Introduction

Helicobacter pylori (H. pylori) infection is a common etiological cause of gastritis, peptic ulcer, atrophic gastritis, gastric adenocarcinoma, and mucosa-associated lymphoid tissue lymphoma. Accurate diagnosis and sufficient efficacy evaluation duration are both critical for effective treatment to avoid precancerous conditions.

Aims & Methods

This retrospective, observational, multicenter, real-world study (NCT05073367) was performed across 3 hospitals using a preexisting electronic medical record (EMR) database between January 1, 2019, and March 31, 2021, to evaluate the diagnosis and treatment pattern of H. pylori infection in China. The study included adult patients (aged ≥18 years) with a record of diagnostic tests or positive results of H. pylori infection. Here we analyzed the current pattern of diagnosis testing, eradication efficacy testing after eradication therapy, and the duration (≤4 or >4 weeks) from the termination of eradication therapy to efficacy evaluation testing.

Results

A total of 22,971 patients with H. pylori infection data was extracted from EMR databases. Among them, 15,712 patients had 15713 initial diagnostic testing records before the eradication therapy (One participant had both RUT testing and UBT at the index date), and 1,626 patients received efficacy evaluation after the eradication therapy. Of 15,713 initial diagnostic testing records, non-invasive testing was the main diagnostic test used by 99.99% (n=15,712) of records, and invasive testing was used by only 0.01%（n=1）. Among non-invasive testing, ¹³C- Urea breath testing (UBT) was used by 76.8% and ¹⁴C-UBT was used by 23.19%. An increasing trend was observed in the use of ¹³C-UBT diagnostic test with 47.54%, 73.20%, and 99.98% in 2019, 2020, and 2021, respectively. ¹⁴C-UBT was 52.46% in 2019，26.80% in 2020，0% in 2021.Among 1,426 patients with eradication efficacy evaluation (duration ≥ 4 weeks), non-invasive testing- UBT was the only evaluation method used, with ¹³C-UBT in 72.3% and ¹⁴C-UBT in 27.7%. In 2019, ¹³C-UBT was used by 53.69%, in 2020 it was 69.88%, and in 2021, ¹³C-UBT was the only evaluation method to assess the efficacy (Table 1). The mean (Standard Deviation) duration from the termination of eradication therapy until the eradication efficacy evaluation testing was 7.0 weeks (4.37). Of 1626 patients with efficacy evaluation, 87.7% had > 4 weeks duration and 12.3% had ≤ 4 weeks. In 2019, 83.4% had a duration of > 4 weeks, 91.21% in 2020, and in 2021, 90.68% had a duration of > 4 weeks to receive an efficacy evaluation.
Table 1. Diagnostic Testing Used Before and After Eradication Therapy

Testing condition	Total count (N)	Invasive testing, RUT, n (%)	Overall Noninvasive testing, UBT, n (%)	Noninvasive testing, 13C-UBT, n (%)	Noninvasive testing, 14C-UBT, n (%)
Diagnostic testing used before eradication therapy	15,713*	1 (0.01)	15,712 (99.99)	12,068 (76.80)	3644 (23.19)
· Year 2019 Year 2020 Year 2021	4516 4757 6440	0 (0) 0 (0) 1 (0.02)	4516 (100) 4757 (100) 6439 (99.98)	2147 (47.54) 3482 (73.20) 6439 (99.98)	2369 (52.46) 1275 (26.80) 0 (0)
efficacy evaluation testing used after eradication therapy ≥ 4 weeks	1426	0 (0)	1426 (100)	1031 (72.30)	395 (27.70)
· Year 2019 Year 2020 Year 2021	583 415 428	- - -	583 (100) 415 (100) 428 (100)	313 (53.69) 290 (69.88) 428 (100)	270 (46.31) 125 (30.12) 0 (00.00)

Abbreviations: RUT, Rapid Urease Test; UBT, Urea Breath Testing
*A patient may have ≥1 diagnostic test. One participant had both RUT testing and UBT at the index date.

Conclusion

In China, non-invasive testing was dominant for the initial diagnosis of H. pylori infection, and ¹³C UBT was commonly used compared with ¹⁴C-UBT. The eradication efficacy evaluation testing was the same. Even over a tenth had insufficient evaluation duration, a higher proportion of evaluation duration >4 weeks was discovered with an increasing tendency.

Disclosure

The study was funded by Takeda China. Wensheng Pan, Yan Zhao, and Hongwei Xu have no conflicts of interest. Pengfei Li, Fang Zhou, and Li Xie are the employees of Takeda, and they hold Takeda stock options. Medical writing for the development of this abstract was provided by Kusuma Kumari G, Ph.D., of Indegene Private Limited, and funded by Takeda China. Authors retained full control of the abstract content.

Introduction

Renal disorders are among the extra-intestinal manifestations of inflammatory bowel disease (IBD), and treatments may also lead to renal failure. However, the incidence of end-stage renal disease (ESRD), defined as the need for renal replacement therapy (dialysis and/or renal transplantation (RT)), is poorly known. The primary objective of our study was to assess the incidence of ESRD in IBD patients, and to compare it with the general health insurance scheme population.

Aims & Methods

We conducted a prognostic cohort study based on data from the French National Health Insurance Database(SNDS). Prevalent cases of IBD affiliated to the general health insurance scheme during the period 2011-2020 were identified on the basis of declarations long-term diseases ALD 24 or the presence of 2 hospital stays for IBD with ICD-10 codes or a single stay with reimbursement of specific treatments. Incident cases of ESRD were identified on the basis of a stay with a RT or a period with dialysis sessions for at least 45 days. Crude incidence rates of ESRD were calculated over the period for the IBD and the non-IBD population, with their 95% confidence intervals.

Results

A total of 280,283 IBD patients were included in the study over the period 2011-2020, 134,567 with ulcerative colitis(UC) and 145,716 with Crohn’s disease(CD). The mean age at study inclusion was 39.8 (± 17.1) years. The M/F sex ratio was 0.9. The mean age at incidence of ESRD in the non-IBD population was 65.0 (±17.0) years, the M/F sex ratio cases was 1.7.
Among IBD patients, 534 patients began replacement therapy by dialysis or RT, they were younger than non-IBD patients (60.3(±16.7)years, P<0.001).The mean incidence rate of ESRD over the period was 26.4 per 100,000 person-years (IC95% 23.1-29.6), 480 (89.9%) patients entered ESRD by dialysis, and 54 (10.1%) by preemptive RT. In the non-IBD population the mean rate of ESRD was 15.9 per 100,000 person-years (IC95% 14.8- 17.1; P<0.0001 compared with IBD): 79,606 (94.5%) patients entered ESRD by dialysis, and 4,634 (5.5%) by RT (as compared with IBD,P<0.001). In subgroup analysis, the mean incidence rate of ESRD was 22.8 per 100,000 person-years (IC95% 18.9-26.7) in UC patients and 29.5 (IC95% 25.3-33.6) in CD patients (P<0,0001). The rates of preemptive RT were 12.4% in UC patients (87.6% dialysis) and 8.6% in CD patients (91.4% dialysis).
Over a median follow-up of 6.8 years, the survival rate after ESRD was 40.8% in ESRD-IBD patients VS 34.2% in ESRD non-IBD patients (P<0.001). This difference remained significant for patients under 65 (p<0.0073).
No significant difference for the risk of re-hospitalization after RT (p=0.84), of retransplantation during the follow-up period in RT patients (p=0.67), or for the risk of hospitalization for severe infection (p=0.97) after RT in patients from the general population compared with IBD patients. The same was true for the type of severe infections after RT (p= 0.068) and for the risk of solid and haematological cancer after RT (p=0.48). However, there was a significant difference in the type of first severe infection after RT(p=0.003), but we are waiting for the results to tell us which one.

Conclusion

The incidence of ESRD is significantly higher in IBD than in the general data base population, confirming the need for regular monitoring of renal function in our patients.
Survival after ESRD onset, is higher in IBD patients.
The high incidence of RT in the IBD population confirms that access to transplantation is not restricted in this
population.

References

Kirchgesner et al, Gastroenterology 2018
Meyer et al, Aliment Pharmacol Ther. 2020
Tuppin et al, Nephrol Ther 2016

Introduction

Patients with IBD often have related anxiety and depression which may negatively impact disease activity and have been consistently highlighted as an unmet need by patient groups. Timely access to psychiatric and psychological support can be difficult and costly. We investigated the effectiveness of a novel cognitive behavioural therapy (CBT) program delivered by a trained mental health nurse in place of a formal psychologist.

Aims & Methods

A retrospective review of all CBT referrals made for adult patents between Sep 2019 – Dec 2022 in a tertiary IBD Centre. Referrals were from IBD Consultants, senior medical Trainees, IBD Nurses and a liaison psychiatrist. Patients are offered high-intensity CBT for up to 8 consecutive weeks as per local protocol of a minimum 4 sessions. The CBT took place virtually; over the phone or video call via MS Teams. Patients who completed at least 4 sessions of CBT were included in this review.
Our primary measure was to assess if there was an improvement in mental health using CORE-10, a brief validated psychometric questionnaire, completed at the start and end of therapy. A score of greater than 11 was an indicator of psychological distress, and a reduction of 6 points is clinically meaningful[i].

Results

96 patients were referred to the inflammatory bowel disease CBT service. Of those 47 patients went on to complete at least 4 sessions of CBT, with an average age of 33. 91% of referrals were for either anxiety or depression. With other cited indications including; anger management, PTSD and functional pain.
15 patients (32%) had UC, 31 patients (66%) had Crohn’s disease and 1 patient had indeterminate colitis. The majority of patients had 8 sessions of CBT of which all were completed virtually. The average disease duration was least 8 years at the time of referral.
26 (55%) of patients were on biologics at the time of initiating CBT, with 23% patient of patients referred having undergone at least one surgery prior to referral. Physician global assessment at the initiation of CBT showed 25 (56%) patients were in clinical remission. 21 (45%) patients were in clinical remission following their course of CBT.
Following the completed CBT sessions 37 patients had some improvement in their CORE-10 score with a mean reduction for all patients of 7.6. 20 patients had a CORE-10 reduction of at least 6. 33 patients (70%) had a CORE10 score of >11 at baseline, indicating significant psychological distress. Of the 33 patients with an initial score >11, 20 patients 61% showed reliable clinical improvement.
10 patients (21%) referred for CBT showed, either an increase (8 patients) or no change (2 patients) in their CORE10 score following at least 4 sessions of CBT.

Conclusion

Studies have consistently demonstrated a high burden of anxiety amongst patients with IBD which can have a detrimental effect on quality of life and disease outcomes. CBT delivered by a trained mental health nurse is an effective and relatively low-cost intervention for patients with IBD, delivering beneficial treatment outcomes, and maintaining good levels of engagement; including those with a severe phenotype of disease.
CBT did not significantly influence disease activity as measured by physician global assessment.

References

[i] Barkham, M., Bewick, B., Mullin, T., Gilbody, S., Connell, J., Cahill, J., Mellor-Clark, J., Richards, D., Unsworth, G. and Evans, C. (2013b). The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13(1), pp.3–13. doi:https://doi.org/10.1080/14733145.2012.729069.

Disclosure

nil

Introduction

Metabolic Associated Steatotic Liver Disease (MASLD) affects 25-30% of the European population and is projected to rise further. These patients are at increased risk for liver-related complications and higher overall mortality, emphasizing the need for early detection to improve outcomes. While abdominal ultrasound serves as the primary imaging modality for suspected liver disease, its sensitivity for diagnosing mild steatosis is inadequate, and gold-standard methods for quantifying liver steatosis infiltration, such as magnetic resonance imaging or liver biopsy are impractical for widespread use.

Aims & Methods

This study aimed to assess the diagnostic accuracy of the Attenuation Coefficient (ATT) as a complementary method to B-mode ultrasound for early detection of hepatic steatosis. Consecutive patients referred for transient elastography were prospectively enrolled. Liver steatosis was graded using a 4-point scale (normal, mild, moderate, or severe) in B-mode ultrasound for each patient, and ATT was measured in accordance with manufacturer quality criteria instructions (Fujifilm®). Additionally, the Hepato-Renal Index (HRI) was calculated for each patient, and Controlled Attenuation Parameter (CAP, Fibroscan®) was measured.

Results

A total of 128 patients, 61.7% male, with a mean age of 56.8±12.8 years, were included. Among them, 78.1% exhibited at least one cardiometabolic risk factor. The main referral indications were fibrosis assessment in viral hepatitis (42.2%), MASLD (21.9%), and alcoholic liver disease (11.7%). The median vibration-controlled elastography result was 5.8kPa. B-mode ultrasound steatosis assessment classified 44.5% as normal, 10.2% with mild steatosis, 21.1% with moderate steatosis, and 24.2% with severe steatosis. The area under the ROC curve for steatosis detection was 0.796 for HRI, 0.894 for ATT, and 0.896 for CAP, highlighting robust diagnostic performance, particularly for the latter two methods. There was a strong correlation between ATT and CAP (r=0.710). Using a CAP>248dB/m to define steatosis, the area under the ROC curve for ATT was 0.890. For an ATT cutoff value ≥0.66, Sensitivity, Specificity, Negative Predictive Value, and Positive Predictive Value were 82.7%, 77.3%, 72.3%, and 86.1%, respectively. The sensitivity of B-mode ultrasound for steatosis detection was 79.5%, increasing to 90.4% when combined with ATT measurement.

Conclusion

ATT demonstrated excellent accuracy for steatosis detection, comparable to CAP and superior to HRI. Importantly, combining B-mode ultrasound with ATT significantly improved the diagnostic sensitivity. These findings suggest that ATT has the potential to become a valuable non-invasive tool alongside ultrasound for early detection of hepatic steatosis, aiding in earlier intervention and improved patient outcomes.

References

Tamaki N, Koizumi Y, Hirooka M, et al. Novel quantitative assessment system of liver steatosis using a newly developed attenuation measurement method. Hepatol Res. 2018;48(10):821-828. doi:10.1111/hepr.13179
Bozic D, Podrug K, Mikolasevic I, Grgurevic I. Ultrasound Methods for the Assessment of Liver Steatosis: A Critical Appraisal. Diagnostics. 2022;12(10):2287. doi:10.3390/diagnostics12102287

Introduction

Helicobacter pylori (HP) is regarded as a class I carcinogenic factor and eradication therapy can reduce the risk of gastric cancer. Patients with HP infections are administered with bismuth quadruple therapy (BQT), triple and dual therapies based on their eradication effectiveness. BQT (bismuth + acid suppressants + 2 antibiotics) and dual therapy are both recommended in China now. Comprehensive understanding on the distribution of current eradication therapies is required to identify gaps observed in real-world practice.

Aims & Methods

This multicenter, retrospective, real-world study (NCT05073367) extracted preexisting electronic data including adult patients (aged ≥18 years) with HP infection between January 1, 2019 and March 31, 2021 from 3 hospitals to assess the diagnosis and treatment pattern of HP infection and effectiveness of eradication therapy in China. In this abstract, we reported the distribution of eradication therapies, difference in initiation year for treatment, and treatment duration.

Results

Of the 22,971 eligible patients with HP infection, 13,233 (57.61%) were prescribed eradication regimens. Mean ± SD age of patients with eradication treatment was 43.7 ± 14.0 years; 65.94% of patients had medical insurance; and 54.50% of patients were women.
In patients who received eradication therapy, the BQT therapy was predominantly prescribed (85.39%; n=11301), followed by triple therapy (7.55%; n=999) and dual therapy (7.06%; n=934). Among those receiving BQT, use of amoxicillin + clarithromycin based regimens (38.72%; n=4376) were the most prevalent, followed by amoxicillin +furazolidone (18.35%; n=2074) and amoxicillin + levofloxacin (17.76%; n=2007) based combination regimens. Proportion of patients receiving BQT decreased over years: 97.24% patients in 2019, 79.98% in 2020, and 78.71% in 2021. The proportion of patients receiving dual and triple therapy increased over the years in 2019, 2020, and 2021 were shown in Table 1. A total of 10,903 patients were analyzed according to various treatment durations with the usage of various eradication therapies. Treatment duration is defined as the number of days that prescribed drugs can cover. Out of the three types of treatments, BQT had the highest proportion of 14-day treatment duration at 90.16%, followed by triple therapy at 76.78%, while dual therapy had the least proportion at 14.42%. For treatment duration >14 days, BQT, dual and triple therapy had a proportion of 4.38%, 82.35%, and 17.27% respectively.
Table 1. Distribution of eradication therapy based upon the type and year of treatment initiation

Treatment	Type of Eradication therapy (N=13, 234) n (%)a	Year of treatment initially prescribed , 2019 (N=4492) n (%)a	Year of treatment initially prescribed, 2020 (N=4125) n (%)a	Year of treatment initially prescribed, 2021 (N=4616) n (%)a
Total Bismuth quadruple therapy Amoxicillin and Clarithromycin Amoxicillin and Furazolidone Amoxicillin and Levofloxacin Amoxicillin and Metronidazole Amoxicillin and Tetracycline Furazolidone and Tetracycline Other Bismuth quadruple Triple therapyc Dual therapyc	13,234b (-) 11,301 (85.39) 4376 (38.72) 2074 (18.35) 2007 (17.76) 76 (0.67) 9 (0.08) 12 (0.11) 2747 (24.31) 999 (7.55) 934 (7.06)	4492 (-) 4368 (97.24) 1800 (41.21) 689 (15.77) 1021 (23.37) 27 (0.62) 5 (0.11) 1 (0.02) 825 (18.89) 105 (2.34) 19 (0.42)	4125 (-) 3299 (79.98) 1324 (40.13) 480 (14.55) 516 (15.64) 10 (0.30) 1 (0.03) 0 (0.00) 968 (29.34) 551 (13.36) 275 (6.67)	4617 (-) 3634 (78.71) 1252 (34.45) 905 (24.90) 470 (12.93) 39 (1.07)) 3 (0.08) 11 (0.30) 954 (26.25) 343 (7.43) 640 (13.86)

Abbreviations: N, total number; n, number in respective category.
^a% = The total usage count of BQT or Triple or Dual eradication therapy/the total usage count of all standard eradication therapies received by eligible participants. Of BQT, the total usage count of different BQT/the total usage count of all BQT.
^bThere is a recurrent patient who changed the treatment pattern from triple therapy (ilaprazole, clarithromycin, levofloxacin) to dual therapy (ilaprazole, ornidazole) after the recurrence.
^cConsidering the table size, outcomes of different treatment regimens under dual and triple therapy were not included in the table.

Conclusion

BQT-based regimen for 14 days was the predominant eradication regimens in all therapies, amoxicillin + clarithromycin based BQT was the most prevalent. Use of dual therapy gradually increased with years for HP eradication in the Chinese real-world clinical practice.

Disclosure

The study was funded by Takeda China. Wensheng Pan, Yan Zhao, and Hongwei Xu have no conflicts of interest. Pengfei Li, Fang Zhou, Li Xie are the employees of Takeda, and they hold Takeda stock options. Medical writing for the development of this abstract was provided by Kusuma Kumari G, PhD, of Indegene Private Limited, and funded by Takeda China. Authors retained full control of the abstract content.

Introduction

PEUGIC (Post-Endoscopy Upper Gastrointestinal Cancer) is defined as carcinoma in the upper gastrointestinal (GI) tract which was preceded by negative upper endoscopy in the last 3 years. According to current knowledge, the rate of PEUGIC is an important parameter of quality and should not exceed 10 %. The aim of this study was to evaluate the occurrence and risk factors of PEUGIC at non-university hospital in Frydek-Mistek (Czech Republic) between 2013 and 2023.

Aims & Methods

This is a retrospective analysis of the patients diagnosed with upper GI cancer from January 2013 to December 2023. The data analyzed included family history of upper GI cancer, indications of the examination, therapy, tumor location and histological type. Risk factors for PEUGIC were calculated using the Chi-squared test and Fisher's exact test, with p <0,05 considered significant.

Results

During the study period, a total of 22727 gastroscopies were performed in total, and 122 patients were diagnosed with upper GI cancer (88 men and 34 women), including 35 esophageal tumors, 80 gastric tumors, and 7 duodenal tumors. Family history of upper GI tumor was reported in 10 patients. PEUGIC was identified in 12 patients (9,84%, 9 men and 3 women, mean age 69,25 years), including 6 in the esophagus, 5 in the stomach, and 1 in the duodenum. Two patients had early detection as part of adequate surveillance (Barrett's esophagus, post-polypectomy). Thus, we can evaluate 10 patients as true PEUGIC (8,20%). The rate of PEUGIC was 17,14 % (6/35) in the esophagus, 6,25 % (5/80) in the stomach, and 14,3 % (1/7) in the duodenum. Tumor location (for esophagus p=0,086, for stomach p=0,065, for duodenum p=0,525), histology (for adenocarcinoma p=0,332, for spinocelular cancer p=0,402, for neuroendocrine tumor p=0,25), male gender (p=0,815), or family history of upper GI tumor (p=0,335) were not statistically significant risk factors for detecting PEUGIC.

Conclusion

The overall rate of PEUGIC at our institution over the 11-year study period was 9,86 %, without early detected lesions as part of adequate surveillance, it was 8,20 %. Early detection of PEUGIC, which indicate poorer endoscopy quality, need to be distinguished from early detection of carcinoma within adequate surveillance.