Publications by authors named "Hisashi Doyama"

90 Publications

Real-time histological imaging of a squamous cell carcinoma in situ in the anal canal using endocytoscopy.

Endoscopy 2021 Oct 25. Epub 2021 Oct 25.

Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.

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http://dx.doi.org/10.1055/a-1655-8401DOI Listing
October 2021

Risk Factors for Bleeding After Endoscopic Submucosal Dissection for Gastric Cancer in Elderly Patients Older Than 80 Years in Japan.

Clin Transl Gastroenterol 2021 Sep 24;12(9):e00404. Epub 2021 Sep 24.

Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.

Introduction: As the aging of people in a society advances, the number of elderly patients older than 80 years in Japan with gastric cancer continues to increase. Although delayed ulcer bleeding is a major adverse event after endoscopic submucosal dissection (ESD), little is known about characteristic risk factors for bleeding in elderly patients undergoing ESD. This study aimed to evaluate risk factors for delayed bleeding after ESD for gastric cancer in elderly patients older than 80 years.

Methods: We retrospectively evaluated the incidence of delayed bleeding after ESD in 10,320 patients with early-stage gastric cancer resected by ESD between November 2013 and January 2016 at 33 Japanese institutions and investigated risk factors for delayed bleeding in elderly patients older than 80 years.

Results: The incidence of delayed bleeding in elderly patients older than 80 years was 5.7% (95% confidence interval [CI]: 4.6%-6.9%, 95/1,675), which was significantly higher than that in nonelderly (older than 20 years and younger than 80 years) patients (4.5%, 4.1%-5.0%, 393/8,645). Predictive factors for ESD-associated bleeding differed between nonelderly and elderly patients. On multivariate analysis of predictive factors at the time of treatment, risk factors in elderly patients were hemodialysis (odds ratio: 4.591, 95% CI: 2.056-10.248, P < 0.001) and warfarin use (odds ratio: 4.783, 95% CI: 1.689-13.540, P = 0.003).

Discussion: This multicenter study found that the incidence of delayed bleeding after ESD in Japanese patients older than 80 years was high, especially in patients receiving hemodialysis and taking warfarin. Management of ESD to prevent delayed bleeding requires particular care in patients older than 80 years.
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http://dx.doi.org/10.14309/ctg.0000000000000404DOI Listing
September 2021

Outcomes of endoscopic resection for superficial duodenal tumors: 10 years' experience in 18 Japanese high-volume centers.

Endoscopy 2021 Sep 8. Epub 2021 Sep 8.

Cancer Center, School of Medicine, Keio University, Tokyo, Japan.

Background And Study Aim: There is no enough data for endoscopic resection (ER) of superficial duodenal epithelial tumors (SDETs) due to its rarity. There are two main kinds of ER techniques for SDETs: EMR and ESD. In addition, modified EMR techniques, underwater EMR (UEMR) and cold polypectomy (CP), are getting popular. We conducted a large-scale retrospective multicenter study to clarify detailed outcomes of duodenal ER.

Patients And Methods: Patients with SDETs who underwent ER at 18 institutions from January 2008 to December 2018 were included. The rates of en bloc resection and delayed adverse events (AEs) (defined as delayed bleeding or perforation) were analyzed. Local recurrence was analyzed using Kaplan-Meier method.

Results: In total, 3107 patients (including 1017 receiving ESD) were included. En bloc resection rates were 79.1%, 78.6%, 86.8%, and 94.8%, and delayed AE rates were 0.5%, 2.2%, 2.8%, and 7.3% for CP, UEMR, EMR and ESD, respectively. The delayed AE rate was significantly higher for ESD group than non-ESD group among lesions less than 19 mm (7.4% vs 1.9%, p<0.0001), but not among lesions larger than 20 mm (6.1% vs 7.1%, p=0.6432). The local recurrence rate was significantly lower in ESD group than non-ESD group (p<0.001). Furthermore, for lesions larger than 30 mm, the cumulative local recurrence rate at 2 years was 22.6% in non-ESD group compared to only 1.6% in ESD group (p<0.0001).

Conclusions: ER outcomes for SDETs were generally acceptable. ESD by highly experienced endoscopists might be an option for very large SDETs.
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http://dx.doi.org/10.1055/a-1640-3236DOI Listing
September 2021

Influence of hospital volume on bleeding after endoscopic submucosal dissection for early gastric cancer in Japan: a multicenter propensity score-matched analysis.

Surg Endosc 2021 Sep 7. Epub 2021 Sep 7.

Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.

Background: Information on whether there is a relationship between hospital volume and bleeding after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is limited. This study aimed to compare the bleeding rates after ESD for EGC according to the hospital volume.

Methods: Patients who underwent ESD for EGC at 33 institutions in Japan between November 2013 and October 2016 were included in this multicenter retrospective study. Hospital volume was categorized into three groups, based on the average annual number of ESD procedures: low- and medium-volume group (LMVG), high-volume group (HVG), and very high-volume group (VHVG). The bleeding rate after ESD for EGC was compared between the three hospital volume groups after propensity score matching.

Results: A total of 10,320 patients, including 2797 patients in the LMVG, 4646 patients in the HVG, and 2877 patients in the VHVG, were identified. Propensity score matching yielded 2002 patients in each hospital volume group, with an improved balance of confounding variables between the three groups. The bleeding rates in the LMVG, HVG, and VHVG were 4.3%, 3.7%, and 4.9%, respectively, and no significant difference was noted between the three groups.

Conclusions: The bleeding rate after ESD for EGC did not differ between hospitals in Japan. The finding indicated that ESD for EGC is equally feasible across Japanese hospitals of different volumes regarding bleeding after ESD.
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http://dx.doi.org/10.1007/s00464-021-08721-6DOI Listing
September 2021

[Number of hospitalizations due to colonic diverticular bleeding as a predictive factor for readmission:an exploratory study].

Nihon Shokakibyo Gakkai Zasshi 2021 ;118(5):437-444

Department of Gastroenterology, Ishikawa Prefectural Central Hospital.

Colonic diverticular bleeding often recurs and requires hospital readmission. This study aimed to examine the relationship between the rate of readmission and the number of hospitalizations due to colonic diverticular bleeding. We retrospectively studied 98 patients first admitted between January 2008 and July 2017 for the treatment of colonic diverticular bleeding. We investigated the subsequent number of hospitalizations due to colonic diverticular bleeding and classified the patients into 3 groups:those admitted for the first time (first group), those admitted for the second time (second group), and those admitted for the third time or later (third group). Generally, the readmission rate increased as the number of hospitalizations increased (P<0.01). The 1-year readmission rates were 11.6%, 23.2%, and 34.2% in the first, second, and third groups, respectively. The 2-year readmission rates were 15.1%, 50.1%, and 62.4% in the first, second, and third groups, respectively. The 3-year readmission rates were 21.7%, 50.1%, and 74.9% in the first, second, and third groups, respectively. Thus, the number of hospitalizations due to colonic diverticular bleeding could be a predictive factor for readmission. We also classified the patients into 2 additional groups:those who had been readmitted (readmission group) and those who had not (no readmission group). Furthermore, we examined background and therapeutic factors, and found hypovolemic shock on admission to be an independent risk factor (odds ratio 14.1). Preventive treatments for such high-risk patients should be considered.
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http://dx.doi.org/10.11405/nisshoshi.118.437DOI Listing
May 2021

Chemoprevention with low-dose aspirin, mesalazine, or both in patients with familial adenomatous polyposis without previous colectomy (J-FAPP Study IV): a multicentre, double-blind, randomised, two-by-two factorial design trial.

Lancet Gastroenterol Hepatol 2021 06 2;6(6):474-481. Epub 2021 Apr 2.

Department of Drug Discovery Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Background: The only established treatment for preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) is colectomy, which greatly reduces patient quality of life. Thus, an alternative method is warranted. In this trial, we aimed to clarify the individual and joint effects of low-dose aspirin and mesalazine on the recurrence of colorectal polyps in Japanese patients with FAP.

Methods: This was a randomised, double-blind, placebo-controlled, multicentre trial with a two-by-two factorial design done in 11 centres in Japan. Eligible patients were aged 16-70 years and had a history of more than 100 adenomatous polyps in the large intestine, without a history of colectomy. Before the study, patients underwent endoscopic removal of all colorectal polyps of at least 5·0 mm in diameter. Randomisation was done with a minimisation method with a random component to balance the groups with respect to the adjustment factors of sex, age (<30 years vs ≥30 years), or smoking status at the time of entry. Patients and researchers were masked to the treatment group. There were four groups: aspirin (100 mg per day) plus mesalazine (2 g per day), aspirin (100 mg per day) plus mesalazine placebo, aspirin placebo plus mesalazine (2 g per day), or aspirin placebo plus mesalazine placebo. Treatment was continued until 1 week before 8 month colonoscopy. The primary endpoint was the incidence of colorectal polyps of at least 5·0 mm at 8 months and was assessed in the intention-to-treat population. Safety was assessed in the ITT population. We also did a per-protocol analysis including only patients who took at least 70% of the allocated study drug. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000018736, and is complete.

Findings: Between Sept 25, 2015, and March 13, 2017, 104 patients were randomly assigned to receive either aspirin or aspirin placebo (n=52) or mesalazine or mesalazine placebo (n=52). Two patients withdrew from the aspirin plus mesalazine placebo group. 26 (50%) of 52 patients who received no aspirin had colorectal polyps of at least 5·0 mm at 8 months, as did 15 (30%) of the 50 patients who received any aspirin, 21 (42%) of the 50 patients who received no mesalazine, and 20 (38%) of the 52 patients who received any mesalazine. The adjusted odds ratio for polyp recurrence was 0·37 (95% CI 0·16-0·86) in the patients who received any aspirin and 0·87 (95% CI 0·38-2·00) in any who received mesalazine. The most common adverse events were grade 1-2 upper gastrointestinal symptoms in three (12%) of 26 patients who received aspirin plus mesalazine, one (4%) of 24 patients who received aspirin plus mesalazine placebo, and one (4%) of 26 patients who received mesalazine plus aspirin placebo. There was one grade 4 event in the mesalazine plus aspirin placebo group, but not related to the treatment.

Interpretation: Low-dose aspirin safely suppressed the recurrence of colorectal polyps larger than 5·0 mm in patients with FAP. These results suggest an effect of low-dose aspirin for FAP and could be an alternative method for preventing colorectal cancer in FAP.

Funding: Japan Agency for Medical Research and Development.
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http://dx.doi.org/10.1016/S2468-1253(21)00018-2DOI Listing
June 2021

White globe appearance is an endoscopic predictive factor for synchronous multiple gastric cancer.

Ann Gastroenterol 2021 7;34(2):183-187. Epub 2020 Dec 7.

Department of Gastroenterology (Teppei Masunaga, Naohiro Yoshida, Shinichiro Akiyama, Gen Sugiyama, Hirokazu Hirai, Saori Miyajima, Shigenori Wakita, Yosuke Kito, Hiroyoshi Nakanishi, Kunihiro Tsuji, Kazuhiro Matsunaga, Shigetsugu Tsuji, Kenichi Takemura, Hisashi Doyama).

Background: White globe appearance (WGA) is a small white lesion with a globular shape identified during magnifying endoscopy with narrow-band imaging. However, the association between WGA and synchronous multiple gastric cancer (SMGC) remains unclear.

Methods: Consecutive patients who underwent endoscopic submucosal dissection for gastric cancer (GC) between July 2013 and April 2015 at our institution were eligible for this study. We excluded patients with a history of gastric tumor or gastrectomy. Patients who had more than 2 GCs in their postoperative pathological evaluation were classified as SMGC-positive, and patients who had at least 1 WGA-positive GC were classified as WGA-positive patients. The primary outcome was a comparison of the prevalence of WGA in patients classified as SMGC-positive and SMGC-negative. Univariate and multivariate analyses were performed using the following variables: WGA, age, sex, atrophy, and () status.

Results: There were 26 and 181 patients classified as SMGC-positive and SMGC-negative, respectively. Univariate analysis revealed that WGA-positive classification (50% vs. 23%, P=0.008) and male sex (88% vs. 66%, P=0.02) were significant factors associated with SMGC classification, while age ≥65 years (81% vs. 81%, P>0.99), severe atrophy (46% vs. 46%, P>0.99), and positivity (69% vs. 65%, P=0.8) were not. In the multivariate analysis, only WGA-positive classification (odds ratio 2.78, 95% confidence interval 1.16-6.67; P=0.02) was a significant independent risk factor for SMGC.

Conclusions: Our exploratory study showed the possibility of WGA as a predictive factor for SMGC. In cases of WGA-positive gastric cancer, careful examination might be needed to diagnose SMGC.
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http://dx.doi.org/10.20524/aog.2020.0565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903575PMC
December 2020

Rebleeding in patients with delayed bleeding after endoscopic submucosal dissection for early gastric cancer.

Dig Endosc 2021 Feb 4. Epub 2021 Feb 4.

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

Objectives: Delayed bleeding is a major adverse event in endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Some patients may experience rebleeding after successful hemostasis for delayed bleeding, yet the details of rebleeding remain unclear. We aimed to clarify the frequency and risk factors of rebleeding.

Methods: Among 11,452 patients who underwent ESD for EGC at 33 institutions in Japan between 2013 and 2016, we analyzed 489 patients showing delayed bleeding. The rate of rebleeding was investigated. Subsequently, 15 candidate variables were evaluated for their influence on the risk of rebleeding via logistic regression analysis.

Results: Rebleeding occurred in 11.2% (55/489) of the enrolled patients. Multivariate analysis revealed that warfarin [odds ratio (OR), 2.71; 95% confidence interval (CI), 1.26-5.84] and a resection size >40 mm (OR, 1.99; 95% CI, 1.08-3.67) were independent risk factors for rebleeding. In the analysis of the management of warfarin after index bleeding, only warfarin discontinuation (OR, 3.66; 95% CI, 1.37-9.78) was significantly associated with rebleeding in comparison with no use of warfarin. However, many rebleeding events (75.0%) occurred following the resumption of warfarin. The rebleeding rate during discontinuation status and that in taking warfarin (continuation or resumption) were 6.1% and 20.0%, respectively.

Conclusions: Rebleeding was not a rare event in patients experiencing delayed bleeding after ESD for EGC. In addition to having a resection size >40 mm, warfarin usage placed patients at high risk for rebleeding, especially at the timing of its resumption following discontinuation as well as its continuation.
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http://dx.doi.org/10.1111/den.13943DOI Listing
February 2021

Does previous biopsy lead to cancer overdiagnosis of superficial non-ampullary duodenal epithelial tumors?

Endosc Int Open 2021 Jan 1;9(1):E58-E65. Epub 2021 Jan 1.

Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.

 We aimed to evaluate the diagnostic performance of magnifying endoscopy with narrow-band imaging (M-NBI) in superficial non-ampullary duodenal epithelial tumors (SNADETs) regarding the absence or presence of biopsy before M-NBI diagnosis.  Clinicopathological data were retrospectively reviewed for 99 SNADETs from 99 patients who underwent endoscopic resection. The 99 tumors were divided into the non-biopsy group (32 lesions not undergoing biopsy before M-NBI examination) and the biopsy group (67 lesions undergoing biopsy before M-NBI examination). We investigated the correlation between the M-NBI diagnosis and the histopathological diagnosis of the SNADETs in both groups.  According to the modified revised Vienna classification, 31 tumors were classified as category 3 (C3) (low-grade adenoma) and 68 as category 4/5 (C4/5) (high-grade adenoma/cancer). The accuracy, sensitivity, and specificity of preoperative M-NBI diagnoses in the non-biopsy group vs the biopsy group were 88 % (95 % confidence interval: 71.0 - 96.5) vs 66 % (51.5 - 75.5),  = 0.02; 95 % (77.2 - 99.9) vs 89 % (76.4 - 96.4),  = 0.39; and 70 % (34.8 - 93.3) vs 14 % (3.0 - 36.3),  < 0.01, respectively. Notably, in the biopsy group, the specificity of M-NBI in SNADETs was low at only 14 % because we over-diagnosed most C3 lesions as C4/5. M-NBI findings might have been compromised by the previous biopsy procedure itself.  In the non-biopsy group, the accuracy of M-NBI in SNADETs was excellent in distinguishing C4/5 lesions from C3. The M-NBI findings in SNADETs should be evaluated while carefully considering the influence of a previous biopsy.
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http://dx.doi.org/10.1055/a-1293-7487DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775803PMC
January 2021

A nonrandomized, single-arm confirmatory trial of expanded endoscopic submucosal dissection indication for undifferentiated early gastric cancer: Japan Clinical Oncology Group study (JCOG1009/1010).

Gastric Cancer 2021 Mar 8;24(2):479-491. Epub 2020 Nov 8.

Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Background: While endoscopic submucosal dissection (ESD) is recognized as a minimally invasive standard treatment for differentiated early gastric cancers (EGCs), it has not been indicated for undifferentiated EGC (UD-EGC) because of a relatively high risk of lymph node metastasis (LNM). However, patients with surgically resected mucosal (cT1a) UD-EGC ≤ 2 cm in size with no lymphovascular invasion or ulceration are reported to be at a very low risk of LNM. This multicenter, single-arm, confirmatory trial was conducted to evaluate the efficacy and safety of ESD for UD-EGC.

Methods: The key eligibility criteria were endoscopically diagnosed cT1a/N0/M0, single primary lesion, size ≤ 2 cm, no ulceration and histologically proven components of undifferentiated adenocarcinoma on biopsy. Based on the histological findings after ESD, additional gastrectomy was indicated if the criteria for curative resection were not satisfied. The subjects of the primary analysis were patients with UD-EGC as the dominant component. The primary endpoint was 5-year overall survival (OS) of patients with UD-EGC.

Results: Three hundred 46 patients were enrolled from 49 institutions. The proportion of en bloc resection was 99%. No ESD-related Grade 4 adverse events were noted. Delayed bleeding and intraoperative and delayed perforation occurred in 25 (7.3%), 13 (3.8%), and 6 (1.7%) patients, respectively. Among the 275 patients who were the subjects of the primary analysis, curative resection was achieved in 195 patients (71%), and 5-year OS was 99.3% (95% CI: 97.1-99.8).

Conclusions: ESD can be a curative and less invasive treatment for UD-EGC for patients meeting the eligibility criteria of this study.
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http://dx.doi.org/10.1007/s10120-020-01134-9DOI Listing
March 2021

Docetaxel-induced fluid retention during adjuvant chemotherapy with S-1 plus docetaxel.

Clin J Gastroenterol 2021 Feb 18;14(1):84-87. Epub 2020 Oct 18.

Department of Gastroenterology, Ishikawa Prefectural Central Hospital, 2-1 Kuratukihigashi, Kanazawa, Ishikawa, 920-8530, Japan.

S-1 plus docetaxel is the standard postoperative adjuvant chemotherapy regimen for patients with stage III gastric cancer in Japan, which has increased the use of docetaxel. One of the most common adverse events of docetaxel, which is widely used to treat several malignancies, is fluid retention. Conversely, the most worrisome cause of ascites in patients who receive adjuvant chemotherapy is recurrence. Sometimes, the differential diagnosis of ascites is difficult if ascitic cytology is negative. In this study, we presented the case of a patient with massive ascites that appeared during adjuvant chemotherapy with S-1 plus docetaxel.
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http://dx.doi.org/10.1007/s12328-020-01265-7DOI Listing
February 2021

Exploration of the characteristics of chronotypes in upper gastrointestinal tract diseases: a multicenter study in Japan.

Chronobiol Int 2021 04 15;38(4):534-542. Epub 2020 Oct 15.

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Japan.

Characteristics of the chronotypes of patients with gastrointestinal disease are unknown. We evaluated chronotypes of patients with upper gastrointestinal diseases with the Munich ChronoType Questionnaire (MCTQ). A total of 2027 subjects from 29 institutions in Japan who had undergone esophagogastroduodenoscopy were asked to answer the MCTQ. The subjects' chronotypes were divided into three groups (early, intermediate, and late chronotype) using the sleep-corrected mid-point of sleep on free days (MSF) values. According to their endoscopic diagnosis and abdominal symptoms, the subjects were divided into the reflux esophagitis (RE) group, gastroduodenal ulcer (GDU) group, upper gastrointestinal carcinoma (CA) group, functional dyspepsia (FD) group, non-FD group, and control group. In total, 1128 subjects were eligible for the analysis. The MSF (average ± standard deviation, clock hours, h) of each disease group was as follows: control group: 02.51 ± 1.22, non-FD group: 02.69 ± 1.14, FD group: 02.91 ± 1.19, RE group: 02.58 ± 1.05, GDU group: 02.47 ± 1.31, and CA group: 02.11 ± 1.08 h. Compared to the control group, the rate of late chronotype of the FD group significantly increased to 33.3%, whereas that of early chronotype of the CA group significantly increased to 38.3% ( = .0177 and 0.0036, respectively). In both the FD and CA groups, chronotype was the independent factor related to the diseases. The adjusted odds ratio of late chronotype to early chronotype was 3.01 [95% CI, 1.23-7.35] in the FD group and 0.44 [95% CI, 0.23-0.85] in the CA group. In conclusion, late chronotype was common in patients with FD, and early chronotype was common in patients with upper gastrointestinal carcinoma.
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http://dx.doi.org/10.1080/07420528.2020.1830791DOI Listing
April 2021

Colitis induced by Lenvatinib in a patient with advanced hepatocellular carcinoma.

Clin J Gastroenterol 2021 Feb 6;14(1):187-192. Epub 2020 Oct 6.

Departments of Gastroenterology, Ishikawa Prefectural Central Hospital, 2-1 Kuratukihigashi, Kanazawa, Ishikawa, 920-8530, Japan.

Lenvatinib is a standard molecular targeted agent for the first-line treatment of unresectable hepatocellular carcinoma. Here, we report a case of colitis induced by Lenvatinib treatment in a patient with hepatocellular carcinoma. A 78-year-old man previously treated with Lenvatinib for unresectable hepatocellular carcinoma was admitted to our hospital complaining of right lateral abdominal pain without diarrhea. Our endoscopic findings showed multiple ulcers and erosions on his ascending colon, and he was diagnosed with colitis induced by Lenvatinib treatment. After the discontinuation of Lenvatinib, his colitis improved, and he resumed Lenvatinib at a lower dose. Colitis is a rare adverse event of Lenvatinib, and this is the first detailed report of colitis induced by Lenvatinib with endoscopic findings.
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http://dx.doi.org/10.1007/s12328-020-01249-7DOI Listing
February 2021

Near-focus magnification and second-generation narrow-band imaging for early gastric cancer in a randomized trial.

J Gastroenterol 2020 Dec 6;55(12):1127-1137. Epub 2020 Oct 6.

Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Background: Magnifying endoscopy with narrow-band imaging (NBI) is effective for the diagnosis of early gastric cancer (EGC). However, magnifying endoscopy is not yet popular globally because of the required level of skill and lack of availability. To overcome these problems, dual-focus endoscopy (standard- and near-focus (NF) modes) has been developed. In this study, we evaluated the diagnostic performance of NF with second-generation (2G)-NBI (NF-NBI) for the diagnosis of EGC.

Methods: This was a secondary analysis of a multicenter randomized controlled trial of 4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan. Patients were randomly assigned to white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI. Lesions suspicious for EGC, newly detected by non-magnifying WLI or 2G-NBI, were subsequently observed with NF-NBI. All detected lesions were biopsied or resected. The diagnostic performance of NF-NBI was compared with the final histology.

Results: A total of 870 detected lesions (145 EGC, 725 non-EGC) were analyzed. Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%. There were no significant differences in diagnostic performance between lesions detected by WLI or 2G-NBI. For lesions diagnosed with high (333 lesions) and low (537 lesions) confidences, accuracy was 92.2% and 84.9%, sensitivity was 64.7% and 58.5%, and specificity was 90.5% and 88.8%, respectively.

Conclusion: The diagnostic performance of NF-NBI is good and acceptable for diagnosis of EGC in combination with either WLI or 2G-NBI.
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http://dx.doi.org/10.1007/s00535-020-01734-3DOI Listing
December 2020

Integrated genetic and epigenetic analysis of cancer-related genes in non-ampullary duodenal adenomas and intramucosal adenocarcinomas.

J Pathol 2020 11 12;252(3):330-342. Epub 2020 Sep 12.

Division of Translational and Clinical Oncology, Cancer Research Institute, Kanazawa University, Kanazawa, Japan.

The molecular and clinical characteristics of non-ampullary duodenal adenomas and intramucosal adenocarcinomas are not fully understood because they are rare. To clarify these characteristics, we performed genetic and epigenetic analysis of cancer-related genes in these lesions. One hundred and seven non-ampullary duodenal adenomas and intramucosal adenocarcinomas, including 100 small intestinal-type tumors (90 adenomas and 10 intramucosal adenocarcinomas) and 7 gastric-type tumors (2 pyloric gland adenomas and 5 intramucosal adenocarcinomas), were investigated. Using bisulfite pyrosequencing, we assessed the methylation status of CpG island methylator phenotype (CIMP) markers and MLH1. Then using next-generation sequencing, we performed targeted exome sequence analysis within 75 cancer-related genes in 102 lesions. There were significant differences in the clinicopathological and molecular variables between small intestinal- and gastric-type tumors, which suggests the presence of at least two separate carcinogenic pathways in non-ampullary duodenal adenocarcinomas. The prevalence of CIMP-positive lesions was higher in intramucosal adenocarcinomas than in adenomas. Thus, concurrent hypermethylation of multiple CpG islands is likely associated with development of non-ampullary duodenal intramucosal adenocarcinomas. Mutation analysis showed that APC was the most frequently mutated gene in these lesions (56/102; 55%), followed by KRAS (13/102; 13%), LRP1B (10/102; 10%), GNAS (8/102; 8%), ERBB3 (7/102; 7%), and RNF43 (6/102; 6%). Additionally, the high prevalence of diffuse or focal nuclear β-catenin accumulation (87/102; 85%) as well as mutations of WNT pathway components (60/102; 59%) indicates the importance of WNT signaling to the initiation of duodenal adenomas. The higher than previously reported frequency of APC gene mutations in small bowel adenocarcinomas as well as the difference in the APC mutation distributions between small intestinal-type adenomas and intramucosal adenocarcinomas may indicate that the adenoma-carcinoma sequence has only limited involvement in duodenal carcinogenesis. © 2020 The Authors. The Journal of Pathology published by John Wiley & Sons, Ltd. on behalf of The Pathological Society of Great Britain and Ireland.
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http://dx.doi.org/10.1002/path.5529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693035PMC
November 2020

Influence of anticoagulants on the risk of delayed bleeding after gastric endoscopic submucosal dissection: a multicenter retrospective study.

Gastric Cancer 2021 Jan 18;24(1):179-189. Epub 2020 Jul 18.

Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.

Background And Aims: Delayed bleeding after gastric endoscopic submucosal dissection (ESD) in patients receiving anticoagulants remains an unpreventable adverse event. Although direct-acting oral anticoagulants (DOACs) have superior efficacy in preventing thromboembolism, their effects on the occurrence of delayed bleeding remain unclear. This study aimed to elucidate the clinical effect of DOACs on delayed bleeding after gastric ESD.

Patients And Methods: We retrospectively examined 728 patients who received anticoagulants and were treated for gastric neoplasms with ESD in 25 institutions across Japan. Overall, 261 patients received DOACs, including dabigatran (92), rivaroxaban (103), apixaban (45) and edoxaban (21), whereas 467 patients were treated with warfarin.

Results: Delayed bleeding occurred in 14% of patients taking DOACs, which was not considerably different in patients receiving warfarin (18%). Delayed bleeding rate was significantly lower in patients receiving dabigatran than in those receiving warfarin and lower than that observed for other DOACs. Multivariate analysis showed that age ≥ 65, receiving multiple antithrombotic agents, resection of multiple lesions and lesion size ≥ 30 mm were independent risk factors, and that discontinuation of anticoagulants was associated with a decreased risk of bleeding. In multivariate analysis among patients taking DOACs, dabigatran therapy was associated with a significantly lower risk of delayed bleeding.

Conclusions: The effects of DOACs on delayed bleeding varied between agents, but dabigatran therapy was associated with the lowest risk of delayed bleeding. Switching oral anticoagulants to dabigatran during the perioperative period could be a reasonable option to reduce the risk of delayed bleeding after gastric ESD.
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http://dx.doi.org/10.1007/s10120-020-01105-0DOI Listing
January 2021

[A case of Edwardsiella tarda colitis, which proved challenging to distinguish from immune-related adverse events with nivolumab].

Nihon Shokakibyo Gakkai Zasshi 2020 ;117(6):514-520

Department of Gastroenterology, Ishikawa Prefectural Central Hospital.

The patient, a man in his 80s, presented with diarrhea following one year of treatment for non-small cell lung cancer with Nivolumab. CT results showed discontinuous wall thickening of the large bowel and cholangitis. Blood and stool culture tests ruled out immune-related adverse events and identified Edwardsiella tarda;bacterial colitis was diagnosed in the patient. This case confirmed that basic examination should not be neglected, and culture tests should be performed.
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http://dx.doi.org/10.11405/nisshoshi.117.514DOI Listing
July 2020

Automatic detection of different types of small-bowel lesions on capsule endoscopy images using a newly developed deep convolutional neural network.

Endoscopy 2020 09 17;52(9):786-791. Epub 2020 Jun 17.

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

BACKGROUND : Previous computer-aided detection systems for diagnosing lesions in images from wireless capsule endoscopy (WCE) have been limited to a single type of small-bowel lesion. We developed a new artificial intelligence (AI) system able to diagnose multiple types of lesions, including erosions and ulcers, vascular lesions, and tumors. METHODS : We trained the deep neural network system RetinaNet on a data set of 167 patients, which consisted of images of 398 erosions and ulcers, 538 vascular lesions, 4590 tumors, and 34 437 normal tissues. We calculated the mean area under the receiver operating characteristic curve (AUC) for each lesion type using five-fold stratified cross-validation. RESULTS : The mean age of the patients was 63.6 years; 92 were men. The mean AUCs of the AI system were 0.996 (95 %CI 0.992 - 0.999) for erosions and ulcers, 0.950 (95 %CI 0.923 - 0.978) for vascular lesions, and 0.950 (95 %CI 0.913 - 0.988) for tumors. CONCLUSION : We developed and validated a new computer-aided diagnosis system for multiclass diagnosis of small-bowel lesions in WCE images.
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http://dx.doi.org/10.1055/a-1167-8157DOI Listing
September 2020

Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score.

Gut 2021 03 4;70(3):476-484. Epub 2020 Jun 4.

Division of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.

Objective: Bleeding after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) is a frequent adverse event after ESD. We aimed to develop and externally validate a clinically useful prediction model (BEST-J score: Bleeding after ESD Trend from Japan) for bleeding after ESD for EGC.

Design: This retrospective study enrolled patients who underwent ESD for EGC. Patients in the derivation cohort (n=8291) were recruited from 25 institutions, and patients in the external validation cohort (n=2029) were recruited from eight institutions in other areas. In the derivation cohort, weighted points were assigned to predictors of bleeding determined in the multivariate logistic regression analysis and a prediction model was established. External validation of the model was conducted to analyse discrimination and calibration.

Results: A prediction model comprised 10 variables (warfarin, direct oral anticoagulant, chronic kidney disease with haemodialysis, P2Y12 receptor antagonist, aspirin, cilostazol, tumour size >30 mm, lower-third in tumour location, presence of multiple tumours and interruption of each kind of antithrombotic agents). The rates of bleeding after ESD at low-risk (0 to 1 points), intermediate-risk (2 points), high-risk (3 to 4 points) and very high-risk (≥5 points) were 2.8%, 6.1%, 11.4% and 29.7%, respectively. In the external validation cohort, the model showed moderately good discrimination, with a -statistic of 0.70 (95% CI, 0.64 to 0.76), and good calibration (calibration-in-the-large, 0.05; calibration slope, 1.01).

Conclusions: In this nationwide multicentre study, we derived and externally validated a prediction model for bleeding after ESD. This model may be a good clinical decision-making support tool for ESD in patients with EGC.
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http://dx.doi.org/10.1136/gutjnl-2019-319926DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873424PMC
March 2021

Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging.

Gut 2021 01 2;70(1):67-75. Epub 2020 Apr 2.

Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan

Objective: Early detection of gastric cancer has been the topic of major efforts in high prevalence areas. Whether advanced imaging methods, such as second-generation narrow band imaging (2G-NBI) can improve early detection, is unknown.

Design: This open-label, randomised, controlled tandem trial was conducted in 13 hospitals. Patients at increased risk for gastric cancer were randomly assigned to primary white light imaging (WLI) followed by secondary 2G-NBI (WLI group: n=2258) and primary 2G-NBI followed by secondary WLI (2G-NBI group: n=2265) performed by the same examiner. Suspected early gastric cancer (EGC) lesions in both groups were biopsied. Primary endpoint was the rate of EGC patients in the primary examination. The main secondary endpoint was the positive predictive value (PPV) for EGC in suspicious lesions detected (primary examination).

Results: EGCs were found in 44 (1.9%) and 53 (2.3%; p=0.412) patients in the WLI and 2G-NBI groups, respectively, during primary EGD. In a post hoc analysis, the overall rate of lesions detected at the second examination was 25% (n=36/145), with no significant differences between groups. PPV for EGC in suspicious lesions was 13.5% and 20.9% in the WLI (50/371 target lesions) and 2G-NBI groups (59/282 target lesions), respectively (p=0.015).

Conclusion: The overall sensitivity of primary endoscopy for the detection of EGC in high-risk patients was only 75% and should be improved. 2G-NBI did not increase EGC detection rate over conventional WLI. The impact of a slightly better PPV of 2G-NBI has to be evaluated further.

Trial Registration Number: UMIN000014503.
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http://dx.doi.org/10.1136/gutjnl-2019-319631DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7788198PMC
January 2021

Image-Enhanced Endoscopy and Its Corresponding Histopathology in the Stomach.

Gut Liver 2021 05;15(3):329-337

Department of Endoscopy, Fukuoka University Chikushi Hospital, Chikushino, Japan.

In recent years, the technological innovation and progress of endoscopic equipment have been remarkable, and various endoscopic observation techniques have been developed. Among them, representative techniques are magnified observation and narrow-band imaging. Magnifying endoscopy with narrow-band imaging (M-NBI) can visualize superficial microanatomies in the stomach. The normal morphology of the microanatomy visualized using M-NBI differs according to the part of the stomach. The vessel plus surface (VS) classification system has been developed as a diagnostic criterion for early gastric cancer using M-NBI, and its usefulness has been proven. Based on the VS classification system, a magnifying endoscopy simple diagnostic algorithm for early gastric cancer (MESDA-G), a simplified algorithm used for early gastric cancer diagnosis, was created. We aimed to describe the anatomic structure of the stomach that can be viewed using M-NBI and outline the principles and clinical application of the VS classification system and MESDA-G.
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http://dx.doi.org/10.5009/gnl19392DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129655PMC
May 2021

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

BMJ Open 2020 02 26;10(2):e033604. Epub 2020 Feb 26.

Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.

Introduction: Recently, the use of various endoscopic procedures under X-ray fluoroscopic guidance, such as endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasonography (EUS), enteral endoscopy and stenting, has been rapidly increasing because of the minimally invasive nature of these procedures compared with that of surgical intervention. With the spread of CT and fluoroscopic interventions, including endoscopic procedures under X-ray guidance, high levels of radiation exposure (RE) from medical imaging have led to major concerns throughout society. However, information about RE related to these image-guided procedures in gastrointestinal endoscopy is scarce, and the RE reference levels have not been established. The aim of this study is to prospectively collect the actual RE dose and to help establish diagnostic reference levels (DRLs) in the field of gastroenterology in Japan.

Methods And Analysis: This is a multicentre, prospective observational study that is being conducted to collect the actual RE from treatments and diagnostic procedures, including ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement. We will measure the total fluoroscopy time (min), the total dose-area product (Gycm) and air-kerma (mGy) of those procedures. Because we are collecting the actual RE data and identifying the influential factors through a prospective, nationwide design, this study will provide guidance regarding the DRLs of ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement.

Ethics And Dissemination: Approval was obtained from the Institutional Review Board of Toyonaka Municipal Hospital (25 April 2019). The need for informed consent will be waived via the method of each hospital website.

Trial Registration Number: The UMIN Clinical Trials Registry, UMIN000036525.
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http://dx.doi.org/10.1136/bmjopen-2019-033604DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202697PMC
February 2020

Optimal number of endoscopic biopsies for diagnosis of early gastric cancer.

Endosc Int Open 2019 Dec 2;7(12):E1683-E1690. Epub 2019 Dec 2.

Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.

No recommendations are available for optimal number of endoscopic biopsies for early gastric cancer (GC), and whether detection of early GC is improved by increasing the number of biopsy is unclear. We therefore evaluated the relationship between number of biopsies and diagnostic accuracy. We retrospectively evaluated 858 early GCs (623 from endoscopic submucosal dissection and 235 surgical specimens), which we classified as obtained after one, two, or three or more biopsies. We assessed diagnostic accuracy by number of biopsies, and in subgroups by tumor diameter, gross type, and surface color. Almost half the lesions were obtained after one biopsy each, 30 % after two biopsies, and 20 % after three or more biopsies. Although diagnostic accuracy increased with biopsy number, it was significantly greater for the two-biopsy group than the one-biopsy group, (92.5 % vs. 83.9 %,  = 0.0009), but did not significantly differ between the two- and three or more-biopsy groups. This finding was seen when tumors were evaluated by size, but not by elevated type and surface color, for which more biopsies did not improve diagnostic accuracy. Multivariate analysis demonstrated that two or more biopsies was the independent significant factors for diagnostic accuracy. Two biopsies are the optimal number required to diagnose early GC.
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http://dx.doi.org/10.1055/a-1007-1730DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887641PMC
December 2019

Efficacy and Safety of Early vs Elective Colonoscopy for Acute Lower Gastrointestinal Bleeding.

Gastroenterology 2020 01 26;158(1):168-175.e6. Epub 2019 Sep 26.

Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.

Background & Aims: We performed a large, multicenter, randomized controlled trial to determine the efficacy and safety of early colonoscopy on outcomes of patients with acute lower gastrointestinal bleeding (ALGIB).

Methods: We performed an open-label study at 15 hospitals in Japan of 170 patients with ALGIB randomly assigned (1:1) to groups that underwent early colonoscopy (within 24 hours of initial visit to the hospital) or elective colonoscopy (24-96 hours after hospital admission). The primary outcome was identification of stigmata of recent hemorrhage (SRH). Secondary outcomes were rebleeding within 30 days, endoscopic treatment success, need for transfusion, length of stay, thrombotic events within 30 days, death within 30 days, and adverse events.

Results: SRH were identified in 17 of 79 patients (21.5%) in the early colonoscopy group vs 17 of 80 patients (21.3%) in the elective colonoscopy group (difference, 0.3; 95% confidence interval, -12.5 to 13.0; P = .967). Rebleeding within 30 days of hospital admission occurred in 15.3% of patients in the early colonoscopy group and 6.7% of patients in the elective colonoscopy group (difference, 8.6; 95% confidence interval, -1.4 to 18.7); there were no significant differences between groups in successful endoscopic treatment rate, transfusion rate, length of stay, thrombotic events, or death within 30 days. The adverse event of hemorrhagic shock occurred during bowel preparation in no patient in the early group vs 2 patients (2.5%) in the elective colonoscopy group.

Conclusions: In a randomized controlled study, we found that colonoscopy within 24 hours after hospital admission did not increase SRH or reduce rebleeding compared with colonoscopy at 24-96 hours in patients with ALGIB. ClinicalTrials.gov, Numbers: UMIN000021129 and NCT03098173.
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http://dx.doi.org/10.1053/j.gastro.2019.09.010DOI Listing
January 2020

Factors associated with technical difficulty of endoscopic submucosal dissection for early gastric cancer that met the expanded indication criteria: post hoc analysis of a multi-institutional prospective confirmatory trial (JCOG0607).

Gastric Cancer 2020 01 18;23(1):168-174. Epub 2019 Jul 18.

Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Background: There are few reports on the technical difficulty of gastric endoscopic submucosal dissection (ESD). The aim of this study was to investigate the factors associated with the technical difficulty of ESD for early gastric cancer (EGC) using the data from the multicenter non-randomized confirmatory trial of expanded indication criteria of ESD (JCOG0607).

Methods: The major inclusion criteria were as follows: (1) histologically proven intestinal-type adenocarcinoma; (2) cT1aN0M0; (3) lesion without finding of ulcer (UL-negative) with > 2 cm in size, or UL-positive with ≤ 3 cm; (4) age 20-75 years. The difficult case was defined as ESD taking ≥ 120 min, piecemeal resection, and/or developing perforation during procedure.

Results: Between June 2007 and October 2010, 470 patients were enrolled from 29 institutions. Median procedure time was 79 (range 14-462) min, and it was ≥ 120 min in 127 patients. Twelve patients developed perforation during ESD, and the procedure time was ≥ 120 min in 9 of them. Therefore, 130 patients (27.7%) were identified as difficult cases. Multivariable analysis showed that UL-negative with > 5 cm (vs. UL-negative with ≤ 3 cm, odds ratio, 24.993; 95% CI 6.130-101.897, p < 0.0001) had the largest odds ratio and followed by UL-negative with 3-5 cm upper or middle portion of stomach and age ≤ 60 years were significantly associated with difficulty.

Conclusions: UL-negative lesion with > 3 cm, upper or middle portion of stomach and age ≤ 60 years were independent factors associated with technical difficulty of ESD for EGC. Trial registered number was UMIN000000737.
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http://dx.doi.org/10.1007/s10120-019-00991-3DOI Listing
January 2020

Self-study of the non-extension sign in an e-learning program improves diagnostic accuracy of invasion depth of early gastric cancer.

Endosc Int Open 2019 Jul 3;7(7):E871-E882. Epub 2019 Jul 3.

Department of Endoscopy, Mie University Hospital, Tsu, Japan.

 We developed an e-learning program for endoscopic diagnosis of invasion depth of early gastric cancer (EGC) using a simple diagnostic criterion called non-extension sign, and the contribution of self-study quizzes to improvement of diagnostic accuracy was evaluated.  We conducted a prospective randomized controlled study that recruited endoscopists throughout Japan. After completing a pretest, the participants watched video lectures and undertook post-test 1. The participants were then randomly allocated to either the self-study or non-self-study group, and participants in the first group completed the self-study program that comprised 100-case quizzes. Finally, participants in both groups undertook post-test 2. The primary endpoint was the difference in post-test 2 scores between the groups. The perfect score for the tests was set as 100 points.  A total of 423 endoscopists completed the pretest and were enrolled. Post-test 1 was completed by 415 endoscopists and 208 were allocated to the self-study group and 207 to the non-self-study group. Two hundred and four in the self-study group and 205 in the non-self-study group were included in the analysis. Video lectures improved the mean score of post-test 1 from 72 to 77 points. Participants who completed the self-study quizzes showed significantly better post-test 2 scores compared with the non-self-study group (80 76 points, respectively,  < 0.0001).  Our e-learning program showed that self-study quizzes consolidated knowledge of the non-extension sign and improved diagnostic ability of endoscopists for invasion depth of EGC.
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http://dx.doi.org/10.1055/a-0902-4467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611729PMC
July 2019

Association between macrocytosis and metachronous squamous cell carcinoma of the esophagus after endoscopic resection in men with early esophageal squamous cell carcinoma.

Esophagus 2020 04 8;17(2):149-158. Epub 2019 Jul 8.

Department of Clinical Oncology, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.

Background: Macrocytosis is associated with an increased risk of squamous cell carcinoma (SCC) arising in the esophagus in men. The aim of this study was to evaluate the association between macrocytosis and metachronous SCC of the esophagus after endoscopic resection (ER) of early esophageal SCC in men.

Methods: The study group comprised 278 men with early esophageal SCC after ER. The main study variables were as follows: (1) cumulative incidence and total number of metachronous SCC of the esophagus according to the presence or absence of macrocytosis (mean corpuscular volume ≥ 106 fl) and (2) predictors of metachronous SCC of the esophagus as assessed with a multivariate Cox proportional-hazards model.

Results: The median follow-up was 50.3 months. Macrocytosis was associated with a higher 2-year cumulative incidence of metachronous SCC of the esophagus (without macrocytosis vs. with macrocytosis: 11.4% vs. 38.1%, p = 0.002). Macrocytosis was also associated with a higher total number of metachronous SCC of the esophagus per 100 person-years (without macrocytosis vs. with macrocytosis: 7.7 vs. 31.5 per 100 person-years, p < 0.0001). In addition, macrocytosis was a significant predictor of metachronous SCC of the esophagus on multivariate Cox proportional-hazards analysis (relative risk 2.23).

Conclusion: Macrocytosis is a useful predictor of the risk of metachronous SCC of the esophagus after ER of early esophageal SCC in men.
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http://dx.doi.org/10.1007/s10388-019-00685-wDOI Listing
April 2020

Utility of Mesalazine in Familial Adenomatous Polyposis: Clinical Report of Reduction of Polyp Size in Patients with Ulcerative Colitis, and Safety Examination in Familial Adenomatous Polyposis Patients.

Pharmacology 2019 8;104(1-2):51-56. Epub 2019 May 8.

Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Mesalazine is the gold standard drug for treatment of ulcerative colitis (UC). Here, we describe 4 cases of familial adenomatous polyposis (FAP) patients with UC that showed reduction of intestinal polyp diameter by mesalazine treatment. Of note, the effects of mesalazine on the development of intestinal polyps in FAP patients have not been reported, and we further investigated whether the short-term use of high-dose mesalazine (4 g/day) has harmful effects on FAP patients or not. The authors found that the treatment showed slightly adverse events in FAP patients. However, mesalazine tended to reduce the number of colon polyps in male subjects with FAP. This report provides basic information for planning a double-blind, randomized, clinical trial that aims to show mesalazine's potential to suppress intestinal polyp development in FAP.
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http://dx.doi.org/10.1159/000500226DOI Listing
December 2019

Analysis of factors related to poor outcome after e-learning training in endoscopic diagnosis of early gastric cancer using magnifying narrow-band imaging.

Gastrointest Endosc 2019 09 26;90(3):440-447.e1. Epub 2019 Apr 26.

Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.

Background And Aims: An e-learning system teaching endoscopic diagnostic process for early gastric cancer using magnifying endoscopy with narrow-band imaging (M-NBI) was established, and its efficacy in improving the diagnostic performance for early gastric cancer was proven in a multicenter randomized controlled trial. The aim of this study was to clarify the difference in learning effect in each lesion characteristic.

Methods: Three hundred sixty-five participants diagnosed 40 gastric lesions based on M-NBI findings using the vessel-plus-surface classification system. The diagnosis data collected from each participant were assessed in this study. The accuracy of NBI cancer diagnosis was assessed using area under the receiver operating characteristics curve (AUC/ROC) analysis. AUC/ROCs were separately calculated in each lesion characteristic (shape and size), and the data were compared between tests 1 and 3.

Results: Continuous net reclassification improvement (cNRI) analysis of all lesions revealed significant improvement in reclassification when participants underwent e-learning (cNRI, 1.17; P < .01). The integrated discrimination improvement analysis demonstrated that the e-learning system improved diagnostic ability (.19; P < .01). According to the analysis depending on the lesion's characteristics, high AUC/ROCs were demonstrated in depressed and small lesions (<10 mm; .90 and .93, respectively). The cNRI analysis showed remarkable e-learning improvement in both depressed (cNRI, 1.33; P < .01) and small lesions (cNRI, 1.46; P < .01). However, no significant e-learning improvement was observed in elevated or flat lesions.

Conclusions: In M-NBI education for endoscopists, a good learning outcome was obtained in depressed and small lesions, but a poor learning outcome was demonstrated in elevated and flat lesions. (Clinical trial registration number: UMIN000008569.).
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http://dx.doi.org/10.1016/j.gie.2019.04.230DOI Listing
September 2019

Efficacy of Endoscopic Resection and Selective Chemoradiotherapy for Stage I Esophageal Squamous Cell Carcinoma.

Gastroenterology 2019 08 20;157(2):382-390.e3. Epub 2019 Apr 20.

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

Background & Aims: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER).

Methods: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed.

Results: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%).

Conclusions: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.
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http://dx.doi.org/10.1053/j.gastro.2019.04.017DOI Listing
August 2019
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