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.

Proximal gastrectomy (PG) has reemerged as a viable surgical option for managing proximal gastric cancer and gastroesophageal junction cancer, particularly for early-stage tumors, offering potential advantages over total gastrectomy (TG). This review examines the evolution of PG, emphasizing surgical techniques and outcomes. Although PG was initially abandoned due to postoperative complications such as reflux esophagitis, advances in reconstruction methods, such as the double-flap technique and double-tract reconstruction, have significantly improved patient quality of life and reduced complications. Modern techniques focus on preserving gastric function, enhancing postoperative nutritional status, and minimizing morbidity, especially compared to TG. However, debates persist regarding the optimal extent of lymphadenectomy, oncological safety, and the risk of metachronous gastric cancer after surgery. Various international guidelines support PG for specific cases, particularly where lymph node involvement is limited, and functional preservation is prioritized. Despite promising survival and quality-of-life outcomes, certain risks, such as anastomotic stenosis and metachronous cancer, remain. The role of PG in treating cancer of the gastroesophageal junction continues to be investigated, with ongoing studies further clarifying its effectiveness. The evolving techniques and increased focus on patient-centered outcomes suggest a renewed role of PG in the surgical management of gastric cancer.

Proximal gastrectomy (PG) has reemerged as a viable surgical option for managing proximal gastric cancer and gastroesophageal junction cancer, particularly for early-stage tumors, offering potential advantages over total gastrectomy (TG). This review examines the evolution of PG, emphasizing surgical techniques and outcomes. Although PG was initially abandoned due to postoperative complications such as reflux esophagitis, advances in reconstruction methods, such as the double-flap technique and double-tract reconstruction, have significantly improved patient quality of life and reduced complications. Modern techniques focus on preserving gastric function, enhancing postoperative nutritional status, and minimizing morbidity, especially compared to TG. However, debates persist regarding the optimal extent of lymphadenectomy, oncological safety, and the risk of metachronous gastric cancer after surgery. Various international guidelines support PG for specific cases, particularly where lymph node involvement is limited, and functional preservation is prioritized. Despite promising survival and quality-of-life outcomes, certain risks, such as anastomotic stenosis and metachronous cancer, remain. The role of PG in treating cancer of the gastroesophageal junction continues to be investigated, with ongoing studies further clarifying its effectiveness. The evolving techniques and increased focus on patient-centered outcomes suggest a renewed role of PG in the surgical management of gastric cancer.

Proximal gastrectomy (PG) has reemerged as a viable surgical option for managing proximal gastric cancer and gastroesophageal junction cancer, particularly for early-stage tumors, offering potential advantages over total gastrectomy (TG). This review examines the evolution of PG, emphasizing surgical techniques and outcomes. Although PG was initially abandoned due to postoperative complications such as reflux esophagitis, advances in reconstruction methods, such as the double-flap technique and double-tract reconstruction, have significantly improved patient quality of life and reduced complications. Modern techniques focus on preserving gastric function, enhancing postoperative nutritional status, and minimizing morbidity, especially compared to TG. However, debates persist regarding the optimal extent of lymphadenectomy, oncological safety, and the risk of metachronous gastric cancer after surgery. Various international guidelines support PG for specific cases, particularly where lymph node involvement is limited, and functional preservation is prioritized. Despite promising survival and quality-of-life outcomes, certain risks, such as anastomotic stenosis and metachronous cancer, remain. The role of PG in treating cancer of the gastroesophageal junction continues to be investigated, with ongoing studies further clarifying its effectiveness. The evolving techniques and increased focus on patient-centered outcomes suggest a renewed role of PG in the surgical management of gastric cancer.

Purpose: Prevention of pancreas-related complications after gastric cancer surgery is critical.Polyglycolic acid (PGA) mesh reduces postoperative pancreatic fistula formation following pancreatic resection. However, the clinical efficacy of PGA mesh in gastric cancer surgery has not been adequately investigated. Materials and Methods: This retrospective study compared the short-term outcomes between two groups: patients who underwent minimally invasive R0 gastrectomy for gastric cancer with the use of a PGA mesh (PGA group) and those without the use of a PGA mesh (non-PGA group) at the Cancer Institute Hospital, Tokyo, between January 2019 and May 2023. Propensity score matching (PSM) was performed to adjust for the possible confounding factors. Results: A total of 834 patients were initially included, of whom 614 (307 in each group) remained after PSM. The amylase levels in the drained abdominal fluid on postoperative days 1 and 3 were similar between the PGA and non-PGA groups. The PGA group had a significantly lower incidence of pancreas-related complications of Clavien-Dindo grade ≥2 than that in the non-PGA group (6.8% vs. 2.9%, P=0.025). In subgroup analyses, the odds ratio for pancreas-related complications appeared to be better in the PGA group than in the non-PGA group in patients with American Society of Anesthesiologists Physical Status Classification score of 2 or 3, those operated via a laparoscopic approach, and those undergoing procedures other than proximal gastrectomy. Conclusions The use of PGA mesh significantly reduced pancreas-related complications after minimally invasive surgery for gastric cancer and might thus benefit patients at risk of such complications.

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: 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