Clinical Case Summary

We present a 69-year-old previously healthy jaundiced woman diagnosed with an pancreatic head neoplasm with liver metastases, staged as a cT2N1M1. Palliative chemotherapy after biliary drainage was proposed after multidisciplinary meeting. Due to a symptomatic non transversable duodenal stricture, biliary drainage was achieved by an endoscopic ultrasound guided choledocoduodenostomy (EUS-CD), using a 6x8mm lumen-apposing metal stent (LAMS) with a 7Fr coaxial double pig-tail plastic stent (DPPS). At the same occasion an EUS-guided gastroenterostomy (EUS-GE), using a 20x10mm LAMS was performed. The post-procedural recovery was uneventful, with a decline in bilirubin levels and resumption of diet.
Two months post-procedure, the patient presented to the hospital with fever (38°C), abdominal pain, leukocytosis of 22 x10⁹/L, a C-reactive protein level of 253 mg/L and total bilirubin (TB) of 7,3 mg/dL). Abdominal computed tomography demonstrated intrahepatic bile duct dilation with aerobilial diffuse parietal thickening, and distal fiiling of the bile duct above the stricture.
Given suspicion of EUS-CD dysfunction, the patient underwent endoscopic retrograde cholangiopancreatography (ERCP). The DPPS was removed, revealing distal irregular filling upon cholangiography. Through the EUS-CD, a transpapillary guided wire was inserted. Through the EUS-GE, the second duodenum was accessed with a therapeutic gastroscope and an uncovered self-expandable metal stent(SEMS) of 60/10mm was placed transpapilary, through the placed wire.
After full expansion of the biliary stent the patient underwent ERCP, during which the common bile duct was explored through the papilla, with a balloon catheter, and removal of food debris, supporting the diagnosis of a sump syndrome.
The patient improved and was discharged with complete resolution of the symptoms and TB of 2,67 mg/dL. After 1 month of follow up no other episodes of cholangitis were recorded.

Introduction

Liver elastography is one of the basic diagnostic tools in hepatology practice. The most widely used and most studied tool in the world is transient elastography (Fibroscan), however, this system is unevenly available in Slovakia. Shear-wave elastography is a more accessible method because it is built into standard ultrasound systems. However, the problem of shear-wave elastography remains the interpretation of its results, since the threshold values for significant fibrosis (SF) and advanced fibrosis (AF) are unique for each system.

Aims & Methods

To compare the results of transient elastography (TE) and point shear-wave elastography (pSWE) in a cohort of patients examined simultaneously with both systems and to determine the clinical benefit of pSWE in practice.
We examined all indicated patients over a 15-month period using both TE and pSWE (Hitachi Arietta V70). We recorded liver stiffness values in kPa, and baseline demographic and laboratory parameters. We used TE as the gold standard, with a threshold of >10 kPa for SF and >15 kPa for AF. We evaluated the accuracy of pSWE in predicting the detection of SF and AF. We used three models: the first one containing only pSWE values, and two logit models using pSWE together with common demographic and laboratory parameters. We identified the area under the curve (AUROC) and threshold values for each model and evaluated the probability of SF and AF according to these values.

Results

We examined 500 patients with a median age of 60 (IQR 48-69), male/female 214/286, with a SF rate of 30.8% and AF of 18.4%. The stiffness values according to TE and pSWE showed a highly significant correlation (rho=0.593, P<0.001). We found the accuracy of pSWE alone in predicting SF (AUROC=0.812), and AF (AUROC=0.839) with threshold values of SF>6.34 and AF>8.45 kPa. For values of pSWE<6.34, 6.34-8.45, and >8.45 kPa, the probability of SF was 11.1, 40.9, and 65.4% and AF was 5.0, 14.77, and 48.9%. We created two probability models (for P, range 0 to 1): ASTEL1 (N=369) that included pSWE, GGT, and platelets (AUROC SF=0.856, AUROC AF=0.908), and ASTEL2 (N=467) using pSWE, age, sex, AST/ALT, GGT (AUROC SF=0.857, AUROC AF=0.901). We set a threshold of P<0.33 to exclude SF and P>0.66 to confirm AF. At P<0.33, P=0.33-0.66, and P>0.66, SF was present in 15.6, 62, and 94.2% (ASTEL1) and 13.92, 50.7, and 86.8% (ASTEL2). At P<0.33, P=0.33-0.66 and P>0.66, AF was present in 5.6, 30, and 79.7% (ASTEL1) and in 4.4, 28, 73.68% (ASTEL2).

Conclusion

pSWE alone has an excellent negative predictive value (<6.34 kPa, 88.9-95%) in the diagnosis of SF and AF. Higher accuracy of positive prediction of SF (86.8-94.2%) and AF (73.7-79.7%) can be achieved by using one of two probability models (for P>0.66) combining SWE values with common demographic and laboratory parameters.

Introduction

Hepatic encephalopathy (HE) after Transjugular Intrahepatic Portosystemic Shunt (TIPS) affect 35-50% of patients. The use of prophylactic agents (Lactulose and Rifaximin) to prevent post-TIPS HE remains controversial and currently not recommended by professional guidelines. Our aim was to assess real world practice and identify potential predictors for post-TIPS HE and benefit from post-TIPS prophylaxis.

Aims & Methods

Retrospective cohort study of patients undergoing TIPS at the Tel-Aviv Medical Center (2016-2024). The primary outcome was overt HE, with secondary outcomes of liver transplantation (LT) and mortality.

Results

Seventy-nine patients underwent TIPS, median age was 60 years and 52% were male. Primary liver disease was metabolic dysfunction-associated steatohepatitis (MASH) in 34%, viral (20%), and alcohol-related liver disease (ALD) (16.5%). Indications for TIPS were variceal bleeding (52%) and refractory ascites (38%). Prior to the procedure 31% had ≥ 1 episodes of HE, 21.5% were treated with Lactulose and/or Rifaximin, and 58% were on betablocker treatment. At the time of the procedure, the patient's Child-Pugh score was A/B/C in 19%/66%/11% respectively, with a median MELD-Na of 10.9. Median follow up was 22.75 months. Overall, 22 patients died during follow-up and 8 underwent liver transplantation. 45 patients (57%) developed post-TIPS HE, 60% of them during the first three months. Early post-TIPS HE treatment was given to 49%: 10% Lactulose, 5% Rifaximin, and 34% both. Among those patients, 44% were previously (pre-TIPS) on HE treatment. Development of HE was not predicted by pre-or post-TIPS MELD-Na or Child-Pugh score, TIPS diameter, postTIPS gradient, or post-procedure ammonia levels. Rates of HE also did not differ according to initial prophylaxis treatment (59% with treatment, 56% without, p=1). Pre-TIPS AST and albumin were associated with post-TIPS HE (36.6U/L vs. 60.44 U/L, p=0.03; 34.6g/dl vs. 31.8g/dl, p = 0.05). Prior beta-blocker treatment was associated with post-TIPS HE (14% vs 32%, p = 0.01) but not varices as the indication for TIPS. Mortality rate was not affected by the occurrence of post-TIPS HE (28% among those who developed HE vs. 26% among those who didn't, p = 1).

Conclusion

Early post-TIPS preventive treatment was mostly given to patients previously treated with Lactulose/Rifaximin, however it did not affect the rate of post-TIPS HE. Development of HE did not increase mortality.

References

1. Wolfgang el al. ASSLD practice Guidance, Hepatology (2024)
2. Yao el al.J Gastrointestin Liver Dis (2015)

Introduction

Alkaline phosphatase (ALP) is an important marker in primary biliary cholangitis (PBC) associated with risk for disease progression. In the pivotal, Phase 3, placebo-controlled RESPONSE trial (NCT04620733), seladelpar, a first-in-class delpar (selective PPAR-delta agonist), led to a significantly higher percentage of PBC patients achieving the composite biochemical endpoint (ALP <1.67 x upper limit of normal [ULN], ALP decrease ≥15%, and total bilirubin [TB] ≤ULN) compared with placebo (61.7% vs 20%) and decreased mean ALP levels after one year (-42.4% vs -4.3%, respectively). Here, we report additional data on ALP changes in the RESPONSE trial.

Aims & Methods

PBC patients who received ursodeoxycholic acid (UDCA) for ≥12 months or were UDCA intolerant and had ALP ≥1.67 x ULN and TB ≤2 x ULN were randomised 2:1 to daily seladelpar 10 mg or placebo. We assessed ALP changes across demographic subgroups, baseline ALP quartiles, and in patients who did not meet the composite biochemical endpoint. Worsening of ALP (increase >0 U/L from baseline) and safety by baseline ALP subgroup were also evaluated.

Results

128 patients were randomised to seladelpar and 65 to placebo with mean baseline ALP 314.6 U/L and 313.8 U/L, respectively; 53 (27.5%) patients had baseline ALP ≥350 U/L. Seladelpar reduced ALP at month 12 similarly across all subgroups, including in patients with cirrhosis, aged <50 years at PBC diagnosis, and of Hispanic/Latino ethnicity, vs placebo. For patients with baseline ALP ≥350 U/L, seladelpar led to a greater decrease (-44.8%; -216.1 U/L) in ALP vs placebo (-11.6%; -56.4 U/L); similar percent decreases were seen in patients with baseline ALP <350 U/L. Seladelpar reduced ALP similarly across baseline ALP quartiles. Among patients who did not meet the composite biochemical endpoint at month 12, ALP was decreased by -129.9 U/L for seladelpar vs -6.4 U/L for placebo. Seladelpar prevented worsening of ALP, with 7 (5.5%) seladelpar patients vs 19 (29.2%) placebo with increases in ALP from baseline at month 12. Adverse events were reported in 86.4% of patients with baseline ALP <350 U/L and 84.9% of patients with ALP ≥350 U/L, with similar proportions in seladelpar vs placebo patients.

Conclusion

Seladelpar led to robust and consistent ALP decreases across all subgroups studied. Substantial ALP decreases were also observed in patients who did not meet the composite endpoint criteria at month 12. Seladelpar was overall safe and well tolerated, regardless of baseline ALP level.

Disclosure

KVK reports receiving grants or contracts from 89Bio; Boston Scientific; Corcept Therapeutics; CymaBay Therapeutics; Genfit; Gilead Sciences, Inc.; GSK; Hanmi Pharmaceuticals; Intercept Pharmaceuticals; Ipsen; Janssen; Madrigal Pharmaceuticals; Mirum Pharma; NGM Bio; Novo Nordisk; Pfizer; Pliant Therapeutics; Terns Pharmaceuticals; Viking Therapeutics; and Zydus Pharmaceuticals; royalties or licences from UpToDate; consulting fees from 89Bio; CymaBay Therapeutics; Genfit; Gilead Sciences, Inc.; GSK; HighTide Biopharma; Inipharm; Intercept Pharmaceuticals; Ipsen; Madrigal Pharmaceuticals; Mirum Pharma; NGM Bio; and Zydus Pharmaceuticals; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie; Gilead Sciences, Inc.; and Intercept Pharmaceuticals; participation on a data safety monitoring board or advisory board with CTI and Medpace; and stock or stock options with Inipharm. KKY reports receiving honoraria from Gilead Sciences, Inc. SK reports receiving grants or contracts from Gilead Sciences, Inc.; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Gilead Sciences, Inc. EM reports receiving payment or honoraria for speakers bureaus from AbbVie; Eli Lilly; Gilead Sciences, Inc.; and Ipsen; and support for attending advisory boards from AbbVie; Eli Lilly; Gilead Sciences, Inc.; and Ipsen. AB reports receiving grants or contracts and consulting fees from Chemomab; CymaBay Therapeutics; Gilead Sciences, Inc.; GSK; Intercept Pharmaceuticals; Ipsen; and Mirum Pharma; royalties or licences from UpToDate; payment for expert testimony from UMass; and participation on a data safety monitoring board or advisory board with Pfizer. KGR reports receiving grants or contracts from COUR Pharmaceuticals; CymaBay Therapeutics; Gilead Sciences, Inc.; and Pliant Therapeutics; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Mallinckrodt Pharmaceuticals and Gilead Sciences, Inc. CC reports consulting for CymaBay Therapeutics and Ipsen. JMS reports consultant honoraria from 89Bio; Alentis; Alexion; Altimmune; AstraZeneca; Bionorica; Boehringer Ingelheim; Gilead Sciences, Inc.; GSK; Inventiva Pharma; Ipsen; Lilly; Madrigal Pharmaceuticals; MSD; NorthSea Therapeutics; Novartis; Novo Nordisk; Pfizer; Roche; Sanofi; and Siemens Healthineers; speaker honoraria from AbbVie; Boehringer Ingelheim; Echosens; Gilead Sciences, Inc.; Madrigal Pharmaceuticals; Medscape; and Novo Nordisk; and stockholder options with AGED Diagnostics and Hepta Bio. SC, KY, and DBC are employees of Gilead Sciences, Inc., and may own stock in Gilead Sciences, Inc. CAM reports former employment with CymaBay Therapeutics, a Gilead Sciences, Inc., company, from 2007 to 2024; receiving consulting fees from Gilead Sciences, Inc.; being listed as an inventor on seladelpar patents; and a leadership or fiduciary role (paid or unpaid) with 89Bio (independent director).

Introduction

Quality assessment is a priority in the field of gastroenterology. However, limited data are available from Greece regarding adherence to quality standards in gastrointestinal endoscopy.

Aims & Methods

This study aims at assessing the knowledge and compliance of Greek gastroenterologists with established quality standards for upper and lower digestive endoscopy, while exploring factors that may influence compliance.
​This prospective study recorded data on the quality of upper and lower digestive endoscopy performed in Greece from October 2024 to January 2025. All members of the Hellenic Society of Gastroenterology (n=668) were invited to participate via an electronic survey. The survey included a questionnaire designed specifically for this study, covering demographic and professional characteristics, as well as quality indicators for gastroscopy and colonoscopy.

Results

A total of 164 gastroenterologists participated (response rate 24.55%), of whom 107(65.24%) were male, and 102(62.2%) working in public or academic hospitals. The duration of gastroscopy was not recorded by 116(70.73%) participants, while 102(62.2%) systematically used photodocumentation. Most participants utilized the Prague and Los Angeles classifications 156(95.12%) and 159(96.95%) respectively. Additionally, 140(85.37%) followed the Seattle protocol, and 158(96.34%) conducted biopsies according to ESGE guidelines for precancerous gastric lesions. However, 83(50.61%) don’t use a registry for patients with Barrett’s esophagus. Complications were systematically recorded after gastroscopy by 103(62.8%) and after colonoscopy by 90(54.88%).
In colonoscopy, 149(90.85%) use the BBPS scale, and 158(96.34%) reported successful cecal intubation. Withdrawal times exceeded six minutes for 151(92.07%) participants. An adenoma detection rate of over 25% was achieved by 117(71.78%), while 103(62.8%) consistently used the Paris classification. Proper polypectomy techniques were employed by 111(67.68%), but 100(60.98%) recommended follow-up intervals shorter than guidelines suggest. Patient experience following gastroscopy and colonoscopy was not recorded by 126(76.83%) and 116(70.73%) participants, respectively. Overall, compliance with quality indicators for upper and lower digestive endoscopy was observed in 87(53.05%) and 75(45.73%) participants, respectively. Multivariate analysis revealed that 5-15 years of experience (p=0.05), the use of video recording (p=0.01) and use of high-resolution endoscopes (p<0.01) were associated with improved compliance with quality indicators of upper endoscopy. Whereas age above 55 (p<0.01), use of high-resolution endoscopes(p<0.01), use of video recording (p=0.02) and attendance of educational seminars relevant with quality in endoscopy (p=0.05) were associated with improved compliance with quality indicators of colonoscopy.

Conclusion

In this study, discrepancies were observed in the compliance of Greek endoscopists with endoscopic quality indicators, highlighting the need for further improvement. The systematic recording of these quality indicators is essential, underlining the important role of scientific societies in this process.

Introduction

The increasing prevalence of antibiotic resistance and the scarcity of therapeutic options for patients with penicillin allergy have highlighted the necessity for novel treatment regimens. Keverprazan, a novel potassium-competitive acid blocker, provides potent and sustained gastric acid suppression.

Aims & Methods

This study was designed to evaluate the efficacy and safety of keverprazan-minocycline (KM) dual therapy compared with keverprazan-amoxicillin (KA) dual therapy in patients with Helicobacter pylori (H. pylori) infection. From October 2024 to April 2025, a total of 240 patients with H. pylori infection were recruited from six hospitals in Fujian province and randomly assigned to receive either KA dual therapy (amoxicillin 1 g three times daily plus keverprazan 20 mg once daily) or KM dual therapy (minocycline 100 mg twice daily plus keverprazan 20 mg once daily) for a duration of 14 days. The primary endpoint was the H. pylori eradication rate assessed at 4 weeks post-treatment. Secondary endpoints included the symptom relief rate, incidence of adverse events, and patient compliance.

Results

In the intention-to-treat (ITT) analysis, the H. pylori eradication rates were 85.83% (103/120) in the KA group and 87.50% (105/120) in the KM group. In the per-protocol (PP) analysis, the eradication rates were 86.95% (100/115) in the KA group and 90.35% (102/113) in the KM group. No statistically significant differences were observed between the two groups (P = 0.704 for ITT and P = 0.421 for PP analysis). Additionally, symptom remission rates (73.88% vs. 82.50%) and treatment adherence rates (97.01% vs. 97.50%) also showed no significant intergroup differences (both P > 0.05). However, the KM group exhibited a significantly higher overall incidence of adverse events compared with the KA group (38.33% vs. 17.16%, P < 0.001), primarily driven by mild dizziness (25.83% vs. 2.23%, P < 0.001). However, these adverse reactions were mild and did not affect treatment adherence.

Conclusion

The keverprazan-minocycline dual regimen demonstrated high eradication efficacy and acceptable safety in patients with H. pylori infection, with eradication effectiveness comparable to that of the keverprazan-amoxicillin dual therapy and mild adverse reactions. This regimen is recommended for the clinical treatment of H. pylori infection, particularly in patients with penicillin allergy.

Disclosure

There is no conflict of interest.

Clinical Case Summary

Diffuse nodular lymphoid hyperplasia (DNLH) of the gastrointestinal tract is a rare benign disease characterized by multiple polypoid nodules, associated with inborn errors of immunity (IEI) such as common variable immunodeficiency (CVID) and infections like Giardia lamblia. To date, there are few cases reported in Southeast Asia. We present a patient in Singapore with DNLH associated with CVID.
A 39-year-old man presented with one year of intermittent diarrhoea with nocturnal episodes, associated with abdominal pain. Colonoscopy revealed a normal colon, but there were multiple diminutive polyps in the terminal ileum (TI). Histology showed mild chronic inflammation with lymphoid aggregates, without any microorganisms. Magnetic resonance enterography did not identify any sizeable polyps within the small bowel, which would have led to further evaluation for gastrointestinal lymphoma.
Stool studies, sent on a subsequent bout of diarrhoea, returned positive for Giardia lamblia. He was treated with metronidazole but his diarrhoea persisted. On probing further, he had a history of recurrent rhinosinusitis and febrile illnesses since childhood, prompting further laboratory studies which showed a normal full blood count, erythrocyte sedimentation rate of 11mm/hour, and hypogammaglobulinemia. A diagnosis of CVID was made and he was initiated on regular intravenous immunoglobulin (IVIG) replacement with resolution of his diarrhoea.
Surveillance colonoscopy three years later demonstrated prominent lymphoid follicles from the ascending to rectosigmoid colon, in addition to the TI. Histology was consistent with DNLH without dysplasia. He remains well and asymptomatic on regular IVIG.
In summary, as DNLH is associated with IEI and parasitic diseases, it is important to evaluate for these diseases upon diagnosis. DNLH is also associated with gastrointestinal lymphoma that may warrant surveillance, though the clinical course is unclear and there are no guidelines for surveillance.

References

ALBUQUERQUE. A. Nodular lymphoid hyperplasia in the gastrointestinal tract in adult patients: A review. World J. Gastrointest. Endosc., 2014, 6 (11) : 534-540.
Illustrative material in final poster
1. Endoscopic image of prominent lymphoid follicles in colon and terminal ileum
2. Pathological image of terminal ileum biopsy demonstrating lymphoid aggregates