Introduction

The prevalences of Barrett’s esophagus (BE) are gradually increasing in recent decades in some Asia-Pacific regions, thus an accurate diagnosis of BE is important to determine the surveillance program. However, most endoscopists in Asia did not adhere to the Seattle biopsy protocol, and the optimal numbers of endoscopic biopsies and their yield rates of intestinal metaplasia (IM) and dysplasia had never been elucidated.

Aims & Methods

The aim of this study is to investigate the yield of IM and dysplasia according to the biopsy numbers. We retrospectively reviewed the upper gastrointestinal endoscopic reports from the database of outpatient setting from January 2008 to December 2020 at E-Da hospital in Taiwan. The numbers of biopsy, length of columnar-lined esophagus (CLE) and the corresponding histology were analyzed to assess the yield rates of IM and dysplasia per-biopsy in patients with endoscopic CLE and without visible cancerous lesions.

Results

A total of 120,362 endoscopies were reviewed, and 5,963 (5.0 %) cases in 3,135 patients were diagnosed as endoscopic CLE (Length, mean:1.4±0.97cm; range, 1-10). The time-trend of cases of endoscopic CLE and BE were slightly increasing in recent decades. Among them, 4,675 (78.4%) cases received a total of 8887 biopsies (number, median: 1; range, 1-9). The histology from biopsies revealed that 1,642 (35.1%) cases and 217 (4.6%) cases per-endoscopy yielded the IM and dysplasia, respectively (Table 1). Among the 913 patients with histology-confirmed BE, the mean age was 53.2 (53.2±15.1) years old and short-segment (<3cm) Barrett's esophagus (SSBE) were predominated (91%). Overall, the yields of IM (75% vs. 33%) and dysplasia (17% vs. 3.5%) were both higher in the long-segment than those in short-segment CLE. The yield rates were positively correlated with the numbers of biopsies for both IM and dysplasia in short-segment CLE. Taking one biopsy only revealed a 26% yield of IM and 3.5% yield of dysplasia, respectively. On the contrary, one biopsy could get a 53% yield of IM and 14% yield of dysplasia in long-segment CLE.

Table 1. yields of intestinal metaplasia according to the number of biopsies per-endoscopy

Conclusion

Sampling bias is a major concern in current clinical practice for diagnosis and management of Barrett’s esophagus. The yield rates of IM and dysplasia were suboptimal by taking one biopsy, especially for short-segment CLE. A randomized study is required to determinate the optimal biopsy number for SSBE-predominant Asian populations.

Disclosure

There was no conflict of interest

Introduction

Many irritable bowel syndrome (IBS) patients report gastrointestinal (GI) symptoms due to various foods, resulting in food avoidance. However, a detailed description of trigger foods and related GI symptoms and avoidance behaviour is lacking. Therefore, we evaluated the extent and nature of food intolerance and avoidance in IBS patients, and its relation to GI symptoms and psychological comorbidities.

Aims & Methods

Food intolerance and avoidance behaviour were evaluated in 124 IBS patients and 113 healthy controls (HC) using a questionnaire with 257 food products of 13 food groups. Per product, participants were asked if they experience symptoms (i.e. nausea, constipation, diarrhoea, bloating, abdominal pain) after consumption, and if they consumed this product despite these symptoms. Furthermore, IBS symptom severity and psychological factors were assessed.

Results

IBS patients reported a higher number of food products with perceived intolerance than HC (median of 18.0 (25^th-75^th percentile 10.0-33.5) vs 1.0 (0.0-8.0), p<0.001). A wide variety of trigger foods was reported, with gas-producing foods and fatty/cream-based dairy products most frequently reported by both groups. Predominant symptoms were abdominal pain and bloating. The number of avoided foods was higher in IBS (15.0 (8.0-27.0) vs 1.0 (0.0-7.0), p<0.001). Food avoidance was not significantly related to symptom type, but was associated with an IBS diagnosis, female sex, and higher screening scores for somatisation and Avoidant/Restrictive Food Intake Disorder.

Conclusion

Self-reported food intolerance and avoidance is higher in IBS than HC, with a wide variety of trigger foods. Food avoidance was significantly related to psychological factors, but not to symptom type. This warrants individual dietary guidance, as well as attention for psychological factors.

Disclosure

D Keszthelyi: DK reports receiving research funding from ZonMw, MLDS, UEG, Rome Foundation, Horizon Europe, Horizon 2020, Grunenthal, Allergan and speaker’s fee from Dr Falk (paid to host institute).
DMAE Jonkers: DMAEJ reports receiving a public–private partnership grant of TKI Well on Wheat? and TKI grants from Agri & Food and Health Holland, the Carbokinetics programme as part of the Netherlands Organisation for Scientific Research–Carbohydrate Competence Center partnership, Organic A2BV/Mothersfinest, and Horizon 2020.

Introduction

The acid-suppressive drug such as proton pump inhibitor (PPI) is one of treatment options for functional dyspepsia (FD). However, the efficacy of potassium-competitive acid blockers(P-CABs) for treating FD is not established. This study aimed to assess the efficacy and safety of tegoprazan in patients with FD in a prospective, multicenter clinical trial.

Aims & Methods

Investigated FD was diagnosed using the Rome IV criteria. All patients received tegoprazan 50mg once daily for 8 weeks. Dyspeptic symptoms were assessed by a dyspepsia symptom questionnaire (5-point Likert scale, NDI-K, and GERD-HRQL). The main outcome was the rate of satisfactory relief of dyspeptic symptoms at 8weeks.

Results

A total of 173 patients were enrolled in this study. The rate of satisfactory relief of dyspeptic symptoms at 4 and 8weeks was 74.6% and 86.7%, respectively. The complete symptom relief rate at 4 and 8weeks was 15.0% and 24.9%, respectively. The symptom resolution rate was significantly higher at 8weeks than at 4weeks. (86.7% vs. 74.6%, p<0.001; 24.9% vs. 15.0%, p=0.003). The mean score of NDI-K and GERD-HRQL also significant decreased at 8weeks. The efficacy was not influenced by subtypes of FD or Helicobacter pylori status. There was no serious adverse event or death during the study.

Conclusion

Tegoprazan 50mg once daily significantly provides satisfactory symptom relief for FD. (International clinical trial registry number: KCT0005600)

Introduction

ESD of the colorectal lesions involving the appendiceal orifice (AO) is technically challenging because of the thin wall and narrow working space. On the other hand, even if the lesions are small and benign, it is difficult to perform EMR because of the narrow snaring space. We previously reported strip biopsy (SB) resection of the AO lesion. The SB technique is as follows (1) Insert a 2-channel scope and check the lesion. (2) Insert a snare and grasping forceps into each channel, and hold the grasping forceps in the snare. (3) Grasp the appendiceal end of the lesion with the grasping forceps, open the snare, grasp the lesion, and resect it. This method makes it possible to snare the lesion after confirming the distal border of the AO. In the present study, we evaluated the feasibility of SB for AO lesions.

Aims & Methods

This was a retrospective study in which SB for AO lesions was performed on 10 patients at our hospital. Inclusion criteria for the study cohort were (1) the lesion less than 15 mm, and (2) visible lesion margin on the appendicular side. Polyps suspected to be cancerous were excluded.

Results

Male to female ratio was 8:2, median age (range) was 76 years (44-89). The median tumor size was 10 mm (10-15). The pathological findings were 8 cases of SSL and 2 cases of low-grade tubular adenoma. All lesions were resected en bloc, with a median treatment time of 10 minutes (range (5-10)). No complications were observed. Pathology results were negative for 8 cases and unknown for 2 cases. All lesions were resected endoscopically with no residuals.

Conclusion

SB technique for AO lesions is safe and it appeared that this could be one option for endoscopic treatment of AO lesions.^​

Introduction

CT-P13 subcutaneous (SC) infliximab formulation demonstrated superiority over placebo in maintenance therapy in Crohn's disease (CD)¹ and Ulcerative Colitis (UC)² patients in two parallel 54 weeks studies (LIBERTY-CD and LIBERTY-UC). We performed a post-hoc subgroup analysis comparing patients treated with CT-P13 SC with and without combination immunosuppressants (IS) at baseline in CD and UC.

Aims & Methods

Patients with moderately to severely active CD and UC who responded at W10 to CT-P13 intravenous infliximab 5mg/kg (Weeks 0, 2 and 6) were randomized (2:1) to receive CT-P13 SC 120 mg (CT-P13 SC) or placebo every 2 weeks until W54 as maintenance therapy. IS (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) were allowed if patients maintained stable doses at least 8 weeks prior to W0, and stable doses were maintained up to W54.

Results

231 CD and 294 UC patients were randomized to receive CT-P13 SC maintenance therapy. Among them, 71 (30.7%) and 65 (22.1%) patients received CT-P13 SC with IS in CD and UC, respectively (In CD; 63, 4 and 4 patients of AZA, 6-MP, MTX, respectively, In UC; 63, 2 and 0 patients of AZA, 6-MP, MTX, respectively). There were no statistically significant differences in all of the efficacy outcomes between monotherapy and combination therapy groups at W54 in both studies (Table 1). A trend is seen for higher rates of corticosteroid-free remission with combination therapy in both CD and UC patients.
No statistically significant differences were seen between monotherapy and combination therapy groups in the maintenance period in incidences of treatment-emergent adverse event (TEAE), systemic injection reactions (SIR) in combined analysis of CD and UC patients (TEAE 68.0% vs 74.3% [p=0.1989], SIR 3.3% vs 1.4% [p=0.3743], respectively).
A significantly lower incidence of infection was seen with monotherapy during the maintenance period in combined analysis of both studies (26.9 % monotherapy vs 36.4% combination therapy [p=0.0400]). In the combined analysis of both studies, the serious infections were reported for 10 (2.5%) patients in the monotherapy and 3 (2.1%) patients in the combination therapy.
In combined analysis of CD and UC patients, rate of anti-drug antibody [ADA] positive conversion up to W54 was statistically lower in combination therapy group (70.2% monotherapy vs 47.8% combination therapy [p<0.0001]).

Table 1. Proportion of patients achieving efficacy outcomes at W54

Conclusion

No statistical differences in efficacy outcomes at W54 were observed between monotherapy and combination therapy in CD and UC patients. Concomitant IS use was associated with less ADA formation, whereas more infections are seen for combination therapy during maintenance period in CD and UC patients. The overall safety profile during maintenance period was otherwise comparable between monotherapy and combination therapy in CD and UC patients. This post-hoc analysis suggests limited benefit of concomitant IS with CT-P13 SC but a higher infection risk. Notably, patients were not randomized according to IS use nor were the studies ‘powered’ to demonstrate differences.

References

1 Colombel JF et al. DOP86 Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: A phase 3, randomised, placebo-controlled study (LIBERTY-CD). Journal of Crohn’s and Colitis. 2023;17(Supplement_1):i161-i162
2 Sands BE et al. P492 subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A phase 3, randomized, placebo-controlled study: Results of the Liberty-UC Study. Journal of Crohn's and Colitis. 2023;17(Supplement_1):i623–i624.

Disclosure

- S. Schreiber: Consultancy and personal fees from AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, Falk, Ferring, Fresenius, Gilead, HIKMA, IMAB, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Sandoz, Takeda, and Theravance.
- J.F. Colombel: Receiving research grants from AbbVie, Janssen Pharmaceuticals and Takeda. Receiving payment for lectures from AbbVie, Amgen, Allergan, Inc. Ferring Pharmaceuticals, Shire, and Takeda. Receiving consulting fees from AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi,Takeda, TiGenix, Vifor. Hold stock options in Intestinal Biotech Development.
- S.B. Hanauer: Consultancy from AbbVie, Allergan, Amgen, Arena, Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cosmos, Catalys Pacific, Covance, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Progenity, Prometheus, Receptos, Salix, Samsung Bioepis, Seres Therapeutics, Sorriso, Takeda, TLL, UCB, Vhsquared. Clinical Research for AbbVie, Allergan, Amgen, Celgene, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer, Prometheus, Receptos, Takeda, UCB. Speaker for AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Takeda. Independent Data Monitoring Conference for Arena, Boehringer Ingelheim, Bristol Myers Squibb, Gossamer, Prometheus, Protagonist.
- W.J. Sandborn: Consulting fees from Abbvie, Abivax, Alfasigma, Alimentiv, Beigene, Biora (Progenity), Celltrion, Forbion, Genentech, Gossamer Biosciences, Index Pharmaceuticals, Prometheus Biosciences, Protagonist Therapeutics, Shoreline Biosciences, Vedanta Biosciences, Ventyx Biosciences, Zealand Pharma. Stock or stock options from BeiGene, Gossamer Bio, Biora (Progenity), Prometheus Biosciences, Prometheus Laboratories, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivreon Gastrosciences. Employee at Shoreline Biosciences and Ventyx Biosciences.
- B.E. Sands: Consultant/ Speaker’s fees from AbbVie, Abivax, Adiso Therapeutics, Alimentiv, Amgen, Arena Pharmaceuticals, Artizan Biosciences, Artugen Therapeutics, AstraZeneca, Bacainn Therapeutics, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celltrion Healthcare, ClostraBio, Connect Biopharm, Cytoki Pharma, Eli Lilly and Company, Entera, Evommune, Ferring, Fresenius Kabi, Galapagos, Gilead, Genentech, Glaxo SmithKline, Gossamer Bio, HMP Acquisition, Imhotex, Immunic, InDex Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Ironwood Pharmaceuticals, Janssen, Johnson & Johnson, Kaleido, Kalyope, Merck, MiroBio, Morphic Therapeutic, MRM Health, OSE Immunotherapeutics, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, RedHill Biopharma, Sun Pharma Global, Surrozen, Synlogic Operating Company, Takeda, Target RWE, Theravance Biopharma R&D, TLL Pharmaceutical, USWM Enterprises, Ventyx Biosciences, Viela Bio. Stock options from Ventyx Biosciences.
- S. Danese: Consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor. Reports lecture fees from Abbvie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
- S.J. Lee, S.H Kim, Y. Bae, S. Lee, S.G. Lee, J.H. Lee, J.M. Kim, S. Yang, J. Lee, G. Park, J. Lee: Employee of Celltrion, Inc.

Introduction

The revised Finnish guidelines for coeliac disease in 2018 enabled for the first time to establish a no-biopsy diagnosis in adults with serum transglutaminase antibodies >10x upper limit of normal and positive endomysial antibodies. We investigated the implementation of the new guidelines and significance of the diagnostic process on the treatment success and patients´ experiences.

Aims & Methods

Altogether 194 adult members of the Finnish Coeliac Society diagnosed after 2018 answered to a comprehensive study questionnaire concerning socio‐demographic and health-related characteristics and quality of life and various coeliac disease-related issues. The results were compared between patients diagnosed with and without duodenal biopsy.

Results

Sixty-nine (36%) patients were diagnosed without a biopsy. They were younger (median age 44 vs. 52 years, p=0.029), diagnosed less often in hospital settings (11% vs. 35%, p=0.001), suffered less often from oesophageal symptoms (17% vs. 30%, p=0.047) and osteoporosis (1% vs. 10%, p=0.035) and experienced the diagnostic process more often easier (49% vs. 30%, p=0.032) than those diagnosed by biopsy (n=125). The no-biopsy group had also been informed on their diagnosis more often by other healthcare professional than a physician (14% vs. 4%, p=0.046) and reported more persistent symptoms (36% vs. 21%, p=0.026) and stress due to the gluten-free diet (68% vs. 47%, p=0.042). The groups did not differ in gender, socio-economic characteristics, general health, quality of life, other than oesophageal symptoms, diagnostic delay, presence of follow-up or experiences of a gluten-free diet or dietary adherence. After adjusting the groups with age, the difference in osteoporosis was no longer significant.

Conclusion

Up to one-third of adult coeliac disease patients were diagnosed without gastrointestinal endoscopy, which may provide less burdensome diagnostic process and significant healthcare savings. However, increased risk for persistent symptoms and dietary stress in these patients remind that adequate guidance at diagnosis regardless of the diagnostic process and healthcare unit should be provided.