Clinical Case Summary

A 29 year old women was diagnosed with Crohn’s disease with ileocolonic involvement and a penetrating behaviour (Montreal classification A2L3B3). After the pre imunosupression workup we proposed the patient to start Infliximab (IFX) with a dosage of 5 mg/kg.
During the first infusion the patient referred sudden visual impairment. There were no visible inflamation of the sclera, conjunctiva or peri orbital area. The patient reported no pain and there were no signs of ophthalmoparesis. We stopped the infusion immediately and asked for an urgent observation by Ophtalmology. Although the fundoscopic examination didn’t detect any abnormalities, there was a significant decrease in the visual acuity of the left eye.
The patient regained full visual acuity the day after the event. We decided to switch the biologic therapy to Ustekinumab. The patient was reevaluated in the outpatient clinic two weeks after discharge, she maintained full visual acuity and showed significant improvement of her symptoms.
IFX is a generally well tolerated drug, participating in the therapeutic approach of a wide variety of autoimmune conditions. Despite its favorable safety profile, IFX is associated with rare paradoxical adverse events that correspond to the development or exacerbation of an inflammatory condition during IFX therapy. Ocular adverse events represent part of this group of complications known as paradoxical adverse events. In the literature we can find reports of: uveitis, optic neuritis, endophthalmitis and orbital apex syndrome.
We report a case of a paradoxical adverse event manifested as a transitory sudden asymmetric loss of visual acuity.
From our research, this is the first report in the literature of transitory visual loss due to IFX. We intend to publish this case to further amplify the medical knowledge regarding the therapy with this drug and better inform both patients and physicians regarding the potential advserse events of IFX.

Introduction

Antiplatelets and anticoagulants significantly increase the risk of upper gastrointestinal bleeding by impairing normal clotting mechanisms. Patients on dual or combined therapy often present with more severe bleeds and poorer endoscopic control. This leads to higher rates of rebleeding, complications, and mortality compared to those not on these therapies.

Aims & Methods

To evaluate the risk and outcomes of non-variceal upper gastrointestinal bleeding (UGIB) in patients on single antiplatelet therapy, dual antiplatelet therapy, and combined antiplatelet-anticoagulant therapy, and to assess associated morbidity, mortality, and rebleeding rates.
A prospective study was conducted involving 150 patients (90 males, 60 females) aged 40–60 years, presenting with upper GI bleeding between 1st January 2023 till 1st January 2025. Patients had co-morbid conditions including hypertension, diabetes mellitus, coronary artery disease, or prior cerebrovascular events, and were on their respective medications for at least 3 months. Patients using NSAIDs, having liver disease, or known bleeding disorders were excluded. Clinical presentations included melena, hematemesis, or both. All patients underwent upper GI endoscopy, with Forrest classification used to characterize ulcers. Laboratory investigations included CBC, LFTs, renal function, PT, and APTT. Bleeding profiles and endoscopic outcomes were analyzed across three medication groups: single antiplatelet (n=60), dual antiplatelet (n=50), and combined antiplatelet-anticoagulant therapy (n=40).

Results

UGIB was reported in 6 (10%) of the single antiplatelet group, 16 (32%) of the dual antiplatelet group, and 14 (35%) of the combined therapy group. Endoscopic findings predominantly revealed Forrest class IIA ulcers. Patients on dual or combined therapy had poorer endoscopic hemostasis. Four patients experienced rebleeding refractory to standard endoscopic measures, requiring angioembolization. One mortality was recorded in the dual antiplatelet group due to massive bleeding and shock.

Conclusion

Dual antiplatelet and combined antiplatelet-anticoagulant therapies significantly increase the risk and severity of non-variceal UGIB, with higher rates of poor endoscopic hemostasis, rebleeding, and mortality. These findings underscore the importance of risk stratification and prophylactic strategies in patients requiring long-term antithrombotic therapy.

References

1. Hao, W., Liu, A., Zhu, H. et al. Risk factors and management of gastrointestinal bleeding in patients with or without antiplatelet and anticoagulation therapy: a multicenter real-world prospective study. BMC Gastroenterol 24, 155 (2024). https://doi.org/10.1186/s12876-024-03238-3
2. Risk of Gastrointestinal Bleeding Increases With Combinations of Antithrombotic Agents and Patient Age Abraham, Neena S. et al. Clinical Gastroenterology and Hepatology, Volume 18, Issue 2, 337 - 346.e19

Introduction

International guidelines recommend performing emergency gastroscopy within 12 hours for variceal (V) bleeding and within 24 hours for non-variceal (NV) bleeding in cases of upper gastrointestinal bleeding (UGIB).

Aims & Methods

This study aimed to analyze the time elapsed between emergency department admission and time of endoscopy, referred to as "door-to-endoscopy time" (DET), and to identify factors influencing DET across different UGIB subgroups. We conducted a retrospective cohort analysis of patients who underwent emergency gastroscopy for UGIB between January 1, 2022, and December 31, 2023, at the Department of Emergency Medicine at Semmelweis University. Data were collected on clinical parameters and 30-day mortality. NV patients were categorized into high-risk (HNV) and low- risk (LNV) groups based on endoscopic findings (Forrest classification). Welch’s t-test was used for comparing mean DET among the subgroups, whereas for hemoglobin linear regression was applied. The significance level was set at 0.05 for all analyses.

Results

Among 654 patients, we identified 126 V and 528 NV UGIB cases, with the latter comprising 99 HNV and 429 LNV cases. Rebleeding occurred in 5.4% of patients (V: 12.7%, HNV: 10.1%, LNV: 2.1%), and 30-day mortality was 19.7% in the cohort (V: 24.8%, HNV: 22.6%, LNV: 17.6%). The mean DET was 7.28 hours (SD=±6.04), with subgroup averages as follows: V: 5.87±3.77 hours, HNV: 6.33±4.04 hours, and LNV: 7.92±6.83 hours, with significant differences between LNV-HNV (p=0.003) and LNV-V (p<0.0001) groups; no significant difference was observed between HNV-V (p=0.37). In the entire cohort, shorter DET was significantly associated with tachycardia (6.61 vs. 7.73 hours, 95% confidence interval (CI) -1.99 to -0.25, p=0.01), hematemesis (5.82 vs. 8.09 hours, 95% CI -3.11 to -1.43, p<0.0001), syncope (6.25 vs. 7.57 hours; 95% CI -2.30 to -0.33, p=0.009), and lower hemoglobin levels (1 g/L decrease in hemoglobin reduced DET by an average of 1 minute, p=0.029). DET was not associated with 30-day mortality (p=0.501), vasopressor use (p=0.857), shock index (p=0.091), coffee-ground emesis (p=0.192), hematochezia (p=0.564), intubation (p=0.566), rebleeding rate (p=0.462), or melena (p=0.961). In the V group, DET was significantly shorter in case of hematemesis (5.20 vs. 7.25 hours, 95% CI -3.61 to -0.49, p=0.011) and tachycardia (5.19 vs. 6.64 hours, 95% CI -2.84 to -0.08, p=0.039); whereas in HNV patients with coffee-ground emesis, DET was significantly reduced (4.94 vs. 6.58 hours, 95% CI -3.08 to -0.20, p=0.026); in LNV patients, DET was shorter in patients with hematemesis (6.42 vs. 8.38 hours, 95% CI -3.20 to -0.71, p=0.002) and syncope (6.56 vs. 8.25 hours, 95% CI -3.10 to -0.29, p=0.019).

Conclusion

In our retrospective cohort study, DET significantly differed between LNV-V and LNV-HNV subgroups. Shorter DET correlated with tachycardia, hematemesis, syncope, and lower hemoglobin levels. DET showed no association with 30-day mortality or rebleeding rate.

Introduction

The current universal standard of care in primary biliary cholangitis (PBC) is ursodeoxycholic acid (UDCA), although its clinical benefit in PBC has never been reported in absolute measures.

Aims & Methods

This cohort aimed to assess the prevalence of incomplete response to UDCA and determine non-response predictors.
Patients with PBC as main diagnosis were included from the hospital's centralized electronic medical records system, over a 10-year period. Overlap syndromes (PBC-Auto-Immune Hepatitis) were also included. Main endpoints included incomplete response to UDCA treatment according to Paris I, Paris II criteria, and Globe score.

Results

A total of 50 patients were included in this study. The mean age at diagnosis was 52.74 years (24-73 years) and 92% females. Only one patient was asymptomatic at onset and 82% had positive anti‐mitochondrial antibodies. All patients were treated with ursodeoxycholic acid (UDCA). Corticosteroids and immunosuppressive therapies were associated in 26% of cases. Incomplete response to UDCA was observed in 28% and 34% of patients according to Paris I and II criteria, respectively. Non-response predictors were poor therapeutic adherence, Overlap syndrome and hepatocellular carcinoma in 14%, 6% and 4% respectively. Five patients were lost to follow-up and five cases died from cirrhosis ’complications. The median ΔGLOBE score was 0.42 (IQR: -1.58 to 3.92). The 5, 10 and 15 years liver transplantation-free survival (median) was: +10%, +7.38% and +5% respectively. Liver transplantation (LT) was considered in one patient with excellent outcomes at last follow-up.

Conclusion

A considerable proportion of patients showed incomplete response to UDCA treatment according to Paris II criteria. Early identification of patients at risk of incomplete response could improve patient management and overall disease prognosis.

References

- Treatment response to ursodeoxycholic acid in primary biliary cholangitis: A systematic review and meta-analysis. DOI: 10.1016/j.dld.2022.12.010
- Pretreatment prediction of response to ursodeoxycholic acid in primary biliary cholangitis: development and validation of the UDCA Response Score. doi: 10.1016/S2468-1253(18)30163-8. Epub 2018 Jul 13.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is recognized as a foundational procedure within the realm of interventional gastroenterology. Nevertheless, a significant amount of hands-on experience is required to achieve proficiency in this procedure, particularly with regard to the performance of sophisticated therapeutic maneuvers. Access to authentic training cases remains limited, while the use of cadaveric or live animal models presents distinct ethical, logistical and financial challenges (1). The advent of 3D printing technology paved the way for the development of advanced medical simulators. This study utilized computer-aided design and fused deposition modeling techniques to engineer an ERCP simulator that is both anatomically accurate and enables the training of trainee physicians in the intricate procedures of their chosen discipline (2). The simulator's modular design allows it to replicate a spectrum of papillary conditions, enabling targeted training in anatomies that are resistant to cannulation, as well as high-risk procedures like precut sphincterotomy and fistulotomy.

Aims & Methods

The design process for the ERCP simulator employed accessible parametric modeling software. Fabrication of the primary structural components, including the pancreas, the duodenum, and the bile ducts, were undertaken using polylactic acid (PLA) filament, a material that is both widely accessible and economical, thereby ensuring adequate rigidity and durability. The interchangeable papillary components were produced using flexible thermoplastic polyurethane (TPU) 95A filament, selected for its elasticity and capacity to be readily incised during procedures such as endoscopic sphincterotomy (EST). This allowed for easy exchangeability and facilitated the acquisition of skills by novice endoscopists. This process were selected on the basis of accessibility, user-friendly interface and cost-effectiveness, enabling replication in diverse settings. The biliary and pancreatic ductal lumens were meticulously calibrated to represent a range of procedural difficulty, with internal diameters that closely mirrored real anatomical variations.

Results

The simulator exhibited a high degree of anatomical and biomechanical fidelity, featuring a structurally stable duodenal framework and a flexible papillary interface. The simulator accurately reproduced tactile feedback experienced by gastroenterologists during ERCP, thereby validating its efficacy as a training tool. Furthermore, the simulator was enabled meticulous rehearsal of EST through sphincterotomy incisions and facilitated fistulotomy simulation using an elastomeric papilla structure. The simulator's design is both cost-effective and easily replicable, making it a valuable asset for continuing education and training in this field (3,4).

Conclusion

The ERCP simulator, fabricated using 3D printing technology, can be regarded as both technologically advanced and economically efficient for a number of complex procedures. These encompass endoscopic sphincterotomy, precut techniques, fistulotomy and stent placement. The simulator's design, featuring a modular papillary system, was crafted to provide a structured and progressive learning environment for novice users as well as experienced endoscopists. The simulator's cost-effectiveness, ease of scaling up and potential for wide dissemination signify a paradigm shift in ERCP education, facilitating proficiency acquisition in complex interventional endoscopy with greater efficiency and safety. Further investigations are needed for the simulator in ERCP training.

References

1. Lee S, Ahn JY, Han M, Lee GH, Na HK, Jung KW, et al. Efficacy of a three-dimensional-printed training simulator for endoscopic biopsy in the stomach. Gut and liver. 2017;12(2):149.
2. Zhang Y, Chen L, Hu B. Advances of 3D printing in gastroenterology and where it might be going. International Journal of Bioprinting. 2023;9(6):0149.
3. Lee DS, Ahn JY, Lee GH. A newly designed 3-dimensional printer-based gastric hemostasis simulator with two modules for endoscopic trainees (with video). Gut and Liver. 2019;13(4):415.
4. Bundy JJ, Weadock WJ, Chick JFB, Srinivasa RN, Patel N, Johnson E, et al. Three-dimensional printing facilitates creation of a biliary endoscopy phantom for interventional radiology-operated endoscopy training. Current Problems in Diagnostic Radiology. 2019;48(5):456-61.