Publications by authors named "Kazuya Sumi"

35 Publications

Once-daily, single-inhaler indacaterol/mometasone versus twice-daily salmeterol/fluticasone in Asian patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies.

J Asthma 2021 Aug 24:1-11. Epub 2021 Aug 24.

Department of Allergology, Medical Center for Allergy and Immune Diseases, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.

Objective: PALLADIUM and IRIDIUM studies demonstrated efficacy and safety of indacaterol/mometasone (IND/MF) versus salmeterol/fluticasone (SAL/FLU). This analysis of pooled data from PALLADIUM and IRIDIUM studies evaluated efficacy and safety of IND/MF versus SAL/FLU in Asian patients with inadequately controlled asthma.

Methods: Both studies were Phase III, 52-week, randomized, double-blind, active-controlled that included patients with predicted pre-bronchodilator FEV (PALLADIUM, ≥50%-<85%; IRIDIUM, <80%), ACQ-7 score ≥1.5. Patients treated with IND/MF high- (150/320 μg) or medium-dose (150/160 μg) or SAL/FLU high-dose (50/500 μg) were included. Lung function, asthma control, and asthma exacerbations were evaluated.

Results: In total, 323 patients (IND/MF high-dose,  = 107; IND/MF medium-dose,  = 106, SAL/FLU high-dose,  = 110) were included. IND/MF high-dose showed improvement in trough FEV versus SAL/FLU high-dose at Weeks 26 (Δ, 42 mL; 95% CI, -35 to 120 mL), and 52 (Δ, 41 mL; 95% CI, -37 to 120 mL). IND/MF high-dose exhibited numerically greater improvement in ACQ-7 score versus SAL/FLU high-dose at Weeks 26 (Δ, -0.215; 95% CI, -0.385 to -0.044) and 52 (Δ, -0.176; 95% CI, -0.348 to -0.005). Improvements in trough FEV and ACQ-7 score were comparable between IND/MF medium-dose and SAL/FLU high-dose. IND/MF high- and medium-dose showed reductions in moderate or severe (45%; 30%), severe (39%; 41%), and all (9%; 25%) exacerbations, respectively, versus SAL/FLU high-dose over 52 weeks. All treatments were well tolerated.

Conclusions: Once-daily, single-inhaler IND/MF high-dose improved lung function with better asthma control, reduced asthma exacerbations with comparable safety versus twice-daily SAL/FLU high-dose. IND/MF medium-dose showed comparable outcomes to SAL/FLU high-dose at a reduced steroid dose.
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http://dx.doi.org/10.1080/02770903.2021.1962342DOI Listing
August 2021

Diagnosis of congenital esophageal stenosis in adults and treatment with peroral endoscopic myotomy.

Ann Gastroenterol 2021 Jul-Aug;34(4):493-500. Epub 2021 Mar 23.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan (Haruo Ikeda, Haruhiro Inoue, Mary Raina Angeli Abad, Yusuke Fujiyoshi, Yohei Nishikawa, Akiko Toshimori, Mayo Tanabe, Yuto Shimamura, Kazuya Sumi, Yugo Iwaya, Manabu Onimaru).

Background: Congenital esophageal stenosis (CES) in adults is a rare disorder that can present as achalasia, particularly in the distal esophagus. We describe the salient features of CES in adults and identify the feasibility and short-term outcomes of peroral endoscopic myotomy (POEM) for CES.

Methods: In this retrospective, single-center case series, we included 6 patients with a "misdiagnosis" of achalasia established elsewhere, ultimately diagnosed with CES and referred to our institution for POEM. Symptom improvement (clinical success rate), defined as an Eckardt Symptom Score (ESS) of <3 at 2-month follow up was assessed.

Results: Six patients (median age: 40 [range: 18-58] years; 4 males) were included. A long-standing history of dysphagia, ring-shaped stenosis on endoscopic examination, "lopsided hourglass" sign on barium esophagogram, and high-resolution manometry findings indicated by a compartmentalized intrabolus pressure pattern with distinction between the stenotic area and the lower esophageal sphincter were the salient features identified. POEM could not be completed in the first 2 cases due to technical challenges. All subsequent 4 patients who underwent successful POEM, exhibited improved ESS of ≤3 (clinical success rate 100%) at 2 months post-POEM.

Conclusions: Along with identification of salient features on several diagnostic modalities, a differential diagnosis of CES in adults must be considered in patients presenting with long-standing history of dysphagia arising from childhood and persisting into adulthood. Although favorable short-term outcomes of POEM were achieved, further evaluation is still warranted, and an inexperienced operator should not attempt POEM on CES patients due to its technical difficulties.
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http://dx.doi.org/10.20524/aog.2021.0618DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276369PMC
March 2021

Long-term clinical results of per-oral endoscopic myotomy (POEM) for achalasia: First report of more than 10-year patient experience as assessed with a questionnaire-based survey.

Endosc Int Open 2021 Mar 19;9(3):E409-E416. Epub 2021 Feb 19.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Since per-oral endoscopic myotomy (POEM) was introduced in 2010, it has become accepted as one of the standard treatments for esophageal achalasia worldwide. This study aimed to present long-term clinical results of POEM over 10 years and evaluate the technique and outcomes at the institution where it was first used in clinical settings. Questionnaire-based surveys were sent to patients who received POEM in our institution from September 2008 to May 2010. Patient demographics and procedural outcomes and open-ended questions were posed about the postoperative courses, including symptom improvement and recurrence, additional treatments, and post-POEM gastroesophageal reflux disease (GERD) symptoms. Achalasia symptoms and post-POEM GERD symptoms were evaluated with Eckhardt scores and GerdQ systems, respectively.  Thirty-six consecutive POEMs were performed in that period and 10-year follow-up data were obtained from 15 patients (41.7 %). Although four cases (26.7 %) required additional pneumatic balloon dilatation (PBD), reduction in post-Eckardt scores were observed in 14 cases (93.3 %). GerdQ score was positive in one patient (6.7 %). Proton pump inhibitors (PPI) were taken by four patients (26.7 %) and their symptoms were well-controlled.  Clinical results of POEM over 10 years were favorable regardless of various factors. Symptoms improved even in patients who required additional treatments, suggesting that POEM plays a significant role in treatment of achalasia.
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http://dx.doi.org/10.1055/a-1333-1883DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895648PMC
March 2021

A novel endoscopic purse-string suture technique, "loop 9", for gastrointestinal defect closure: a pilot study.

Endoscopy 2021 Jan 20. Epub 2021 Jan 20.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

BACKGROUND : This study aimed to assess the feasibility and efficacy of the novel loop 9 method of gastrointestinal (GI) defect closure. METHODS : 20 patients underwent a GI procedure that required defect closure. Loop 9 can be delivered through a single instrument channel (3.2 mm) and released at the defect site. After it has been anchored by two clips positioned on opposite sides of the defect edge, the loop 9 is tightened by pulling the end of the suture intraluminally using biopsy forceps. Additional clips are placed to achieve complete closure. The primary outcome was complete closure rate. The secondary outcomes were closure time, sustained closure rate, and adverse events. RESULTS : Complete closure was achieved in 100 % of cases. The mean size of the mucosal defects was 17.5 mm (range 10-55 mm). The median closure time was 14 minutes. The sustained closure rate was 90 %. No adverse events were noted. CONCLUSIONS : The loop 9 technique is feasible and effective in achieving complete and sustained closure of therapeutic endoscopy-related GI defects.
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http://dx.doi.org/10.1055/a-1364-4160DOI Listing
January 2021

Diagnostic yield of fourth-generation endocytoscopy for esophageal squamous lesions using a modified endocytoscopic classification.

Dig Endosc 2020 Dec 15. Epub 2020 Dec 15.

Digestive Disease Center, Showa University Koto, Tokyo, Japan.

Objectives: Endocytoscopy (EC) is an ultra-high magnification endoscopy designed to provide in vivo histologic assessment. This study aimed to evaluate the diagnostic yield of the newly developed fourth-generation EC for esophageal squamous lesions by using a modified EC classification.

Methods: A total of 2548 EC images of 57 esophageal targeted areas between June 2015 and October 2017 were retrospectively collected. Two lesions with low-quality images were excluded. Only EC images were independently reviewed by two expert and two non-expert endoscopists. The lesions were classified according to a three-tier modified EC classification. We used a multilevel logistic regression to analyze the data.

Results: The sensitivity and specificity of diagnosing non-squamous cell cancer (SCC) vs SCC were 82.5% and 83.0% by the experts; 90.1% and 75.0% by non-experts. The interobserver agreement among the four raters was good (kappa statistic 0.59). The diagnostic accuracy of experts and non-experts was similar (P = 0.16 for specificity and P = 0.20 for sensitivity). The sensitivity and specificity of EC for non-neoplasia vs neoplasia were 88.7% and 74.6% by experts; 90.3 and 52.1% by non-experts. The interobserver agreement among the four raters was moderate (kappa statistic 0.44). The specificity of experts was higher compared to non-experts, although the difference did not reach statistical significance (P = 0.08 for specificity and P = 0.93 for sensitivity).

Conclusions: Fourth-generation EC offers acceptable diagnostic accuracy and reliability in both experts and non-experts, especially when diagnosing SCC lesions.
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http://dx.doi.org/10.1111/den.13914DOI Listing
December 2020

Characterization of intragastric pressure waveform in endoscopic pressure study integrated system: Novel diagnostic device for gastroesophageal reflux disease.

Dig Endosc 2021 Jul 8;33(5):780-787. Epub 2020 Dec 8.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Objectives: Endoscopic pressure study integrated system (EPSIS) is a novel diagnostic tool for gastroesophageal reflux disease (GERD). EPSIS has been developed to evaluate lower esophageal sphincter function by monitoring the intragastric pressure (IGP) while insufflating the stomach during gastroscopy. Based on previous data, EPSIS could diagnose GERD with good accuracy by assessing IGP waveform pattern. This study aimed to further characterize the waveform to improve the diagnostic yield of EPSIS.

Methods: We conducted a retrospective analysis of patients with typical GERD symptoms who underwent both EPSIS and 24-h impedance-pH monitoring (MII-pH) at a single tertiary referral center from October 2018 to May 2020. EPSIS was performed by using a through-the-scope catheter connected to the pressure measuring system (TR-W550, TR-TeH08, AP-C35; Keyence, Osaka, Japan) to monitor IGP. Abnormal acid reflux was defined as acid exposure time (AET) over 6.0%. Pressure waveform was characterized as follows: (i) Basal IGP, (ii) Maximum IGP, (iii) Pressure difference, (iv) Gradient of the waveform.

Results: A total of 57 patients with GERD symptoms were analyzed. Twenty-one patients presented abnormal AET on MII-pH. Among EPSIS parameters, pressure difference during insufflation correlated with AET (ρ = -0.66, P < 0.01) and showed the best diagnostic accuracy for AET with the cutoff value of 4.7 mmHg (area under the curve [AUC], 0.87). The gradient of EPSIS waveform also revealed good diagnostic accuracy for abnormal AET with the cutoff value of 0.07 mmHg/s (AUC, 0.81).

Conclusions: Endoscopic pressure study integrated system waveform parameters, especially pressure difference, presented high diagnostic accuracy for the presence of abnormal acid reflux.
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http://dx.doi.org/10.1111/den.13867DOI Listing
July 2021

Real-life safety and efficacy of omalizumab in Japanese patients with severe allergic asthma who were subjected to dosing table revision or expansion: A post-marketing surveillance.

Pulm Pharmacol Ther 2020 10 17;64:101950. Epub 2020 Sep 17.

Department of Respiratory Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address:

Background: Omalizumab is an anti-immunoglobulin E monoclonal antibody approved for patients with severe allergic asthma in Japan. With regard to omalizumab dosage in Japanese adults with severe allergic asthma in clinical practice settings, this post-marketing surveillance evaluated safety and efficacy of the dosing table revision (DTR) based on a dosing regimen of omalizumab administration every 4 weeks dosing regimen and dosing table expansion (DTE) for patients with baseline IgE levels >700 IU/mL.

Methods: This 52-week, multicenter study, conducted from September 2013 to November 2018, evaluated omalizumab safety outcomes including adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), efficacy outcomes including Global Evaluation of Treatment Effectiveness (GETE), change in oral corticosteroid dose, and asthma exacerbation-related events such as hospitalization, emergency room visits, and worsening of symptoms.

Results: Of the 405 patients registered in the study, safety was evaluated in 392 and efficacy in 390. The mean age of patients was 58.5 years and 58.7% were women. In total, 41.3% of the patients were subjected to DTE and 58.7% to DTR. In the safety dataset, 6.6% experienced an ADR, 32.9% experienced an AE, and 16.1% experienced an SAE. In the efficacy dataset, 63.3% of patients at Week 16 and 63.5% at Week 52 had an 'effective' or 'good' GETE score. Omalizumab was associated with a reduction in worsening of asthma symptoms requiring systemic corticosteroids and frequency of hospitalization. All outcomes were comparable among the DTE and DTR subgroups.

Conclusion: The findings from this study support the safety and efficacy of omalizumab administered based on the revised and expanded dosing table in Japanese patients with severe allergic asthma.
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http://dx.doi.org/10.1016/j.pupt.2020.101950DOI Listing
October 2020

Importance of second-look endoscopy after per-oral endoscopic myotomy for safe postoperative management.

Dig Endosc 2021 Mar 2;33(3):364-372. Epub 2020 Sep 2.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Objectives: Per-oral endoscopic myotomy (POEM) is a safe and effective treatment for achalasia and esophageal motility disorders. The role of second-look endoscopy (SE) on postoperative day 1 has not been examined. This study aimed to evaluate the findings and need of SE after POEM.

Methods: This is a single-center, retrospective study. All consecutive patients who underwent POEM and SE on postoperative day 1 between December 2017 and September 2019 were included. The primary endpoint was the rate of newly-detected adverse events (nAE) during SE that required endoscopic intervention or deviation from the normal postoperative course. Multivariate logistic regression was used to identify predictors of nAE.

Results: Four-hundred-ninety-seven patients (mean age, 50.3 years; female, 49.9%) were included. SE identified abnormal findings in a total of 71 patients (14.3%). nAE which required endoscopic intervention or deviation from the normal postoperative course were identified in 12 patients (2.4%): eight (1.6%) entry site dehiscence; two (0.4%) submucosal hemorrhage or hematoma; and two (0.4%) dehiscence of an intraoperative perforation site after endoclip closure. Other findings such as mucosal thermal damage without perforation and small submucosal hematoma were found in 54 patients (10.9%) and five patients (1.0%), respectively. Multivariate analysis showed that longer operation time and intraoperative adverse events (AE) were associated with clinically significant nAE during SE.

Conclusions: Second-look endoscopy can detect and treat nAE that may lead to severe AE. Thus, SE should be highly considered before starting oral ingestion in all cases, and especially in those who present an intraoperative AE and longer operation time.
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http://dx.doi.org/10.1111/den.13770DOI Listing
March 2021

Reply to Letter to the Editor of Digestive Endoscopy.

Dig Endosc 2021 03 5;33(3):464-465. Epub 2020 Sep 5.

Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan.

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http://dx.doi.org/10.1111/den.13767DOI Listing
March 2021

Diffuse esophageal spasm in which twitching appears due to insufflation evaluation.

Dig Endosc 2020 Sep 22;32(6):994. Epub 2020 Jul 22.

Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan.

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http://dx.doi.org/10.1111/den.13759DOI Listing
September 2020

Endoscopic treatment of proton pump inhibitor-refractory gastroesophageal reflux disease with anti-reflux mucosectomy: Experience of 109 cases.

Dig Endosc 2021 Mar 11;33(3):347-354. Epub 2020 Aug 11.

Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan.

Objectives: Some patients with gastroesophageal reflux disease (GERD) are refractory to proton pump inhibitor (PPI) therapy. Anti-reflux mucosectomy (ARMS) is a minimally invasive endoscopic procedure for treatment of GERD. In this study, we retrospectively evaluated the outcomes of ARMS performed in patients with PPI-refractory GERD at our institution.

Methods: A total of 109 patients with PPI-refractory GERD who underwent ARMS were retrospectively reviewed. Pre- and post-ARMS questionnaire scores, acid exposure time (AET), DeMeester score, proximal extent, and PPI discontinuation rate were compared.

Results: There was a significant improvement in the symptom score (P < 0.01) and 40-50% of patients were able to discontinue PPI after ARMS. In patients who were followed up for 3 years, sustained improvement in subjective symptoms was observed. AET and DeMeester score significantly improved after ARMS (P < 0.01); however, there was no significant improvement in proximal extent (P = 0.0846).

Conclusions: Anti-reflux mucosectomy is an effective minimally invasive therapy for patients with PPI-refractory GERD. The therapeutic efficacy is attributable to suppression of acid backflow due to contraction of the scar tissue in cardia.
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http://dx.doi.org/10.1111/den.13727DOI Listing
March 2021

Endoscopic pressure study integrated system reflects gastroesophageal junction competence in patients with erosive esophagitis and Barrett´s esophagus.

Dig Endosc 2020 Nov 29;32(7):1050-1056. Epub 2020 Mar 29.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Showa University, Tokyo, Japan.

Objectives: The endoscopic pressure study integrated system (EPSIS) is a novel diagnostic tool for gastroesophageal reflux disease (GERD) by monitoring intragastric pressure (IGP). Evaluation of the lower esophageal sphincter (LES) function may be achieved endoscopically by utilizing this newly developed diagnostic tool. This study aimed to evaluate the association between EPSIS results and gastroesophageal reflux-related diseases, e.g., erosive esophagitis (EE) and Barrett's esophagus (BE).

Methods: This was a retrospective, single-center study. All patients who underwent EPSIS between November 2016 and July 2018 were included. EPSIS was performed during esophagogastroduodenoscopy with a dedicated electronic device and a through-the-scope catheter. The maximum IGP (IGP-max) and IGP waveform pattern (flat or uphill) were recorded with this system. Evaluation of an EE and BE was based on the Los Angeles classification and Prague classification, respectively.

Results: A total of 104 patients were enrolled; 29 (28%) had EE and 42 (40%) had BE. Patients with EE had lower IGP-max values (16.0 vs 18.8 mmHg, P = 0.01) and an EPSIS flat pattern was seen more frequently (82.8% vs 37.3%, P < 0.001). Similarly, patients with BE displayed a lower IGP-max (15.7 vs 19.6 mmHg, P < 0.001) and presented with an EPSIS flat pattern in a higher proportion (69% vs 37.1%, P < 0.001). These differences remained significant on multivariate analysis.

Conclusions: The EPSIS, as a novel diagnostic tool, was shown to exhibit a relation with EE and BE, implying that EPSIS is a promising modality to evaluate gastroesophageal reflux-related diseases and LES function endoscopically.
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http://dx.doi.org/10.1111/den.13644DOI Listing
November 2020

Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study.

Endosc Int Open 2020 Feb 22;8(2):E133-E138. Epub 2020 Jan 22.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

 The incidence of proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) has been increasing. While surgical intervention with Laparoscopic Nissen Fundoplication remains the gold standard, less invasive anti-reflux interventions are desired. We have developed a minimally invasive anti-reflux mucosal ablation (ARMA) treatment. Herein, we report its technical details and describe its feasibility, safety, and efficacy in PPI-refractory GERD.  We conducted a prospective single-center single-arm interventional trial evaluating the outcome of ARMA in 12 patients with PPI-refractory GERD. GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) evaluation, Frequency Scale for the Symptoms of GERD (FSSG) assessment, and impedance-pH monitoring were performed at baseline and at 2 months post-ARMA.  A total of 12 patients underwent ARMA with a median follow-up duration of 9 months (range: 6 - 14 months). Median GERD-HRQL score significantly improved from 30.5 to 12 (  = 0.002); median FSSG score significantly improved from 25 to 10.5 (  = 0.002), and median DeMeester score decreased from 33.5 to 2.8 (  = 0.049) at 2 months follow-up. No immediate complications were observed.  Our pilot study has shown that ARMA, a new endoscopic treatment for PPI-refractory GERD, is simple, safe, and improves GERD-related symptoms and objective acid reflux parameters.
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http://dx.doi.org/10.1055/a-1031-9436DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976329PMC
February 2020

Combination of laparoscopic and endoscopic approaches for neoplasia with non-exposure technique (CLEAN-NET) for gastric submucosal tumors: updated advantages and limitations.

Ann Transl Med 2019 Oct;7(20):582

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Laparoscopic and endoscopic cooperative surgery (LECS) for gastric submucosal tumors (SMTs) has been developed under the concept of resecting gastric tumors with both complete curability and preserving organ functions. Precise resection is obtained by classical LECS, however, concerns regarding intraoperative bacterial infection and dissemination of the tumor cells into the abdominal cavity by LECS with exposure technique still remain. To prevent these concerns, several LECS-related procedures with non-exposure techniques, such as combination of laparoscopic and endoscopic approaches for neoplasia with non-exposure technique (CLEAN-NET) and non-exposed endoscopic wall-inversion surgery (NEWS), have been reported to be safe and feasible. Classical LECS, CLEAN-NET, and NEWS have the same concept, however, each has its own different characteristic procedures; exposure or non-exposure technique, inversion of the tumor into or outer the lumen, retrieval of tumor per oral or through the abdominal cavity, and dominance in the role of the endoscopist or the laparoscopic surgeon. Familiarization with these procedure details is important to understand their indications, advantages and limitations, resulting in providing a tailored minimally invasive surgery for patients. The main scope of this review article is to introduce readers to the clinical application, procedure, and results of CLEAN-NET, both from previous literatures and from our experience, as well as to offer a closer look at its advantages and limitations while comparing with other LECS procedures from the viewpoint of introducing CLEAN-NET first.
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http://dx.doi.org/10.21037/atm.2019.09.19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6861760PMC
October 2019

A novel endoscopic assessment of the gastroesophageal junction for the prediction of gastroesophageal reflux disease: a pilot study.

Endosc Int Open 2019 Nov 23;7(11):E1468-E1473. Epub 2019 Oct 23.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo 135-8577, Japan.

 Hiatal hernia and lower esophageal sphincter (LES) dysfunction play major roles in gastroesophageal reflux disease (GERD) pathogenesis. We developed a novel endoscopic assessment to evaluate the gastroesophageal junction (GEJ). This study aims to evaluate the feasibility of this method for the diagnostic prediction of GERD.  A retrospective analysis of patients with GERD symptoms who underwent gastroscopy and esophageal pH-impedance monitoring was conducted. The novel assessment evaluated the following in retroflex view: 1) Cardiac Opening (CO): diameter of the opening of the cardia, 2) Sliding Hernia (SH): length from the diaphragmatic crus to the squamocolumnar junction, 3) Scope Holding Time% (SHT%): the percentage of time that the Scope Holding Sign (SHS) was observed out of 30 seconds. The SHS is defined as the lower esophagus holding the endoscope under excessive insufflation. The results of this assessment and that of pH-impedance monitoring were compared.  In total, 61 patients (mean age ± SD, 54.1 ± 16.4 years, 32 males) were enrolled. CO and SH were significantly correlated with acid exposure time (AET) (ρ = 0.36,  = 0.005, and ρ = 0.36,  = 0.004). The optimal cutoff of CO for AET > 6 % was 3 cm (Sensitivity = 72.4 %, Specificity = 46.9 %, AUC = 0.64) and that of SH was 2 cm (Sensitivity = 55.2 %, Specificity = 75.0 %, AUC = 0.70). When the population was stratified according to this cutoff, patients with CO > 3 cm and those with SH > 2 cm presented higher AET (15.1 vs 4.1 %,  = 0.037, and 23.0 vs 3.6 %,  = 0.026). Optimal cutoff of SHT% for the number of all reflux episodes > 80 was 75 % (Sensitivity = 81.8 %, Specificity = 54.6%, AUC = 0.67). Patients with SHT% < 75 % presented a higher number of all reflux episodes (88 vs 65,  = 0.014). Sensitivity, specificity, and accuracy of SHT% < 75 % for all reflux episodes > 80 were 81.8 % (95 %CI: 67.7 - 91.8), 54.5% (95 %CI: 40.4 - 64.5), and 68.2 % (95 %CI: 54.0 - 78.1).  This novel endoscopic assessment of GEJ significantly predicted the presence of GERD and merits further testing in future studies.
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http://dx.doi.org/10.1055/a-0990-9737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6811351PMC
November 2019

Utilizing fourth-generation endocytoscopy and the 'enlarged nuclear sign' for in vivo diagnosis of early gastric cancer.

Endosc Int Open 2019 Aug 8;7(8):E1002-E1007. Epub 2019 Aug 8.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

 Fourth-generation endocytoscopy is an ultra-high magnification endoscopic technique designed to provide excellent quality in vivo histologic assessment of gastrointestinal lesions. This study aims to evaluate the diagnostic accuracy of endocytoscopy in early gastric cancer diagnosis.  A single-center, retrospective analysis of prospectively collected data from all gastric endocytoscopic examinations was conducted. Two expert endoscopists, blinded to white-light and narrow-band imaging findings as well as histopathologic diagnosis, independently reviewed and diagnosed all endocytoscopic images. A newly recognized "enlarged nuclear sign" was detected, and its implication in early gastric cancer diagnosis was evaluated. The diagnostic performance of fourth-generation endocytoscopy was assessed while using the gold standard histopathology as a reference.  Forty-three patients (mean age±SD, 72.6 ± 12.1 years; 31 males) were enrolled. Based on histopathology, 23 had well-differentiated adenocarcinomas, four adenomas, and 16 non-neoplastic lesions. The sensitivity, specificity, and accuracy of fourth-generation endocytoscopy for gastric cancer diagnosis were 87.0 % (95 % CI: 67.9 - 95.5), 80.0 % (95 % CI: 58.4 - 91.9), and 83.7 % (95 % CI: 70.0 - 91.9) by endoscopist A; and 91.3 % (95 % CI: 73.2 - 97.6), 75.0 % (95 % CI: 53.1 - 88.8), and 83.7 % (95 % CI: 70.0 - 91.9) by endoscopist B. The inter-observer agreement, statistic = 0.71 (95 % CI: 0.50 - 0.93), was good. The sensitivity, specificity, and accuracy of the enlarged nuclear sign for early gastric cancer diagnosis were 87.0 % (95 % CI: 67.9 - 95.5), 95.0 % (95 % CI: 76.4 - 99.1), and 90.7 % (95 % CI: 78.4 - 96.3) by endoscopist A; and 82.6 % (95 % CI: 62.9 - 93.0), 85.0 % (95 % CI: 64.0 - 94.8), and 83.7 % (95 % CI: 70.0 - 91.9) by endoscopist B. The inter-observer agreement, statistic = 0.68 (95 % CI: 0.51 - 0.89) was good. Fourth-generation endocytoscopy appears to aid in the diagnosis of early gastric cancer, particularly well-differentiated adenocarcinomas, due to its good diagnostic accuracy and identification of the "enlarged nuclear sign," and deserves further evaluation in future studies.
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http://dx.doi.org/10.1055/a-0957-2866DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687508PMC
August 2019

Clinical outcomes of per-oral endoscopic tumor resection for submucosal tumors in the esophagus and gastric cardia.

Dig Endosc 2020 Mar 22;32(3):328-336. Epub 2019 Jul 22.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

Objectives: The clinical success of per-oral endoscopic myotomy (POEM) has led to the development of a new field of 'submucosal endoscopy'. This study aimed to evaluate the safety, efficacy, and limitations of per-oral endoscopic tumor resection (POET) in the management of submucosal tumors (SMTs) in the esophagus and the gastric cardia.

Methods: POET was performed in 47 patients from January 2011 to December 2017. The indication for POET was SMTs ≤ 30 mm in minor axis diameter. Patient and tumor characteristics (age, gender, tumor location, size, and histology), operative and clinical results of POET (procedure time and completion rate, en bloc resection rate, length of hospitalization, adverse events and tumor recurrence) were analyzed retrospectively.

Results: POET was successfully completed in 43 patients (91.5%) without any major adverse events (Clavien-Dindo IIIb-IV). Four patients required conversion to an open surgical procedure due to suboptimal visualization during POET. Four patients underwent piecemeal resection of their SMTs including GISTs. Median follow-up was 44 months (10-96 months), during that time, there were no incidences of tumor recurrence. Tumors that had a minor axis diameter > 30 mm or a tumor mass index (TMI) [major axis diameter (mm) × minor axis diameter (mm)] >1000 had a high likelihood of being converted to surgical resection.

Conclusions: POET is a safe and effective treatment for SMTs. However, in patients where the minor axis diameter is > 30 mm or the TMI > 1000, surgical excision should be considered. Furthermore, application of POET for SMTs with malignant potential should be carefully considered to ensure optimal oncologic outcomes.
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http://dx.doi.org/10.1111/den.13471DOI Listing
March 2020

Diagnostic performance of the endoscopic pressure study integrated system (EPSIS): a novel diagnostic tool for gastroesophageal reflux disease.

Endoscopy 2019 08 19;51(8):759-762. Epub 2019 Jun 19.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Showa University, Tokyo, Japan.

Background: The endoscopic pressure study integrated system (EPSIS) is a prototypic system for monitoring intragastric pressure (IGP) fluctuations that result from opening of the cardia during gastric distension. The performance of EPSIS for the diagnosis of gastroesophageal reflux disease (GERD) was evaluated.

Methods: A retrospective analysis was conducted of data prospectively collected over a 2-year period from 59 patients who underwent gastroscopy, EPSIS, and 24-hour pH monitoring. Using a dedicated electronic device and a through-the-scope catheter, maximum IGP (IGP) and IGP waveform pattern (uphill/flat) were recorded.

Results: The optimal IGP cutoff was 18.7 mmHg. IGP < 18.7 mmHg (sensitivity 74.2 %, 95 % confidence interval [CI] 56.8 - 86.3; specificity 57.1 %, 95 %CI 39.1 - 73.5) and flat pattern (sensitivity 71.0 %, 95 %CI 53.4 - 83.9; specificity 82.1 %, 95 %CI 64.4 - 92.1) were associated with GERD. "Double" EPSIS positivity (IGP < 18.7 mmHg and flat pattern) provided maximum specificity (85.7 %, 95 %CI 68.5 - 94.3), whereas "any" EPSIS positivity (IGP < 18.7 mmHg or flat pattern) provided maximum sensitivity (80.6 %, 95 %CI 63.7 - 90.8). Maximum specificity and sensitivity for nonerosive reflux disease (NERD) was > 70 %. In multivariate analysis, "double" EPSIS positivity was the strongest predictor of GERD (odds ratio [OR] 16.05, 95 %CI 3.23 - 79.7) and NERD (OR 14.7, 95 %CI 2.37 - 90.8).

Conclusion: EPSIS emerges as a reliable adjunct to routine gastroscopy for GERD diagnosis, and might prove helpful for the stratification and management of patients with reflux disorders.
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http://dx.doi.org/10.1055/a-0938-2777DOI Listing
August 2019

Peroral endoscopic myotomy and fundoplication: a novel NOTES procedure.

Endoscopy 2019 02 17;51(2):161-164. Epub 2019 Jan 17.

Digestive Diseases Center, Showa University Koto Toyosu Hospital, Showa University, Tokyo, Japan.

Background: Peroral endoscopic myotomy (POEM) has become the minimally invasive endoscopic treatment for achalasia; however, gastroesophageal reflux (GER) post-POEM has been reported. A pilot study was conducted in which an endoscopic fundoplication was added to the standard POEM (POEM + F) procedure to overcome this issue. We report the technical details of POEM + F and short-term safety results.

Methods: POEM + F was performed in 21 patients. After completing myotomy, the endoscope was advanced from the submucosal tunnel into the peritoneal cavity. A partial mechanical barrier was created by retracting the anterior gastric wall at the esophagogastric junction with the use of endoclips and an endoloop.

Results: POEM + F was technically feasible in all cases and created a visually recognizable fundoplication. The clinical course after POEM + F was uneventful. No immediate or delayed complications occurred.

Conclusion: POEM + F may help mitigate the post-POEM incidence of GER and serve as a minimally invasive endoscopic alternative to a laparoscopic Heller-Dor procedure. This is the largest case series of peroral natural orifice transluminal endoscopic surgery without laparoscopic assistance in the human foregut.
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http://dx.doi.org/10.1055/a-0820-2731DOI Listing
February 2019

Peroral endoscopic myotomy (POEM) for complex achalasia and the POEM difficulty score.

Dig Endosc 2019 Mar 3;31(2):148-155. Epub 2019 Feb 3.

Digestive Diseases Center, Showa University, Koto-Toyosu Hospital, Tokyo, Japan.

Background: Peroral endoscopic myotomy (POEM) for achalasia is technically challenging to carry out in patients with type III, multiple prior treatments, prior myotomy, and sigmoid type. Herein, we present a series of consecutive patients with complex achalasia and introduce the POEM difficulty score (PDS).

Aim: To demonstrate the application and discuss the utility of PDS and present the feasibility, safety, and efficacy of POEM in complex achalasia patients.

Methods: Forty consecutive POEM were carried out with 28 meeting the criteria for complex achalasia. Primary outcome was clinical success (Eckardt score ≤3) at a minimum of 3 months follow-up. Secondary outcomes included adverse events, procedural velocity and PDS.

Results: Twenty-eight complex and 12 non-complex POEM procedures were carried out with 100% and 92% clinical success, respectively, without any major adverse events with a median follow up of 15 months (complex) and 8 months (non-complex). Mean velocities for non-complex, type III, prior myotomy, ≥4 procedures and sigmoid type were as follows: 4.4 ± 1.6, 4.8 ± 1.5, 5.9 ± 2.2, 6.9 ± 2.2 and 8.2 ± 3.2 min/cm, respectively. Median PDS for non-complex, type III, prior myotomy, ≥4 treatments and sigmoid type were 1 (0-3), 2 (0-4), 2.5 (1-6), 3 (2-6) and 3.5 (1-6), respectively. PDS was shown to correlate well with procedural velocity with a correlation coefficient of 0.772 (Spearman's P < 0.001).

Conclusions: PDS identifies the factors that contribute to challenging POEM procedures and correlates well with procedural velocity. The order of increasing difficulty of POEM in complex achalasia appears to be type III, prior myotomy, ≥4 treatments and sigmoid type.
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http://dx.doi.org/10.1111/den.13294DOI Listing
March 2019

Multipoint traction technique in endoscopic submucosal dissection.

VideoGIE 2018 Jul 2;3(7):207-208. Epub 2018 May 2.

Digestive Disease Center, Showa University Koto Toyosu Hospital, Tokyo, Japan.

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http://dx.doi.org/10.1016/j.vgie.2018.03.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6098703PMC
July 2018

History of surgical therapy and recent advancement of endoscopic therapy for GERD.

Nihon Shokakibyo Gakkai Zasshi 2017;114(10):1797-1803

Digestive Disease Center, Showa University Koto Toyosu Hospital.

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http://dx.doi.org/10.11405/nisshoshi.114.1797DOI Listing
March 2018

The effect of consuming small volumes of beer on gastric motility and the involvement of gene polymorphisms.

Biomed Res 2016 ;37(5):305-310

Department of Gastroenterology, Fujita Health University.

The aim of this study was to investigate the effect of consuming small amounts of beer or a nonalcoholic beer taste beverage (non-beer) on gastric emptying and the polymorphisms in alcohol metabolism-related enzyme-encoding genes. Twenty male healthy volunteers were questioned regarding their alcohol consumption status, and body measurement was performed. The genetic polymorphisms in ADH1B (rs1229984, Arg47His) and ALDH2 (rs671 Glu487Lys) were analyzed. The subjects consumed 150 mL of beer or non-beer once per week, followed by the ingestion of 200 kcal of the test nutrient containing C-acetate 15 min later, after which the subjects' exhalations were collected up to 120 min. The concentration peak of C was measured as Tmax. Diamine oxidase (DAO) activity for the marker of small intestinal function activity was also measured the day after the test. Gastric emptying was significantly slower in the group that consumed a small amount of beer, and in daily beer consumption group, and also in the ADH1B *2/*2, ALDH2 *1/*2 genotypes compared to non-beer drinking group. DAO values were not significantly changed between beer and non-beer group. The consumption of even a small amount of beer and the polymorphisms in ADH1B / ALDH2 affects gastric motility.
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http://dx.doi.org/10.2220/biomedres.37.305DOI Listing
January 2017

Adjustable countertraction during endoscopic submucosal dissection of a large, fundus-body, laterally spreading tumor.

Gastrointest Endosc 2016 Sep 26;84(3):524-5. Epub 2016 Mar 26.

Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Toyosu, Koto-Ku, Tokyo, Japan.

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http://dx.doi.org/10.1016/j.gie.2016.03.1476DOI Listing
September 2016

New endoscopic classification of the cardiac orifice in esophageal achalasia: Champagne glass sign.

Dig Endosc 2016 Sep 21;28(6):645-9. Epub 2016 Apr 21.

Gastroenterology, Showa University Fujigaoka Hospital, Yokohama, Japan.

Background And Aim: Endoscopy, barium esophagram and manometry are used in the diagnosis of achalasia. In the case of early achalasia, characteristic endoscopic findings are difficult to recognize. As a result, the diagnosis of achalasia is often made several years after symptom onset. Therefore, we examined the endoscopic findings of the cardiac orifice in achalasia and propose a new classification.

Methods: A total of 400 patients with spastic esophageal motility disorders who underwent peroral endoscopic myotomy (POEM) at our hospital between March 2014 and August 2015 were screened for this study. Champagne glass sign (CG) was defined as when the distal end of the lower esophageal sphincter relaxation failure (LESRF) was proximal to the squamocolumnar junction (SCJ) and the SCJ was dilated in the retroflex view. Specifically, CG-1 was defined as a distance from the SCJ to the lower end of LESRF of <1 cm, and CG-2 was defined as a distance ≥1 cm.

Results: CG-0 was seen in 73 patients (28.0%), whereas the CG sign was seen in 186 patients (71.3%), of whom 170 (65.1%) were CG-1 and 16 (6.1%) were CG-2.

Conclusions: The CG sign is often observed in esophageal achalasia patients. CG-0 (equal to Maki-tsuki) was observed in 28.0% of achalasia patients only. Its absence with dilated SCJ cannot be used to rule out achalasia. Barium esophagram and manometry should be done if esophageal achalasia is strongly suspected.
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http://dx.doi.org/10.1111/den.12642DOI Listing
September 2016

Peroral endoscopic myotomy: first human experience with a water-jet-assisted triangle knife.

Gastrointest Endosc 2016 Jun 6;83(6):1279. Epub 2016 Jan 6.

Digestive Diseases Center, Showa University Koto-Toyosu Hospital, Tokyo, Japan.

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http://dx.doi.org/10.1016/j.gie.2015.12.031DOI Listing
June 2016

Association between common genetic variants in pre-microRNAs and prognosis of advanced gastric cancer treated with chemotherapy.

Anticancer Res 2014 Sep;34(9):5199-204

Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan.

Background: Common single-nucleotide polymorphisms (SNPs) in pre-miRNAs (hsa-mir-196a2, hsa-mir-146a and hsa-mir-499) have been associated with various malignancies and their prognoses. We evaluated the associations of three selected SNPs (rs11614913, rs2910164, and rs3746444) in pre-miRNAs (hsa-mir-196a2, hsa-mir-146a and hsa-mir-499) with the prognosis of advanced gastric cancers (GCs) treated by chemotherapy.

Materials And Methods: The rs11614913 (T>C), rs2910164 (C>T), and rs3746444 (A>G) SNPs were genotyped in 130 advanced GCs performing chemotherapy. Survival and response evaluation was based on overall survival (OS) and progression-free survival (PFS). Response rate (RR) was also evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Results: 63 patients performed gastrectomy after chemotherapy (neoadjuvant chemotherapy) and the remaining cases performed chemotherapy alone as treatment (chemotherapy alone). The majority of cases performed S-1-based chemotherapy as the first line treatment (n=119, 92%). The rs3746444 (A>G) SNP was significantly associated with OS by the log-rank test (p=0.018), while other SNPs were not associated with OS. The rs3746444 (A>G) SNP was also associated with OS and PFS among cases of neoadjuvant chemotherapy (p=0.038, 0.024, respectively). Multivariate survival analysis using the Cox's regression model revealed that non-responder by the RECIST (Hazard ratio (HR): 2.14 95%CI 1.06-4.19), upper third cancer (HR: 2.48 95%CI 1.12-5.49) and more advanced stage (HR: 4.12 95%CI 1.06-16.02) were predictive factors for worse OS, while the rs3746444 A allele carrier was predictive factor for better OS (HR: 0.33 95%CI 0.18-0.75).

Conclusion: The rs3746444 A allele carrier in the hsa-mir-499 is associated with better prognosis in advanced GC performing chemotherapy.
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http://dx.doi.org/10.1016/s0016-5085(14)61200-2DOI Listing
September 2014

Change in DNA methylation patterns of SLC6A4 gene in the gastric mucosa in functional dyspepsia.

PLoS One 2014 22;9(8):e105565. Epub 2014 Aug 22.

Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.

Background: The neurochemical serotonin (5-HT) is an important signaling molecule in the gastrointestinal motor and sensory functions. A key regulator of 5-HT levels is the transmembrane serotonin transporter (5-HTT; SLC6A4) that governs the reuptake of 5-HT. Recent studies have indicated 5-HTT expression may be regulated by epigenetic mechanisms. We investigated DNA methylation status of SLC6A4 gene in the gastric mucosa from functional dyspepsia (FD) because of their potential role in dyspeptic symptoms.

Methods: Endoscopic gastric biopsies were obtained from 78 subjects with no upper abdominal symptoms and 79 patients with FD. Bisulfite Pyrosequencing was carried out to determine the methylation status of promoter CpG islands (PCGIs), promoter non-CpG islands (PNCGIs) and gene body non-CpG islands (NPNCGIs) in the SLC6A4 gene. Gene expression was examined by real-time PCR.

Results: In overall, methylation level of PCGIs was significantly lower in FD compared to control subjects (p = 0.04). On the other hand, methylation level of NPNCGIs was significantly higher in FD compared to control subjects (p = 0.03). Lower methylation level in PNCGIs was highlighted in the patients with PDS (p = 0.01), while higher methylation level in NPNCGIs was more prominent in the patients with EPS (p = 0.017). Methylation levels of PCGIs and PNCGIs were inversely correlated, while methylation levels of NPNCGIs was positively correlated with SLC6A4 mRNA levels in FD patients.

Conclusions: Our data suggest that change in DNA methylation pattern of SLC6A4 in the gastric mucosa may have a role for developing FD. A role of epigenetics for developing FD needs to be further evaluated.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0105565PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4141787PMC
May 2015

Fusobacterium detected in colonic biopsy and clinicopathological features of ulcerative colitis in Japan.

Dig Dis Sci 2015 Jan 8;60(1):205-10. Epub 2014 Aug 8.

Department of Gastroenterology, Fujita Health University School of Medicine, 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi, 470-1192, Japan,

Background And Aims: Fusobacterium species are part of the gut microbiome in humans, but some species have been recognized as opportunistic pathogens implicated in inflammatory diseases including inflammatory bowel diseases. Here, we performed prevalence screening of Fusobacterium in ulcerative colitis (UC) in Japanese patients.

Methods: We examined Fusobacterium nucleatum (F. nucleatum) and whole Fusobacterium species (Pan-fusobacterium) by quantitative real-time PCR in 163 inflamed mucosae from 152 UC patients. Data were correlated with clinical subtypes of UC.

Results: In an initial prevalence screen, F. nucleatum and Pan-fusobacterium were detected in 6.3 % (4/64) and 53.1 % (34/64). For all 163 mucosae, the prevalence of Pan-fusobacterium was 54.6 % (89/163). Pan-fusobacterium status was concordant in inflamed and normal adjacent samples, and the matched cases during 1-year follow-up colonoscopy. The higher amount of Pan-fusobacterium was observed in chronic continuous type compared to one attack and relapse/remitting type (p = 0.039). The higher amount of Pan-fusobacterium was also associated with rather mild clinical course of disease, such as non-steroid dependency (p = 0.015), non-refractory phenotype (p = 0.013), and non-severe phenotype (p = 0.04). Based on the distribution of Pan-fusobacterium measurable cases, we identified 10 cases as having a high amount of Pan-fusobacterium (FB-high). The clinicopathological features of FB-high UC cases were also highlighted by chronic continuous type and mild phenotypes of disease.

Conclusion: Whole Fusobacterium species, but not F. nucleatum, are common in UC patients and have a role in persistence of colonic inflammation in UC. However, Fusobacterium infection is associated with rather mild clinical phenotypes of UC.
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http://dx.doi.org/10.1007/s10620-014-3316-yDOI Listing
January 2015

A case of plummer-vinson syndrome showing rapid improvement of Dysphagia and esophageal web after two weeks of iron therapy.

Case Rep Gastroenterol 2014 May 7;8(2):211-5. Epub 2014 Jun 7.

Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan.

Plummer-Vinson syndrome (PVS) is a rare entity characterized by upper esophageal webs and iron deficiency anemia. We report a case of PVS whose esophageal web was rapidly improved by iron therapy. A 77-year-old woman was admitted to our hospital with complaints of dysphagia, vomiting, shortness of breath and weight loss for 1 month. Physical examination revealed conjunctival pallor, koilonychia, angular cheilitis and smooth tongue, and laboratory findings were consistent with microcytic hypochromic anemia with iron deficiency. Gastrointestinal endoscopy and barium-swallow esophagography detected a web that prevented passage of the endoscope into the upper portion of the esophagus. The patient received oral iron therapy daily; the hemoglobin concentration rose to 8.9 g/dl and the complaints of dysphagia were dramatically improved after 2 weeks, with improvement of luminal stenosis confirmed by gastrointestinal endoscopy and barium-swallow esophagography. The PVS described in this report had a distinct clinical course, showing very rapid improvement of dysphagia and esophageal web after 2 weeks of oral iron therapy.
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http://dx.doi.org/10.1159/000364820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4086037PMC
May 2014
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