Introduction

Diverticular disease of the colon is one of the most common diseases in Western world. Despite in the natural history in most of cases diverticulosis remains asymptomatic or manifests with mild abdominal pain, complications may occur. Bleeding from diverticula is one of the most common complications and, despite it is usually a self-limiting event, it may lead to anemia or shock. Among the endoscopic interventions for active bleeding, direct or indirect clipping of the diverticulum is the most diffuse one. However, it has been hypothesized that endoscopic band ligation (EBL) may be more effective, since it may improve the chance to close the bleeding vessel, with a better outcome on long term. Therefore we performed a meta-analysis comparing clipping versus EBL for diverticular bleeding.

Aims & Methods

Literature search on main databases (PubMed, Web of science, SCOPUS, EMBASE) was performed in November 2022. Studies comparing clip versus EBL for acute diverticular bleeding were selected. We excluded case series, abstract and articles not written in English. The following outcomes were analysed: short term effectiveness, early rebleeding, tardive rebleeding and need for surgery or radiologic embolization. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculate according to Mantel-Haenszel method. Heterogeneity was estimated by I² statistic with chi square test, and, if present, a random effect model was used, otherwise a fixed one was adopted.

Results

Seven studies were selected, overall enrolling 2322 patients (979 in EBL and 1343 in clip groups). Immediate haemostasis was achieved in the EBL and clipping group respectively in the 96.8% and 96.5% (OR=0.94, 95% CI 0.59-4.19, p=0.79). Early rebleeding was observed more frequently in the clipping (25.0%) than in the EBL group (11.8%), with an OR=0.40 (95% CI 0.32-0.51, p<0.001). Similarly, tardive rebleeding was more common in the clipping arm (37.4%) than in the EBL (24.5%), OR=0.39, 95% CI 0.22-0.68, p=0.0001. Patients receiving clipping needed more frequently salvage surgery or embolization than EBL (1.48% versus 0.53%, OR=0.40, 95% CI 0.17-0.93, p=0.03).

Conclusion

Despite EBL and clip have similar effectiveness in achieving immediate haemostasis, EBL showed better effectiveness in maintaining it on longer interval times, with less probable need for major surgical/radiologic interventions.

Introduction

The Phase 3 QUASAR Induction Study (NCT04033445) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of guselkumab (GUS), an interleukin-23 p19 subunit antagonist, as induction therapy in patients (pts) with moderately to severely active ulcerative colitis (UC). Here the early onset of symptom improvement was evaluated.

Aims & Methods

Pts were randomized in a 3:2 ratio to receive IV GUS 200mg or placebo (PBO) at Weeks (Wks) 0, 4, and 8. The primary analysis population included treated pts with a baseline modified Mayo score of 5 to 9, , and an endoscopy subscore ≥ 2 (centrally read). Through Wk12, pts recorded stool production and episodes of rectal bleeding in a diary. Symptomatic remission at Wks 2, 4, and 12 were major secondary endpoints. All other analyses were prespecified but not multiplicity controlled (nominal p-values).

Results

Seven hundred one pts were randomized and treated in the primary analysis population (mean UC duration, 7.5yrs, Mayo endoscopy subscore=3 [severe disease], 67.9%, and mean modified Mayo score, 6.9, at baseline). At baseline, 49.1% had prior inadequate response/intolerance to advanced therapies (ADT-IR) for UC; nearly half of these (47.4%) had ≥2 ADT-IR classes. At baseline, for the GUS and PBO groups, respectively, the mean absolute number of stools per day were 7.10 and 6.96; stool frequency subscores of 0 or 1 were observed in 10.0% and 9.6%; and mean rectal bleeding subscores were 1.7 and 1.8.
As early as Wk2 and increasing through Wk12, greater symptomatic improvements were seen in pts treated with GUS compared with PBO. At Wks 2, 4, 8, and 12, symptomatic response was achieved by GUS- vs PBO-treated pts in 34.0% vs 23.6%, 53.2% vs 30.0%, 66.0% vs 39.6%, and 71.7% vs 35.0% (all p<0.001, except Wk2, p<0.01), respectively. Percentages of pts who achieved symptomatic remission with GUS vs PBO at Wks 2, 4, 8, and 12 were 12.1% vs 9.3%, 22.6% vs 12.9%, 39.7% vs 20.7%, and 49.9% vs 20.7% (all p<0.001, except Wk2, p=0.210), respectively. Mean changes from baseline in absolute number of stools per day at Wks 2, 4, 8 and 12 were -1.19 vs -0.61, -2.05 vs -0.75, -2.75 vs -1.31, and -3.15 vs -1.36 (all p<0.001, except Wk2, p<0.01), respectively. Percentages of pts with stool frequency subscore of 0 or 1 at Wks 2, 4, 8, and 12 were 26.1% vs 18.2%, 41.3% vs 25.4%, 53.4% vs 29.6%, and 60.1% vs 31.8% (all p<0.001, except Wk2, p<0.05), respectively. Mean changes from baseline in rectal bleeding subscores at Wks 2, 4, 8, and 12 were -0.6 vs -0.5, -0.8 vs -0.5, -1.1 vs -0.6, and -1.2 vs -0.6 (all p<0.001, except Wk2, p<0.01), respectively. Percentages of pts with rectal bleeding subscores of 0 at Wks 2, 4, 8, and 12 were 24.2% vs 19.3%, 36.8% vs 22.9%, 55.8% vs 33.2%, and 64.6% vs 28.6% (all p<0.001, except Wk2, p=0.110), respectively. Treatment differences for GUS vs PBO were evident across Wk 12 symptomatic outcomes (Table).

Table 1. Symptomatic outcomes at Wk12

Conclusion

GUS 200mg IV induction was effective in improving symptoms as early as 2 weeks after the first dose in pts with moderately to severely active UC. Symptomatic improvements increased through Wk12.

Disclosure

Gary R. Lichtenstein discloses relationships with Janssen/ Janssen Orthobiotech (Consultant, Research, Funding to University of PA [IBD Fellow Education]). Steering Committee member for Janssen.
Axel Dignass reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Janssen; consultancy fees from Janssen; payment from lectures including service on speakers bureaus from Janssen. Steering Committee member for Janssen.
David T. Rubin has served as a consultant and Steering Committee member to Janssen Pharmaceuticals.
Shadi Yarandi is an employee of Johnson & Johnson and owns company stock/stock options.
Kuan-Hsiang G. Huang is an employee of Johnson & Johnson and owns company stock/stock options.
Matthew Germinaro is an employee of Johnson & Johnson and owns company stock/stock options.
Ye Miao is an employee of Johnson & Johnson and owns company stock/stock options.
Hongyan Zhang is an employee of Johnson & Johnson and owns company stock/stock options.
Jaroslaw Kierkus is a clinical investigator and consultant for Janssen.
Ursula Seidler reports research grants from and is advisor/speaker for Janssen.
Atsuo Maemoto is a clinical investigator and consultant for Janssen.
Jessica R. Allegretti is a consultant and Steering Committee member for Janssen.
Brian Bressler is an advisor/speaker and Steering Committee Member for and has received research support from Janssen.
Laurent Peyrin-Biroulet reports personal fees from Janssen and is a Steering Committee member for Janssen.

Introduction

Though the burden of musculoskeletal injury(MSI) by long-term accumulation of endoscopy procedures is well known, there is little data on the techniques that can reduce or prevent MSI.

Aims & Methods

The purpose of this study is to develop a new method for MSI assessment in long-term endoscopy practitioners and to establish an individualized MSI restoration plan through the special 16-week intervention of Kinetic Ergonomics based on Movement Analysis(KEMA) program by physical therapists.
Fifteen volunteer endoscopists practicing more than 10 years from 4 tertiary medical centers, were evaluated by demographics, endoscopy burden, location and degree of pain, and endoscopy posture. A comprehensive functional evaluations of ergonomic position, posture, and MSI and load during endoscopy was made by the physical therapist and self-perception questionnaire for involved joints was also evaluated. Then personalized KEMA program (musculoskeletal function evaluation and customized exercise program based on ergonomics) was delivered for 16 weeks by physical therapists on a one to one basis. KEMA program included recommendations for individualized exercises, static and dynamic posture re-education during and between procedures, optimization of procedure suite set-up and pain education. The endoscopists were re-evaluated regarding their perception and adherence to ergonomics and subjective symptoms at the end of the program.

Results

Various ergonomic problems were found to varying degrees in all 15 long-term endoscopy practioners including ergonomic inefficiencies and suboptimal movement patterns. Among 12 areas evaluated, pain areas were most commonly found in the order of the low back, neck, shoulder, wrist, and thumb. In addition, cumulative endoscopy time and neck and thumb pain, cumulative number of endoscopy cases and neck, back, and hip pain scores, neck and shoulder pain, and wrist and elbow pain showed positive correlations with each other. After 16-weeks KEMA program, among these 5 main painful joints, the remaining 4 joints (80%) showed improvement in the intensity and frequency of pain, except for the shoulder. Before and after the program, the level of understanding of knowledge about ergonomics increased from an average of 28 points to 33.6 (5-point scale of 10 items), but unfortunately, ergonomic attitudes and performance did not show significant changes.

Conclusion

The evaluation of MSI based on kinetic ergonomics for endoscopists and customized exercise program helped to recognize one's own body condition and relieve pain and recovery of the MSI even with a relatively short-term management of 16 weeks. These ergonomic interventions used here could potentially contribute to career longevity, decreased burnout, reduce lost days of work and most importantly reduction in pain and fatigue among practitioners.

Clinical Case Summary

A 77-year-old man underwent liver transplantation in 2008 due to alcoholic cirrhosis associated with hemochromatosis, and was taking tacrolimus and mycophenolate mofetil since that.
He was admitted in the Emergency Department in February 2023 with right upper quadrant abdominal pain and diarrhea for one week. Abdominal computed tomography(CT) showed ileal thickening. Laboratory tests revealed leukocytosis(19,000 leukocytes/mm3) and elevated C-reactive protein(16 mg/dL). Acute gastroenteritis was assumed and he was discharged on metronidazole with clinical improvement. One month later, he returned to the Emergency Department with abdominal pain for two days. CT revealed concentric wall thickening of the last ileal loop and a probable enteromesenteric fistula. He was admitted for further evaluation. Colonoscopy revealed deep mucosal ulceration of the terminal ileum. After colonoscopy, his abdominal pain worsened, so he repeated the abdominal CT, which showed a new organized collection in the right flank measuring 63 mm and small gas bubbles of pneumoperitoneum in the right upper quadrant. He underwent ileocecal resection with terminal ileostomy, and the histopathological evaluation revealed a neoplasm composed of atypical lymphoid proliferation, with positive immunohistochemistry for CD45, CD20, CD79a, BCL2, and BCL6, compatible with diffuse large B-cell lymphoma. After staging and exclusion of distant disease, the patient was proposed for chemotherapy following reduction of immunosuppression.
The clinical presentation of Inflammatory Bowel Disease can be quite heterogeneous and several pathologies can mimic its clinical, endoscopic, and/or histological findings. This case illustrates the importance of considering the diagnosis of small bowel lymphoma as a differential diagnosis of Crohn's disease, especially in elderly patients with risk factors, such as chronic immunosuppression.