Introduction

Evidence is scarce regarding the impact of overweight and obesity on the interpretation of high-resolution esophageal manometry (HREM) parameters. We aimed to investigate whether the presence of overweight and/or obesity influences the HREM parameters.

Aims & Methods

Retrospective cohort study including adult patients undergoing HREM (Manoscan® 36-sensor probe) between 2019-2022, regardless of the indication, with measurement of height and weight at the time of HREM. A HREM diagnosis was obtained according to the Chicago 4.0 classification and the following HREM parameters were collected: esophageal length, length and type of esophagogastric junction (EGJ), presence and extent of hiatal hernia, minimum basal, mean and residual lower esophageal sphincter pressures, basal and residual upper esophageal sphincter pressures, percentage of failed, weak, ineffective, with pressurization, premature, fragmented, intact, hypercontractile swallows and mean and after multiple rapid swallows distal contractile integral. Body mass index (BMI) was calculated, and patients were categorized as underweight (<18.5), normal weight (18.5-24.9), overweight (25-29.9) and obesity (≥30). The relationship between BMI and its categories with the HREM parameters was evaluated.

Results

A total of 249 patients were included, mostly women (59.8%) with a mean age of 56 ± 14 years. The median BMI was 26 (IQR 5) kg/m2 and 115 (46.2%) patients were overweight, 91 (45.7%) normal weight and 43 (17.3%) obese. A normal HREM (51.8%), followed by ineffective esophageal motility (21.7%) and EGJ outflow obstruction (8.8%) were the most frequent HREM diagnoses. There were no statistically significant differences between the presence of overweight and/or obesity and the HREM parameters evaluated, regardless of the HREM diagnosis.

Conclusion

Overweight and obesity do not seem to influence HREM parameters, so its interpretation should not be influenced by these factors.

Introduction

There has been a resurgence in the use of bismuth-quadruple therapy (PPI, bismuth, tetracycline and metronidazole) in Europe with the commercialization of a three-in-one single-capsule formulation, but the experience with this regimen is still limited.

Aims & Methods

To evaluate the effectiveness and safety of the three-in-one single-capsule in the European Registry on Helicobacter pylori management (Hp-EuReg).
International, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H. pylori management by European gastroenterologists. All infected adult patients treated with 10-day single-capsule according to data sheet (3 capsules/6h) or alternative three times a day (4 capsules/8h) prescriptions were systematically registered at AEG-REDCap e-CRF until January 2023. Variables included: Patient’s demographics, previous eradication attempts, prescribed treatment, adverse events, and outcomes. Modified intention-to-treat (mITT) and per-protocol (PP) analyses were performed, and data were subject to quality review.

Results

Of the 59,689 patients in the Hp-EuReg, 8,302 (14%) received single-capsule bismuth-quadruple therapy. The majority of these patients were naïve (75%), with an average age of 52 years, 62% female and 14% with peptic ulcer. Overall, the single-capsule achieved a high eradication rate based on the mITT (91.5%) and PP (92%) analyses. Effectiveness (mITT) was higher when using the single-capsule as a first-line treatment (93%), but it had also high effectiveness as a rescue therapy, both in second-line (87%) or subsequent lines of therapy (3^rd-6^th lines: 86%) (Table 1). Compliance with treatment (>90% of drug intake) was reported in 93% of cases and was the factor most closely associated with the effectiveness of treatment. Adverse events (26%) were generally mild-to-moderate and transient; only 0.1% of patients reported a serious adverse event, leading to the discontinuation of treatment in 1.7% of patients.

Conclusion

The 10-day treatment with single-capsule bismuth-quadruple therapy achieves H. pylori eradication in approximately 90% of patients by mITT in real-world clinical practice, both as a first-line and rescue treatment, with a favourable safety profile.

Disclosure

Olga P. Nyssen received research funding from Mayoly and Allergan.
Javier P. Gisbert served as speaker, consultant, and advisory member for or received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen.

Introduction

Autoimmune pancreatitis (AIP) is a rare disease that can be diagnosed, according to the International Consensus Diagnostic Criteria (ICDC). Contrast-enhanced MRI with MRCP has now largely replaced other imaging techniques and ERCP for the assessment of ductal morphology in AIP. A number of MRI-criteria have been proposed, but due to the rarity of the disease the diagnostic imaging criteria have not yet been systematically validated. Aim of the study is to review and optimize the MR-morphologic diagnostic criteria for AIP in terms of specificity and sensitivity in the diagnosis and differential diagnosis of the pancreaticobiliary system.

Aims & Methods

We analyzed retrospectively hundred-fiftysix (n=156) high-quality MRIs: AIP n=56, chronic pancreatitis (CP) n=25, pancreatic cancer (PDAC) n=25, primary sclerosing cholangitis (PSC) n=25, Non-HPB subjects n=25. The MRI reading was conducted in a blinded fashion, using defined criteria by at least two radiological experts. The statistical analysis was performed by means of Proportion test, Chi-square test or Fisher’s exact test, One-way ANOVA and Cohen’s Kappa Statistic of the level of agreement.

Results

The level of agreement between two readers was moderate to substantial agreement (κ 0.23-0.85). Sausage-like enlargment (Reader 1: Sens 30.91%, Spec 98.98%, NPV 71.85%, accuracy 74.51%; Reader 2: Sens 26.79%, Spec 98.00%, NPV 70.50%, accuracy 72.43%), restricted diffusion (Reader 1: Sens 47.83%, Spec 89.29%, NPV 75.76%, accuracy 74.51%; Reader 2: Sens 56.86%, Spec 73.26%, NPV 74.12%, accuracy 72.30%), delayed enhancement in the venous phase (Reader 1: Sens 8.70%, Spec 83.15%, NPV 63.79%, accuracy 74.10%; Reader 2: Sens 32.61%, Spec 79.31%, NPV 69.00%, accuracy 75.19%), the icicle sign (Reader 1: Sens 10.91%, Spec 100%, NPV 66.67%, accuracy 65.30%; Reader 2: Sens 37.50%, Spec 91.00%, NPV 72.22%, accuracy 71.79%) and hyperenhancement of ductal wall (Reader 1: Sens 14.29%, Spec 96.67%, NPV 67.44%, accuracy 71.90%; Reader 2: Sens 8.51%, Spec 95.45%, NPV 66.14%, accuracy 74.10%) show a good accuracy distinguishing AIP from controls. Apparent diffusion coefficient (ADC) was significantly different between AIP, PDAC and CP (ANOVA). The area under the receiver operating characteristic curve (AUROC) was 0.85 (CI 0.73 – 0.97) and 0.68 (CI 0.51 – 0.85) respectively for CP and PDAC.

Conclusion

Our study showed that the Sausage-like enlargment, restricted diffusion, delayed enhancement in the venous phase, the icicle sign and hyperenhancement of ductal wall show a good accuracy distinguishing AIP from controls.

Introduction

Several gastrointestinal diseases have been linked to acute pancreatitis, but the risk of acute pancreatitis in microscopic colitis (MC) has not been studied.

Aims & Methods

To assess the risk of acute pancreatitis in patients with MC, we conducted a nationwide, population-based, matched cohort study in Sweden of 12,140 patients with biopsy-verified MC (diagnosed in 2003-2017), 57,806 matched reference individuals, and 12,781 siblings without MC with follow-up until 2021. Data on MC were obtained from all of Sweden's regional pathology registers (n=28) through the ESPRESSO cohort. Data on acute pancreatitis were collected from the National Patient Register. Adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were calculated using Cox regression.

Results

During a mean follow-up of 9.9 years (SD=4.3), 146 MC patients and 437 reference individuals were diagnosed with acute pancreatitis (127.8 vs. 80.1 per 100,000 person-years), corresponding to an aHR of 1.57 (95%CI=1.30-1.90). Moreover, we found a positive association between MC and acute non-gallstone-related pancreatitis (aHR 1.99 (95%CI=1.57-2.51)), but not with acute gallstone-related pancreatitis (aHR 1.08 (95%CI=0.78-1.49)). Comparing patients with MC to their unaffected siblings yielded an aHR of 1.28 (95%CI=0.92-1.78).
The risk of acute pancreatitis remained elevated also for MC patients with a follow-up exceeding 10 years (aHR 1.75 (95%CI=1.14-2.67)).

Conclusion

This nationwide study of more than 12,000 patients with MC demonstrated an increased risk of acute pancreatitis after MC. Hence, clinicians should have a low threshold for evaluation of acute pancreatitis in patients with MC. Also, these patients should receive advice and care aimed at reducing the risk of acute pancreatitis.

References

NA

Disclosure

Dr. Ludvigsson coordinates a study on behalf of the Swedish IBD quality register (SWIBREG). That study has received funding from the Janssen corporation. Dr Ludvigsson has also received financial support from MSD to develop a paper reviewing national healthcare registers in China.
Dr Olén has been PI on projects at Karolinska Institutet financed by grants from Janssen, Pfizer, AbbVie, Takeda, and Ferring, and Karolinska Institutet has received fees for lectures and participation on advisory boards from Janssen, Ferring, Galapagos, Bristol Myer Squibb, Takeda, and Pfizer.
Dr Olén also reports grants from Pfizer, Galapagos, and Janssen in the context of national safety monitoring programs.

Introduction

Infection with SARS-CoV-2 leads to pronounced changes in the intestinal microbiome and also decay of tryptophan that are both related to disease severity. Supplementation of tryptophan metabolism using ileocolonic-release nicotinamide may stabilize the microbiome and alleviate COVID-19 symptoms.

Aims & Methods

This prospective, double-blind, randomized, placebo-controlled trial evaluated safety and efficacy of a 4-week intervention with a novel oral formulation of nicotinamide (1,000 mg/d) in symptomatic, unvaccinated, non-hospitalized outpatients with PCR-proven early COVID-19. The primary outcome was full recovery from reduced physical performance after 2 weeks in the prespecified symptomatic primary analysis population with at least one risk factor for severe COVID-19. Stools from a part of the patients (4 timepoints) were submitted to 16S rRNA (n=70) and shotgun metagenomics (n=18) sequencing.

Results

Screening of 7,013 patients resulted in randomization of 900 participants (nicotinamide or placebo (1:1), from which 867 received the investigational product and 500 qualified for the acute disease analysis population. 110 of 191 patients (57.6%) receiving nicotinamide and 80 of 188 patients receiving placebo (42.6%) recovered from their performance drop at week 2 (absolute difference, 15.0 percentage points; odds ratio, 1.33; 95% confidence interval, 1.03 to 1.70; P=0.004). Nicotinamide was also superior in the secondary endpoints ability to perform normal activities (P=0.009) and shortness of breath (P=0.012). Substantial effects on gut microbiome constitution were seen counteracting COVID-19 related changes. Reduction of tryptophan biosynthesis in the microbiome in placebo patients was restored and NAD salvage pathways were activated in nicotinamide-treated individuals. No relevant safety signals were observed.

Conclusion

Oral treatment with nicotinamide stabilized the gut microbiome against COVID-19 related changes and led to faster recovery of physical performance in symptomatic patients at risk for severe Covid-19. (Funded by the German Research Foundation [DFG], the State of Schleswig-Holstein and the UEG Research Prize; ClinicalTrials.gov number: NCT04751604)

Disclosure

SS reports indirect stock ownership in Gerion Biotech GmbH as well as consulting and personal fees from AbbVie, Allergosan, Amgen, Arena, BMS, Biogen, Celltrion, Celgene, Falk, Ferring, Fresenius, Galapagos/Gilead, HIKMA, I-Mab, Janssen, Lilly, Morphic, MSD, Mylan, Pfizer, Prometheus, Protagonist, Provention Bio, Sandoz/Hexal, Takeda, and Theravance.
GHW is employed part-time by CONARIS Research Institute AG (Kiel, Germany).
TB reports consulting fees, honoraria or other support from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Merck, MSD, Novartis, Pfizer, and Roche.
KA reports consulting fees, honoraria or other support from AbbVie, Falk, Galapagos, Janssen, Pfizer, and Takeda.
ML reports a lecture honorarium and travel support by AstraZeneca.
PR reports stock ownership in Gerion Biotech GmbH and consulting fees from Takeda.

Introduction

Despite EUS-guided drainage (EUS-FCD) is the preferred modality for management of peripancreatic fluid collections (PFCs), factors predicting the need for step-up to additional procedures (including radiology, surgery or additional endoscopies) are retrospectively explored in studies restricted to Lumen Apposing Metal Stents (LAMS) or excluding pseudocysts and post-surgical collections, which might require a step-up as well.

Aims & Methods

All consecutive candidates to EUS-FCD with either LAMS or Double-pigtail Plastic Stents (DPPS) between 2020-2023 were included in a Prospective Registry of Therapeutic EUS (PROTECT). The role of baseline clinical and morphological factors, including the Quadrant / Necrosis / Infection (QNI) score, in predicting the need for any step-up to additional procedures was evaluated by stepwise logistic regression.

Results

Twenty-three post-surgical PFCs, 19 pseudocysts and 18 walled-off necrosis [WOPN]) were included, 42% treated with LAMS and 58% with DPPS based on morphology. Clinical success was 92.9%, but 38% of patients required a step-up to necrosectomy (26.7%) or additional procedures. Patients requiring step-up versus those sufficing drainage had a higher number of quadrants involved (OR=3.6 [1.5-8.4]), a more frequent paracolic extension (OR=6 [1.4-26]), a higher necrosis content (>30%, OR=7.2 [1.8-28.4] ; >60% OR=25.2 [4.2-153]) and were in the high-risk group according to the QNI score, with no difference in the diameter and rate of superinfection. At multivariate analysis, being in the high-risk QNI group was the only independent predictor of step-up (OR=9.8 [2.9-32.9]). The score however was not able to stratify in analyses restricted to WOPN only or LAMS only. High-risk QNI patients presented also a longer hospital stay (17.5 [8-45] vs 4 [2-6.5], p=0,001), without any difference in ICU stay and nutritional support.

Conclusion

In this prospective series of consecutive non-selective PFCs undergoing EUS-FCD, QNI score was the only independent predictor of any need for step-up to additional procedures, and strongly correlated to the EUS-FCD allocation to LAMS versus DPPS, unravelling a potential additional utility.

Disclosure

GV reports travel grants from Pentax Medical, Boston Scientific and Euromedical, and lecture fees by Boston Scientific.
All the other authors ​declare no conflict of interest.

Introduction

Increased lipase level is a serological hallmark of the diagnosis of acute pancreatitis (AP) but can be detected in various other diseases associated with lipase leakage due to inflammation of organs surrounding the pancreas or reduced renal clearance and/or hepatic metabolism. This non-pancreatic hyperlipasemia (NPHL) is puzzling for attending physicians during the diagnostic procedure for AP. It would be clinically beneficial to identify the clinical and laboratory variables that hinder the accuracy of lipase diagnosis with the aim of improve it. A more precise description of the NPHL condition could potentially provide prognostic factors for adverse outcomes which is currently lacking.

Aims & Methods

We aimed to provide a detailed clinical and laboratory characterization of a large prospective NPHL patient cohort and assess parameters determining disease outcomes.
A Hungarian patient cohort with serum lipase levels at least three times higher than the upper limit of normal (ULN) was prospectively evaluated over 31 months. Patients were identified using daily electronic laboratory reports developed to support an ongoing observational, multicenter, prospective cohort study called the EASY trial (ISRCTN10525246) to establish a simple, easy, and accurate clinical scoring system for early prognostication of AP. Diagnosis of NPHL was established based on ≥ 3 × ULN serum lipase level in the absence of abdominal pain or abdominal imaging results characteristic of pancreatitis.

Results

A total of 808 patients [male, n = 420 (52%); median age (IQR): 65 (51-75) years] were diagnosed with ≥ 3 × ULN serum lipase levels. A total of 392 patients had AP, whereas 401 had NPHL with more than 20 different etiologies. Sepsis and acute kidney injury (AKI) were the most prevalent etiologies of NPHL (27.7% and 33.2%, respectively). The best discriminative cut-off value for lipase was ≥ 666 U/L (sensitivity, 71.4%; specificity, 88.8%). The presence of AKI or sepsis negatively affected the diagnostic performance of lipase. NPHL was associated with a higher in-hospital mortality than AP (22.4% vs 5.1%, P < 0.001). In multivariate binary logistic regression, not lipase but increased amylase level (> 244 U/L) and neutrophil-to-lymphocyte ratio (NLR) (> 10.37, OR: 3.71, 95%CI: 2.006-6.863, P < 0.001), decreased albumin level, age, and presence of sepsis were independent risk factors for in-hospital mortality in NPHL.

Conclusion

NPHL is a common cause of lipase elevation and is associated with high mortality rates. Increased NLR value was associated with the highest mortality risk. The presence of sepsis/AKI significantly deteriorates the serological differentiation of AP from NPHL.