Introduction

Until a few years ago, there existed only off-label medical treatment options for eosinophilic esophagitis (EoE) such as proton pump inhibitors (PPI) or swallowed topical corticosteroids (STC) with various formulations and ingredients. Since the approval of a budesonide orodispersible tablet (BOT), the first biological agent (Dupilumab) has been approved by the EMA and FDA, and another budesonide oral suspension has been received approval by the FDA recently. Currently, many phase 3 trials with different drugs are running, resulting in various treatment options in the next years. However, data about patients’ perspectives are lacking. We therefore aimed to assess patients’ awareness, beliefs and restrictions to medical treatment options in EoE

Aims & Methods

We developed a web-based survey using SurveyMonkey and sent a questionnaire comprised of 47 questions about patients’ preferences regarding medical treatment options to patients with established EoE in Switzerland, Austria and Germany.

Results

A total of 56 patients (64% male, 66% with other atopic diseases) from Switzerland (64%), Austria (34%) and Germany (2%) answered the questionnaire. A swallowed topical therapy was ranked first (71% of patients) in terms of patient’s preference followed by a subcutaneous therapy every 4 weeks (21.4%) and by an oral therapy with systemic effect (7%). Although one third do not have reservations against long-term medical therapy, nearly half of patients (42%) are skeptical about long-term treatment and 65% are afraid of adverse events. However, a third of patients are not aware that STC are locally effective medications with nearly no systemic effect. Furthermore, 48% of patients believe that physicians underemphasize adverse events of medication. Nearly all patients understand the importance of not only treating symptoms but also inflammation (85%).

Conclusion

Patients with EoE prefer topical agents over other available routes of administration. Patient education should be carried out to address reservations about long-term treatment.

Disclosure

Falk Pharma, Sanofi (both consultency meetings)

Introduction

Helicobacter pylori (Hp) infection is one of the major causes of gastric cancer and represents a significant global public health challenge. In Japan, where the incidence of gastric cancer is high, reducing the risk through the eradication of Hp is deemed crucial. While enhancing awareness about Hp is thought to encourage testing and contribute to treatment, there is a lack of evaluation regarding the Japanese population's awareness of Hp.

Aims & Methods

In this cross-sectional study, we aim to assess baseline knowledge and attitude tuwards Hp among Japanese population. Participants were recruited through an online survey platform (Macromill, Inc), with ages ranging from 20 to 69, reflecting the age demographic composition of Japan equally across genders. Referencing the existing surveys on Hp^1-3, we assessed knowledge on five key aspects related to Hp: risk of infection (scored out of 7), diseases caused by Hp (scored out of 7), methods of testing (scored out of 5), benefits and side effects of Hp eradication (scored out of 8), and knowledge of gastric cancer prevention (scored out of 10). Attributes of participants, socioeconomic factors, and health literacy (HLS-14)⁴ were also evaluated to study their correlation with knowledge about Hp.

Results

A total of 3,095 individuals participated. Of these, 56.3% reported having some knowledge about Hp. 865 participants (28.0%) had undergone Hp testing, 354 (11.4%) confirmed Hp infection, and 283 (9.1%) had received treatment for Hp. About 55.6% (1,722 participants) consider that the treatment for Hp posed a significant financial burden. The average correct response rate across all knowledge items was 45.6% (SD: 19.0%). The individual correct response rates were 57.3% for risk of Hp infection, 50.9% for diseases caused by Hp, 24.5% for methods of testing, 45.6% for benefits and side effects of Hp eradication, and 44.4% for knowledge of gastric cancer prevention. Higher scores were significantly associated with having an income over 4 million yen, a family history of Hp, personal Hp testing history, Hp treatment history, and higher health literacy. Over 80% of respondents acknowledged that understanding the relationship between Hp and stomach symptoms, recognizing Hp as a gastric cancer risk, and knowing that Hp eradication reduces future gastric cancer risk influenced their decision on the need for eradication. Similarly, the same proportion reported that believing that the harshness of the treatment exceeds the current symptoms and the high costs of testing and treatment influenced their decisions for eradication.

Conclusion

The level of understanding of Hp among the Japanese population is moderate and influenced by income level, health literacy, and personal experience with the Hp infection. Many consider testing and treatment burdensome. Enhancing correct understanding of Hp could potentially increase testing and treatment rates, contributing to the future reduction of gastric cancer in Japan.

References

1. Kimberly S Bailey, et al., Helicobacter pylori treatment knowledge, access and barriers: a cross-sectional study. Helicobacter 2023;28(2):e12954.
2. You Wu, et al., Awareness and attitudes regarding Helicobacter pylori infection in Chinese physicians and public population: A national cross-sectional survey.Helicobacter 2020;25(4):e12705
3. Thomas Zheng Jie Teng, et al., Helicobacter pylori knowledge and perception among multi-ethnic Asians.Helicobacter 2021;26(3):e12794.
4. Machi Suka, et al.,The 14-item health literacy scale for Japanese adults (HLS-14). Environ Health Prev Med. 2013;18(5):407-15.

Introduction

Endoscopic ultrasound-guided gallbladder drainage is usually reserved for high surgical risk patients. The procedure was usually performed under deep sedation to ensure the best tolerability for the patient and facilitate the endoscopist’s performance.
However, many of them showed a high-risk even for deep sedation.

Aims & Methods

Our aim was to evaluate the safety and efficacy of EUS-GBD under conscious sedation (CS).
All consecutive EUS-GBD under CS performed in our hospital were prospectively enrolled from January 2020 to December 2022.
Patient characteristics, type and dosage of anesthetic drug administered (Fentanyl (FNT), Pethidine (PTD) or Benzodiazepine (BZD)), size of lumen-apposing-metal-stent (LAMS), gallbladder (GB) access, technical success, clinical success, early and late adverse events (AEs) rate were evaluated. Safety was defined as AEs occurrence. The efficacy of EUS-GBD was expressed as technical and clinical success. We defined as “conscious sedation” a drug-induced depression of consciousness during which patients respond to verbal commands or react to touch. Breathing remains intact and no support is needed.

Results

A total of 49 patients (41.7% male, mean age 82,9±10 years-old) underwent EUS-GBD under in our Unit. Among all the 49 EUS-GBD in CS, 47 (95.9%) were indicated as treatment for acute cholecystitis in high-surgical-risk patients and 2 (4.1%) as rescue-strategy after ERCP fail.
In 45 (91.8%) EUS-GBD a 10x10mm LAMS was deployed, in 3 (6.2%) procedures a 15x10mm and in 1 (2%) an 8x8mm LAMS. GB was accessed from the duodenum in 68.8% of cases.
A combination of PTD+BZD was administered in 29 (59.2%) EUS-GBD, while 18 (36.7%) procedures were performed under FNT+BZD. Only 2 (4.1%) EUS-GBD were performed only under BZD.
Mean FNT, PTD, BZD dose were 50(±11.5) mcg, 38.4(±25.6) mg and 4(±1.5) mg, respectively.
Technical success of EUS-GBD under CS was 97.9%. In one procedure the distal flange of the LAMS did not open due to LAMS malfunction. The clinical success of EUS-GBD under CS was 97.9% since in one procedure there was not a decrease of inflammatory, cytolysis and cholestasis indices. Only in 1 (2%) EUS-GBD an early AE was reported. No late AEs were described.
The statistical analysis showed that the administration of a combination of fentanyl and benzodiazepine or a combination of pethidine and benzodiazepines or the administration of only benzodiazepines affected neither technical nor clinical success, nor AEs rate (Table 1).

Conclusion

EUS-GBD under CS was a safe procedure with a low AEs rate.
The administration of FNT+BZD, PTD+BZD or BZD alone did not affect procedure outcome.

Introduction

Current endoscopic ultrasound technologies (EUS) are suboptimal in the assessment of pancreatic cystic lesions (PCLs). We developed a new through-the-needle brush, the "loop brush", to improve the cellular yield, and thereby sensitivity, of EUS fine needle aspiration (EUS-FNA) of pancreatic cysts.

Aims & Methods

We aim to evaluate the "loop brush" safety, robustness, and efficacy.
We performed an in-vivo randomized controlled trial in pigs using artificial cysts. In one group, the loop brush was deployed through a 22G EUS-FNA needle into the cysts. In the control group, cystic punction was performed with standard EUS-FNA. Loop brushes were visually inspected post-procedure. Cytological assessment, cell counting, and hemoglobin analysis were performed in samples from both groups.

Results

Artificial cysts (n=114) were punctured in six pigs, 57 in each group. Neither adverse events nor significant device malfunction occurred during loop brushing. Samples collected with the brush had non-detectable concentrations of hemoglobin in 72% (41/57) of cases, and 26% (16/57) had less than 0.6 g/dL, with no significant difference to the controls (p=0.32). Brushing cell counts were associated with significantly increased cell counts (11.7× median difference, p<.0001). Cytological smears
were diagnostic in 77% of cases in the brushing group, while 54% in the control group (p=0.01, Fisher’s exact test; p=0.006, Chi-square test).

Conclusion

The new loop brush procedure appears to be safe, causing neither significant bleeding nor device malfunction. Samples obtained with the loop brush were suitable for cytological analysis and showed significantly higher cell yield than controls. Further clinical studies are warranted.

References

DOI: 10.1053/j.gastro.2020.10.007
DOI: 10.1186/s12916-018-1215-3
DOI: 10.3389/fonc.2021.688377
DOI: 10.1136/gutjnl-2016-313127
DOI: 10.1038/ajg.2018.14
Mohamed, E.; et al. Role of radiological imaging in the diagnosis andcharacterization of pancreatic cystic lesions: a systematic review. Pancreas 2018, 47, 1055–1064.
Cazacu, I. M.; et al. A quarter cen- tury of EUS-FNA: Progress,milestones, and future directions. Endoscopic ultrasound 2018, 7, 141
DOI: 10.1038/s41598-021-81065-2
doi: 10.4103/eus.eus_93_17
Shirley, L. A.; et al. Routine cyst fluid cytology is not indicated in the evaluation of pancreatic cystic lesions. Journal of Gastrointestinal Surgery 2016, 20, 1581–1585.
Muniraj, T.; et al. Devices for endoscopic ultrasound-guided tissue acquisition. Techniques in Gastrointestinal Endoscopy 2018, 20, 2–9.
Balaban, V. D.; et al. EUS- through-the-needlemicrobiopsy forceps in pancreatic cystic lesions: A systematic review. Endoscopic Ultrasound 2021, 10, 19.
Marques, F.; et al. A loop-shaped minimally invasive brush for improved cytology sampling of pancreatic cysts during EUS-FNA. Medical Devices & Sensors 2021, 4, e10165.
doi: 10.1177/0271678X20943823.
doi: 10.3748/wjg.v18.i34.4659
DOI: 10.3748/wjg.v27.i26.4194

Disclosure

FM, WW, UA, NR, and FBS have patent applications for the brush technology and are co- founders of Lucky LoopMedical AB, a company commercializing technology for improved sampling in EUS-FNA. UA has received a research grant from Boston Scientific and is a consultant to Boston Scientific, Medtronic, and Ambu. IS declares no conflict ofinterest.

Introduction

Endoscopic ultrasound-guided fine needles biopsy (EUS-FNB) is nowadays considered mandatory for the assessment of solid pancreatic lesions (SPLs) in the neoadjuvant era. Even if most recent guidelines suggest that not less than 3 passes are sufficient to obtain adequate histological characterization, the right number of needle passes with the newest generation of FNB needles remains a topic of debate. In our study we aim to evaluate if less than 3 passes are enough to ensure high rates of confirmed histological diagnosis with the newest generation of FNB cutting needles.

Aims & Methods

Consecutive patients with SPLs requiring tissue sampling through EUS-FNB were enrolled in our study between October 2022 and March 2023. Tissue sampling was performed by the same expert endoscopist through a new 22G needle with asymmetric three-prong tip with the slow-pull technique and fanning when possible. The number of needle passes was determined by the macroscopic onsite evaluation (MOSE), and samples, coming from different passes, were divided into different test tubes. Our endpoints were diagnostic accuracy, positive core procurement yield and sample quality considering each test tube separetely.

Results

53 lesions (of which 75% pancreatic ductal adenocarcinoma) were sampled with an average size of 31 mm (SD=12mm). Sampling was performed with 2 or 3 passes, according to MOSE. Regarding the first needle pass, diagnostic accuracy was 97% (51 confirmed histological diagnosis) which reached 98% considering the second needle pass. Sample adequacy reached approximately 99%. Positive core procurement and tissue quality were >95% in all test tubes. No major adverse events were detected.

Conclusion

In patients with SPLs, the newest generation of histology needles for EUS-FNB could ensure a high diagnostic accuracy with only one needle pass, becoming extremely relevant in terms of time-saving, cost-effectiveness and safety, especially in high volume centers. Due to the limited number of patients additional data are needed.

Introduction

Acute upper gastrointestinal (UGI) bleeding is a common medical emergency among the elderly. There is limited data on the management and outcomes of non-variceal UGI bleeding in the elderly in India.

Aims & Methods

We aimed to study clinical presentation, endoscopic findings, and outcomes in elderly patients with acute non-variceal UGI bleeding. All elderly patients (≥ 60 years of age) who presented with acute UGI bleed and were admitted for the same from 2021 to 2022 were retrospectively analysed. Baseline characteristics, blood transfusions before and after endoscopy, endoscopic diagnosis and therapy, AIMS65 score, complete Rockall score, and outcomes such as in-hospital re-bleeding and mortality were recorded.

Results

Of the 399 patients who had acute non-variceal UGI bleed, 309 patients aged <60 years were excluded. Of the 90 patients studied, the mean age of presentation was 69.8 ± 7.35 years, with 81.1% males. The most common presentation was melena (30%). Forty-one (45.5%) patients had a history of antiplatelet and anticoagulant use. The most common endoscopic finding was gastric ulcer (54.4%), followed by duodenal ulcer (22.2%), gastroesophageal junction ulcer (7.7%), Mallory-Weiss tear (6.6%), duodenal diverticular bleed (2.2%). The majority of ulcers were Forrest III (43.3%), followed by Forrest IIa (23.3%) and IIc (18.3%). Around 65% of patients with non-variceal UGI bleeds did not require endotherapy. Dual endotherapy was done in 25.5.5% of patients. Triple endotherapy was done in two patients. AIMS65 score was 1 in 50% of patients and 2 in 24.5% of patients. The majority (81.1%) of patients had a complete Rockall score of 3-7, indicating a moderate risk of re-bleeding and mortality. All the 90 patients were discharged without any mortality.

Conclusion

Our study showed that gastric ulcer was the most common cause of acute non-variceal UGI bleeding in the elderly, and melena was the most common presentation. Early endoscopic therapy may reduce blood transfusion requirements, in-hospital re-bleeding, and mortality.

Introduction

Current guidelines advise esophagectomy for submucosal esophageal adenocarcinoma (T1b EAC). However, data from retrospective studies suggest that endoscopic follow-up (FU) may be a valid alternative in patients without signs of lymph node metastases (LNM) at baseline. In this international multicenter, prospective cohort study (NCT03222635), we aim to evaluate the safety of a watchful waiting strategy with regular endoscopic FU in patients treated endoscopically for T1b EAC.

Aims & Methods

This ongoing prospective study is conducted in 19 hospitals in Europe and Australia, and aims to include 141 patients with 5-year FU. After radical endoscopic resection of T1b EAC, patients are re-staged with endoscopic ultrasound (EUS) and CT/PET. In the absence of LNM or distant metastases (N0M0), and upon consent for endoscopic FU, patients are included and undergo strict endoscopic FU with gastroscopy and EUS every 3 months during year 1 and 2, every 6 months during year 3 and 4, and at year 5. CT/PET is repeated after 1 year. We divided our cohort into two groups: ‘high-risk’ (submucosal invasion ≥500um, a/o poorly/undifferentiated tumor (G3-4), a/o lymphovascular invasion (LVI+)) and ‘low-risk’ if no high risk features are present. Primary outcome parameters are 5-year disease specific survival and overall survival; secondary outcome parameters are rate of LNM and local recurrence.

Results

Since July 2017, 134 patients (112 men, median age 69 ±10 years) were included with a median FU of 22 (IQR 11-35) months: 87 high-risk and 47 low-risk patients. 6 patients (4% [95%CI 0.2-8.8]) were diagnosed with LNM (table 1) after median FU of 8 (IQR 5-16) months. Of these 6 patients, 2/6 were referred for neoadjuvant chemo(radio)therapy with esophagectomy (ypT0N1M0, ypT0N0M0), 1/6 underwent esophagectomy only (pT0N2M0), 3/6 underwent a selective surgical resection of the tumor-positive LN.
7 patients (5% [95%CI 0.8-9.6] were diagnosed with an intra-luminal tumor recurrence not eligible for endoscopic re-treatment after median FU of 7 (IQR 6-15) months. 5 had initial ESD and 2 cap-based EMR. Of these 7 patients, 2/7 underwent esophagectomy (pT1bN0M0, pTisN0M0), 1/7 had neoadjuvant chemoradiotherapy and esophagectomy (ypT1aN0M0), 3/7 underwent (chemo)radiotherapy only, of which 1 patient eventually died as result of stenosing EAC, 1/7 refused additional treatment. No distant metastases were diagnosed during FU in both cohorts. Five patients died during FU of a cause unrelated to EAC. Five patients discontinued FU due to old age. Two patients were lost to FU.

Conclusion

The preliminary analysis from our ongoing prospective study suggest that in patients with radically removed high- or low-risk T1b EAC, without LNM at baseline, a strict endoscopic follow-up protocol is feasible and the window for curative therapy remains open for those patients who develop LNM (4%) or a local intra-luminal recurrence (5%) during FU. Most patients demonstrate uneventful FU.

Disclosure

No conflict of interests.