Publications by authors named "Manabu Onimaru"

87 Publications

Unified magnifying endoscopic classification for esophageal, gastric and colonic lesions: a feasibility pilot study.

Endosc Int Open 2021 Sep 16;9(9):E1306-E1314. Epub 2021 Aug 16.

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

Image-enhanced magnifying endoscopy allows optimization of the detection and diagnosis of lesions found in the gastrointestinal tract. Current organ-specific classifications are well-accepted by specialized endoscopists but may pose confusion for general gastroenterologists. To address this, our group proposed the Unified Magnifying Endoscopic Classification (UMEC) which can be applied either in esophagus, stomach, or colon. The aim of this study was to evaluate the diagnostic performance and clinical applicability of UMEC. A single-center, feasibility pilot study was conducted. Two endoscopists with experience in magnifying narrow band imaging (NBI), blinded to white-light and non-magnifying NBI findings as well as histopathological diagnosis, independently reviewed and diagnosed all images based on UMEC. In brief, UMEC is divided into three categories: non-neoplasia, intramucosal neoplasia, and deep submucosal invasive cancer. The diagnostic performance of UMEC was assessed while using the gold standard histopathology as a reference. A total of 303 gastrointestinal lesions (88 esophageal squamous lesions, 90 gastric lesions, 125 colonic lesions) were assessed. The overall accuracy for both endoscopists in the diagnosis of esophageal squamous cell cancer, gastric cancer, and colorectal cancer were 84.7 %, 89.5 %, and 83.2 %, respectively. The interobserver agreement for each organ, Kappa statistics of 0.51, 0.73, and 0.63, was good. UMEC appears to be a simple and practically acceptable classification, particularly to general gastroenterologists, due to its good diagnostic accuracy, and deserves further evaluation in future studies.
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http://dx.doi.org/10.1055/a-1499-6638DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8367430PMC
September 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

Utility of a new automated diagnostic program in high-resolution esophageal manometry.

J Gastroenterol 2021 Jul 13;56(7):633-639. Epub 2021 May 13.

Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, 3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan.

Background: A new automated diagnostic program for high-resolution esophageal manometry (HREM) has been developed. This diagnostic program could detect locations of landmarks and could make final diagnoses automatically. However, the accuracy of the program is not known. The aim of this study was to evaluate the accuracy of the automated diagnostic program for HREM.

Methods: A total of 445 studies were enrolled. An HREM system (Starlet®) was used, and esophageal motility was diagnosed using the Chicago classification v3.0. First, the locations of the upper esophageal sphincter, transition zone, lower esophageal sphincter, esophago-gastric junction, crural diaphragm and stomach were determined, and each swallow was checked manually. Then, the parameters of the Chicago classification were calculated using an analytic program of the Starlet, and diagnoses were made by three experts. Second, all study raw data were analyzed again by the automated diagnostic program. Diagnoses made by the program were compared to those made by experts to evaluate the accuracy of the diagnoses.

Results: The new diagnostic program could identify the landmarks of each swallow, calculate the parameters and make a final diagnosis within 10 s. The diagnoses made by the automated diagnostic program were not matched to those made by experts in only 10 studies, and the overall accuracy of the new automated diagnostic program thus reached 97.8% (435/445).

Conclusions: The new automated diagnostic program for HREM is clinically useful in terms of high diagnostic accuracy and time-saving.
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http://dx.doi.org/10.1007/s00535-021-01794-zDOI Listing
July 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

Simplified endoscopic pressure study integrated system for the diagnosis of gastroesophageal reflux disease.

Dig Endosc 2021 May 22;33(4):663-667. Epub 2021 Mar 22.

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

Endoscopic pressure study integrated system (EPSIS) is a novel tool for the diagnosis of gastroesophageal reflux disease. It enables the evaluation of the function of the lower esophageal sphincter by monitoring intragastric pressure (IGP) while insufflating the stomach during esophagogastroduodenoscopy. EPSIS can predict abnormal acid reflux with high accuracy based on previous studies. IGP was measured by inserting through the working channel of the scope an intragastric catheter connected to a pressure measuring device. Herein, we assess the feasibility of an updated EPSIS system, which can be performed just by connecting a flush tube to the working channel. This method does not require inserting foreign objects in the stomach and spares catheter insertion in order to simplify the procedure and reduce costs. A single-center pilot study was conducted to evaluate the association between catheter-based EPSIS and the updated EPSIS. The results of EPSIS in 20 patients who underwent both methods were assessed. In all cases, the waveform pattern of IGP measured by catheter-based EPSIS and updated EPSIS was consistent with 15 uphill pattern and five flat pattern. Intraobserver agreement of waveform pattern was perfect between two examiners with kappa value = 1. Intraclass correlation coefficient (ICC) for intraobserver reliability for maximum IGP was excellent with 0.91 (95% confidence interval [CI] of 0.77 < ICC < 0.96) and for pressure gradient was also good with 0.89 (95% CI of 0.71 < ICC < 0.95). In conclusion, our study suggests that the updated EPSIS can be performed without the use of a catheter.
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http://dx.doi.org/10.1111/den.13947DOI Listing
May 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

Peroral endoscopic myotomy with diverticulum resection.

VideoGIE 2020 Nov 26;5(11):534-538. Epub 2020 Sep 26.

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

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http://dx.doi.org/10.1016/j.vgie.2020.06.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7652700PMC
November 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

Safety and effectiveness of peroral endoscopic myotomy in patients on antiplatelet or anticoagulant therapy: an international multicenter case-control study.

Gastrointest Endosc 2021 04 24;93(4):839-849. Epub 2020 Jul 24.

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

Background And Aims: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes.

Methods: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30.

Results: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases.

Conclusions: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding.
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http://dx.doi.org/10.1016/j.gie.2020.07.030DOI Listing
April 2021

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

Peroral endoscopic fundoplication: a brand-new intervention for GERD.

VideoGIE 2020 Jun 29;5(6):244-246. Epub 2020 Apr 29.

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

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http://dx.doi.org/10.1016/j.vgie.2020.02.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7280158PMC
June 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

Peroral endoscopic myotomy for achalasia: a prospective multicenter study in Japan.

Gastrointest Endosc 2020 05 21;91(5):1037-1044.e2. Epub 2019 Nov 21.

Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Yamanashi, Japan.

Background And Aims: Peroral endoscopic myotomy (POEM) is an available treatment modalities for achalasia. The reported efficacy of POEM in the only prospective multicenter study was 82%; however, a retrospective multicenter study in Japan reported a higher efficacy rate of 95%. The aim of this study was to prospectively verify treatment outcomes after POEM at multiple facilities in Japan.

Methods: This was a prospective single-arm trial of POEM for achalasia at 8 facilities in Japan between April 2016 and March 2018 to evaluate its safety and efficacy. Patients were re-evaluated at 3 months and up to 1 year after POEM.

Results: Among the 233 patients with achalasia who underwent POEM, procedure-related adverse events occurred in 24 patients (10.3%), none of whom required surgical intervention. In the 207 patients satisfying the inclusion criteria, the efficacy rate of POEM, defined by an Eckardt score ≤3 at 1 year, was 97.4% (95% CI, 95.3%-99.7%). The Eckardt score decreased significantly from 6.6 ± 2.0 preoperatively to 1.1 ± 1.1, 1 year after POEM. Postoperative reflux esophagitis, severe reflux esophagitis, and symptomatic GERD were reported in 54.2%, 5.6%, and 14.7%, respectively, and proton pump inhibitors were administered in 21.1%.

Conclusions: Our prospective multicenter study in Japan showed greater efficacy of POEM for achalasia compared with the results of a previous prospective multicenter study. POEM is safe and highly effective for at least 1 year. (Clinical trial registration number: UMIN 000021550.).
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http://dx.doi.org/10.1016/j.gie.2019.11.020DOI Listing
May 2020

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

Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience.

Esophagus 2020 01 26;17(1):3-10. Epub 2019 Sep 26.

Department of Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.

It has been 10 years since peroral endoscopic myotomy (POEM) was reported for the first time, and POEM has currently become the standard treatment for achalasia and related disorders globally because it is less invasive and has a higher curative effect than conventional therapeutic methods. However, there are limited studies comparing the long-term outcomes of POEM with those of conventional therapeutic methods, particularly in the occurrence of gastroesophageal reflux disease (GERD) after therapy. With this background, we held a consensus meeting to discuss the pathophysiology and management of GERD after POEM based on published papers and experiences of each expert and to discuss the prevention of GERD and dealing with anti-acid drug refractory GERD. This meeting was held on April 27, 2018 in Tokyo to establish statements and finalize the recommendations using the modified Delphi method. This manuscript presents eight statements regarding GERD after POEM.
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http://dx.doi.org/10.1007/s10388-019-00689-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976544PMC
January 2020

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

Multicenter collaborative retrospective evaluation of peroral endoscopic myotomy for esophageal achalasia: analysis of data from more than 1300 patients at eight facilities in Japan.

Surg Endosc 2020 01 10;34(1):464-468. Epub 2019 Jun 10.

Heart Life Hospital, Okinawa, Japan.

Background: Peroral endoscopic myotomy (POEM) is a novel, minimally invasive treatment for esophageal achalasia. We retrospectively examined and evaluated the results following POEM to verify the technique's efficacy and safety.

Methods: We retrospectively analyzed data for patients who underwent POEM at eight Japanese facilities between September 2008 and October 2015. Pre- and postoperative assessments 3 months and 1 year after POEM included patient interviews, endoscopy, and manometry.

Results: A total of 1346 patients underwent POEM during the study period. Achalasia was the straight type in 1105 patients (82%) and the sigmoid type in 241 patients (18%). The average patient age was 47.2 years (range 3-95 years); 617 patients (46%) were men and 729 (54%) were women. Previous treatment included balloon dilatation in 381 patients (28%) and Heller-Dor operation in 43 patients (3%). The average operation time was 99.6 min. The mean length of the myotomy in the esophageal body was 10.8 cm, and the myotomy extended into the stomach a mean of 2.8 cm. The response rate (Eckardt score ≤ 3) was 95.1% 3 months postoperatively and 94.7% 1 year postoperatively. We noted 50 adverse events (3.7%) of Clavien-Dindo classification grade ≤ IIIa, and all resolved with conservative treatment. There were no Clavien-Dindo classification grade ≥ IIIb adverse events. After POEM, erosive esophagitis according to the Los Angeles classification was absent in 37% of the patients, grade A in 33%, B in 24%, C in 6%, and D in 0.2%. Symptomatic gastroesophageal reflux disease after POEM was confirmed in 14.8% of the patients; both erosive esophagitis and symptomatic gastroesophageal reflux disease responded to treatment with a proton-pump inhibitor.

Conclusion: Our results confirmed the safety and efficacy of POEM in a large patient series and support POEM as the first-line and standard treatment for esophageal achalasia.
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http://dx.doi.org/10.1007/s00464-019-06833-8DOI Listing
January 2020

Anterior versus posterior myotomy during poem for the treatment of achalasia: systematic review and meta-analysis of randomized clinical trials.

J Gastrointestin Liver Dis 2019 Mar;28(1):107-115

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

Background And Aims: The optimal orientation of the myotomy during peroral endoscopic myotomy (POEM) is unknown. This meta-analysis aims to compare anterior and posterior myotomy regarding clinical success and safety.

Methods: PubMed, Embase, Cochrane Library, WOK, and clinicaltrials.gov were searched to identify randomized clinical trials (RCTs) comparing anterior and posterior myotomy during POEM for the treatment of achalasia. The primary outcome was clinical success. Secondary outcomes included postprocedural gastroesophageal reflux disease (GERD), adverse events (AEs), manometric findings, and procedure-related parameters. Random-effects models were used for the primary analysis.

Results: Four RCTs enrolling 488 patients were included. Overall clinical success 3-12 months after POEM was 97% (95% confidence interval [CI] 93-100%) and did not differ between anterior and posterior myotomy (Relative risk [RR] 0.98, 95%CI: 0.96-1.01; I2: 0%). Incidence of GERD after POEM based on 24-hour pH monitoring (RR 0.98, 95%CI: 0.75-1.28), endoscopy (RR 1.04, 95%CI: 0.78-1.38), and symptoms (RR 0.89, 95%CI: 0.55-1.42) was similar. Posterior myotomy was associated with fewer AEs (RR 0.63, 95%CI: 0.42-0.94), lower risk of mucosotomy (RR 0.42, 95%CI: 0.27-0.66) and shorter incision closure time (mean difference: -2.28 minutes, 95%CI: -3.46 to -1.10). Anterior myotomy was associated with a shorter length of hospitalization (mean difference: 0.31 days, 95%CI: 0.05-0.57), although the clinical relevance of this finding is negligible. No significant differences were found regarding manometric outcomes, total operation and myotomy time.

Conclusions: Anterior and posterior myotomy are equally effective for the treatment of achalasia, without significant differences in postprocedural GERD. Posterior POEM was associated with fewer AEs and a shorter incision closure time.
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http://dx.doi.org/10.15403/jgld.2014.1121.281.pomDOI Listing
March 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

Clinical practice guidelines for peroral endoscopic myotomy.

Dig Endosc 2018 Sep;30(5):563-579

Japan Gastroenterological Endoscopy Society, Tokyo, Japan.

Peroral endoscopic myotomy (POEM) is a novel clinical technique developed in Japan used to treat esophageal achalasia and esophageal motility disorders. This technique has been rapidly accepted and widely disseminated throughout our clinical practice because of its low invasiveness, technical novelty, and high efficacy. Since the advent of POEM, there have been no clinical guidelines that clearly indicated its standard of care, and these guidelines have been anticipated both nationally and internationally by clinicians who engage in POEM practice. In 2017, to meet these needs, the Japan Gastroenterological Endoscopy Society (JGES) launched the guideline committee for POEM. Based on the guideline development process proposed by the Medical Information Network Distribution Service (MINDS), the guideline committee initially created research questions on POEM and conducted a systematic review and meta-analysis on each topic. The clinical research extracted from databases for these clinical questions and the systematic review mainly comprised a few retrospective studies with a small number of participants and short trial periods; hence, the strength of the evidence and recommendations derived from these results was low. Throughout this process, the guideline committee met thrice: once on May 13, 2017, and again on September 17, 2017, to formulate the draft. A consensus meeting was then held on January 14, 2018, in Tokyo to establish the guideline statements and finalize the recommendations using the modified Delphi method. This manuscript presents clinical guidelines regarding current standards of practice and recommendations in terms of the nine chief topics in POEM.
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http://dx.doi.org/10.1111/den.13239DOI Listing
September 2018

Retraction notice to "Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study": [YMGE 85 (2017) 927-933].

Gastrointest Endosc 2018 04;87(4):1164

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research Hospital, Milan, Italy.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted due to overlapping/duplicate material. Data from some patients from this study have previously been published in other journals without cross-referencing. Twenty patients overlap with a paper by Kumbhari et al. Thirty-five patients overlap with the study by Ngamruengphong et al..
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http://dx.doi.org/10.1016/j.gie.2018.02.005DOI Listing
April 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
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