% (n = 15 971) were IBD surveillance. Although 56.8% of endoscopists performed at least one surveillance procedure, 18.9% performed one or more per month and delivered 57.1% of all surveillance. IBD surveillance quality was high (cecal intubation 96.1%; median withdrawal time 13 min), but adequate bowel preparation was below target (80.2%). Endoscopists performing ≥1 surveillance/month had higher adjusted polyp detection (used as a surrogate marker of mucosal inspection quality rather than true dysplasia) (odds ratio [OR] 1.26), and procedures allocated extended time had higher detection (OR 1.40). Conclusion These findings suggest that regular exposure to IBD surveillance, adequate procedural time, and consistent use/documentation of dye-based chromoendoscopy are associated with higher polyp detection during IBD surveillance colonoscopy. Importantly, these findings relate to polyp detection rather than histologically confirmed dysplasia detection. Further work is required to determine whether service concentration or minimum surveillance volumes improve dysplasia-related outcomes. Service-level pathways analogous to English Bowel Cancer Screening with national standards and performance monitoring may warrant consideration.
Background At 1-year of follow-up, the ProtDilat trial indicated that endoscopic balloon dilatation (EBD) was more effective than self-expandable metal stents (SEMSs) for treating Crohn's disease (CD) strictures. We aimed to assess the long-term outcomes of ProtDilat participants, focusing on surgery-free rates, factors related to surgery, and endoscopic retreatment.Methods We retrospectively collected data on medical treatment, endoscopic-surgical interventions, and smoking status. The primary outcome was the percentage of patients who remained free of surgery at the end of follow-up.Results Eighty participants were included (39 SEMS, 41 EBD); 39 were women and the median age was 45 years (IQR: 38-55). Over a 7-year follow-up (median 77 months; IQR 61-84), 31.5% (25/80) of patients required surgery, with a median time to surgery of 30.6 months (IQR 6.4-55.2). Surgery-protective factors were no-intensification of medical therapy (HR 0.22 [0.08-0.58]), EBD treatment (HR 0.26 [0.10-0.68]), and single endoscopic treatment (HR 0.33 [0.15-0.74]). Among the 55 patients who avoided surgery, the median number of endoscopic treatments was two. Notably, 36.3% (29/80) required neither surgery nor endoscopic retreatment. Among the 53 patients (20 SEMS vs 33 EBD) with successful initial endoscopic treatment in the ProtDilat, the long-term effectiveness (free of surgery and endoscopic retreatment) was 45% and 57.6% respectively (P = .374). Treatment-related adverse events occurred in 8.75% (7/80) of endoscopic cases vs 36% (9/25) of surgical cases (P = .003), with a severity (AGREE/Clavien-Dindo >= 3) of 38% (3/8) vs 84% (10/12), respectively (P = .011).Conclusions Endoscopic approaches (especially EBD) are effective long-term therapies for avoiding surgery and requiring few endoscopic treatments. Stable medical management and single EBD therapy were independently associated with a lower likelihood of surgery during follow-up. Our findings also highlight the higher frequency and severity of adverse events associated with surgical intervention compared to endoscopic management.
Abstract Background & Aims Unlike antitumor necrosis factor (anti-TNF)-induced cutaneous adverse events, skin lesions occurring during ustekinumab therapy are uncommon and poorly characterized. We aimed to describe their clinical features, management, and outcomes in patients with Crohn’s disease (CD). Methods We conducted a retrospective multicenter study across 7 Groupe d’Études Thérapeutiques des Affections Inflammatoires Digestives centers between June 2015 and December 2024. Adult CD patients who developed significant noninfectious skin lesions during ustekinumab treatment requiring dermatological assessment were included. Clinical characteristics, dermatological diagnoses, management, and outcomes were collected. Results Thirty-two patients (21 women; median age 38 years) developed noninfectious skin lesions. Considering the 740 patients exposed to ustekinumab in our cohort during the study period, the estimated prevalence of such lesions was 4.3% among ustekinumab-exposed patients. A history of atopy or psoriasis was present in 40% of patients, and 65% had previously experienced anti-TNF-induced immune-mediated skin lesions. At lesion onset, 59% had active CD. Psoriasiform (40%) and eczematous (31%) eruptions were most common, followed by acneiform lesions (25%) and 1 case of cutaneous vasculitis. Lesions predominantly involved the face (43%) and trunk (40%). Topical treatments were prescribed in 81% of patients, resulting in improvement in 70% of eczematous, 50% of psoriasiform, and 37% of acneiform lesions. Ustekinumab was discontinued in 8 patients (25%). Prior anti-TNF-induced immune-mediated skin lesions were associated with an increased risk of psoriasiform eruptions under ustekinumab (OR 12.0, 95% CI, 1.3-112.7; P = .03). Conclusions Skin lesions requiring dermatological assessment occurred during ustekinumab treatment and displayed heterogeneous clinical phenotypes. A history of anti-TNF-induced immune-mediated skin reactions may identify patients at increased risk, particularly for psoriasiform eruptions.
