Introduction

Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment.

Aims & Methods

Multicentre, descriptive, and observational study including Crohn’s disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD–GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks.

Results

One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD; 44% women and 56% men; age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Pre-switch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged. Median SC-IFX levels significantly increased from baseline of 4.5 μg/dl [range 2.6-9.2] to 14 μg/dl [range 9.5-16.2] at week 12 and 13.2 μg/dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery).

Conclusion

The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.

Introduction

Fecal incontinence is a diagnosis represented by recurrent uncontrolled passage of fecal material for at least 3 months. It is relatively common, with an assumed prevalence of up to 7% of the worldwide population. The therapy is challenging and often with insufficient clinical results. It should be specifically tailored to different symptom presentations meaning urge or passive incontinence. One of the relatively and therefore not widely used treatment options for incontinence is local sphincter stimulation which is a safe non or minimally invasive method. This stimulation could be performed in at home setting, so it presents a substantial time and cost-saving option for the patient and for the healthcare system. However, the data published on this topic so far are scarce with heterogeneous studied populations and results with no universally accepted treatment protocol.

Aims & Methods

This study aims to evaluate the effect of local sphincter stimulation on the functional parameters of sphincters and symptoms based on the different phenotypes. This is a retrospective single-center study analysis on patients with fecal incontinence (age> 18 years). The duration of the training was 12 weeks, with training once daily for 6 days a week. The parameters of the home stimulation device were as follows: Frequency: 40 Hz; Impulse Width: 0.2 s; Ramp-up time: 1s; Workout time: 6s; Rest: 15s. Training duration: 20min. During the perceived stimulation patients were instructed to squeeze the sphincter. 3D anorectal manometry was performed according to the IAPWG protocol at the initiation visit and the control visit. Clinical evaluation was performed by self-reporting Wexner’s score for fecal incontinence at both visits.

Results

Twenty-three patients (23) were consecutively screened for eligibility and assigned for the therapy. Three patients (3) did not adhere to the training due to various personal reasons one (1) patient did not tolerate stimulation. Therefore, 19 patients (10 passive, 9 urge) completed the full treatment protocol for 12 weeks and were considered for the final analysis. The total average increase in sphincter rest medium pressure was 22.53%, with significantly higher improvement in the urge group compared to the passive group (46.24% vs. 1.18% respectively). The total average increase in sphincter rest maximum pressure was 25.69%, with significantly higher improvement in the urge group compared to the passive group (46.92% vs. 6.59% respectively). The total average increase in sphincter maximum squeeze pressure was 36.13%, with significantly higher improvement in the urge group compared to the passive group (57.82% vs. 16.61% respectively). The average improvement in Wexner score was 3.1 points, with higher improvement in the urge group compared to the passive group (4.2 points vs. 2.1 points respectively).

Conclusion

The home-administered local anal sphincter stimulation for 12 weeks seems to be an effective treatment option for both types of fecal incontinence and significantly more effective in the urge type. Therefore this could be considered as a cost and time-effective treatment option compared to standard office-based therapy. Although a home stimulation device is simple to use, the ability of the patient to adhere to the protocol should be evaluated during the screening process.
Funding: European Parliament and Council Recovery and Resilience Plan of the Slovak Republic 2021 – 2027, code: 09I03-03-V04-00761

Introduction

Environmental pollution is significantly driven by endoscopic waste generation. Previous studies have found a range of 0.5 to 3.0 kg of waste per endoscopic procedure depending on the geographical origin.

Aims & Methods

This study aimed to evaluate endoscopic waste generation in hospitals and offices to assess its healthcare system impact and propose waste reduction strategies. A prospective, multicentre, observational study was conducted over four-week periods in two tertiary hospitals and two gastroenterology offices in Germany in 2023. Waste from 2275 patients in 2889 procedures was collected, sorted, and weighed. Recyclable waste was categorised. National waste generation from gastrointestinal endoscopies in Germany was estimated using insurance data.

Results

The mean quantity of waste generated per procedure was 1119 g (hospitals: 1167 g; offices: 1094 g). Office-based procedures generated significantly less solid waste compared to equivalent hospital-based procedures (EGD: -51%, colonoscopy: -50%, their combination: -47% and sigmoidoscopy: -69%, all p < 0.001). Combining consecutive procedures could reduce waste by up to 39% for EGD and colonoscopy and 33% for EUS and ERCP. Waste from suction bags had an impact of 35% per procedure and could be processed via the sewage system instead of being disposed. Replacing single-use gowns with reusable ones could reduce personal protective equipment waste by 54%. Furthermore, 23% of endoscopic waste was potentially recyclable.
Gastrointestinal endoscopies in Germany generate extrapolated 8024 tonnes of waste, annually, equivalent to the annual waste generation of 18533 German citizens. This resulted in a total of 3924 tonnes of greenhouse gas emissions.
This figure corresponded to approximately 33.7 million kilometres driven by passenger cars or 4242 economy flights from Frankfurt to New York. If this waste was recycled according to the present study results with a recycling share of 23%, the waste could have been reduced by the equivalent annual waste generation of 3616 German citizens and a reduction of 1427 tonnes of greenhouse gas equivalents. This reduction would have been equivalent to about 12.3 million kilometres driven by car or 1542 economy flights from Frankfurt to New York.

Conclusion

The mass of endoscopic waste generated in Germany is comparable with the domestic waste of a small town. Implementing a waste reduction system in endoscopic practices, prioritizing prevention, reduction, reuse, recycling, and recovery, could significantly reduce waste generation.

Disclosure

Nothing to disclose by the authors.

Introduction

Chronic pancreatitis (CP) is a progressive inflammatory disorder that predisposes patients to various complications, including vascular events. Among these, splenic vein thrombosis (SVT) represents a siginficant, but often underdiagnosed complication, with reported prevalence rates varying widely. SVT may lead to sinistral portal hypertension, resulting in gastric varices and, in severe cases, life-threatening gastrointestinal hemorrhage. This systematic review and meta-analysis aims to determine the true pooled prevalence of SVT in CP patients and to evaluate the bleeding rate among those with splenic thrombosis by synthesizing data from studies in which all participants underwent appropriate imaging for SVT detection.

Aims & Methods

An exploratory search was conducted to identify key articles reporting on the prevalence of SVT among CP patients. Four studies were selected based on their provision of relevant, poolable data on prevalence with the use of proper imaging techniques for detecting SVT, encompassing a total of 1,973 patients. A random effects meta‐analysis was performed using SPSS, and a forest plot was genrated to visually represent both individual and overall prevalence estimates. An ongoing PRISMA compliant systematic literature search continues to capture all pertinent studies on this topic.

Results

Analysis of data from the four selected studies (n = 1,973) revealed a pooled SVT prevalence of 12.7% in CP patients. Although individual study estimates varied, likely reflecting differences in study design, CP etiology, and follow-up duration, the overall result indicates that approximately one in eight patients with CP develops SVT.

Conclusion

Our preliminary findings demonstrate that, when appropriate imaging is employed, SVT occurs in approximately 12.7% of chronic pancreatitis cases. These results underscore the clinical importance of SVT, particularly given its association with an increased risk of gastrointestinal hemorrhage. Routine evaluation for SVT in CP patients should be considered, and further research is warranted to elucidate underlying risk factors and to refine management strategies for this potentially life-threatening vascular complication.