Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.
Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.
Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.

Purpose: To identify the nature of personal growth of family primary caregivers after bereavement and to explore the association between such growth and the experience of caring for a terminally ill cancer patient at home. Methods: A self-administered questionnaire survey was mailed to 112 bereaved family primary caregivers who, with assistance from a palliative care service, had cared for a terminally ill cancer patient at home. The main outcomes were measured using the After Bereavement Growth Inventory, previously developed. Results: Responses from 73 questionnaires were analyzed (effective response rate, 66%). The post-bereavement growth score was significantly higher among the study group than among the general population who had experienced bereavement due to illness-related death. Multiple regression analysis revealed that post-bereavement growth was more likely to occur among those family members who, "at the time they chose to provide home palliative care, intended to care for a patient at home until the time of death" and when "the patient desired home palliative care", those who "felt a deepening of their bond with the patient", and those who "felt the death was peaceful". Conclusion: Our findings suggest that for primary family caregiver's to experience personal growth after bereavement, medical professionals should support patients' preference of place at the end of life and caregivers' preparation for the expected home death, respect the family's bond with the patient, and through appropriate symptom management in home palliative care to maintain the patient's sense of peacefulness until the end of life.

A 66-year-old man with a history of multiple transurethral resections for recurrent bladder tumors, staged as Ta according to the International Union Against Cancer staging guidelines, presented with a complaint of dry cough. A round nodule with a diameter of 7.5 cm was detected in the lung by chest computed tomography, and a video-assisted thoracoscopic lobectomy was performed. Pulmonary metastasis of recurrent bladder cancer was diagnosed by immunohistochemistry staining for the urothelium-specific protein uroplakin Ia. Subsequently, 2 cycles of systemic chemotherapy were administered. Two and a half years after treatment, no recurrence of pulmonary lesions has been detected. A combination of complete resection of pulmonary lesions and systemic chemotherapy may result in a good prognosis for patients with non-muscle-invasive bladder cancer.
Cough ; Fluorescent Antibody Technique, Indirect ; Humans ; Immunohistochemistry ; Lung ; Neoplasm Metastasis ; Neoplasm Staging ; Prognosis ; Recurrence ; Solitary Pulmonary Nodule ; Thorax ; Urinary Bladder ; Urinary Bladder Neoplasms ; Uroplakin Ia

In order to carry out mass examination for detection of stomach ailments effectively and improve screening accuracy, the Nagano Prefectural Welfare Federation of Agricultural Cooperatives, with its mass gastric examination committee as a driving force, has made every endeavor in close collaboration with Federation-affiliated hospitals.
The ratio of those receiving detailed examination to the total number of those who have undergone mass screenings, and the detection ratio of gastric cancer cases, especially those in early stages, have increased steadily over the past years.
This is due in the main to untiring effort exerted by public health nurses and other persons concerned with health problems.
However, the results of X-ray examination made on the basis of the diagnostic standards prepared by the Federation show that there is much need of improving examiners' ability to read mass miniature radiographs correctly.

A 55-year-old man visited our hospital for a detailed examination of a gastric submucosal tumor that was first detected 10 years prior. The tumor continued to grow and had developed a depressed area in its center. A histopathological examination of biopsy specimens revealed gastric adenocarcinoma of the fundic gland type (GA-FG). It was diagnosed as T2 based on the invasion depth as determined by white-light endoscopy and endoscopic ultrasonography. A total gastrectomy with lymphadenectomy was performed and a GA-FG in the mucosa and submucosa was confirmed histopathologically. However, there was a gradual transition to an infiltrative tubular adenocarcinoma with poorly differentiated components in the muscular and subserosal layers. Metastasis was identified in a dissected lymph node (LN). This is the first report of a GA-FG progressing to an aggressive cancer with LN metastasis. These findings modify our understanding of the pathophysiology of GA-FG.
Adenocarcinoma* ; Biopsy ; Endoscopy ; Endosonography ; Gastrectomy ; Gastric Mucosa ; Humans ; Lymph Node Excision ; Lymph Nodes* ; Middle Aged ; Mucous Membrane ; Neoplasm Metastasis*

PURPOSE: Postoperative pancreatic fistula is a serious and fatal complication of gastrectomy for gastric cancer. Blunt trauma to the parenchyma of the pancreas can result from an assistant's forceps compressing and retracting the pancreas, which in turn may result in pancreatic juice leakage. However, no published studies have focused on blunt trauma to the pancreas during laparoscopic surgery. Our aim was to investigate the relationship between compression of the pancreas and pancreatic juice leakage in a swine model. MATERIALS AND METHODS: Three female pigs were used in this study. The pancreas was gently compressed dorsally for 15 minutes laparoscopically with gauze grasped with forceps. Pancreatic juice leakage was visualized by fluorescence imaging after topical administration of chymotrypsin-activatable fluorophore in real time. Amylase concentrations in ascites collected at specified times was measured. In addition, pancreatic tissue was fixed with formalin, and the histology of the compressed sites was evaluated. RESULTS: Fluorescence imaging enabled visualization of pancreatic juice leaking into ascites around the pancreas. Median concentrations of pancreatic amylase in ascites increased from 46 U/L preoperatively to 12,509 U/L 4 hours after compression. Histological examination of tissues obtained 4 hours after compression revealed necrotic pancreatic acinar cells extending from the surface to deep within the pancreas and infiltration of inflammatory cells. CONCLUSIONS: Pancreatic compression by the assistant's forceps can contribute to pancreatic juice leakage. These findings will help to improve the procedure for lymph node dissection around the pancreas during laparoscopic gastrectomy.
Acinar Cells ; Administration, Topical ; Amylases ; Ascites ; Female ; Formaldehyde ; Gastrectomy* ; Hand Strength ; Humans ; Laparoscopy ; Lymph Node Excision* ; Lymph Nodes* ; Optical Imaging ; Pancreas ; Pancreatic Fistula ; Pancreatic Juice ; Stomach Neoplasms ; Surgical Instruments ; Swine ; Wounds, Nonpenetrating

Purpose: Although dumping symptoms are thought to involve postprandial glycemic changes, postprandial glycemic variability without dumping symptoms remains poorly understood due to the lack of a method that allows the easy and continuous measurement of blood glucose levels. Materials and Methods: Patients having undergone distal gastrectomy with Billroth-I (DGBI) or Roux-en-Y reconstruction (DG-RY), total gastrectomy with RY (TG-RY) and pylorus preserving gastrectomy (PPG) for gastric cancer 3 months to 3 years prior, diagnosed as pathological stage I or II, were prospectively enrolled from March 2018 to January 2020. The interstitial tissue glycemic levels were measured every 15 min, up to 14 days by continuous glucose monitoring. Moreover, using a diary recording the diet and symptoms, asymptomatic glucose profiles without sugar supplementation within 3 h postprandially were compared among the four procedures. Results: A total of 40 patients were enrolled, 10 patients for each of the four procedures. There were 47 glucose profiles with DG-BI, 46 profiles with DG-RY, 38 profiles with TGRY, and 46 profiles with PPG. PPG showed the slowest increase with a subsequent gradual decrease in glucose fluctuations, without hyperglycemia or hypoglycemia, among the four procedures. In contrast, TG-RY and DG-RY showed spike-like glycemic variability, sharp rises during meals, and rapid drops. The glucose profiles of DG-BI were milder than those of RY. Conclusions The asymptomatic glycemic changes after meals differ among the types of surgical procedures for gastric cancer. Given the mild glycemic fluctuations in PPG and the glucose spikes in TG-RY and DG-RY, pylorus preservation and physiological reconstruction without changes in food pathways may optimize postprandial glucose profiles after gastrectomy.

Purpose: The incidence of early gastric cancer is increasing in older patients alongside life expectancy. For early gastric cancer of the upper third of the stomach, laparoscopic functionpreserving gastrectomy (LFPG), including laparoscopic proximal gastrectomy (LPG) and laparoscopic subtotal gastrectomy (LSTG), is expected to be an alternative to laparoscopic total gastrectomy (LTG). However, whether LFPG has advantages over LTG in older patients remains unknown. Materials and Methods: We retrospectively analyzed data of consecutive patients aged ≥75 years who underwent LTG, LPG, or LSTG for cT1N0M0 gastric cancer between 2005 and 2019. Surgical and nutritional outcomes, including blood parameters, percentage body weight (%BW) and percentage skeletal muscle index (%SMI) were compared between LTG and LPG or LSTG. Survival outcomes were also compared between LTG and LFPG groups. Results: A total of 111 patients who underwent LTG (n=39), LPG (n=48), and LSTG (n=24) were enrolled in this study. To match the surgical indications, LTG was further categorized into “LTG for LPG” (LTG-P) and “LTG for LSTG” (LTG-S). No significant differences were identified in the incidence of postoperative complications among the procedures. Postoperative nutritional parameters, %BW and %SMI were better after LPG and LSTG than after LTG-P and LTG-S, respectively. The survival outcomes of LFPG were better than those of LTG. Conclusions LFPG is safe for older patients and has advantages over LTG in terms of postoperative nutritional parameters, body weight, skeletal muscle-sparing, and survival.Therefore, LFPG for upper early gastric cancer should be considered in older patients.

A 24-year-old man was admitted to another hospital due to fever and chest and back pain. Enhanced chest computed tomography showed an aneurysm between the distal aortic arch and left pulmonary artery. The patient was transferred to our hospital for surgery. Because of suspicion of an infectious ductus arteriosus aneurysm, antibiotic therapy was started. Urgent graft replacement of the descending aorta was performed on the third day due to the enlargement of the aneurysm. All blood cultures including the preoperative examination, and the aneurysmal culture were negative. The histopathological study showed non-specific inflammatory response with plasma cell, T lymphocyte, and B lymphocyte infiltrations. There was no evidence of infection. Eventually we diagnosed this patient as having a ductus arteriosus aneurysm with non-specific inflammation. The antibiotic therapy was terminated on postoperative day 10, and the postoperative course was uneventful.