Introduction

Operator dexterity is recognised as a critical determinant of outcomes after surgery (1-2). No such recognition exists for the quality of endoscope tip manipulation (tip-control) and no objective measurement scale exists.

Aims & Methods

The aim of this study was to develop and validate a score for tip-control in an ex-vivo setting.
A web application containing a timed-score with clickable buttons to indicate correct and incorrect application of snare tip soft coagulation (STSC) was developed. The score was tested on a training model containing 4 shapes constructed from 1-4 identical circles (radius 1.4cm) connected at their mid-points drawn onto a single piece of cooked ham.
Endoscopists with varied profiles consented to video recording of their timed complete application of STSC (hits) to sequential circles using a gastroscope. Correct application was defined as any visualised diathermy application touching the marked lines. Median correct-hits/incorrect-hits (accuracy) and correct hits/second (speed) were determined by a single rater over the 4 recordings and stratified by shape and endoscopist demographics.

Results

22 endoscopists (8[36.4%] trainees, 6[27.3%] non-interventional consultant gastroenterologists and 8[36.4%] interventional endoscopists) participated.
Participant median accuracy was 82.0% (IQR17.5, 95%CI 77.0-85.0) and correct hits/second 0.141 (IQR0.095, 95%CI 0.120-0.160). Accuracy strongly correlated with blinded rater opinion of the macroscopic ham appearance (correlation coefficient=0.78, P<.001).
A scatter plot of endoscopist accuracy versus correct hits/second categorized endoscopists into 4 groups (combinations of accurate/inaccurate, fast/slow)(Figure 1). Interventional endoscopists were commonly fast and accurate (accuracy 88.0%[P=.001], correct hits 0.191/s[P=.04]) versus other participants. Non-interventional consultants had the lowest accuracy numerically and statistically similar tip-control to other participants (accuracy 69.0%[P=.15], correct hits 0.135/s[P=.97])(inaccurate). Trainees had similar accuracy to non-trainees but lower correct hits/second (accuracy 73.6%[P=.25], correct hits 0.153/s [P=.03])(slow). Endoscopists with >5 years experience did not have better tip-control (accuracy 88.0%[P=.07], correct hits 0.132/s[P=.36]) when compared to the rest of the participants (table 1).

Conclusion

This is the first demonstration of an ex-vivo objective tool to assess the quality of endoscopic tip manipulation. Tip-control reliably stratifies endoscopists by important demographics including interventional profile, number of polypectomies performed and those performing difficult polypectomy but does not correlate with years of endoscopy experience.
If tip-control can be linked to established performance indicators it may provide an objective benchmark for endoscopy and interventional procedures allowing tracking of progress over time.

References

1. Fecso AB, Szasz P, Kerezov G, Grantcharov TP. The Effect of Technical Performance on Patient Outcomes in Surgery: A Systematic Review. Ann Surg. 2017 Mar;265(3):492-501. doi: 10.1097/SLA.0000000000001959. PMID: 27537534.
2. Goldenberg MG, Garbens A, Szasz P, Hauer T, Grantcharov TP. Systematic review to establish absolute standards for technical performance in surgery. Br J Surg. 2017 Jan;104(1):13-21. doi: 10.1002/bjs.10313. Epub 2016 Sep 30. PMID: 27686465.

Disclosure

David James Tate consulting fees and research support from Olympus Medical. The remaining authors have no competing interests to disclose.

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

Focal cryoballoon ablation (FCBA) is a relatively new ablation modality for the treatment of Barrett’s esophagus (BE) related neoplasia. This prospective, European multicenter study (Euro-Coldplay, NTR NL7253) aimed to evaluate the efficacy and safety of FCBA for the treatment of limited BE.

Aims & Methods

In eight European Barrett referral centers, patients with C≤2M≤5 BE with an indication for ablation therapy were eligible for inclusion. Before entry, any visible lesion had to be removed by endoscopic resection (max. 2cm in length and 50% of circumference). FCBA was performed by experienced and trained endoscopists at 3 month intervals until complete endoscopic eradication of BE (max. 5 sessions). During every session, the esophagogastric junction was treated circumferentially followed by all visible BE using side-by-side ablations with a dose of 8 seconds per ablation. After at least two FCBA sessions, add-on treatment was allowed with either argon plasma coagulation (APC) for BE lesions of <5mm (max. 2 sessions) or a single endoscopic mucosal resection for lesions of >5mm. Outcomes included complete eradication of intestinal metaplasia (CE-IM) and dysplasia (CE-D), and adverse event rate.

Results

107 patients (91 males; mean age 65) with a median BE length of C0M2 were included, containing low-grade dysplasia (32%), high-grade dysplasia (32%) or early cancer (39%) as worst baseline histology. Currently, 5/107 patients are still under treatment and therefore excluded from further analysis. Of the remaining patients, 97 (97/102; 95%) patients have finished the treatment phase per protocol, while four (4/102; 4%) patients left the study prematurely. Only one (1/102; 1%) patient could not be treated with FCBA due to a device malfunction requiring a switch to radiofrequency ablation. Overall, 65/102 (64%) patients underwent endoscopic resection at entry followed by a median of 2 (IQR 2-2) FCBA treatments with a median of 7 (IQR 5-9) ablations per treatment session. During the treatment phase, 3/102 (3%) patients developed a new visible, neoplastic lesion amenable for endoscopic resection (high-grade dysplasia n = 2, low-risk T1 cancer n = 1). Add-on treatment after at least two FCBA sessions was performed in 38/102 (37%) patients, of whom the most were treated with APC for small remaining Barrett islands (37/38; 97%). CE-D was achieved in 95% (97/102) and CE-IM in 91% (93/102), per intention-to-treat analysis. Per-protocol analysis, CE-D and CE-IM were achieved in 100% (97/97) and 96% (93/97), respectively. Esophageal stricture was the most common adverse event in 13/102 (13%) patients, which resolved after a median of 2 (IQR 1-4) dilations. Only three (3/102; 3%) patients suffered a severe stricture requiring >3 dilations. No perforation or bleeding were observed, while buried BE glands were seen in 1/102 (1%).

Conclusion

In expert hands, endoscopic eradication therapy with FCBA seems to be highly effective with an acceptable safety profile for patients with limited BE. Long-term follow-up is warranted to evaluate the durability of the treatment response.

Disclosure

C.N. Frederiks have received speaker's fee and reimbursement of study-related travel costs from Pentax Medical. A. Overwater has received reimbursement of study-related travel costs from Pentax Medical. J.J.G.H.M. Bergman is a consultant for Medtronic, Cook Medical, and Boston Scientific, and has received research funding from Pentax Medical, C2 Therapeutics, Medtronic, Aqua Medical, Olympus Endoscopy, and Fuji-film. R.E. Pouw is a consultant for MicroTech, and has received speaker’s fee from Medtronic. R. Bisschops is a consultant for Pentax Medical, Medtronic, and Erbe Medical, and has received research funding and speaker’s fees from Pentax Medical, Medtronic, and Erbe Medical. T. Beyna is consultant for Medtronic, Erbe Medical, Microtech Endoscopy, Olympus Endoscopy, and Boston Scientific. B.L.A.M. Weusten has received research funding from Pentax Medical, C2 Therapeutics, and Aqua Medical. The remaining authors declare to have no disclosures relevant to this manuscript.

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

Surveillance colonoscopy in patients with Inflammatory Bowel Disease (IBD) poses a unique challenge due to the subtle nature of flat dysplasia. But this challenge is further compounded by the number of additional lesions seen as a result of inflammation, such as pseudo-polyps and inflammatory polyps which can result in additional biopsies or unnecessary resection. Computer aided diagnosis (CADx) could improve lesion characterisation in this cohort of patients but a dedicated CADx algorithm has yet to be developed. Here we compare the performance of endoscopists and an existing generic colon CADx algorithm on lesion characterisation in IBD patients.

Aims & Methods

In phase 1, endoscopist performance on image based characterisation was assessed using still images of lesions in patients with IBD. Frames were taken in both white light imaging (WLI) and Image Enhancement (IE). Images were checked by an independent reviewer for the quality of images. Characterisation was then performed by 12 endoscopists (6 experts who regularly perform IBD surveillance and 6 non-expert) who categorised them as neoplastic (adenoma with low or high grade dysplasia) or non-neoplastic (hyperplastic, regenerative, inflammatory or pseudo-polyps).

In phase 2, an existing generic colon CADx algorithm was used in video based analysis of prospectively collected IBD colonoscopy videos. Lesions were characterised as neoplastic or non-neoplastic. Ground truth in both phases was histology.

Results

In phase 1, 57 lesions (34 neoplastic, 23 non-neoplastic) were characterised by endoscopists. For non-experts, sensitivity, specificity and accuracy were 73.0%, 55.3% and 65.9% respectively on white light and 73.9%, 49.1% and 64.7% on IE. For expert endoscopists, sensitivity, specificity and accuracy were 70.1%, 66.7% and 68.7% respectively on WLI and 78.3%, 60.8% and 72.0% on IE.

In phase 2, full withdrawal videos in 20 patients undergoing surveillance colonoscopy were collected. 17 patients had Ulcerative Colitis, 3 patients had Crohn’s disease. 86 lesions were identified (21 neoplastic, 65 non-neoplastic). Video based CADx performance for sensitivity, specificity and accuracy was 88.89%, 80.64% and 74.44% respectively.

Conclusion

Our data highlights the challenges of lesion characterisation IBD patients, with a low sensitivity and specificity in both experts and non-experts. In particular, non-experts have a very low specificity meaning there may be a high number of unnecessary resections/biopsies performed. A generic CADx algorithm performed better than endoscopists and with dedicated training of this algorithm with IBD lesions could further improve characterisation and reduce the number of non-neoplastic lesions which are removed.

Disclosure

Professor Bhandari has received research grants or is the advisory board for Fujifilm, Boston, Olympus, Pentax, 3-D matrix, NEC (Japan), Medtronic