Evaluation of Intensive Adjuvant Chemotherapy in Gastric Cancer Using Life Expectancy Compared with Log-Rank Test as a Measure of Survival Benefit

BACKGROUND: The goal of radical cancer surgery with or without adjuvant therapy is to cure disease rather than to delay death. There is concern that the survival benefit of curative treatment may not be properly appreciated by the log-rank test (LRT), which is more sensitive to treatment that delays death than to treatment that achieves cure. To confirm this concern and to evaluate the survival benefit of adjuvant chemotherapy, the data from a previous randomized controlled trial are analyzed using both traditional and new methods. METHODS: In this trial, 1410 gastric cancer patients with serosal or subserosal invasion had been classified by nodal and serosal status into four strata and randomized to receive high-dose or low-dose adjuvant regimens (mitomycin and tegafur-uracil) after gastrectomy. The two treatment groups were compared using the LRT as well as the life expectancy (LE) derived from the Boag model and the competing risk model. RESULTS: The LRT showed no significant difference between the two groups, whereas the LE increased significantly with high-dose chemotherapy (1.4-year gain; 95% CI = 0.1-2.8). A greater gain of 4.4 years occurred exclusively in the serosa-negative node-positive stratum, associated with a 21% increase in cure rate. The gain in LE was particularly greater in younger patients. CONCLUSIONS: Parametric LE analysis offers more relevant information about curative treatment than LRT. It suggests that high-dose chemotherapy may achieve cure in a subset of patients, eradicating residual malignancies left behind after gastrectomy and providing greater survival benefit than expected from LRT.     

Endosonographic diagnosis of intraductal papillary‐mucinous pancreatic tumors by intraductal ultrasonography

Background: Intraductal papillary‐mucinous pancreatic tumors (IPMT) are intraductal lesions formed by mucin‐producing epithelium, which proliferates in a papillary pattern, and presents a spectrum from hyperplasia to adenocarcinoma. The value of intraductal ultrasonography (IDUS) for excluding malignancy has not been assessed in a case series previously. Methods: Intraductal ultrasonography was performed in 17 patients with IPMT (12 with adenocarcinoma and five with adenoma) between November 1993 and June 2002. Intraductal ultrasonography was used to determine the maximum height and maximum cross‐sectional area of protruding lesions. Results were compared after dividing the tumors into three groups: a benign lesion group, a non‐invasive cancer group, and an invasive cancer group. The resection line was located over 10 mm from the edge of the protruding lesion visualized by intraductal ultrasonography. Results: All adenocarcinomas had a height ≥ 5 mm and all benign lesions had a height ≤ 3 mm, with this difference being significant (P = 0.0034). The height of non‐invasive and invasive cancer was similar. The maximum cross‐sectional area of the protrusion was smaller for benign lesions (≤ 15 mm²) than for non‐invasive cancer (≥ 34 mm², P = 0.0034). The cross‐sectional area of the protrusion was greater in patients with invasive cancer than in those with non‐invasive cancer (P = 0.0367). All surgical margins have remained clear and no patient has suffered from a recurrence during 1 to 8 years of follow‐up computed tomography and ultrasonography. Conclusions: Intraductal ultrasonography can distinguish benign from malignant IPMT based on the height and maximum cross‐sectional area of the protruding tumor.     

Ultraminiature encapsulated accelerometers as a fully implantable sensor for implantable hearing aids

Experiments were conducted to evaluate a silicon accelerometer as an implantable sound sensor for implantable hearing aids. The main motivation of this study is to find an alternative sound sensor that is implantable inside the body, yet does not suffer from the signal attenuation from the body. The merit of the accelerometer sensor as a sound sensor will be that it will utilize the natural mechanical conduction in the middle ear as a source of the vibration. With this kind of implantable sound sensor, a totally implantable hearing aid is feasible. A piezoresistive silicon accelerometer that is completely encapsulated with a thin silicon film and long flexible flex-circuit electrical cables were used for this study. The sensor is attached on the middle ear ossicles and measures the vibration transmitted from the tympanic membrane due to the sound in the ear canal. In this study, the sensor is fully characterized on a human cadaveric temporal bone preparation. Earlier portion of the work in this paper was presented at the 13th International Conference on Solid-State Sensors, Actuators and Microsystems (Transducers) 2005, Seoul Korea.     

Coronary risk factors used to predict coronary artery disease by logistic regression analysis.

Risk factor analysis in coronary artery disease was conducted in 303 patients who underwent coronary arteriography to identify associations between personal characteristics and the prevalence of coronary heart disease. Age, sex, obesity, smoking, alcohol intake, hypertension, diabetes mellitus, serum uric acid, total cholesterol, LDL- and HDL-cholesterol, triglyceride, and atherogenic indices were statistically analyzed. All 13 variables were first compared between patients with positive and negative ergonovine tests. Only total cholesterol was significantly different, while significant differences in age, sex, history of diabetes, total cholesterol, LDL- and HDL-cholesterol, triglyceride and atherosclerotic indices were observed between patients with and without organic coronary artery stenosis. A multivariate analysis was performed, and the resulting equation was tested using the remaining patients. Logistic analysis of all 13 variables identified 5 (age, sex, diabetes mellitus, LDL- and HDL-cholesterol) which accounted for the differences between patients with and without significant coronary artery disease and that were validated in the test group. The sensitivity for prediction of coronary artery disease was 75.8%, specificity 68.5%, and predictive accuracy 71.5% in the test group. Thus, risk factor analysis appears to be very valuable in screening subjects with high-risk organic coronary stenosis and in optimizing the preventive and therapeutic modalities, but not in predicting vasospastic subjects.     

Self-expandable metallic stent placement as palliative treatment of obstructed colorectal carcinoma

Background Stent placement in palliation of unresectable colon cancer is an alternative to surgical treatment. The through-the-scope stent for the exclusive treatment of colorectal cancer is not available in Japan. This report describes the use of an esophageal stent and the technical modifications required for its success in the treatment of colorectal strictures. We describe various technical strategies for colorectal stent placement and report on the outcomes.Methods Medical records of patients who underwent palliative colonic stenting between June 1997 and March 2003 were reviewed retrospectively, and the clinical outcome was evaluated.Results Insertion of a metallic esophageal stent was attempted in 12 patients (mean age, 73.0 years; 5 male, 7 female). Location of the stricture was in the rectum in 4 patients and in the sigmoid, descending, or transverse segments of the colon in 5, 1, and 2 patients, respectively. Two patients had recurrent colon cancer after surgery. The remaining 10 patients did not undergo surgery. Stent placement was technically successful in 11 patients, giving a technical success rate of 92%. Following successful stent placement, all but 1 patient obtained clinical success, generating a clinical success rate of 83%. Late complications occurred in 4 patients and included 2 migrations, 2 bleeds, and 1 obstruction. The complication rate of the procedure was 33.3%. There was no mortality or severe complications. The median survival period was 120 days.Conclusions Stent placement can be considered safe and effective palliation for unresectable colorectal cancer. With technical modification of an esophageal stent, this procedure is now feasible.     

Novel control system for blood glucose using a model predictive method

We developed a novel blood glucose control system, using a model predictive method, to achieve optimal control of the blood glucose level in severely diabetic or pancreatectomized patients. This system is designed to predict glucose level changes in advance, considering delayed response time and the administered doses of insulin. This method is also designed to calculate the most appropriate insulin infusion rate by considering differences in individual response to insulin. In this study, we compared our system with a conventional proportional and differential controller (PD controller) to determine whether the new system could regulate the glucose level efficiently in pancreatectomized dogs. The model predictive control method resulted in a significant reduction of mean insulin infusion rate compared with the conventional PD controller (0.71 mU/kg per min vs. 1.81 mU/kg per min, p = 0.0005), when the glucose level in both methods reached the planned target level (100 mg/dl). The new system also tended to have a reduced mean glucose infusion rate for compensating for overshooting of the glucose level compared with the PD controller (0.7 mg/kg per min vs. 1.1 mg/kg per min, p = 0.16). These results indicate that the new system should be a useful tool for regulating the glucose level in severely diabetic patients.     

Clinical and endoscopic features of metachronous gastric cancer with possible lymph node metastasis after endoscopic submucosal dissection and Helicobacter pylori eradication

Gastric Cancer - Several studies have reported the metachronous gastric cancers (MGCs) with possible lymph node metastasis (LNM) after endoscopic submucosal dissection (ESD) and Helicobacter pylori...