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

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 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

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

Hemorrhoidal disease (HD) is the most common pathology in proctology, with an estimated prevalence of between 4.4% and 39%. It can be managed in a variety of ways: hygienic-dietary measures, medical, instrumental or surgical treatment. The latter is considered especially after failure of medical and instrumental treatment.

Aims & Methods

Aims : The aim of our study is to report our experience with Milligan and Morgan technique in the management of hemorrhoidal disease.

Materials and methods: This was a monocentric retrospective descriptive-analytical study conducted over a 12-year period: from January 2011 to January 2023. The data studied were age, sex, clinical manifestations, stage of HD on proctological examination and therapeutic data. All patients who underwent Milligan and Morgan hemorrhoidectomy (MMH) and presented with stage IV and III hemorrhoids (after failure of instrumental treatment) were included in our study. Excluded were asymptomatic patients, patients with surgical contraindications and other stages treated by non-surgical means. The statistical study was carried out using IBM-SPSS 20.0 software. The chi-2 test was used to compare categorical variables.

Results

468 patients were enrolled during the study period. The mean age of this population was 41 years (22-71). The sex ratio M/F was 2,1. Clinical expression was dominated by rectal discharge in 246 patients (74%), proctalgia in 132 patients (28%), anal pruritus in 119 patients (25%) and anal oozing in 56 patients (12%). Proctological examination revealed stage IV haemorrhoids in 201 patients (43%) and stage III haemorrhoids in 267 patients (57%). 25 patients (5.3%) had an associated anal fissure. Anemia was present in 341 patients (72.8%), with a mean hemoglobin value of 7.8 g/dl. Transfusion was required in 65 patients (14%) who presented with severe anemia of less than 7g/dl. Colonoscopy was indicated in 87 patients (18.5%) over the age of 45 with rectal bleeding, and in 42 patients (9%) with a history of digestive cancer. Milligan and Morgan's indication was stage III hemorrhoids with severe anemia in 65 patients (14%), after failure of infrared photocoagulation in 194 patients (41.4%); after failure of HAL-RAR treatment n=8 (1.7%) and stage IV hemorrhoids in 201 patients (43%). The procedure performed was a hemorrhoidectomy.An open pedicle MMH type was performed. Patients with an associated anal fissure (5.3%) underwent the Bellan procedure in addition to hemorrhoidectomy. Immediate post-operative complications included post-operative pain in all our patients, urinary retention in 31 patients (6.6%), significant post-operative bleeding in 2 patients (0.5%) treated by electrocoagulation in the OR, and minimal post-operative bleeding in 117 patients (25%) treated by compression bandaging. The latter was reported in 43 patients (36.7%) with stage III hemorrhoids and 74 patients (63.2%) with stage IV hemorrhoids. This difference was statistically significant (p<0.001). Late complications included delayed healing in 9 patients (1.9%), 4 of whom were diabetic, anal stenosis in 5 patients (1%), requiring sphincterotomy combined with anoplasty in 3 patients, and finger dilatation in 2 patients. Anal stenosis was reported in 4 patients who did not undergo postoperative digital rectal examination and 1 patient who did. This difference is statistically significant p=0.03.

Conclusion

MMH remains the gold standard for the treatment of hemorrhoidal disease. The results are satisfactory, especially in the long term. Post-hemorrhoidectomy anal stenosis remains the most serious complication.

Introduction

Axial spondyloarthritis (axSpA), characterised by chronic inflammation of the sacroiliac joints (SIJs) and spine, is a common extraintestinal manifestation in Inflammatory Bowel Disease (IBD). It is associated with poor outcomes and a substantial impact on quality of life. Thus, early detection is important to optimally tailor treatment and suppress the inflammation in all disease domains. However, the prevalence and pattern of axial involvement have not been described in early IBD.

Aims & Methods

We aimed to describe the prevalence and distribution of axial symptoms, clinical findings and MRI-determined inflammatory and structural lesions in the spine and SIJs of patients with newly diagnosed IBD. Patients with newly diagnosed IBD from a prospective population-based inception cohort were consecutively included. Structured rheumatological interview collecting data on peripheral and axial symptoms and clinical evaluation were performed. MRI assessment for spine and SIJ inflammation and structural lesions was based on validated and widely applied scoring systems [1,2]. Further, an expert assessment of the MRIs as +/- indicative of axSpA applying standardized definitions was performed [3,4].

Results

Of 110 included patients (mean age 42 years, 40% male, 40 with Crohn’s disease (CD), 70 with ulcerative colitis (UC)), 74 had active IBD. At the time of evaluation, 4 patients received treatment with systemic glucocorticoid and one received TNF-inhibitor. Nine patients were HLA-B27 positive. None were previously diagnosed with SpA.
Back and/or buttock pain was reported by 48(44.9%) patients and inflammatory back pain by 10(9.1%). In 23(21.5%) patients the pain could not be better explained by competing conditions (for example degenerative disc disease, nerve root compression, osteoporosis or fibromyalgia) according to the assessing rheumatologist. The axial symptoms were accompanied by peripheral joint and/or entheseal symptoms in 30(62.5 %) patients and 33(68.8%) had tender and/or swollen joints and/or entheses.
According to the MRI expert, MRIs of 17(16.7%) patients were indicative of axSpA (spine and SIJs evaluated together), while 11(10.8%) of the spine-MRIs and 13(12.7%) of the SIJ-MRIs were indicative of axSpA. Only 10 of the 17 patients with typical axSpA MRI findings had axial symptoms. There was no difference in symptoms or MRI findings between patients with UC and CD, or between patients with active and inactive IBD.
Spine bone marrow oedema (BME) in ≥1 slice was present in 30(30.3%) patients. SIJ BME in ≥1 slice was found in 27(26.5%) patients, erosion was present in 24(23.5%) patients, fat lesions in 12(11.8%) and ankylosis in 3(2.9%). The definition of positive MRI for sacroiliitis was fulfilled in 12 (11.8%) patients of whom six had axial symptoms. The Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA were met in 11 cases.

Conclusion

One out of six patients with newly diagnosed IBD had findings indicative of axSpA on spine and SIJs MRI. Since only ̴60% of these patients were symptomatic, we conclude that axSpA may be an underdiagnosed early-occurring condition among IBD patients. Our results indicate a low threshold for performing MRI of the spine and SIJs and a need for multidisciplinary collaboration to ensure early detection of axial involvement to enable an optimal therapeutic strategy and prevent future structural damage and disability.

References

1. Maksymowych et al., Art Rheum, 2005, 53(5) and 53(4)
2. Maksymowych et al., Journal of rheum, 2014
3. Lambert et al., Ann Rheum Dis 2016
4. Maksymowych et al., Rheumatology 2021