Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial).

BACKGROUND: Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric neoplasms (EGN). Controlling intraoperative bleeding is crucial for ensuring safe and reliable procedures. ESD using the spray coagulation mode (SCM-ESD) has been developed to control bleeding more effectively than ESD using the conventional forced coagulation mode (FCM-ESD). This study aims to compare the hemostatic efficacies of SCM-ESD and FCM-ESD. METHODS: This multicenter, prospective, parallel, randomized, open-label superiority trial will be conducted in five Japanese institutions. Patients with a preoperative diagnosis of intramucosal EGC will be randomized to undergo either SCM-ESD or FCM-ESD. The primary outcome measure is the completion of ESD with an electrosurgical knife alone, without the use of hemostatic forceps. Secondary outcomes include the number and duration of hemostasis using hemostatic forceps, procedure time, curability, and safety. A total of 130 patients will be enrolled in this study. DISCUSSION: This trial will provide evidence on the hemostatic efficacy of SCM-ESD compared with FCM-ESD in patients with intramucosal EGN, potentially improving the safety and reliability of ESD procedures. TRIAL REGISTRATION: The trial has been registered at the University Hospital Medical Information Network Clinical Trials Registration (UMIN-CTR) as UMIN000040518. The reception number is R000054009.

Safety and Efficacy of Sedation During Emergency Endoscopy for Upper Gastrointestinal Bleeding: A Propensity Score Matching Analysis.

BACKGROUND AND AIM: This study aimed to compare patients with and without sedation during emergency endoscopy for upper gastrointestinal bleeding (UGIB) and to clarify the safety and efficacy of sedation in emergency endoscopy. METHODS: We retrospectively collected 389 patients who underwent emergency endoscopy for UGIB at Ureshino Medical Center from 2016 to 2021. Patients were divided into two groups: sedation group during emergency endoscopy and nonsedation group. Clinical characteristics, patient status on admission, and UGIB etiology were evaluated. Treatment outcomes and adverse events were evaluated using propensity score matching (PSM), and risk factors for mortality from UGIB were investigated using Cox multivariate analysis. RESULTS: The sedation group was significantly younger, composed of a higher proportion of males, and had chronic liver disease. Blood pressure and hemoglobin level on admission were significantly higher in the sedation group. The main cause of bleeding was peptic ulcer, which was significantly higher in the nonsedation group. PSM created 133 matched pairs. The success rate of endoscopic hemostasis was similar in both groups, and procedure time was significantly shorter in the sedation group than in the nonsedation group (17.6 ± 10.0 versus 20.2 ± 10.2 min, P = 0.04). There were no significant differences in adverse events between groups. Cox multivariate analyses revealed that red blood cell transfusion [hazard ratio (HR) 4.45, P < 0.02] and rebleeding (HR 3.30, P = 0.03) were associated with increased risk of 30-day mortality from UGIB. CONCLUSIONS: Sedation reduced the procedure time during emergency endoscopy for UGIB. Sedation during emergency endoscopy for UGIB is acceptable for safe endoscopic procedures.

Lifestyle- and comorbidity-related factors for the prescription of proton pump inhibitors after Helicobacter pylori eradication in Japan.

BACKGROUND AND AIM: The aim of the present study was to examine the lifestyle- and comorbidity-related determinant factors of the prescription of proton pump inhibitors (PPIs) for patients in whom Helicobacter pylori has been eradicated, and to evaluate the relationship between PPI prescription and the severity of endoscopic esophagitis. METHODS: This retrospective study included patients who underwent H. pylori eradication from May 2012 to September 2016 at Saiseikai Karatsu Hospital. All patients received upper gastrointestinal endoscopy before H. pylori eradication. Patients with open peptic ulcers and/or malignant diseases were excluded, and a final total of 389 patients were evaluated. Medical records were reviewed to determine the prescription of PPIs after H. pylori eradication, lifestyle-related factors, and comorbidities. Lifestyle-related factors were confirmed by a questionnaire. RESULTS: PPIs were administered to 124 of 389 patients (31.9%). The only lifestyle-related risk factor for the prescription of PPIs after H. pylori eradication was older age (P < 0.01). Hypertension increased the prescription of PPIs (P = 0.034). The prescription of PPIs was not influenced by the presence of grade A esophagitis, whereas the PPI prescription rate was significantly increased in patients with grades B/C/D endoscopic esophagitis (P < 0.01). The grade of chronic gastritis before H. pylori eradication had no effect on the prescription of PPIs. CONCLUSION: The lifestyle- and comorbidity-related risk factors for the prescription of PPIs after H. pylori eradication were older age and hypertension, while mild endoscopic esophagitis had no influence on PPI prescription.

Aplastic Anemia in a Patient with Cronkhite-Canada Syndrome.

Cronkhite-Canada syndrome (CCS) is a rare polyposis disorder accompanied by alopecia and onychodystrophy. A 63-year-old man with a history of CCS and repeated embolism developed progressive thrombocytopenia and mild anemia. Laboratory testing, a bone marrow examination, and magnetic resonance imaging of the spine resulted in a diagnosis of concurrent aplastic anemia (AA). Paroxysmal nocturnal hemoglobinuria (PNH)-type cells were detected in a peripheral blood specimen. In addition, human leukocyte antigen (HLA) included DRB1*15:01 and DRB1*15:02. Mesalazine was discontinued in consideration of possible drug-induced pancytopenia. Immunosuppressive therapy ameliorated both the gastrointestinal symptoms of CCS and pancytopenia. A common autoimmune abnormality might underlie both CCS and AA.

An Investigation of Nine Patients with Gastrointestinal Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors.

INTRODUCTION/AIMS: Immune checkpoint inhibitors (ICIs) sometimes cause immune-related adverse events (irAEs), of which there is little information in the literatures. The objective of this study was to characterize the clinical features of gastrointestinal irAEs (GI irAEs). MATERIALS AND METHODS: From a total of 250 patients who were administered anti-PD-1 antibodies (nivolumab and pembrolizumab), we retrospectively identified 9 patients with grade 2 or higher GI irAE based on medical records. Patient characteristics, clinical features, imaging and pathological findings, and treatment course were evaluated. RESULTS: Grade 2 or higher GI irAEs were observed in 9 (3.6%) patients. Of the 9 patients who experienced GI irAE, 8 were male, and mean age was 63.2 years. Five patients received nivolumab and 4 received pembrolizumab. The GI irAEs observed were diarrhea in 7 patients and bloody stool in 2 patients. Grade 2 GI irAEs were identified in 3 patients and grade 3 GI irAEs in 6 patients. The average time from ICI administration to the onset of GI irAEs was 22.2 weeks (range 7-56 weeks) for nivolumab and 19.7 weeks (range 11-28 weeks) for pembrolizumab. Endoscopic findings showed ulcerative colitis-like findings in 3 of 7 patients, and pathological examination revealed crypt epithelial cell apoptosis in 6 of 7 patients. Eight of the 9 patients received steroids, and 2 patients received infliximab additionally. All GI irAEs were manageable. CONCLUSIONS: Because of the lack of specific clinical, imaging, and pathological findings, information of ICI use was indispensable for diagnosis. Although GI irAEs are controllable by steroid and infliximab, further studies regarding management strategy will be needed.

A case-control study of the risk of upper gastrointestinal mucosal injuries in patients prescribed concurrent NSAIDs and antithrombotic drugs based on data from the Japanese national claims database of 13 million accumulated patients.

BACKGROUND: We aimed to identify the adverse effects of nonsteroidal anti-inflammatory drugs (NSAIDs) and antithrombotics on the upper gastrointestinal (GI) mucosa in a clinical setting as a case-control study using a large-scale medical database in Japan. METHODS: We evaluated the risk of upper GI mucosal injuries in patients receiving NSAIDs and antithrombotics using the Japan Medical Data Center claims database with data for 13 million accumulated patients, from January 2009 to December 2014. Endoscopically evaluated upper GI mucosal injuries were peptic ulcers (n = 143,271), upper GI bleeding (n = 10,545), and gastroesophageal reflux disease (n = 154,755). For each patient, ten controls were matched by age, sex, and diagnosis month. RESULTS: The odds ratio (OR) for peptic ulcers was 1.45, 1.31, 1.50, 1.53, and 1.62; for upper GI bleeding: 1.76, 1.62, 1.96, 1.82, and 2.38; and for gastroesophageal reflux disease: 1.54, 1.41, 1.89, 1.67, and 1.91 for NSAIDs, COX-2 selective inhibitors, low-dose aspirin, antiplatelet drugs, and anticoagulants, respectively (all statistically significant: P < 0.001). Polypharmacy with NSAIDs and antithrombotic drugs increased the risk of upper GI injuries compared with single-drug therapy. The injury risk was also increased by lifestyle-related diseases, including diabetes mellitus and hyperlipidemia. CONCLUSIONS: This case-control study using the large organized Japanese claims database provided the risk of upper GI mucosal injuries in patients receiving NSAIDs and antithrombotic drugs.