BACKGROUND AND AIMS:Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric cancer. Intraprocedural bleeding during gastric ESD may result in prolonged procedure time. Therefore, we investigated the efficacy of adding diluted epinephrine to a submucosal injection solution to reduce the procedure time in gastric ESD. METHODS:This international, multicenter, randomized controlled trial was conducted across 12 institutions. Patients with gastric mucosal neoplasia who underwent ESD were eligible. The patients were randomly allocated to either the epinephrine group (1:100,000 diluted epinephrine-added injection solution) or the control group. Randomization was stratified according to lesion location, size, and institution. Patients, endoscopists, and assessors were blinded to the treatment allocation. The primary outcome was the procedure time. Secondary outcomes included the number of intraprocedural hemorrhages requiring the use of hemostatic forceps and postprocedural adverse events. RESULTS:A total of 800 patients were enrolled, 774 of whom were included in the final modified intention-to-treat analysis. A total of 386 and 388 patients were randomized into the epinephrine and control groups, respectively. The mean (SD) procedure time was significantly shorter in the epinephrine group than in the control group: 60 (46) versus 68 (45) minutes, respectively (P = .018). The number of intraprocedural hemorrhages requiring hemostatic forceps was significantly lower in the epinephrine group (mean count: 1.8 vs 3.0; P < .001). There were no significant differences in postprocedural adverse events between the groups. CONCLUSIONS:The addition of diluted epinephrine to the injection solution significantly reduces the procedure time for gastric ESD. (ClinicalTrials.gov: NCT04032119.).
In Japan, endoscopic submucosal dissection (ESD) is the standard treatment for superficial esophageal squamous cell carcinoma (ESCC). Although clinical guidelines outline indications, additional treatment, and stricture prevention, real-world practice patterns remain insufficiently characterized. The present nationwide survey aimed to clarify the current endoscopic management of ESCC in Japan. A web-based, 20-item multiple-choice questionnaire was distributed to endoscopists performing upper gastrointestinal endoscopy at least weekly. Invitations were disseminated through the mailing lists of the Japan Esophageal Society and the individual mailing lists of core study members. The survey assessed diagnostic strategies, endoscopic treatment selection, indications for additional therapy after ESD, and approaches to stricture prevention. Altogether, 303 endoscopists who had performed endoscopic treatment for ESCC within the preceding year were enrolled. Most respondents reported using ESD exclusively. For clinical muscularis mucosa (MM) or shallow submucosa (SM1) lesions, treatment selection depended on circumferential extent, with ESD performed on 95.0
BACKGROUND:The Phoenix definition is widely used to define biochemical recurrence (BCR) after radiation therapy for prostate cancer; however, a definitive definition of cure remains unclear. This study aimed to identify factors associated with late BCR after low-dose-rate brachytherapy (LDR-BT), defined as BCR occurring ≥ 5 years after treatment among patients who remained recurrence-free during the first 5 years, using machine-learning methods. METHODS:We retrospectively analyzed 1419 patients who underwent LDR-BT between 2004 and 2019. Of these, 52 (3.7%) experienced BCR within 5 years, and 244 patients did not have ≥ 5 years of follow-up because of death or loss to follow-up. The remaining 1123 patients were recurrence-free at 5 years and formed the analysis cohort for late BCR (≥ 5 years). Random survival forest (RSF) and survival decision-tree analyses were applied to identify predictive factors, and recurrence-free survival was estimated using the Kaplan-Meier method. RESULTS:The 10-year BCR-free survival rate was 94.8%. RSF identified the 5-year prostate-specific antigen (PSA) value, PSA doubling time (PSA-DT) at 5 years, primary Gleason pattern, and NCCN risk classification as the most important predictors. Optimal cutoff values were 0.93 ng/mL for PSA at 5 years and 5.3 years for PSA-DT. Patients with lower PSA or longer PSA-DT had significantly higher 10-year recurrence-free rates than those at higher risk (97.3% vs. 11.1% and 99.0% vs. 68.1%, respectively; p < 0.001). CONCLUSIONS:PSA level and PSA-DT at 5 years were strong predictors of late BCR after LDR-BT. These findings suggest that follow-up intervals may be safely extended for low-risk patients, thereby reducing the burden of hospital visits and healthcare costs.
Although small bowel bleeding is a known cause of acute lower gastrointestinal bleeding (ALGIB), its outcomes compared to colorectal bleeding remain underexplored. This study aimed to identify baseline characteristics and short- and long-term outcomes associated with small bowel bleeding in comparison to colorectal bleeding. This nationwide retrospective cohort study, based on CODE BLUE-J study, involved 10,342 patients hospitalized for ALGIB. Among 195 patients (2.8%) with acute small bowel bleeding, significant associations were observed with laboratory parameters (e.g., low hemoglobin, platelets, and albumin), clinical signs (e.g., tarry stool), and medical history, compared to 6832 patients with colorectal bleeding. Multivariate regression analysis showed no significant difference in 30-day rebleeding or mortality between small bowel and colorectal bleeding. However, small bowel bleeding was associated with higher transfusion volume, lower endoscopic treatment rate, higher rates of interventional radiology and surgery, and longer hospital stay (all p < 0.005). While long-term cumulative rebleeding rates were similar, cumulative mortality was significantly higher in the small bowel bleeding group (p < 0.001). This large-scale endoscopic study revealed differences in several clinical factors at presentation and in short- and long-term outcomes between small bowel and colorectal bleeding. These findings underscore importance of identifying small bowel bleeding in ALGIB.
Objective:The aim of the study was to evaluate the complete response (CR) rate achieved with selective conventional transarterial chemoembolization (cTACE) using a porous glass membrane emulsification device in hepatocellular carcinoma (HCC). Methods:In a multicenter phase II trial (jRCTs052200095) conducted between January 2021 and June 2023, 50 patients with unresectable HCC (tumor diameter ≤5 cm; Child-Pugh A or B) were enrolled. An emulsion of epirubicin and ethiodized oil (Lipiodol) prepared using the emulsification device was injected into the tumor-feeding arteries, followed by embolization with gelatin sponge particles. The primary endpoint was the CR rate at 3 months post-treatment. Secondary endpoints included the CR rate at 1 month and the incidence of adverse events. Outcomes were compared with a historical control cohort from the JIVROSG-1302 study in exploratory analyses. Results:Two patients were excluded after enrollment, leaving 48 patients who received cTACE (safety set). An additional 3 patients were excluded post-treatment, yielding 45 patients for efficacy analysis. The CR rate at both 1 month and 3 months was 97.8% (95% confidence interval: 88.2-99.9%). Serious adverse events (grade ≥3) included elevated AST in 50.0% of patients, elevated ALT in 29.2%, thrombocytopenia in 2.1%, and elevated ALP in 2.1%. The proportion of patients with deterioration in ALBI grade (≥1 grade increase) at 3 months was 17.8%. In exploratory analyses, CR rates were numerically higher than those observed in the historical control. Conclusion:Selective cTACE using a W/O emulsion prepared with a glass membrane pumping emulsification device was associated with high short-term CR rates in patients with HCC, with an acceptable safety profile. These findings support further clinical investigation.
