Introduction

Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor approved for the treatment of patients with ulcerative colitis (UC) in the UK, EU and Japan. In the phase 2b/3 SELECTION trial (NCT02914522),¹ FIL 200 mg (FIL200) was well tolerated and effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC.

Aims & Methods

This post hoc analysis of SELECTION data further evaluated the prolonged benefit of FIL treatment from week 10 (W10) until W58. In SELECTION, adults with moderately to severely active UC were randomized 2:2:1 to receive FIL200, FIL 100 mg (FIL100) or PBO once daily for 11 weeks in Induction (IND) Studies A and B (biologic-naïve and -experienced patients, respectively). Patients in clinical remission or with a Mayo Clinic Score (MCS) response at W10 (responders) were rerandomized 2:1 to continue their IND FIL dose in the 47-week Maintenance (MNT) Study. This post hoc analysis evaluated the hazard ratio (HR) for protocol-specified disease worsening (PSDW) in patients who continued FIL200 during MNT (FIL200→FIL200) vs those rerandomized from FIL200 to PBO (FIL200→PBO). The proportion of patients with a prolonged benefit at W58 was also evaluated across all FIL200 and FIL100 MNT arms. A prolonged benefit was defined as clinical remission or an MCS response at W58, among W10 responders. Among patients with prolonged benefit at W58, the proportion of those who had Inflammatory Bowel Disease Questionnaire (IBDQ)-remission at W58 was also assessed across all FIL200 and FIL100 MNT arms.

Results

Baseline characteristics were similar between MNT arms, although biologic-experienced status was more common in patients who did not have a prolonged benefit vs those who did. FIL200→FIL200 treatment (n=199) reduced the risk of PSDW by 74% vs FIL200→PBO (n=98) (HR [95% CI]: 0.26 [0.17–0.40]; p<0.0001). PSDW was the most common reason for discontinuation among patients without prolonged benefit, across all arms. In the FIL200→FIL200 arm, 66.8% of patients who were in clinical remission or had an MCS response at W10 had a prolonged benefit at W58 vs 32.7% in the FIL200→PBO arm. Among patients in clinical remission at W10, 79.3% in the FIL200→FIL200 arm had a prolonged benefit (62.1% clinical remission; 17.2% MCS response) vs 44.4% in the FIL200→PBO arm (13.9% clinical remission; 30.6% MCS response). In the FIL200→FIL200 arm, 82.0% of patients with prolonged benefit at W58 had IBDQ remission at W58 (Table).

Table. Proportion of patients with prolonged benefit at W58 and proportion of patients in IBDQ remission at W58 among those with prolonged benefit at W58.

Conclusion

After a year of FIL200 treatment, two-thirds of patients who were in clinical remission or had an MCS response at W10, and ~80% who were in clinical remission at W10, had a prolonged benefit.

References

Feagan BG et al. Lancet 2021;397:2372–84.

Disclosure

DL has received consulting, advisory board and transport fees from AbbVie, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, MSD, Novartis, Pfizer, Prometheus, Roche and Takeda.
AS has received grant support from AbbVie; and consulting or speaker fees from AbbVie, Dr. Falk Pharma, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer, Takeda and Tillotts Pharma.
TK has served as a speaker, a consultant or an advisory board member for AbbVie, Activaid, Ajinomoto Bio-Pharma, Alfresa Pharma, Asahi Kasei Medical, Astellas Pharma, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eisai, Eli Lilly, Ferring Pharmaceuticals, Gilead Sciences, Janssen Pharmaceuticals, JIMRO, JMDC, Kissei, Kyorin Pharmaceutical, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda, Thermo Fisher Scientific and Zeria Pharmaceutical; and has received research funding from AbbVie, Alfresa Pharma, Asahi Kasei Medical, EA Pharma, Kyorin Pharmaceutical, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Sekisui Medical, Thermo Fisher Scientific and Zeria Pharmaceutical.
TM reports personal fees from AbbVie, EA Pharma, Mitsubishi Tanabe Pharma and Takeda; and grant support from Mitsubishi Tanabe Pharma and Nippon Kayaku.
AO, MF and AdH are employees and shareholders of Galapagos NV.
CJ is a contractor at Galapagos NV.
SV reports grants from AbbVie, Galapagos, J&J, Pfizer and Takeda; consulting and/or speaker fees from AbbVie, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia Biologics, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, CvasThera, Cytoki Pharma, Dr Falk Pharma, Ferring Pharmaceuticals, Galapagos, Genentech/Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity, Prometheus, Robarts Clinical Trials, Second Genome, Shire, Surrozen, Takeda, Theravance Biopharma, Tillotts Pharma and Zealand Pharma.
The SELECTION trial was sponsored by Gilead Sciences Inc. Galapagos NV was a collaborator for the SELECTION trial and funded this analysis.
Medical writing support for the development of this abstract was provided by Elvi Nimali, MBiochem, of PharmaGenesis London, London, UK, and was funded by Galapagos NV.

Introduction

Coexistence of bile acid diarrhoea (BAD) and microscopic colitis (MC) has been described (1), and treating this with sequestrants could reduce the need for budesonide. Fasting plasma 7α-hydroxy-4-cholesten-3-one (C4) values >46 ng/mL are specific for BAD but sensitivity is only 47% (37-57%) compared with tauroselcholic [75-Se]
acid (SeHCAT) retention <10% (2). C4 values between 33 and 46 are in a diagnostic grey zone. Budesonide directly affects the bile acid homeostasis making the temporal relation between treatment and testing important. Fortunately, unlike SeHCAT testing, C4 may be sampled immediately when a patient presents with a flare of MC.

Aims & Methods

To assess the prevalence of coexisting BAD in patients with active MC.
Consequtive patients with MC and a flare fulfilling the Hjortswang diarrhoea criteria (≥3 stools or ≥1 watery stool per day) and a negative test for infectious diarrhoea were included. Patients were treated with budesonide 9 mg once daily for 6 weeks. Clinical assessment, Bristol stool charts, and fasting C4 were obtained at baseline, during the last treatment week and 4 weeks after end of treatment. Remission was defined as a daily mean of <1 watery bowel movement and <3 total bowel movements [EudraCT: 2019-002762-12].

Results

49 patients were included; 26 (53%) with collagenous colitis. Mean age was 60 (range 55-70) years, 22% current smoker, none on NSAIDs. Six (12%; 95%CI: 5–25%) of 49 patients had BAD diagnosed by C4. Another 3 patients had grey zone C4 values. Mean C4 did not change during budesonide treatment, 22 and 23 ng/mL at baseline and at week 6, respectively. SeHCAT was performed outside the study in 26 patients of whom 3 had retention of <10% and 6 of <15%. The mean total number of stools per day declined from baseline 7.9 to 1.9 and watery stools from 3.7 to 0.3 during budesonide treatment. Remission was obtained in 45. Twenty-nine had relapsed four weeks after end of budesonide treatment, 5 of 6 (83%; 95%CI: 36–100%) with MC and BAD, and 24 of 43 (56%; 95%CI: 40–71%) with MC and not BAD.

Conclusion

During an inflammatory flare of MC, 12% (5–25%) had C4-defined BAD. However, C4 only identifies about half of patients with BAD compared with the diagnostic gold standard SeHCAT, meaning about 25% of patients with MC could have coexisting BAD. Screening for BAD may have merit in MC patients with relapse of diarrhoea after budesonide treatment.

References

1 Bjørnbak C, Engel PJH, Nielsen PL, Munck LK. Microscopic colitis: clinical findings, topography, and persistence of histopathological subgroups. Aliment Pharmacol Ther. 2011, 34: 1225-34.
2. Borup C, Vinter-Jensen L, Jørgensen SPG, Wildt S, Graff J, Gregersen T, Zaremba A, Andersen TB, Nøjgaard C, Timm HB, Lamazière A, Rainteau D, Hansen SH, Rumessen JJ, Munck LK. Prospective comparison of diagnostic tests for bile acid diarrhoea. Aliment Pharmacol Ther. 2024; 59: 39-50.

Disclosure

Budesonide was donated for study use by Tillotts Pharma as an unrestricted scientific grant. Tillotts Pharma had no influence on the planning, conduct, or reporting of the study.

Introduction

As a chronic condition, eosinophilic oesophagitis (EoE) requires lifelong therapeutic management and multidisciplinary care. Reports suggest clinicians managing EoE have gaps in knowledge and competence, which may lead to suboptimal patient outcomes. We aimed to assess whether a purpose-specific curriculum comprising a series of continuing medical education (CME) activities addressed these gaps.

Aims & Methods

Four faculty-led, CME-accredited activities on EoE were hosted on two free-to-access online medical education websites. Each activity provided 30–60 minutes of education in short videos and addressed learning objectives based on a review of published literature and expert insights. Educational outcomes were assessed using Moore’s expanded outcomes framework Levels 1–4 (participation, satisfaction, knowledge, and competence, respectively). Intent to change practice and need for further education were also assessed. Level 1 data were captured using Google Analytics; Level 2–4 data were captured using pre- and post-activity questionnaires administered by an independent third party and analysed by the authors. Across the curriculum 21,032 participants engaged with the content, with a sample size of 800 available for the Level 2–4 analysis; the margin of error was calculated as ~3% based on a standard confidence interval of 95%.

Results

Within 12 weeks of launch, a mean of 5,258 participants engaged with each curriculum activity (Moore’s Level 1). Mean satisfaction (Moore’s Level 2) was high (87.3%) across the curriculum. From baseline to follow-up, significant average increases in declarative knowledge (24%, p=0.012), procedural knowledge (18%, p<0.001), and competence (16%, p=0.004) were observed (Moore’s Levels 3a, 3b, and 4, respectively) (Table). Gastroenterologists had the highest proportion of correct answers at follow-up across all activities (86–95%). Allergists/immunologists had the largest increase in knowledge from baseline to follow-up (51%, activity 1); the smallest increase was seen for gastroenterologists (7%, activity 2). For all specialities, the lowest proportion of correct answers at follow-up was for questions on pathophysiology/causes of EoE (Table). Overall, 64% of learners would change their practice following participation in ≥1 curriculum activity and ~20% indicated further education would be beneficial.

Conclusion

This expert-led, CME curriculum led to significant improvements in clinician knowledge and competence surrounding the latest research and best practices in the pathophysiology, diagnosis, and management of EoE, which may lead to improvements in patient care and outcomes. Findings support further development of online, multiformat educational activities to address clinical knowledge and competence gaps. Future programs should focus on the underlying pathophysiology of EoE and how this may inform practice.

References

None

Disclosure

Stuart Carr discloses: Consulting fees/advisory board: Sanofi. Honoraria (speakers bureau): Sanofi, Biologix.
Evan S. Dellon discloses: Research funding: Adare/Ellodi, Allakos, Arena, AstraZeneca, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, Shire/Takeda. Consultant: Abbott, Abbvie, Adare/ Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Landos, LucidDx, Morphic, Nexstone Immunology, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, Upstream Bio. Educational grant: Allakos, Holoclara, Invea
Nirmala Gonsalves discloses: Consultant: Allakos, Astra-Zeneca, Regeneron-Sanofi, BMS, Knopp. Speaking: Regeneron-Sanofi. Royalties: Up To Date.
Salvatore Oliva discloses: Consulting fees from Sanofi.
Jonathan M. Spergel discloses: Consultant: Regeneron and Sanofi-Genzyme, Novartis, Allakos. Grants/Research Support: NIH, FARE, Regeneron, Novartis, Sanofi, Celgene. Speaker’s Bureau: Medscape.
Mário C. Vieira: No conflicts of interest associated with the submitted work to declare.
Katie Bickford, Kathy Day, Alex Noble, Anne Nunn and Alison Scott: No financial relationships to disclose.

Introduction

A low incidence of eosinophilic esophagitis (EoE) in children in the North Denmark Region (NDR) were measured in 2007-2017. Few of the children diagnosed before 2017 were treated to remission suggesting a lack of awareness. While there currently are no guidelines for treating EoE in Denmark, a new English guideline was published in 2022 renewing focus on the disease.

Aims & Methods

The aim of this study was to measure the difference of current Danish clinical practice for treatment and follow-up of EoE children in the NDR with the new English guideline from the British Society of Gastroenterology (BSG) and the British Society of Pediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN). This retrospective, register-based DanEoE cohort study included 31 children diagnosed with EoE between 2007–2021 in NDR. Medical records were reviewed and information about treatment and follow-up were collected.

Results

In 32% of the children with EoE in the NDR, first-line treatment initiated corresponded with the recommendations in the new English guideline. One in 6 children were never started on any treatment even though treatment always is recommended. Symptomatic follow-up was completed in 77% (24/31) of children and 85% (11/13) of the children after 2017. Histologic follow-up within 12 weeks was completed in 13% (4/31) of the children and 15% (2/13) of the children after 2017. Combined symptomatic and histologic remission after first-line treatment was achieved in 6% (2/31).

Conclusion

In Denmark focus on improving EoE treatment and follow-up for children is needed, as there is a significant difference between current clinical practice and the recommendations in the new English guideline.

References

Hollænder M, Terkelsen JH, Kramme F, Bredal K, Kragholm K, Dalby K, et al. The incidence of eosinophilic oesophagitis in 2007-2017 among children in North Denmark Region is lower than expected. BMC Pediatr. 2022 Apr;22(1):183.
Dhar A, Haboubi HN, Attwood SE, Auth MKH, Dunn JM, Sweis R, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022 Aug;71(8):1459–87.

Introduction

Laser therapy is a relatively recent technique that allows the treatment of anal fistulas (FIstula-tract LAser Closure: FilaC®), and anal fissure (Laser anal fissure: LSL) with the FilaC fibre, pilonidal sinuses with the SiLaC® fibre (Sinus Pilonidalis treatment), and haemorrhoids with the Laser Hemorrhoido Plasty fibre (LHP®).

Aims & Methods

Our study aims to report the preliminary results of a prospective bicentric study including all patients treated with laser therapy in two private hospitals.​
​This prospective descriptive study includes 141 patients treated with laser therapy for proctological pathology (anal fistulas, pilonidal sinuses, anal fissures, and hemorrhoids) performed in two proctology units. The majority of these procedures were performed under spinal anesthesia. Data were collected directly from the patients using an evaluation form. We studied their clinical data and the immediate and medium-term postoperative follow-up

Results

141 patients were included. The mean age was 44 years (18-76 years). 78% were male and 22% female (sex ratio = 3.5). The anal fistula was the main indication for laser therapy, with FilaC® performed in 105 patients (74.5%), followed by SiLaC® in 16 patients (11.3%), LHP® in 7 patients (5%) and 4 cases of LSL (2.8%). 9 patients benefited from combined treatment: 5 LHP®+ LSL patients (3.5%), 2 FilaC®+ LSL patients (1.4%), 1 FilaC®+ SiLaC® patient (0.7%), and 1 FilaC®+ LHP® case (0.7%). 79 patients (73.2%) benefited from initial drainage of the fistula with a loose seton for 1 to 5 months before FilaC®, while 29 patients (26.8%) with a short direct extrasphincteric fistula benefited from laser therapy.18 patients were lost to follow-up (12,8%). 104 patients (84,5%), all pathologies combined, progressed well with 19 cases of failure (15,5%) with a follow-up time of 1 to 50 months. Fistulas healed in 74 patients (80%). There were 18 confirmed failures. 15 of these were treated surgically with 4 FilaC. Failure was diagnosed within an average of 6 months and was manifested by persistent leakage with no healing of the external orifice. There were no continence problems after the procedure. 16 patients were lost to follow-up. In patients with LHP, 2 patients (15,4%) experienced early post-operative bleeding requiring surgical suturing. All patients treated with SiLaC® had a favorable outcome. The 4 patients treated for anal fissures were satisfied with the procedure.

Conclusion

Laser proctology is a minimally invasive conservative procedure with significant postoperative pain reduction. In the literature, the success rate of this technique ranges from 65 to 80%. Our hospitals were the first in Morocco to introduce this procedure. Preliminary results from our pilot study showed satisfying healing in 84.5% of patients. However, long-term confirmation is required.

References

1- Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol. 2021 Dec 6;14:467-475. doi: 10.2147/CEG.S269464. PMID: 34908858; PMCID: PMC8664604.

Introduction

Ozanimod (OZA), a sphingosine 1-phosphate (S1P) receptor modulator that selectively targets S1P₁ and S1P₅, is approved in the European Union, United States, and other countries for the treatment of moderately to severely active ulcerative colitis (UC). Mucosal healing (MH), a key treatment goal for patients (pts) with UC, is associated with improved long-term pt outcomes.

Aims & Methods

The goal of this analysis was to determine the rate of early MH after treatment with OZA at Week (W) 10 using stringent MH criteria (mucosal endoscopy subscore [MES] = 0 plus histologic remission [Geboes score <2.0]) and to assess the relationship between achievement of stringent MH at W10 and clinical outcomes at W52. Outcomes were compared to pts achieving MH using a standard definition (MES ≤1 plus histologic remission). This analysis included pts from True North (NCT02435992) who achieved clinical response on once-daily oral OZA 0.92 mg at W10 and continued OZA during the 42-wk maintenance period. In this post hoc analysis, we examined MH, clinical remission, and corticosteroid (CS)–free remission at W52 in pts with stringent MH vs without stringent MH at W10 and with stringent MH vs with standard MH.

Results

Of the 230 pts who achieved clinical response on OZA at W10 and continued OZA during the maintenance period, 44 (19.1%) achieved MH using a standard definition and 13 (5.7%) achieved stringent MH at W10. Demographic and clinical characteristics were generally balanced between OZA-treated pts with stringent MH (n=13) and without stringent MH (n=217) at W10. Notably, there were fewer male pts with stringent MH vs without stringent MH, all pts with stringent MH had moderate disease (based on endoscopy), and more pts with stringent MH vs without stringent MH had left-sided UC disease. CS use at screening and prior tumor necrosis factor inhibitor (TNFi) use were lower in those with stringent MH vs without stringent MH. Similar differences in disease severity, extent of disease, and CS and TNFi use were seen in pts with stringent MH vs standard MH. At W52, more pts treated with OZA with stringent MH at W10 vs without stringent MH at W10 had clinical remission (53.8% vs 35.9%), CS-free remission (53.8% vs 30.4%), MH (61.5% vs 27.6%), endoscopic improvement (61.5% vs 44.7), and histologic remission (61.5% vs 31.8%). Except for endoscopic improvement, a slightly higher percentage of pts with stringent MH vs standard MH at W10 achieved clinical outcomes at W52 (Table).

Conclusion

While difficult to achieve, a small proportion of pts treated with OZA experienced stringent MH by W10. Compared with pts who achieved standard MH at W10, those with stringent MH at W10 demonstrated numerically better clinical outcomes at W52 on OZA treatment. Achieving stringent MH at W10 correlated with better clinical, endoscopic, and mucosal outcomes at W52.

Disclosure

The study was funded by Bristol Myers Squibb, Princeton, NJ, USA.
WR: speaker for 4SC, Abbott Laboratories, AbbVie, Aesca, Aptalis, Astellas, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; consulted for Abbott Laboratories, AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Arena, Astellas, AstraZeneca, Avaxia, Roland Berger GmbH, Bioclinica, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernst & Young, Falk Pharma GmbH, Ferring, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Landos, Lipid Therapeutics, LivaNova, Mallinckrodt, MedAhead, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Peri Consulting, Pharmacosmos, Philip Morris Institute, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres, Setpoint Medical, Sigmoid, Sublimity, Takeda, Teva, Therakos, Theravance, TiGenix, UCB, Vifor, Zealand, and Zyngenia; served as an advisory board member for 4SC, Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Biogen IDEC, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cellerix, Celltrion, Centocor, ChemoCentryx, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpoint Medical, Takeda, Therakos, TiGenix, UCB, Zealand, and Zyngenia; received research funding from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnostik, Janssen, MSD, Sandoz, and Takeda.
AH: Consultant, advisory board member, or speaker for AbbVie, Atlantic, Bristol-Myers Squibb, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda. Global Steering Committee for Genentech.
CS: served as a speaker for AbbVie, Bristol Myers Squibb, Janssen, Pfizer, Takeda, and UCB.
RKC: consulted for AbbVie, Bristol Myers Squibb, Janssen, LabCorp, Pfizer, Samsung Bioepis, and Takeda.
HAA, AJ, HW, and MTO: employees and/or shareholders of Bristol Myers Squibb.
RL: consulted for Bristol Myers Squibb and Pfizer.
JA: received consulting fees from AbbVie, BioFire Diagnostics, Janssen, and Pfizer; received research grants from BioFire Diagnostics.

Introduction

Radiofrequency ablation is considered the standard therapy for flat dysplastic BE. Hybrid APC is a newer under evaluation, less expensive technique, but with the need of a special injection device and catheter. Aim of the study: To evaluate the efficacy of a standard APC catheter after submucosal injection for BE ablation.

Aims & Methods

To evaluate the efficacy of a standard APC catheter after submucosal injection for BE ablation. Naïve or after previous treatments patients with BE and low - grade dysplasia (LGD) were prospectively evaluated. Sodium chloride solution 0.9% was injected submucosally with a 23 G needle followed by APC application with a standard catheter (ERBE APC 300, 45Watts) on the created cushion. The same procedure was repeated for most of BE surface to be cauterized, with special attention not to ablate large circumferential areas. Patients were under high dose PPIs. Biopsies were taken according to the Seattle protocol during the follow-up.

Results

31 patients, 28 males (90.3%), 56.7±12.5 years old. Their initial diagnosis was: 19 patients with LGD (61.3%), 7 with high grade dysplasia (22.6%), and 5 with intramucosal cancer (16.1%). Eleven patients (35.5%) had previous endoscopic mucosal resection (EMR) while 7 (22.6%) had received radiofrequency ablation (RFA). Median BE length with LGD at the beginning of APC was 4cm (25th-75th:2-7, min-max:1-10). Median follow-up:10.1(1-108) months. In total 20 (64.5%) patients completely eradicated BE. For the remaining 11 patients APC led to a substantial reduction of BE length [Initial Median: C3M6 (Min: C0M1, Max: C6M8) to a final median: C0M2 (Min:C0M1, Max:C2M5] but the study is ongoing. Initial BE length was correlated to APC sessions needed (r= 0.54, p<0.01) but was not a limiting factor for complete BE eradication. Instead, smoking was an aggravating factor for BE complete eradication (HR=3.12, 95%CI.: 1.2-8.12, p=0.02). No death, hospitalization, severe hemorrhage, or perforation were observed. In 7 patients moderate pain requiring paracetamol, resolved after a few hours of in hospital supervision while 11 patients had mild dysphagia the following days without permanent stenosis.

Conclusion

Conclusions: 1) Standard APC after submucosal injection is safe and tolerable for BE ablation. 2) It may be applied in naïve patients or if other techniques were previously used. 3) Length increases the number of sessions needed but does not seem to be a limiting factor for APC application.