Introduction

Irritable Bowel Syndrome (IBS) is common in patients with inflammatory bowel disease, with a systematic review and meta-analysis of observational studies reporting an overall pooled prevalence of 39% and 35% in patients in clinical remission [1]. This subset of IBD patients report a reduced quality of life and increased anxiety and depression [2]. These patients are usually excluded from randomised clinical trials of treatments for IBS and therefore the evidence base for treatment strategies is small. A multi-strain probiotic (Symprove™, Symprove Ltd, Farnham, United Kingdom) has been shown to lead to improvement in overall symptom severity in patients with IBS and associated with decreased intestinal inflammation in patients with UC, but not in CD and is well tolerated in both populations [3,4].

Aims & Methods

Aim: To assess the efficacy of a liquid, multi-strain probiotic (Symprove) in patients with IBD whose disease is in remission as evidenced by the absence of inflammation but have ongoing IBS symptoms.
Methods: A single-centre double-blind, placebo controlled trial. Baseline demographic and clinical data; IBS symptom severity scores (IBS-SSS), IBD scores, bloods and faecal calprotectin were collected at week 0 and participants will receive either placebo or probiotic. At week 12 we repeated assessment of symptoms, repeat CRP and faecal calprotectin. Participants must be considered in remission from IBD as evidenced by a C-reactive Protein (CRP) <5mg/L and faecal calprotectin (FC) < 250ng/ml at recruitment but with ongoing gastrointestinal symptoms and meeting Rome IV criteria for the diagnosis of IBS.
Primary Outcome: 100-point drop in IBS-SSS post treatment
Secondary Outcomes: Change in IBS-SSS. Negative IBD outcomes including biochemical flare, steroid treatment or escalation of maintenance therapy.

Results

61 patients were enrolled in the study, 40 of whom received active agent and 21 of whom received placebo. The average age of patients was 42 years and 71% of patients were female. 28% (n=17) had Ulcerative Colitis and 72% (n=44) had Crohn's Disease, demographics are outlined in Table 1. Overall 45% of patients receiving the active agent achieved the end point compared to 33% of those receiving placebo (P=0.423). Separating patients with Crohn's Disease from those with UC, 50% of patients with UC receiving placebo achieved the endpoint compared to 44% of those receiving the active agent (p=1.000), however in Crohn's Disease 45% of those receiving the active agent achieved the endpoint compared to 29% of those receiving placebo (p=0.340). 23.8% (n=5) of those receiving placebo experienced a biochemical flare or steroid prescription or Escalation of Therapy compared to 12.5% of those receiving the active agent (p=0.266). In Crohn's Disease the mean IBS-SSS declined by 55 points in the placebo group (SD, -86) ​compared to 74 points in the active group (SD, -125).
.

Conclusion

A tendency among patients with Crohn's Disease towards improved IBS-SSS scores as well as fewer adverse IBD outcomes was noted in the probiotic group. Although this did not reach statistical significance this pilot study allows us to adequately power larger studies addressing this question.

References

1. Halpin SJ and Ford AC. Am J Gastroenterol 2012; 107:1474–1482
2. Gracie DJ et al. Clinical Gastroenterology and Hepatology 2017;15:376–384
3. Sisson G et al. Aliment Pharmacol Ther. 2014;40(1):51-62. ​

Disclosure

Active agent and Placebo were provided by Symprove Ltd, Farnham, United Kingdom

Introduction

Aims & Methods

Results

Conclusion

Disclosure

Introduction

In Hungary, the population-based colorectal carcinoma (CRC) screening programme was introduced at the end of 2018, shortly before the start of the COVID-19 pandemic.

Aims & Methods

The aim of our retrospective cohort study was to evaluate the impact of two presumably opposing causal factors, COVID-19 pandemic and population-based screening, on the incidence and clinical characteristics of CRC. All patients with newly diagnosed CRC from 2014 to 2023 were included and categorized into pre-pandemic (confirmed between 2014-2019), pandemic (confirmed in 2020-2021) and post-pandemic (confirmed in 2022-2023) groups. The extended pre-pandemic period was required to assess the impact of the screening programme, further dividing it into screening-affected (2015, 2016, and 2019) and unaffected (2014, 2017, 2018) subgroups.

Results

A total of 2803 patients were diagnosed with CRC during the study period. The annual number of CRC cases was significantly lower in the pandemic subgroup compared to the pre-pandemic screened and post-pandemic subgroups (254/year, 295/year and 295/year, p=0.009). In addition, in the pandemic subgroup, the incidence rates of CRCs detected at localized stage were significantly lower compared to the other three groups (36.61%, 50.85%, 46.35% and 49.49%, p<0.001). Statistically significant difference in the rate of T1 tumors was only observed between the pandemic and the post-pandemic subgroups (7.09% and 12.20%, p=0.026). In the pandemic period, the annual number of colonoscopies decreased by 64.31% compared to the pre-pandemic period overall, however, the post-pandemic period (n=4574) saw a modest 8.70% increase relative to the pre-pandemic period, offering only partial compensation for the shortage experienced during the pandemic. Furthermore, the annual number of colonoscopies in the extended pre-pandemic subgroup with screening was higher by 20.06% compared to the pre-pandemic subgroup without screening (4591 examinations/year vs 3824 examinations/year) and it was almost the same as the post-pandemic subgroup (4574 examinations/year). Substantially fewer examinations were required to detect a CRC in the pandemic group compared to the pre-pandemic overall and post-pandemic groups (10.67, 15.56, 13.97 and 15.50 examinations, respectively), but within the extended pre-pandemic group, there was no relevant difference between the two subgroups in the mean number of colonoscopies required to detect a CRC (15.56 vs. 13.97).

Conclusion

Our study confirmed the negative impact of COVID-19 pandemic on the CRC epidemiology. The newly introduced population-based CRC screening has only been able to partially compensate this negative effect during pandemic period, however, was moderately compensated by during the pandemic period, but in the post-pandemic period it caused a favorable change in the clinical features of CRC. Our study demonstrates both the effectiveness of the screening programme and that by introducing non-invasive pre-screening of patients (e.g. iFOBT) in a pandemic situation, it can reduce its negative public health impact.

Introduction

The Crohn’s Disease Activity Index (CDAI) is a widely used research tool used to quantify CD patient’ symptoms, evaluate the severity of CD and to determine treatment outcomes.^​

Aims & Methods

The objective of this study was to assess any nuances in treating CD patients with active disease (CDAI score >150), who have remained on the same advanced therapy (biologics/ novel oral molecules) for more than 6 months. The Ipsos CD Therapy Monitor, a multi-centre online medical chart review study of patients with CD was conducted between July – September 2023 among UK, FR, DE, IT & ES gastroenterologists practicing across hospital and private practices. Physicians were screened for practice duration and patient volume. Charts of patients prescribed with advanced therapy were included in the analysis.

Results

208 sampled physicians collectively reported 373 CD patients who were recorded as being on the same advanced therapy for more than 6 months. 286 reported patients were deemed in remission (CDAI score ≤ 150) and 87 patients recorded with active disease (CDAI score >150). Looking at reported CD patient co-morbidities, metabolic conditions were more common in patients with active disease vs those in remission (24% vs 19%)

When looking at extra-intestinal manifestations (EIMs) between the two patient groups, patients with active disease were more likely to experience EIMs vs those in remission.

Table 1: EIMs in reported CD patients (% patients)

Conclusion

Comparisons in this study cohort highlighted that active disease in CD patients, as determined by the CDAI score, is associated with a higher number of patient co-morbidities and a greater likelihood of extra-intestinal manifestations; this indicates a more severe or complicated disease burden. As additional development products with new mechanisms of action become available in gastroenterology, non-TNF therapy usage may grow over time to provide more holistic and individualised treatment strategies for CD patients. Further investigation using comparator cohort is warranted.

References

[1] Use of the Crohn’s disease activity index in clinical trials of biological agents, Hugh James Freeman https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2725371/

Disclosure

No

Introduction

Radiation therapy as part of neoadjuvant treatment for rectal cancer aims to improve local disease control with increased response rates and the possibility of sphincter preservation. The addition of the "watch and wait" (W&W) strategy has increased the efficacy and safety associated with neoadjuvant radiotherapy. Despite the use of low doses (between 40-50.4 Gy), most studies report complete pathological response rates of 10-27%. However, there is still a lack of studies with higher doses to evaluate effectiveness in terms of clinical and pathological response, versus the toxicity associated with increased radiation dose.

Aims & Methods

The aim was to evaluate the efficacy and tolerance of neoadjuvant therapy for potentially resectable rectal cancer with higher radiation doses.
A retrospective observational preliminary study included 41 individuals with potentially resectable rectal cancer (T2-T4, N0-1, M0), treated with capecitabine (825mg/m2 every 12 hours, 5 days a week) and 25 sessions of 54 Gy + 50 Gy to pelvic lymph nodes, considering patients on W&W. Partial response was defined as downstaging of at least 1 level in T and/or N. Complete clinical response was defined as reevaluation by MRI, endoscopy with biopsies, and digital rectal examination without evidence of residual disease. Short- and long-term complications of increased radiation dose were also evaluated.

Results

Out of 41 individuals with potentially resectable disease observed during the study, downstaging was observed in 78% (n=32), with 29% (n=12) showing complete response (clinical and/or pathological). Of the patients with complete clinical response (n=12), 8 underwent total mesorectal excision due to unpassable stenosis affecting adequate visualization of the rectal mucosa (n=1), presence of rectal ulcer with negative biopsies (n=6), and concurrent ulcerative colitis (n=1). All these patients showed complete pathological response. Four patients entered the W&W protocol, 3 of them with residual ulcer and negative biopsies, without recurrence at present (4 years follow-up). Radiation therapy complications were observed in 7% (n=3) of patients, respectively due to rectal stenosis, radiation proctitis, and radiation cystitis.

Conclusion

Our study found higher rates of downstaging and complete response compared to most studies under similar conditions and with lower radiotherapy doses, with a relatively low frequency of adverse effects.

References

Anter, A., Eladawei, G., & Mosbah, M. (2013). Preoperative capecitabine and pelvic radiation in locally advanced rectal cancer: preliminary results (Mansoura experience). Translational Gastrointestinal Cancer, 2(3), 112-117.
Korkolis, D. P., Boskos, C. S., Plataniotis, G. D., Gontikakis, E., Karaitianos, I. J., Avgerinos, K., Katopodi, A., Xinopoulos, D., Dimitroulopoulos, D., Beroukas, K., & Vassilopoulos, P. P. (2007). Pre-operative chemoradiotherapy with oral capecitabine in locally advanced, resectable rectal cancer. Anticancer research, 27(1B), 541–545.
A. De Paoli, et al. (2006). Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study, Annals of Oncology, Volume 17, Issue 2, Pages 246-251,

Introduction

The early-stage pancreatic cancer (e-PC; stage I/II) detection rate is very low at approximately 25%. The role of general physician is very important for e-PC detection.

Aims & Methods

The aim of this study was to evaluate the effectiveness of the check score sheet used clinical findings to detect e-PC in gastroenterology clinic.
Patients of clinic with a score of ≥ 2 points on clinical findings were enrolled: symptoms of abdominal pain/back pain and/or body weight loss (1 point), high amylase, lipase and/or trypsin (1 point), high carbohydrate antigen 19-9 (CA19-9) (1 point), new-onset or worsened diabetes (2 point), family history of pancreatic cancer (2 points) and ultrasonography (US) findings including direct (e.g., a solid pancreatic tumor) and/or indirect findings (e.g., dilatation of a pancreatic diameter of ≥ 2 mm and/or cystic lesions) (2 points). Abdominal CT and/or EUS (Endoscopic ultrasonography) were performed for all these enrolled patients, and we evaluated about pancreatic disease and pancreatic cancer detection rates of this check score sheet.

Results

Between July 2017 and March 2024, 621 patients (mean age 67.6 years, female 391 [63%]), were enrolled in clinic. The 458 pancreatic cystic disease (IPMN and SCN) cases (73.7%), the 28 chronic pancreatitis disease cases (4.5%), the 18 PC patients (2.9%) and the 10 pancreatic solid disease (SPN and NEM) (1.6%) were detected by abdominal CT and/or EUS. The 6 patients with e-PC were detected. The mean clinical finding score of the PC group (3.2 ± 1.4) was significantly higher than that of the overall non-PC group (2.2 ± 0.6) ( p < 0.05). US findings were significantly more frequent in the PC group than in the non-PC group ( p <0.05). Although the sensitivity of direct findings by US was 42.3%, that of indirect-findings was 91.7% in the PC group.

Conclusion

Many pancreatic diseases, which may have potential of pancreatic cancer in future, were detected by this simple check score of ≥ 2 points on clinical findings. And in clinic pancreatic cancers were detected efficiently. Indirect findings by US may play an important role in improving the e-PC detection rate.

Clinical Case Summary

Recently, the concept of neoadjuvant therapy for unresectable locally advanced pancreatic cancer (PC) has received much attention. However, in patients who respond well to neoadjuvant therapy, even if resection is achieved, micro-cancer cells may remain around the major vessels. This may lead to early recurrence. A novel therapeutic strategy is needed to improve prognosis and achieve long-term survival. Under the situations, high-intensity focused ultrasound (HIFU) of new noninvasive therapy is expected as neoadjuvant therapy. A 75-year-old male, who was diagnosed as pancreas body cancer (38mm) infiltrating celiac artery (CA), common hepatic artery (CHA), splenic artery (SPA), and portal vein (PV) by enhanced CT, MRCP and EUS-FNA. There was no indication for surgery, and then chemotherapy (Gem/nab-PTX; GnP) was enforced due to unresectable locally advanced PC (Stage III). The chemotherapy with GnP was administered at 100% dose and performed for 4 courses. The main tumor became smaller (20mm) after 4 months from the diagnosis. However, there was still residual tumor adjacent to the CA, CHA, SPA, and PV (cT4N1aM0: stage III). Therefore, we cauterized the main tumor and the around CA, CHA, SPA, and PV using HIFU system with the aim of obtaining a negative surgical margin for one week before the surgical resection. A total pancreatectomy which included resection of the portal vein, was performed after HIFU therapy. The pathological findings showed that the tumor infiltrated the portal vein that was resected, but no tumor invasion to artery was observed. The surgical margin was negative (R0 resection). In conclusion, the combination of chemo and HIFU therapy may be promising therapies for patients with unresectable locally advanced PC for achieving curative resection.

References

Sofuni A, Asai Y, Tsuchiya T, et al. Novel therapeutic method for unresectable pancreatic cancer the impact of the long term research in therapeutic effect of high intensity focused
ultrasound (HIFU) therapy. Curr Oncol. 2021;28:4845 61.

Disclosure

No COI to report.