Purpose: The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system. Materials and Methods: A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared. Results: In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM. Conclusions Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.

Purpose: The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system. Materials and Methods: A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared. Results: In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM. Conclusions Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.

Purpose: The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system. Materials and Methods: A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared. Results: In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM. Conclusions Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.

Background: The Clauss assay is widely used to quantify blood fibrinogen levels in clinical laboratories. However, by relying on thrombin as the main reagent, the Clauss assay is susceptible to interference from thrombin inhibitors, such as heparin or direct thrombin inhibitors. Here, we developed an innovative fibrinogen assay utilizing both recombinant batroxobin (rBat) and carboxymethyl chitosan (CMCS). Methods: Various biopolymers were tested to identify a suitable candidate that could enhance rBat-induced fibrin clot formation. Chromogenic substrate hydrolysis and sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis showed that CMCS potentiated rBat activity. Consequently, we formulated a novel fibrinogen assay reagent, ANYFIB.C, comprising rBat and CMCS. We compared ANYFIB.C fibrinogen with an established reagent (HemosIL fibrinogen-C) with 96 clinical samples using an ACL-TOP 700 coagulation analyzer. We also evaluated the interfering effects of thrombin inhibitors on fibrinogen measurements. Results: CMCS significantly enhanced the enzymatic activity of rBat and dose-dependently reduced plasma clotting times. ANYFIB.C fibrinogen levels were comparable with those of HemosIL fibrinogen-C, with the 95% confidence intervals of the Passing–Bablok regres-sion intercept and slope being −7.4797 to 6.0185 and 0.9581 to 1.0116, respectively. Nosignificant interference was observed with heparin concentrations up to 10 U/mL or dabigatran concentrations up to 600 µg/L in the ANYFIB.C fibrinogen assays. In contrast, the HemosIL fibrinogen-C reagent demonstrated inhibitory interference at dabigatran concentrations as low as 150 µg/L. Conclusions Our results suggest that ANYFIB.C (a mixture of CMCS and rBat) can be used to measure blood fibrinogen levels effectively and protect from thrombin inhibitor interference.

Background/Aims: Gastrointestinal (GI) manifestations are common in patients with diabetes complications, such as autonomic neuropathy. However, the prevalence of GI symptoms before the development of diabetes complications is unclear. Methods: We conducted an interview survey of functional GI disorders among patients with diabetes visiting the endocrinology clinic of a general hospital using the Rome III criteria. The survey consisted of questions regarding functional dyspepsia, irritable bowel syndrome, and functional constipation, including functional defecation disorder. Results: In total, 509 patients were included in the analysis. The patients were divided into three groups: prediabetes (n = 115), diabetes without neuropathy (n = 275), and diabetes with neuropathy (n = 119). With regard to GI symptoms, the prevalences of functional dyspepsia in the prediabetes, diabetes without neuropathy, and diabetes with neuropathy groups were 16.52%, 27.27%, and 23.53%, respectively; those of irritable bowel syndrome were 8.70%, 11.68%, and 16.81%, respectively, and those of functional constipation were 8.85%, 11.85%, and 15.25%, respectively. In the subgroup analysis, symptoms of postprandial distress syndrome (e.g., postprandial fullness and early satiety) were more prevalent than symptoms of epigastric pain. In the constipation group, symptoms of pelvic outlet obstruction (such as the sensation of anorectal obstruction or blockage and the need for manual maneuvers to facilitate defecation) were more prevalent than symptoms of slow-transit constipation. Conclusions The prevalence of functional GI disorders increases with diabetes severity. Diabetes-related GI symptoms appear long before the onset of diabetes complications.

Background/Aims: Gastrointestinal (GI) manifestations are common in patients with diabetes complications, such as autonomic neuropathy. However, the prevalence of GI symptoms before the development of diabetes complications is unclear. Methods: We conducted an interview survey of functional GI disorders among patients with diabetes visiting the endocrinology clinic of a general hospital using the Rome III criteria. The survey consisted of questions regarding functional dyspepsia, irritable bowel syndrome, and functional constipation, including functional defecation disorder. Results: In total, 509 patients were included in the analysis. The patients were divided into three groups: prediabetes (n = 115), diabetes without neuropathy (n = 275), and diabetes with neuropathy (n = 119). With regard to GI symptoms, the prevalences of functional dyspepsia in the prediabetes, diabetes without neuropathy, and diabetes with neuropathy groups were 16.52%, 27.27%, and 23.53%, respectively; those of irritable bowel syndrome were 8.70%, 11.68%, and 16.81%, respectively, and those of functional constipation were 8.85%, 11.85%, and 15.25%, respectively. In the subgroup analysis, symptoms of postprandial distress syndrome (e.g., postprandial fullness and early satiety) were more prevalent than symptoms of epigastric pain. In the constipation group, symptoms of pelvic outlet obstruction (such as the sensation of anorectal obstruction or blockage and the need for manual maneuvers to facilitate defecation) were more prevalent than symptoms of slow-transit constipation. Conclusions The prevalence of functional GI disorders increases with diabetes severity. Diabetes-related GI symptoms appear long before the onset of diabetes complications.

Background/Aims: Gastrointestinal (GI) manifestations are common in patients with diabetes complications, such as autonomic neuropathy. However, the prevalence of GI symptoms before the development of diabetes complications is unclear. Methods: We conducted an interview survey of functional GI disorders among patients with diabetes visiting the endocrinology clinic of a general hospital using the Rome III criteria. The survey consisted of questions regarding functional dyspepsia, irritable bowel syndrome, and functional constipation, including functional defecation disorder. Results: In total, 509 patients were included in the analysis. The patients were divided into three groups: prediabetes (n = 115), diabetes without neuropathy (n = 275), and diabetes with neuropathy (n = 119). With regard to GI symptoms, the prevalences of functional dyspepsia in the prediabetes, diabetes without neuropathy, and diabetes with neuropathy groups were 16.52%, 27.27%, and 23.53%, respectively; those of irritable bowel syndrome were 8.70%, 11.68%, and 16.81%, respectively, and those of functional constipation were 8.85%, 11.85%, and 15.25%, respectively. In the subgroup analysis, symptoms of postprandial distress syndrome (e.g., postprandial fullness and early satiety) were more prevalent than symptoms of epigastric pain. In the constipation group, symptoms of pelvic outlet obstruction (such as the sensation of anorectal obstruction or blockage and the need for manual maneuvers to facilitate defecation) were more prevalent than symptoms of slow-transit constipation. Conclusions The prevalence of functional GI disorders increases with diabetes severity. Diabetes-related GI symptoms appear long before the onset of diabetes complications.