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.

Impact of an artificial intelligence-aided endoscopic diagnosis system on improving endoscopy quality for trainees in colonoscopy: Prospective, randomized, multicenter study.

OBJECTIVE: This study was performed to evaluate whether the use of CAD EYE (Fujifilm, Tokyo, Japan) for colonoscopy improves colonoscopy quality in gastroenterology trainees. METHODS: The patients in this multicenter randomized controlled trial were divided into Group A (observation using CAD EYE) and Group B (standard observation). Six trainees performed colonoscopies using a back-to-back method in pairs with gastroenterology experts. The primary end-point was the trainees' adenoma detection rate (ADR), and the secondary end-points were the trainees' adenoma miss rate (AMR) and Assessment of Competency in Endoscopy (ACE) tool scores. Each trainee's learning curve was evaluated using a cumulative sum (CUSUM) control chart. RESULTS: We analyzed data for 231 patients (Group A, n = 113; Group B, n = 118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, P = 0.033) and number of missed adenomas per patient (0.5 vs. 0.9, P = 0.004) than Group B. Group A also had significantly higher ACE tool scores for pathology identification (2.26 vs. 2.07, P = 0.030) and interpretation and identification of pathology location (2.18 vs. 2.00, P = 0.038). For the CUSUM learning curve, Group A showed a trend toward a lower number of cases of missed multiple adenomas by the six trainees. CONCLUSION: CAD EYE did not improve ADR but decreased the AMR and improved the ability to accurately locate and identify colorectal adenomas. CAD EYE can be assumed to be beneficial for improving colonoscopy quality in gastroenterology trainees. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN000044031).

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.

Usefulness of discharge standards in outpatients undergoing sedative endoscopy: a propensity score-matched study of the modified post-anesthetic discharge scoring system and the modified Aldrete score.

BACKGROUND: This study aimed to evaluate the usefulness of discharge standards in outpatients undergoing sedative endoscopy by comparing the modified post-anesthetic discharge scoring system (MPADSS) and the modified Aldrete score. METHODS: We prospectively enrolled 376 outpatients who underwent gastrointestinal endoscopy under midazolam sedation; 181 outpatients were assessed regarding discharge after sedative endoscopy using the MPADSS (group M), and 195 patients were assessed by the modified Aldrete score (group A). The clinical characteristics, types of endoscopy, endoscopic outcomes, and anesthesia outcomes were evaluated between the two groups. We compared discharge score, recovery time, and adverse events using propensity-score matching. RESULTS: Propensity-score matching created 120 matched pairs. The proportion of patients who had a recovery time within 60 min after endoscopy was significantly higher in group A than that in group M (42.5% versus 25.0%, respectively; P < 0.01). The proportion of patients who required > 120 min of recovery time after endoscopy was significantly lower in group A than that in group M (0.0% versus 5.0%, respectively; P = 0.03). However, significantly more patients had drowsiness at discharge in group A compared with group M (19.1% versus 5.0%, respectively; P < 0.01). There was no significant difference in the adverse event rate within 24 h of discharge between the groups. CONCLUSIONS: Patients assessed by the modified Aldrete score were allowed to discharge earlier than those assessed by the MPADSS. However, a patient's level of consciousness should be assessed carefully, especially in patients who visit the hospital alone.