Publications by authors named "Ko Watanabe"

68 Publications

DisCaaS: Micro Behavior Analysis on Discussion by Camera as a Sensor.

Sensors (Basel) 2021 Aug 25;21(17). Epub 2021 Aug 25.

Department of Computer Science, University of Kaiserslautern & DFKI GmbH, 67663 Kaiserslautern, Germany.

The emergence of various types of commercial cameras (compact, high resolution, high angle of view, high speed, and high dynamic range, etc.) has contributed significantly to the understanding of human activities. By taking advantage of the characteristic of a high angle of view, this paper demonstrates a system that recognizes micro-behaviors and a small group discussion with a single 360 degree camera towards quantified meeting analysis. We propose a method that recognizes and , which have often been overlooked in existing research, from a video stream of face images and a random forest classifier. The proposed approach was evaluated on our three datasets. In order to create the first and the second datasets, we asked participants to meet physically: 16 sets of five minutes data from 21 unique participants and seven sets of 10 min meeting data from 12 unique participants. The experimental results showed that our approach could detect and with a macro average f1-score of 67.9% in a 10-fold random split cross-validation and a macro average f1-score of 62.5% in a leave-one-participant-out cross-validation. By considering the increased demand for an online meeting due to the COVID-19 pandemic, we also record faces on a screen that are captured by web cameras as the third dataset and discussed the potential and challenges of applying our ideas to virtual video conferences.
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http://dx.doi.org/10.3390/s21175719DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8434061PMC
August 2021

Risk of metastatic recurrence after endoscopic resection for esophageal squamous cell carcinoma invading into the muscularis mucosa or submucosa: a multicenter retrospective study.

J Gastroenterol 2021 07 21;56(7):620-632. Epub 2021 Apr 21.

National University Corporation Hirosaki University, Hirosaki, Japan.

Background: We aimed to elucidate the risk of metastatic recurrence after endoscopic resection (ER) without additional treatment for esophageal squamous cell carcinomas (ESCCs) with tumor invasion into the muscularis mucosa (pT1a-MM) or submucosa (T1b-SM).

Methods: We retrospectively enrolled patients with pT1a-MM/pT1b-SM ESCC after ER at 21 institutions in Japan between 2006 and 2017. We compared metastatic recurrence between patients with and without additional treatment, stratified into category A (pT1a-MM with negative lymphovascular invasion [LVI] and vertical margin [VM]), B (tumor invasion into the submucosa ≤ 200 µm [pT1b-SM1] with negative LVI and VM), and C (others). Subsequently, using multivariate Cox analysis, we evaluated risk factors for metastatic recurrence after ER without additional treatment.

Results: We enrolled 593 patients, and metastatic recurrence occurred in 38 patients. Metastatic recurrence after additional treatment was significantly lower than that after no additional treatment in category C (9.1% vs. 23.6% in 5 years, p = 0.001), whereas no significant difference was noted in categories A (0.0% vs. 2.6%) and B (0.0% vs. 4.3%). In patients without additional treatment after ER, risk factors for metastatic recurrence were lymphatic invasion (hazard ratio [HR], 5.61), positive VM (HR, 4.55), and tumor invasion into the submucosa > 200 μm (HR, 3.25), and, but near half of the patients with metastatic recurrence had no further recurrence after salvage treatment, resulting in excellent 5-year disease-specific survival in categories A (99.6%) and B (100.0%).

Conclusions: Closed follow-up with no additional treatment may be an acceptable option after ER in pT1a-MM/pT1b-SM1 ESCC with negative LVI and VM.
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http://dx.doi.org/10.1007/s00535-021-01787-yDOI Listing
July 2021

A Pilot Randomized Crossover Trial of Wet Suction and Conventional Techniques of Endoscopic Ultrasound-Guided Fine-Needle Aspiration for Upper Gastrointestinal Subepithelial Lesions.

Gastroenterol Res Pract 2021 22;2021:4913107. Epub 2021 Mar 22.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

Methods: Twenty-six patients with UGI-SELs indicated for EUS-FNA were randomly assigned to the dry-first arm using the dry technique for the first two passes or the wet-first arm using the wet technique for the first two passes using a cross-over design with a ratio of 1 : 1. The primary endpoint was the cellularity score of the EUS-FNA specimens rated on a 4-point scale (0-3). The secondary endpoints were the factors influencing cellularity in each suction technique.

Results: The mean cellularity score was 1.65 ± 1.20 for the wet technique and 2.00 ± 0.98 for the dry technique ( = 0.068). Logistic regression analysis showed that higher cellularity may be related to the final diagnosis of gastrointestinal stromal tumors in the dry technique and the SEL location in the upper stomach in the wet technique.

Conclusion: The wet EUS-FNA technique failed to show a potential for improved cellularity of specimens compared to the dry technique for UGI-SELs.
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http://dx.doi.org/10.1155/2021/4913107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8007354PMC
March 2021

Efficacy of Sodium Carboxymethylcellulose Compared to Sodium Hyaluronate as Submucosal Injectant for Gastric Endoscopic Submucosal Dissection: A Randomized Controlled Trial.

Digestion 2021 19;102(5):753-759. Epub 2021 Feb 19.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

Introduction: Sodium hyaluronate (SH) is a useful submucosal injectant for gastric endoscopic submucosal dissection (ESD). On the other hand, sodium carboxymethylcellulose (SCMC), which has high viscosity, has also been applied clinically. We evaluated the efficacy of SCMC compared to that of SH in gastric ESD.

Methods: A prospective randomized controlled trial was conducted to assess the efficacy of 1.0% SCMC as the injectant (SCMC group) compared to 0.4% SH (SH group) for ESD of gastric neoplasms. The primary end point was the procedure time of ESD. Secondary end points were treatment outcomes such as en bloc and R0 resection rates, number of hemostases, amount of injectant, ease of treatment (visual analog scale, 1-10 points), adverse events, and rate of ulcer healing 8 weeks after ESD.

Results: A total of 60 patients were enrolled between October 2014 and October 2018, and 30 patients were allocated in each group. The procedure time (mean ± SD, minutes) was not significantly different between the SCMC (74.7 ± 54.5) and SH groups (67.1 ± 41.4) (p = 0.547). Furthermore, there were no differences between the 2 groups in terms of en bloc and R0 resection rates, number of hemostases, amount of injectant, ease of treatment, and rate of ulcer healing. No serious adverse events were observed in either group.

Conclusion: SCMC was comparable to SH in terms of procedure time, treatment outcome, and ease and safety of treatment in gastric ESD. Further studies are needed to demonstrate the differences between the 2 injectants.
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http://dx.doi.org/10.1159/000513148DOI Listing
September 2021

Gastric carcinoma with lymphoid stroma diagnosed by endoscopic ultrasound-guided fine-needle aspiration.

Clin J Gastroenterol 2021 Apr 1;14(2):471-477. Epub 2021 Jan 1.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

A 78-year-old man with a subepithelial lesion (SEL) in the gastric body and two carcinomas in the gastric antrum was referred to our hospital. Following a diagnosis of SEL, the patient was followed-up by esophagogastroduodenoscopy annually for 4 years. Although the SEL had increased in size over the years, histological evaluation of the forceps biopsies did not reveal any significant findings. We detected a hypoechoic mass in the submucosa by endoscopic ultrasonography, and suspected the lesion to be an aberrant pancreas or mesenchymal tumor. The patient first underwent endoscopic submucosal dissection for the 2 gastric cancers. Histological examination of the resected specimens revealed intramucosal well-differentiated tubular adenocarcinomas. Next, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) was performed for the gastric SEL. Aspirated specimens revealed an adenocarcinoma with lymphocyte infiltration. The lesion was diagnosed as a gastric carcinoma with lymphoid stroma (GCLS). Subsequently, he underwent distal gastrectomy, and the surgical specimen was confirmed as GCLS corresponding to preoperative diagnosis. In addition, the adenocarcinoma cells were positive for Epstein-Barr (EB) virus-encoded small RNA-1 by in situ hybridization. Finally, the lesion was diagnosed as GCLS associated with EB virus. Thus, EUS-FNA is advantageous for diagnosing GCLS associated with EB virus.
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http://dx.doi.org/10.1007/s12328-020-01300-7DOI Listing
April 2021

Which scope is appropriate for endoscopic retrograde cholangiopancreatography after Billroth II reconstruction: An esophagogastroduodenoscope or a colonoscope?

World J Gastrointest Endosc 2020 Aug;12(8):220-230

Department of Gastroenterology, School of Medicine, Fukushima Medical University, Fukushima 9601247, Japan.

Background: Recently, with the advent of more advanced devices and endoscopic techniques, endoscopic retrograde cholangiopancreatography (ERCP) in Billroth II (B-II) patients has been increasingly performed. However, the procedures are difficult, and the techniques and strategies have not been defined.

Aim: To reveal the appropriate scope for ERCP in B-II patients.

Methods: Sixty ERCP procedures were performed on B-II patients between June 2005 and May 2018 at Fukushima Medical University Hospital, and in 44 cases, this was the first ERCP procedure performed by esophagogastroduodenoscopy (EGDS) or colonoscopy (CS) after B-II gastrectomy. These cases were divided into two groups: 17 cases of ERCP performed by EGDS (EGDS group) and 27 cases of ERCP performed by CS (CS group). The patient characteristics and ERCP procedures were compared between the EGDS and CS groups.

Results: The procedural time was significantly shorter in the EGDS group than in the CS group [median (range): 60 (20-100) 90 (40-128) min, value < 0.01]. CS was an independent factor of a longer ERCP procedural time according to the univariate and multivariate analyses (odds ratio: 3.97, 95%CI: 1.05-15.0, value = 0.04).

Conclusion: Compared to CS, EGDS shortened the procedural time of ERCP in B-II patients.
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http://dx.doi.org/10.4253/wjge.v12.i8.220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443825PMC
August 2020

Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis.

Calcif Tissue Int 2020 12 25;107(6):559-566. Epub 2020 Aug 25.

Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.

In this post hoc analysis of the Denosumab Fracture Intervention Randomized Placebo-Controlled Trial (DIRECT) in Japanese postmenopausal women and men with osteoporosis, we evaluated the relationship between vertebral fracture risk and both bone mineral density (BMD) T-score and percent change after 24 months of denosumab treatment at total hip, femoral neck, and lumbar spine. Logistic regression analysis was performed and the proportion of treatment effect explained by BMD in vertebral fracture risk was estimated. The results demonstrate that both total hip BMD T-score and change can be strong predictors of subsequent fracture risk, and that total hip BMD change explained 73%, while T-score explained 23%, of the treatment effect. In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk. Furthermore, although lumbar spine BMD T-score was associated with vertebral fracture incidence, lumbar spine BMD change was inversely related to vertebral fracture risk. Because there was no relationship between lumbar spine BMD change and T-score at 24 months of denosumab treatment, and because there can be small undetectable vertebral deformities that may increase BMD values, these results suggest that lumbar spine BMD change is not a good surrogate for vertebral fracture risk assessment. It is suggested that both total hip BMD change and T-score can be good surrogates for predicting vertebral fracture risk in Japanese patients with osteoporosis under denosumab treatment.ClinicalTrials.gov identifier: NCT00680953.
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http://dx.doi.org/10.1007/s00223-020-00750-yDOI Listing
December 2020

Clinical Characteristics of Intramucosal Gastric Cancers with Lymphovascular Invasion Resected by Endoscopic Submucosal Dissection.

Digestion 2021 13;102(4):546-553. Epub 2020 Aug 13.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

Introduction: In patients with intramucosal gastric cancer (MGC) who have undergone endoscopic submucosal dissection (ESD), lymphovascular invasions (LVIs) such as lymphatic invasion or venous invasion are considered risk factors of lymph node metastasis (LNM). However, the rate of LNM in MGCs with LVI and their clinicopathological features are unclear.

Objective: This study aimed to examine the rate of LNM and clinical characteristics of MGCs with LVI as compared to MGCs without LVI and minimally invasive submucosal gastric cancers (mSMGCs) with LVI.

Methods: Among the early gastric cancers excluding the remnant stomach who underwent ESD at our hospital from July 2003 to September 2018, the MGCs with LVI were included as the target in this study. MGCs without LVI and mSMGCs with LVI were also included as control.

Results: Seventeen lesions in 17 patients with MGCs with LVI, 1,149 lesions in 865 patients with MGCs without LVI, and 29 lesions in 29 patients with mSMGCs with LVI were analyzed. LVI was noted in 1.5% (17/1,166) of MGC cases. During follow-up of the MGC cases with LVI, there were no LNM or recurrences reported, and 14 patients survived and 3 died of other diseases. However, LNM occurred in 2 cases of mSMGC. Among the MGC cases, univariate analysis showed that the pap component, elevated type, and tumor diameters of 20 mm or more were statistically significant factors with respect to LVI, while multivariate analysis showed that the pap component was the only significant factor.

Conclusion: Careful follow-up may be appropriate for MGCs with LVI due to the low risk of LNM. Additionally, the pap component is a significant factor in MGCs with LVI.
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http://dx.doi.org/10.1159/000509599DOI Listing
August 2021

Can the wet suction technique change the efficacy of endoscopic ultrasound-guided fine-needle aspiration for diagnosing autoimmune pancreatitis type 1? A prospective single-arm study.

World J Clin Cases 2020 Jan;8(1):88-96

Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima 960-1295, Japan.

Background: Other than surgery, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the only procedure for histologically diagnosing autoimmune pancreatitis (AIP). However, adequate specimens are difficult to obtain. Recently, more adequate specimens were reported to be obtained with EUS-FNA with a wet suction technique (WEST) than with conventional EUS-FNA.

Aim: To histologically diagnose AIP by EUS-FNA with a WEST.

Methods: Eleven patients with possible type 1 AIP between February 2016 and August 2018 underwent EUS-FNA with a WEST (WEST group), with four punctures by 19 or 22 G needles. As a historical control, 23 type 1 AIP patients who underwent no fewer than four punctures with 19 or 22 G needles were enrolled (DRY group). Patient characteristics and histological findings were compared between the two groups.

Results: Three histopathological factors according to the International Consensus Diagnostic Criteria were significantly greater in the WEST group than the DRY group [lymphoplasmacytic infiltrate without granulocytic infiltration: 9 (81.8%) 6 (26.1%), = 0.003, storiform fibrosis: 5 (45.5%) 1 (4.3%), = 0.008, abundant (> 10 cells/HPF) IgG4-positive cells: 7 (63.6%) 5 (21.7%), = 0.026]. Level 1 or level 2 histopathological findings were observed more often in the WEST group than in the DRY group [8 (72.7%) 3 (13.0%), = 0.001].

Conclusion: EUS-FNA with a WEST was more successful than standard EUS-FNA in histologically diagnosing AIP.
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http://dx.doi.org/10.12998/wjcc.v8.i1.88DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6962058PMC
January 2020

Effectiveness of L-Menthol Spray Application on Lesions for the Endoscopic Clarification of Early Gastric Cancer: Evaluation by the Color Difference.

Digestion 2021 10;102(2):274-282. Epub 2019 Dec 10.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

Introduction: Although L-menthol spray application on lesions has been shown to be effective for the endoscopic clarification of early gastric cancer (EGC), the currently available data are all based on subjective evaluations.

Objectives: This study was aimed to objectively evaluate the effectiveness of L-menthol spray for the endoscopic classification of EGC.

Methods: Patients with EGC treated by endoscopic submucosal dissection were included. Images taken by white light imaging (WLI) and narrow band imaging (NBI) before and after spraying L-menthol directly on a lesion were saved. The primary endpoint was a change in the color difference between the EGC lesion and surrounding mucosa (ΔExy) before and after L-menthol spray application. The secondary endpoints were patient factors related to the change in ΔExy after L-menthol spray application and the pathological findings.

Results: Fifty cases of EGC were included in the analysis. The median ΔExy was significantly larger after L-menthol spray application than before, as assessed by either WLI (p <0.001) or NBI (p < 0.001). An increased ΔExy after L-menthol spray application was noted in 76 and 92% of patients by WLI and NBI, respectively. The percentage of patients with a ΔExy ≥5 (a level distinguishable by human eyes) was significantly larger after L-menthol spray application either by WLI (p <0.001) or NBI (p < 0.001). Pathologically, mucosal vasodilatation and stromal edema were noted after L-menthol spray application in the evaluated 2 cases.

Conclusions: These results objectively demonstrate that L-menthol provides benefits in the endoscopic clarification of EGC.
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http://dx.doi.org/10.1159/000504667DOI Listing
August 2021

Ionic liquid/ZnO(0001[combining macron]) single crystal and epitaxial film interfaces studied through a combination of electrochemical measurements and a pulsed laser deposition process under vacuum.

Phys Chem Chem Phys 2019 Dec 12;21(45):25506-25512. Epub 2019 Nov 12.

Department of Applied Chemistry, School of Engineering, Tohoku University, 6-6-07 Aramaki Aza Aoba, Aoba-ku Sendai, 980-8579, Japan.

O-Polar ZnO(0001[combining macron]) single crystals and ZnO and Mg-doped ZnO (MgZnO) films which were subsequently deposited on the ZnO crystals by a pulsed laser deposition (PLD) method were electrochemically investigated through the interfaces with ionic liquid (IL) in a vacuum. The sample surfaces were confirmed to be atomically clean and flat by reflection high energy electron diffraction (RHEED) observation, prior to their electrochemical measurements. Electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV) were then performed, and the donor density, flat band potential of these ZnO samples, and the electric double layer capacitance at the IL/ZnO interfaces were successfully evaluated. The flat band potentials of ZnO and MgZnO films were found to shift to more negative potentials relative to those of the single crystal ZnO, with different values for thicker films, respectively. Some possible origins of the different flat band potentials between ZnO and MgZnO films, and their film thickness dependence of the flat band potential will be discussed in this paper.
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http://dx.doi.org/10.1039/c9cp04875hDOI Listing
December 2019

Clinical Outcomes and Adverse Events of Endoscopic Submucosal Dissection for Gastric Tube Cancer after Esophagectomy.

Gastroenterol Res Pract 2019 3;2019:2836860. Epub 2019 Mar 3.

Department of Gastroenterology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, Japan.

Background And Aim: The clinical outcomes of endoscopic submucosal dissection (ESD) for gastric tube cancer (GTC) after esophagectomy remain unclear. The aim of this study was to evaluate the clinical outcomes and safety of ESD for GTC.

Patients And Methods: Twenty GTC lesions in 18 consecutive patients who underwent ESD between February 2008 and June 2018 were included in this retrospective study. The endpoints were the treatment outcomes of ESD (i.e., resection rate, complete resection rate, and curative resection rate), the adverse events following ESD, and the long-term outcomes.

Results: The resection rate was 100%, while the complete resection rate and curative resection rate were 80% each. Adverse events were observed in 16.7% (3/18) of patients: one postoperative bleeding, 1 intraoperative perforation that required emergency surgery, and 1 pyothorax that required chest drainage. The 1-, 3-, and 5-year overall survival rates were 100%, 70.9%, and 70.9%, respectively. Although local recurrence was detected in 1 case of noncurative resection, no GTC- or ESD-related deaths were observed.

Conclusion: ESD for GTC was feasible and acceptable to enable resection and to prevent cancer death. However, ESD for GTC should be performed more carefully than common gastric ESD because serious adverse events specific to the gastric tube may occur.
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http://dx.doi.org/10.1155/2019/2836860DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6421774PMC
March 2019

Appropriate number of biliary biopsies and endoscopic retrograde cholangiopancreatography sessions for diagnosing biliary tract cancer.

World J Gastrointest Endosc 2019 Mar;11(3):231-238

Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima 960-1247, Japan.

Background: Biliary ductal cancer (BDC) is a lethal disease; however, diagnosing BDC is challenging. Biliary biopsies are performed to pathologically diagnose BDC, but the appropriate parameters for biliary biopsy [number of biliary biopsies, number of endoscopic retrograde cholangiopancreatography (ERCP) sessions, .] are unknown.

Aim: To clarify what constitutes an adequate method for biliary biopsy.

Methods: In total, 95 patients who underwent endoscopic biliary biopsy without choledochoscopy and who were pathologically diagnosed with BDC were enrolled in this study. The patients were divided into two groups. Seventy-six patients who were diagnosed by biliary biopsy were defined as the positive group (P group), and nineteen patients who were not diagnosed by biliary biopsy were defined as the negative group (N group). The patient characteristics and ERCP-related procedures were compared between the P and N groups.

Results: The numbers of ERCP sessions and biliary biopsies were significantly different between the two groups [ERCP sessions (one/two), P group 72/4 N group 15/4, value = 0.048; number of biliary biopsies, P group 2 (1-6) N group 2 (1-7), value = 0.039]. In a multivariate analysis, fewer than 2 ERCP sessions was an independent factor influencing the positivity of the biliary biopsies.

Conclusion: This study clarified that ERCP and biliary ductal biopsy should only be performed once. If biliary cancer is not pathologically diagnosed after the first ERCP session, other methods (Endoscopic ultrasonography-guided fine needle aspiration or choledochoscopy-guided biliary ductal biopsy) should be employed.
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http://dx.doi.org/10.4253/wjge.v11.i3.231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425282PMC
March 2019

[Laparoscopic Endoscopic Cooperative Surgery(LECS)for Duodenal Tumors].

Gan To Kagaku Ryoho 2018 Dec;45(13):2024-2026

Dept. of Gastrointestinal Tract Surgery, Fukushima Medical University.

We report 2 cases of superficial non-ampullary duodenal tumor resected using laparoscopic endoscopic cooperative surgery( LECS). A man in his5 0's underwent screening esophagogastroduodenoscopy. Endoscopy revealed a 0-Ⅱc lesion at the anal side of the papilla of Vater that measured 5 mm. We performed LECS, and pathologic examination revealed tubular adenoma with no tumor cellsat the edge of the specimen. A man in his 80's underwent screening esophagogastroduodenoscopy. Endoscopy revealed a 0-Ⅱc lesion at the posterior wall above the papilla of Vater that measured 10 mm. The biopsy showed a well-differentiated adenocarcinoma. We performed LECS, and the pathological examination revealed a tubular adenocarcinoma in the mucosal layer with no carcinoma cells at the edge of the specimen. As the treatment strategy for superficial duodenal tumors has not established yet, further accumulation of cases and investigation are necessary.
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December 2018

A case of inflammatory fibroid polyp of the stomach with an "erect penis like appearance" successfully removed by endoscopic submucosal dissection.

Clin J Gastroenterol 2019 Jun 25;12(3):279-284. Epub 2019 Jan 25.

Department of Gastroenterology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, Japan.

A 37-year-old woman was diagnosed by esophagogastroduodenoscopy (EGD) as having a 15-mm subepithelial lesion (SEL) in the gastric body. For 2 years, she experienced epigastric pain and anemia; she then underwent emergency EGD, which revealed a significant morphological change of the lesion. The SEL had a disintegrated tip and its submucosal portion was substantially exposed out of the mucosa, showing an "erect penis like appearance". Based on the pathological findings of biopsied samples from the exposed portion and the endoscopic features, an inflammatory fibroid polyp (IFP) was suspected. This lesion was considered responsible for the anemia and was removed by endoscopic submucosal dissection (ESD). The pathological findings confirmed the lesion to be IFP. This report presents a case of gastric IFP that showed a marked morphological change and unique endoscopic features and was successfully removed by ESD.
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http://dx.doi.org/10.1007/s12328-019-00935-5DOI Listing
June 2019

Non-specific elevation of serum Mac-2 binding protein glycosylation isomer levels in patients with biliary disease.

Mol Clin Oncol 2019 Jan 26;10(1):168-172. Epub 2018 Oct 26.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima 960-1295, Japan.

The aim of the present study was to clarify the clinical significance of a novel fibrotic marker, serum Mac-2 binding protein glycosylation isomer (M2BPGi), in non-cirrhotic patients with biliary diseases. Associations between the serum levels of M2BPGi and clinical features (including background disease and laboratory data) were analyzed. A total of 78 patients with biliary disease (32 with biliary cancer and 46 with benign disease) were evaluated, and their clinical features (age, sex and biliary stricture status), serum level of M2BPGi and other serum laboratory data [aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyltranspeptidase (γ-GTP), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB), c-reactive protein (CRP), carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9)] were compared. In addition, correlations between the serum level of M2BPGi and other laboratory data were also evaluated. The median serum M2BPGi was increased in cases of biliary tumor [cut-off index (COI), 1.91] compared with cases of benign disease (COI, 0.73; P<0.0001). All biliary cancer cases presented with biliary strictures, and 5 patients had liver metastases. Cases with liver metastases exhibited higher M2BPGi levels compared with cases without liver metastases (COI, 3.75 vs. 1.53; P=0.008). The level of M2BPGi was correlated with levels of AST, ALT, γ-GTP, ALP, TB, DB, CRP, CEA and CA19-9. In conclusion, the serum M2BPGi level could be non-specifically elevated, particularly in non-cirrhotic patients with biliary stricture.
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http://dx.doi.org/10.3892/mco.2018.1750DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313959PMC
January 2019

An observation study of the prognostic effect of waiting times in the management of pancreatic ductal adenocarcinoma.

Oncol Lett 2019 Jan 26;17(1):587-593. Epub 2018 Oct 26.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima 960-1295, Japan.

Pancreatic ductal adenocarcinoma (PDAC) is characterized by an aggressive course; therefore, it was hypothesized that waiting times during disease management may serve as a prognostic factor for patients with PDAC. Data for all patients with PDAC who received treatment in Fukushima Medical University Hospital were collected. Median disease-free survival and overall survival time were calculated using the Kaplan-Meier method and utilized as cut-off points to divide the patients into 2 groups: A short and a long survival group. Clinical characteristics, including waiting times, the detection-to-diagnosis waiting time and the diagnosis-to-treatment waiting time, were compared between the 2 survival groups. A total of 149 patients were included in the present study. Among the 72 patients who underwent chemotherapy, no significant differences between the 2 survival groups regarding waiting times were identified; however, the proportion of patients with locally advanced disease and the administration of combination chemotherapy were significantly associated with increased survival. Additionally, no significant differences in the waiting times between the 2 survival groups were identified when evaluating the 79 patients who underwent surgical resection. In conclusion, the results of the present study indicated that detection-to-diagnosis and diagnosis-to-treatment waiting times do not influence the prognosis of patients with PDAC.
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http://dx.doi.org/10.3892/ol.2018.9626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6313220PMC
January 2019

Successful Endoscopic Closure Using Polyglycolic Acid Sheets with Fibrin Glue for Nonhealing Duodenal Ulcer with Perforation after Proton Beam Therapy of Liver Tumor.

Case Rep Gastroenterol 2018 Sep-Dec;12(3):679-685. Epub 2018 Nov 28.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

We describe the first case of a nonhealing duodenal ulcer with perforation after proton beam therapy (PBT) of a liver tumor that was successfully treated endoscopically using polyglycolic acid (PGA) sheets with fibrin glue. A 69-year-old man received PBT for a liver tumor. Esophagogastroduodenoscopy (EGD) 3 months after PBT revealed a duodenal ulcer. A proton pump inhibitor was administered for 7 weeks, and the ulcer healed. Six months after the EGD, recurrence of the duodenal ulcer with perforation occurred. An emergency open surgery with placement of the omental patch was performed. However, 5 days after the surgery, because the EGD revealed a perforation site in the duodenal ulcer that was not closed, the conservative treatment was continued. Twenty-eight days after the surgery, EGD revealed that the perforation size had increased. Therefore, we conducted endoscopic closure therapy using PGA sheets with fibrin glue. Eleven days after the closure procedure, the EGD showed that the perforation site was filled with granulation tissue and was closed. Forty-nine days after the procedure, EGD revealed that the ulcer had healed. This endoscopic closure treatment was effective for a nonhealing duodenal ulcer with perforation after PBT of a liver tumor.
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http://dx.doi.org/10.1159/000494918DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6323404PMC
November 2018

The efficacy of serum cell death biomarkers for diagnosing biliary tract cancer.

Sci Rep 2018 11 19;8(1):16997. Epub 2018 Nov 19.

Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima, Japan.

In this study, we determined the efficacy of the cell death biomarker cytokeratin 18 for diagnosing biliary tract cancer (BTC). We recruited 36 patients with BTC (Malignant group) and 45 patients with benign biliary tract disease (Benign group) for this study. We used M30 and M65 as cell death biomarkers. M30 levels indicate apoptosis, and M65 levels indicate both apoptosis and necrosis. M30 and M65 levels were significantly higher in the Malignant group than in the Benign group (142.4 ± 117.0 vs 48.9 ± 71.2 U/l, P < 0.001; 1513.3 ± 837.4 vs 882.2 ± 831.2 U/l, P = 0.001). The diagnosability of M30 was the highest of the four markers (CEA, CA19-9, M30, M65) (cut-off value: 74.429 U/l, sensitivity: 72.2%, specificity: 77.1%, AUC: 0.771). The sensitivity of M30 (cut-off value: 74.429 U/l) was significantly higher than that of biliary cytology (76% (19/25) vs 12% (3/25), P < 0.001), and the accuracy of M30 was significantly higher than that of biliary cytology (78.3% (36/46) vs 52.2% (24/46), P = 0.015). The sensitivity of M30 (cut-off value: 74.429 U/l) was significantly higher than that of biliary cytology and brush cytology (72.4% (21/29) vs 24.1% (7/29), P < 0.001). In conclusion, cell death biomarkers were increased in patients with BTC, and M30 could efficiently diagnose BTC.
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http://dx.doi.org/10.1038/s41598-018-35278-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6243019PMC
November 2018

Propofol is a more effective and safer sedative agent than midazolam in endoscopic injection sclerotherapy for esophageal varices in patients with liver cirrhosis: a randomized controlled trial.

Fukushima J Med Sci 2018 Dec 21;64(3):133-141. Epub 2018 Oct 21.

Department of Gastroenterology, Fukushima Medical University School of Medicine.

Objective: The efficacy of sedation during endoscopic injection sclerotherapy (EIS) for esophageal varices (EVs) in patients with liver cirrhosis remains unclear. The aim of this study is to compare the efficacy and safety between propofol- and midazolam-based sedation for EIS.

Methods: Twenty-three patients with EVs were prospectively and randomly assigned to midazolam-based (Midazolam group) or propofol-based (Propofol group) sedation. All patients underwent a number connection test (NCT) to evaluate minimal hepatic encephalopathy (MHE) on the day before and at 2 and 24 hours following EIS. The primary endpoint was exacerbation of MHE after EIS, which was defined as deterioration of the NCT. The secondary endpoints were postoperative awareness, technical success rate, frequency of body movement, patient and operator satisfaction, cardiorespiratory dynamics during EIS, and adverse events.

Results: Exacerbations of MHE at 2 hours after EIS compared with those before EIS were not significantly different between the two groups. In both groups, the deterioration of NCT scores before and 2 hours after EIS was observed (Propofol group: 60.0 vs. 70.0 s, P = 0.026; Midazolam group: 42.5 vs. 67.0 s, P = 0.002). There were no significant differences in awareness, technical success rate, or patient satisfaction. However, the frequency of body movement in the Propofol group was significantly lower than that in the Midazolam group (1 vs. 4, P = 0.045), and operator satisfaction in the Propofol group was significantly higher than that in the Midazolam group (P = 0.016). No adverse events were observed.

Conclusions: Propofol-based sedation exacerbated MHE after EIS similarly to midazolam-based sedation in patients with liver cirrhosis. However, propofol-based sedation provided stable sedation with a lower frequency of body movements and high operator satisfaction.
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http://dx.doi.org/10.5387/fms.2018-21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305790PMC
December 2018

Prognostic influence of endoscopic ultrasound-guided fine needle aspiration in IPMN-derived invasive adenocarcinoma.

BMC Cancer 2018 Oct 12;18(1):974. Epub 2018 Oct 12.

Department of Gastroenterology, Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima, 960-1295, Japan.

Background: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for mucinous cystic neoplasm of the pancreas carries a potential risk of inducing peritoneal tumor cell dissemination. We investigated the diagnostic yield and safety of EUS-FNA-based cytology of cells obtained from the pancreatic invasion site of intraductal papillary-mucinous neoplasm-derived adenocarcinoma (IPMC).

Methods: We included 22 surgically resected IPMCs and 84 pancreatic ductal adenocarcinomas (PDACs). Among the IPMC cases, 14 did not undergo EUS-FNA before surgical resection. The diagnostic yield of EUS-FNA was compared between IPMC and PDAC. Additionally, prognosis (relapse-free and overall survival time after resection) and the rate of peritoneal dissemination were compared among IPMC with EUS-FNA, IPMC without EUS-FNA, and PDAC. A survival analysis was performed using the Kaplan-Meier method and log-rank test.

Results: (EUS-FNA diagnosis) There were no significant differences in the number of needle passages (PDAC 2.5 vs. IPMC 2.0 passages, P = 0.84) or puncture route (stomach/duodenum: 2/6 vs. 45/39, P = 0.29). However, the correct diagnosis rate was significantly higher in PDAC (92.9%) than in IPMC (62.5%) (P = 0.03). No procedure-related adverse events occurred. Peritoneal lavage cytology performed during the operation was negative in all cases. (Prognosis) Among IPMC with EUS-FNA, IPMC without EUS-FNA, and PDAC, there were no significant differences in relapse-free survival (21.0 vs. 22.4 vs. 12.5 months, respectively; P = 0.64) or overall survival time (35.5 vs. 53.1 vs. 35.9 months, respectively; P = 0.42), and peritoneal dissemination was detected during the observation period in 25%, 28.5%, and 21.4% cases, respectively (P = 0.82).

Conclusion: Even though a correct diagnosis was more difficult to obtain in IPMC than in PDAC, IPMC allows specimens to be obtained without influencing the rate of recurrence and prognosis.
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http://dx.doi.org/10.1186/s12885-018-4896-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6186033PMC
October 2018

The association between concerns toward adverse reactions during pre-approval drug reviews and the post-approval addition of clinically significant adverse reactions to package inserts: A retrospective analysis of pre-approval drug review reports and safety updates.

Pharmacoepidemiol Drug Saf 2018 11 25;27(11):1265-1276. Epub 2018 Sep 25.

Faculty of Pharmaceutical Sciences, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.

Purpose: To determine if concerns toward adverse reactions (ARs) identified during the drug approval process are associated with their post-approval addition to package inserts.

Methods: Pre-approval concerns toward 24 target ARs were identified in the drug review reports and initial package inserts of 126 target drugs approved for use in Japan between April 2004 and March 2009. Each target drug was monitored for 5 years after approval for the addition of these ARs as clinically significant adverse reactions (CSARs) in the package inserts. Positive predictive values (PPVs) and negative predictive value (NPVs) were calculated. The odds ratios (ORs) and 95% confidence intervals (CIs) were also analyzed to test the association between pre-approval concerns and post-approval CSAR additions.

Results: Target ARs with pre-approval concerns were added as CSARs in 88 of 406 AR-drug pairs (PPV: 21.7%). In contrast, target ARs without pre-approval concerns were added as CSARs in 93 of 2304 drugs (NPV: 96.0%). Hypoglycemia had the highest PPV (100%), whereas hepatitis and myocardial infarction had the lowest PPVs (0.0%). Abnormal hepatic function had the lowest NPV (85.4%), whereas myocardial infarction and convulsions had the highest NPVs (100%). Pre-approval concerns showed a significantly positive association with post-approval CSAR additions (OR: 6.57, 95% CI: 4.74, 9.11; P < 0.001).

Conclusions: The significant association between pre-approval concerns and post-approval CSAR additions indicates that Japan's drug regulatory agency has generally conducted rigorous examination of the safety information available in the submitted data packages during drug review for approval.
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http://dx.doi.org/10.1002/pds.4662DOI Listing
November 2018

Evaluation of inflammation-based markers for predicting the prognosis of unresectable pancreatic ductal adenocarcinoma treated with chemotherapy.

Mol Clin Oncol 2018 Oct 10;9(4):408-414. Epub 2018 Aug 10.

Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima 960-1247, Japan.

Predicting the prognosis of unresectable pancreatic ductal adenocarcinoma (PDAC) is useful in determining the appropriate management strategy. The present study aimed to investigate the association between PDAC prognosis and inflammation-based markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio, prognostic nutritional index, modified Glasgow prognostic score (mGPS) and controlling nutritional status score. A total of 72 patients with unresectable PDAC who received chemotherapy were included. Inflammation-based markers were measured prior to treatment. The median progression-free survival (PFS) and overall survival (OS) were 117 days (range, 10-781 days) and 244 days (range 43-781 days), respectively. The cut-off value of continuous variables that predicted the median OS (244 days) was calcualted. Univariate analysis of PFS showed that disease stage, first-line chemotherapy regimen, carcinoembryonic antigen (CEA), NLR, platelet-to-lymphocyte ratio (PLR), mGPS and controlling nutritional status (CONUT) scores were associated with PFS. Among them, stage, first-line chemotherapy regimen, CEA, NLR and mGPS were independent prognostic factors for PFS in multivariate analysis. Univariate analysis of OS showed that stage, first-line chemotherapy regimen, CA19-9, NLR, PLR, prognostic nutritional index (PNI), mGPS and CONUT score were associated wtih OS. Among them, first-line chemotherapy and mGPS were independent prognostic factors for OS according to multivariate analysis. Univariate and multivariate analyses revealed that a NLR ≥4.0 and mGPS 2 were independent prognostic factors for PFS. For OS, mGPS 2 was an independent prognostic factor. In conclusion, mGPS was the most useful marker in predicting the prognosis of patients with unresectable PDAC who received chemotherapy.
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http://dx.doi.org/10.3892/mco.2018.1696DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142299PMC
October 2018

Endoscopic ultrasound-guided fine needle aspiration for pancreatic cancer.

Fukushima J Med Sci 2018 Dec 8;64(3):111-115. Epub 2018 Sep 8.

Department of Gastroenterology, Fukushima Medical University School of Medicine.

Since the development of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in the early 1990s, its application has been extended to various diseases. For pancreatic cancer (PC), EUS-FNA can obtain specimens from the tumor itself with fewer complications than other methods. EUS-FNA can also be more useful for TNM staging than other imaging modalities. Furthermore, EUS-FNA can contribute to precision medicine by obtaining tissue for immunohistochemical or genetic studies from primary or metastatic sites of diseases. This paper will focus on the role of EUS-FNA in PC.
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http://dx.doi.org/10.5387/fms.2018-14DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305789PMC
December 2018

Delayed perforation after endoscopic submucosal dissection for mucosal colon cancer: A conservatively treated case.

Fukushima J Med Sci 2018 Dec 8;64(3):157-162. Epub 2018 Sep 8.

Department of Gastroenterology, Fukushima Medical University School of Medicine.

A 66-year-old man was diagnosed from colonoscopy as having a 40-mm elevated tumor in the cecum. With a preoperative diagnosis of intramucosal carcinoma, endoscopic submucosal dissection (ESD) was performed. The tumor was resected en bloc, yielding a specimen with a 66-mm diameter. No perforation was detected during the operation.Although neither abdominal pain nor fever was observed immediately after ESD, abdominal pain developed on the following day. Two days after ESD, the abdominal pain ceased. The patient was managed conservatively with fasting and intravenous antibiotic treatment. Four days after ESD, abdominal X-ray revealed marked gas retention. Computed tomography revealed pneumoperitoneum and a pelvic abscess, leading to a diagnosis of delayed perforation after colonic ESD and paralytic intestinal obstruction. A decompression tube was then inserted transnasally into the small intestine. Because a gradual decrease occurred in intestinal gas, the decompression tube was removed. Oral ingestion was resumed 13 days post-ESD.Delayed perforation after colonic ESD often requires emergency surgery. The present case was managed conservatively, despite paralytic intestinal obstruction. This approach is rarely employed for this condition and is therefore worth reporting.
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http://dx.doi.org/10.5387/fms.2018-04DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305787PMC
December 2018

Push pull method for endoscopic ultrasound-guided fine needle aspiration of pancreatic head lesions: Propensity score matching analysis.

World J Gastroenterol 2018 Jul;24(27):3006-3012

Department of Gastroenterology, Fukushima Medical University, School of Medicine, Fukushima 960-1247, Japan.

Aim: To evaluate the efficacy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic head cancer when pushing (push method) or pulling the echoendoscope (pull method).

Methods: Overall, 566 pancreatic cancer patients had their first EUS-FNA between February 2001 and December 2017. Among them, 201 who underwent EUS-FNA for pancreatic head lesions were included in this study. EUS-FNA was performed by the push method in 85 patients, the pull method in 101 patients and both the push and pull methods in 15 patients. After propensity score matching (age, sex, tumor diameter, and FNA needle), 85 patients each were stratified into the push and pull groups. Patient characteristics and EUS-FNA-related factors were compared between the two groups.

Results: Patient characteristics were not significantly different between the two groups. The distance to lesion was significantly longer in the push group than in the pull group (13.9 ± 4.9 mm 7.0 ± 4.9 mm, < 0.01). The push method was a significant factor influencing the distance to lesion (≥ median 10 mm) ( < 0.01). Additionally, tumor diameter ≥ 25 mm (OR = 1.91, 95%CI: 1.02-3.58, = 0.043) and the push method (OR = 1.91, 95%CI: 1.03-3.55, = 0.04) were significant factors contributing to the histological diagnosis of malignancy.

Conclusion: The pull method shortened the distance between the endoscope and the lesion and facilitated EUS-FNA of pancreatic head cancer. The push method contributed to the histological diagnosis of pancreatic head cancer using EUS-FNA specimens.
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http://dx.doi.org/10.3748/wjg.v24.i27.3006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6054953PMC
July 2018

Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail.

World J Gastroenterol 2018 Jun;24(22):2392-2399

Department of Gastroenterology, School of Medicine, Fukushima Medical University, Fukushima 960-1247, Japan.

Aim: To investigate the location to which a pancreatic stent should be inserted to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).

Methods: Over a ten-year period at our hospital, 296 patients underwent their first ERCP procedure and had a pancreatic stent inserted; this study included 147 patients who had ERCP performed primarily for biliary investigation and had a pancreatic stent inserted to prevent PEP. We divided these patients into two groups: 131 patients with a stent inserted into the pancreatic head (head group) and 16 patients with a stent inserted up to the pancreatic body or tail (body/tail group). Patient characteristics and ERCP factors were compared between the groups.

Results: Pancreatic amylase isoenzyme (p-AMY) levels in the head group were significantly higher than those in the body/tail group [138.5 (7.0-2086) 78.5 (5.0-1266.5), = 0.03] [median (range)]. No cases of PEP were detected in the body/tail group [head group, 12 (9.2%)]. Of the risk factors for post-ERCP hyperamylasemia (≥ p-AMY median, 131 IU/L), procedure time ≥ 60 min [odds ratio (OR) 2.65, 95%CI: 1.17-6.02, = 0.02) and stent insertion into the pancreatic head (OR 3.80, 95%CI: 1.12-12.9, P = 0.03) were identified as independent risk factors by multivariate analysis.

Conclusion: Stent insertion up to the pancreatic body or tail reduces the risk of post-ERCP hyperamylasemia and may reduce the risk of PEP.
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http://dx.doi.org/10.3748/wjg.v24.i22.2392DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6000294PMC
June 2018

Fibrosis-related miRNAs as serum biomarkers for pancreatic ductal adenocarcinoma.

Oncotarget 2018 Jan 17;9(4):4451-4460. Epub 2017 Dec 17.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

We investigated whether serum microRNAs (miRNAs) could be diagnostic or prognostic markers in pancreatic ductal adenocarcinoma (PDAC). We first identified miRNAs showing altered expression in human pancreatic stellate cells (hPSCs) co-cultured with PDAC cells (Panc-1 and BxPC-3) as compared to hPSCs cultured alone. Among the miRNAs with altered expression, let-7d exhibited reduced expression in an analysis of The Cancer Genome Atlas data. Inhibition of let-7d resulted in enhanced expression of fibrosis-related genes. We extracted serum miRNA from 45 PDAC patients and 42 healthy controls and quantified expression let-7d using digital PCR. Based on the level of let-7d expression, we were able to distinguish between PDAC patients and controls. Additionally, reduced let-7d expression correlated with poor overall survival. Thus, fibrosis-related miRNAs may be serum biomarkers for PDAC.
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http://dx.doi.org/10.18632/oncotarget.23377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5796986PMC
January 2018

Per-oral endoscopic myotomy for esophageal achalasia in a case of Allgrove syndrome.

Clin J Gastroenterol 2018 Aug 30;11(4):273-277. Epub 2018 Jan 30.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, 960-1295, Japan.

Allgrove syndrome, also known as Triple A syndrome, is a rare autosomal recessive genetic disease characterized by three signs: esophageal achalasia, adrenocorticotropic hormone refractoriness, and alacrima. A 31-year-old male presented to our hospital for treatment of difficulty swallowing caused by esophageal achalasia. Because he had complicating alacrima, a neurologic disease, and a family history of consanguineous marriage, a genetic neurologic disease was suspected. Then, a mutation in the achalasia-addisonianism-alacrima syndrome gene was identified. With the diagnosis of Allgrove syndrome, a per-oral endoscopic myotomy (POEM) was performed for esophageal achalasia. After the POEM, the symptoms and the esophageal pressure findings ameliorated quickly, with no recurrence noted throughout a follow-up of more than 1 year. Here, we report the first case of POEM performed for esophageal achalasia in Allgrove syndrome.
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http://dx.doi.org/10.1007/s12328-018-0819-7DOI Listing
August 2018

Efficacy and safety of sedation during endoscopic submucosal dissection of gastric cancers using a comparative trial of propofol versus midazolam.

Endosc Int Open 2018 Jan 12;6(1):E51-E57. Epub 2018 Jan 12.

Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan.

Background And Study Aims : Proper sedation is necessary for the safe and satisfactory completion of endoscopic submucosal dissection (ESD) for early gastric cancer. This study was conducted as a comparative trial of efficacy and safety, comparing propofol-based sedation and midazolam-based sedation during ESD of early gastric cancer patients.

Patients And Methods : This study examined 64 lesions in 58 patients treated using ESD with midazolam plus pentazocine between July 2013 and January 2014 (group M) and 237 lesions in 216 patients treated by ESD using propofol plus pentazocine between February 2014 and December 2015 (group P). The two groups were compared in terms of the frequency of body movement during ESD as the primary outcome and in terms of the procedure time, en bloc resection rate, intraoperative change in cardiorespiratory dynamics, and postoperative awareness as the secondary outcomes. Body movement was defined as movement by a patient that required interruption of the procedure or restraint of the patient's body trunk, and addition of a sedative agent.

Results : The median frequency of body movement during ESD was significantly lower in group P (0 times) than in group M (3 times) (  < 0.001). No significant difference was found for the mean procedure time (117 min in group P; 127 min in group M). Although no significant difference was found in the incidence of hypoxemia, bradycardia, or bradypnea, the incidence of hypotension was significantly higher in group P (31.5 %) than in group M (6.9 %) (  = 0.004). Patients in group P had significantly higher postoperative awareness immediately after ESD and at 1 hour after ESD (  = 0.002 and 0.022, respectively).

Conclusion : These results demonstrate the efficacy and safety of propofol-based sedation for gastric ESD.
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http://dx.doi.org/10.1055/s-0043-122225DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5766337PMC
January 2018
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