Development of an external-to-internal convertible endoscopic biliary drainage device - a preliminary prospective feasibility study.

BACKGROUND AND STUDY AIMS: Endoscopic nasobiliary drainage (ENBD) for a malignant stricture in the bile duct has some advantages over endoscopic biliary stenting (EBS). However, ENBD may cause nasopharyngeal discomfort. We developed an external-to-internal convertible endoscopic biliary drainage (ETI-EBD) device that enables both internal and external drainage to occur during a single endoscopy. PATIENTS AND METHODS: This device consists of three parts, comprising a 5-Fr ENBD tube (250 cm) (ENBD-t), an 8.5-Fr EBS tube (7 cm) (EBS-t), and an 8-Fr pusher tube for EBS (230 cm) (P-t). The EBS-t is mounted over the ENBD-t at the distal end of the ENBD-t. The P-t is also placed over the ENBD-t. After an endoscopic sphincterotomy, the EBS-t of the device is inserted into the papilla, then the duodenal endoscope is withdrawn, leaving the device in place. After ENBD, only the ENBD-t was withdrawn from the P-t. At this point, the EBS-t was isolated and left without endoscopy or radiography. RESULTS: ETI-EBD was successfully placed in all consecutive 21 patients (100 %). The release of EBS-t from ENBD-t wit was successfully completed in 19 patients (90.5 %). There were 4 patients with kink of P-t when exchanging this device from the mouth to the nose. It was difficult for 2 patients to withdraw the ENBD-t because of poor lubrication performance. There were no significant complications associated with the use of the device. CONCLUSION: This device allows for both external and internal biliary drainage with a single endoscopy.

Investigating the Relationship between Morning Glycemic Variability and Patient Characteristics Using Continuous Glucose Monitoring Data in Patients with Type 2 Diabetes.

Objective To investigate the relationship between patient characteristics and morning glycemic variability. Methods We retrospectively evaluated 106 patients with type 2 diabetes who underwent continuous glucose monitoring during admission. The highest postprandial glucose level (within 3 hours after breakfast; 'highest level'), the time from the start of breakfast to the highest postprandial glucose level ('highest time'), the difference between the pre-breakfast and highest postprandial breakfast glucose level ('increase'), the area under the curve (AUC; ≥180 mg/dL) for the glycemic variability within 3 hours after breakfast ('morning AUC'), and the post-breakfast glucose gradient ('gradient') were calculated. We analyzed the associations between these factors and nocturnal hypoglycemia and the patients' characteristics by using a regression analysis. Results After stepwise multivariate adjustment, significant independent associations were found between 'highest level' and high age, low BMI, and high HbA1c; 'highest time' and high HbA1c, low C-peptide immunoreactivity (CPR), and low fasting plasma glucose (FPG); the 'increase' and high age, low BMI, high HbA1c, low FPG and hypoglycemia; 'morning AUC' and high age, high HbA1c and hypoglycemia; and 'gradient' and long duration of diabetes and low BMI. Conclusion Higher age and lower BMI are associated with higher 'highest' and 'increase' levels. Higher HbA1c levels were linked to a longer 'highest time', and longer durations of the diabetes, while lower BMI values were related to a higher 'gradient'.

Major Increases between Pre- and Post-breakfast Glucose Levels May Predict Nocturnal Hypoglycemia in Type 2 Diabetes.

Objective The aim of this study was to determine whether nocturnal hypoglycemia may be predicted according to morning glucose levels. Methods We retrospectively evaluated 106 patients with type 2 diabetes who underwent continuous glucose monitoring during admission. The pre-breakfast glucose level (Pre-breakfast level), highest postprandial glucose level within 3 hours after breakfast (Highest level), time from the start of breakfast to the highest postprandial glucose level (Highest time), difference between the pre-breakfast and highest postprandial breakfast glucose levels (Increase), area under the glucose curve (≥180 mg/dL) within 3 hours after breakfast (Morning AUC), post-breakfast glucose gradient (Gradient), and the increase-to-pre-breakfast ratio (Increase/Pre-breakfast) were calculated. The subjects were divided into hypoglycemic and non-hypoglycemic patients and compared for the above parameters using the t-test. A receiver operating characteristic analysis was used to determine the optimal cut-off values to predict nocturnal hypoglycemia (Hypoglycemia). Results Twenty-eight patients (26.4%) had hypoglycemia. The Pre-breakfast levels were significantly lower in patients with hypoglycemia than those without (p=0.03). The Increases were significantly higher in patients with hypoglycemia than those without (p=0.047). The Increase/Pre-breakfast ratio were significantly larger in patients with hypoglycemia than those without (p=0.0002). Their cut-off values were as follows (level, sensitivity, specificity, and area under the curve): 123 mg/dL, 0.89, 0.55, and 0.78 (p<0.0001); 90.5 mg/dL, 0.75, 0.64, and 0.76 (p<0.0001); and 90.2%, 0.75, 0.76, and 0.78 (p<0.0001), respectively. Conclusion Major increases between the pre- and post-breakfast glucose levels may predict nocturnal hypoglycemia in patients with type 2 diabetes.

Evaluation of safety of insulin degludec on undergoing total colonoscopy using continuous glucose monitoring.

AIMS/INTRODUCTION: There is little information regarding how to use insulin degludec (D) when diabetic patients are preparing for total colonoscopy (TCS). MATERIALS AND METHODS: A total of 12 patients with type 2 diabetes treated with insulin D and scheduled to undergo TCS were enrolled in the present study. A continuous glucose monitoring device was attached to each patient for 4 days, from two evenings before TCS to the morning after the procedure. The patients fasted for 24 h, starting after 18.00 h the day before TCS. Insulin D was only discontinued the morning of the day TCS was carried out. RESULTS: No patients experienced hypoglycemia during the daytime fasting period (08.00-18.00 h the day of TCS); the hypoglycemic index, mean glucose level, and standard deviation were 0, 141.3 ± 31.5 mg/dL and 15.6 ± 6.5 mg/dL. The mean glucose level and standard deviation during the daytime fasting period were significantly lower than during the daytime control period (08.00-18.00 h the day before TCS; P = 0.003, P = 0.001, respectively). The mean fasting glucose and fasting plasma glucose levels were significantly correlated (r = 0.78, P = 0.002), as were both the mean glucose level and standard deviation during the daytime control period, and the change in the mean glucose level (fasting period minus control period; r = -0.79, P = 0.002, and r = -0.69, P = 0.01, respectively). CONCLUSIONS: Patients can safely undergo TCS when insulin D is discontinued only once on the day of the procedure.

Hypoglycemia and glycemic variability are associated with mortality in non-intensive care unit hospitalized infectious disease patients with diabetes mellitus.

AIMS/INTRODUCTION: We aimed to identify factors - glycemic control, reactive inflammatory biomarkers or vital signs - associated with mortality in diabetic patients admitted to hospital for various infections (non-intensive care unit). MATERIALS AND METHODS: We retrospectively analyzed the cases of 620 diabetic patients admitted to hospital for various infections (non-intensive care unit) who underwent glucose monitoring >3 times per day. We extracted data regarding reactive inflammatory biomarkers and vital signs recorded on day 1 of hospital stay, and data on bacteremia and hypoglycemia status, glycemic variability (GV; coefficient of variation and standard deviation) and mean glucose concentrations during the entire hospital stay. Univariate and stepwise multivariate logistic regression analyses were carried out to determine the association between these factors and mortality. RESULTS: The mortality rate was 10.1%. Reactive inflammatory biomarkers, vital signs and bacteremia were not associated with mortality. According to the results of the adjusted analysis, hypoglycemia showed a significant positive association with mortality, increasing death risk by 266% (odds ratio [OR] 2.66, 95% confidence interval [95% CI] 1.22-5.83; P = 0.0006). High coefficient of variation and standard deviation values were significantly associated with increased mortality, increasing death risk by 18% (OR 1.18, 95% CI 1.01-1.38; P = 0.03) and 9% (OR 1.09, 95% CI 1.01-1.18; P = 0.03), respectively. Mean glucose concentrations were also significantly associated with mortality, increasing death risk by 5% (OR 1.05, 95% CI 1.02-1.08; P = 0.0008). CONCLUSIONS: Glycemic indices (especially hypoglycemia and GV), rather than reactive inflammatory biomarkers or vital signs, were associated with mortality in non-intensive care unit diabetes mellitus patients with infections.

l-Menthol sprayed on gastric mucosa causes edematous change.

BACKGROUND AND STUDY AIMS: l-Menthol (LM), sprayed on the distal gastric mucosa, is a safe antispasmodic agent used during esophagogastroduodenoscopy (EGD). However, it seems to affect gastric mucosal endoscopic findings. Therefore, we evaluated whether LM causes specific changes and impacts the endoscopic morphology of gastric lesions. PATIENTS AND METHODS: A total of 98 patients scheduled to undergo EGD were randomly assigned to receive LM solution (160 mg of 0.8 % LM added to 2.5 mL of indigo carmine [IC]; n = 49; LM group) or decuple-diluted IC solution without LM (n = 49; placebo group). We compared the incidence of specific mucosal changes and the difference in the endoscopic findings of several gastric lesions between these groups. RESULTS: Annular-reticular - like mucosal changes appeared immediately after the administration of LM solution. This change was observed in 71.4 % of the LM group compared with 12.2 % of the placebo group (P < 0.01). In the placebo group, this change was observed in 14.7 % of subjects with atrophic gastritis compared with 6.7 % of those without atrophic gastritis (P = 0.39), whereas in the LM group, this change was observed in 84.8 % of subjects with atrophic gastritis compared with 43.8 % of those without atrophic gastritis (P < 0.01). Most early gastric cancers, erosions, and ulcers observed in this study became well demarcated after LM administration, although the incidence of gastric lesions did not differ significantly between the two groups. CONCLUSION: LM changes the gastric mucosa into edematous mucosa, and this occurs more frequently in atrophic gastric mucosa than in pathologic lesions. LM may facilitate the demarcation of pathologic gastric lesions without intestinal metaplasia.