Association Between Early Stage Colon Neoplasms and False-negative Results From the Fecal Immunochemical Test

BACKGROUND & AIMS: The fecal immunochemical test (FIT) can identify patients with advanced colorectal neoplasms, but it also has a high rate of false-negative results. It would be helpful to characterize colorectal neoplasms that are not detected by FIT to aid in development of new tests. We characterized colorectal neoplasms from patients who had negative results from the FIT. METHODS: We analyzed data from 18,296 subjects who were screened for colorectal cancer by colonoscopy and the FIT at the Health Management Center of National Taiwan University Hospital from September 2005 through September 2010. We identified 4045 subjects with colorectal neoplasms (3385 with nonadvanced adenomas, 632 with advanced adenomas, and 28 with cancer). We analyzed the sensitivity of the FIT in identifying these patients, along with information on lesion size, location, and morphology. RESULTS: The FIT identified patients with nonadvanced adenomas, advanced adenomas, and cancer with sensitivity values of 10.6% (95% confidence interval [CI], 10.2%-12.3%), 28.0% (95% CI, 24.6%-31.7%), and 78.6% (95% CI, 58.5%-91.0%), respectively. The FIT detected proximal advanced adenomas and nonpolypoid lesions with lower levels of sensitivity than distal advanced adenomas; it had a high false-negative rate in detection of adenomas <15 mm (adjusted odds ratio, 2.85; 95% CI, 1.79-4.54) and nonpolypoid adenomas (adjusted odds ratio, 2.15; 95% CI, 1.22-3.80), after adjusting for demographic characteristics, colonoscopy findings, and potential confounders. The FIT produced a higher percentage of false-negative results in detection of carcinoma in situ and T1 cancer than in T2-T4 cancers (66.7% sensitivity vs 100%; P = .049). CONCLUSIONS: The FIT produces a high rate of false-negative results for patients with small or nonpolypoid adenomas. Early-stage cancers are associated with a high rate of false-negative results from the FIT

A Novel Endoscopic Classification on Gastro-esophageal Junctional Morphology — An Agreement Study

研究背景：現行內視鏡診斷胃食道逆流症的標準主要根據黏膜裂(mucosal break)，但診斷結果難與症狀吻合，且不易偵測所有的胃酸逆流，因此我們希望以更優良的判讀標準提升傳統內視鏡的診斷能力。Haruma在2007年依經驗提出胃食道交界處型態在內視鏡下可分為五類，並認為其中某類可能較容易導致胃食道逆流症。在計畫以臨床試驗證實這個分類與胃食道逆流症的相關之前，必須先確立分類，並設計一致性研究來驗證其可靠性。本研究目的為根據Haruma的經驗定義一個胃食道交界處之內視鏡分類法，並去除其中可能不適當的類型而成為簡化的分類法，再從中挑選最可靠的分類法。究方法：先行定義一個「原始5類別胃食道交界處分類法」，再收集250張健康檢查胃鏡的胃食道交界處標準照片，供7位內視鏡醫師依該分類法逐一判讀。依結果計算類別盛行率、評量者內在一致性、及評量者間一致性。再利用類別合併的方式簡化分類法，針對所有簡化方式重新計算其一致性，並與合併前、或其他合併方式之一致性作比較，據以從中挑選一致性最好的分類法。果：評量者內在一致性為kappa統計值0.5為0.79。「原始胃食道交界處分類法」之評量者間一致性指標為平均原始一致性(average raw agreement) 63.4%，平均kappa統計值(mean kappa) 0.42，整體加權kappa統計值(overall weighted kappa) 0.42。與其他共25個各種類別合併而簡化的分類法相較，製作26個分類法的一致性排名。先去除12個臨床上不可行的簡化分類法，再依照排名挑選。最終選擇兩種簡化分類法，一為2類別而另一為4類別，其平均kappa統計值/整體加權kappa統計值分別為0.57/0.55及0.52/0.51。論：本研究依照評量者間一致性的客觀標準，配合臨床可行性的判斷，而製定了兩個可靠的胃食道交界處之內視鏡分類法，並將以此進行分類與胃食道逆流症相關性的研究。Background: Current endoscopic diagnostic criteria for gastro-esophageal reflux disease (GERD) depends on identification of mucosal breaks. However, the diagnosis badly correlates with symptoms and acid reflux. Therefore a refined diagnostic criteria is desirable. Based on personal experience, Haruma et al. proposed that human gastro-esophageal junctional (GEJ) morphology under endoscopy typically varied into 5 categories, and that certain category might be associated with GERD. Prior to prove this association, we plan to define a novel classification of GEJ morphology based on Haruma’s experience. And through category-manipulation and reliability test, we aim to propose a best classification suitable for further studies.ethod: We defined an original 5-category GEJ morphological classification. Two hundreds and fifty standardized endoscopic pictures on GEJ from subjects underwent health check were collected, and subjected to ratings by 7 endoscopists. Categorical prevalence, intra-rater agreement, and inter-rater agreement were calculated. By post-hoc category combination procedures, we repeated the calculations for all 25 possible modified classifications, and compared the result to the original one and each other. The comparison formed the basis for selection.esult: Intra-rater agreements were kappa between 0.5 and 0.79. Inter-rater agreement of the original classification was presented by average raw agreement of 63.4%, mean kappa of 0.42, and overall weighted kappa of 0.42. Added by 25 modified classifications, a ranking of agreements was made for the total 26. Twelve of them were discarded because they were, by definition, not clinically applicable. Finally 2 classifications were selected, 2-category and the other 4-category. The mean kappa/overall weighted kappa was 0.57/0.55, 0.52/0.51, respectively.onclusion: Based on inter-rater agreement and clinical applicability, our study has defined two reliable endoscopic classifications on GEJ. Both classifications are candidates for further association study with GERD.中文摘要………………………………………………………………ii 文摘要………………………………………………………………iii一章 研究背景……………………………………………………1一節 新的內視鏡分類法……………………………………… 1二節 研究目的……………………………………………….....6二節 可靠性的評估…………………………….……..……..…6二章 研究方法………………………………………………………9一節 研究材料………………………………..…….…….……9二節 一致性的計算…………………………………..…….….12三章 結果…………………………………………………………17一節 類別盛行率…………………………….……………….17二節 評量者內的一致性……………………………….…….17三節 評量者間的一致性……………………………….…….18四節 各種可能分類法間一致性的比較…………………………20五節 最可靠分類法的選擇………………………………………23四章 討論…………………………………………………………31考文獻………………………………………………………………3

Association of Diabetes and HbA(1c) Levels With Gastrointestinal Manifestations

OBJECTIVE-To determine the prevalence of gastrointestinal (GI) manifestations associated with diabetes mellitus (DM) in a Taiwanese population undergoing bidirectional endoscopies. RESEARCH DESIGN AND METHODS-Subjects voluntarily undergoing upper endoscopy/colonoscopy as part of a medical examination at the National Taiwan University Hospital were recruited during 2009. Diagnosis of DM included past history of DM, fasting plasma glucose >= 126 mg/dL, or glycated hemoglobin (HbA(1c)) >= 6.5%. Comparisons were made between diabetic and nondiabetic subjects, subjects with lower and higher HbA(1c) levels, and diabetic subjects with and without complications, respectively, for their GI symptoms, noninvasive GI testing results, and endoscopic findings. RESULTS-Among 7,770 study subjects, 722 (9.3%) were diagnosed with DM. The overall prevalence of GI symptoms was lower in DM subjects (30.3 vs. 35.4%, P = 0.006). In contrast, the prevalence of erosive esophagitis (34.3 vs. 28.6%, P = 0.002), Barrett's esophagus (0.6 vs. 0.1%, P = 0.001), peptic ulcer disease (14,3 vs. 8.5%, P < 0.001), gastric neoplasms (1.8 vs. 0.7%, P = 0.003), and colonic neoplasms (26.6 vs. 16.5%, P < 0.001) was higher in diabetic subjects. Diagnostic accuracy of immunochemical fecal occult blood test for colonic neoplasms was significantly decreased in DM (70.7 vs. 81.7%, P < 0.001). Higher HbA(1c) levels were associated with a decrease of GI symptoms and an increase of endoscopic abnormalities. Diabetic subjects with complications had a higher prevalence of colonic neoplasms (39.2 vs. 24.5%, P = 0.002) than those without. CONCLUSIONS-DM and higher levels of HbA(1c) were associated with lower prevalence of GI symptoms but higher prevalence of endoscopic abnormalities