The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Japan Registry of Clinical Trials (jRCT1032230086).

Adherence to treatment strategies is essential for preventing future complications during diabetes management. This study evaluated the association between dropout history, glycated haemoglobin (HbA1c) levels and subsequent risks of dropout (missed appointment)in patients with type 2 diabetes.

This was a secondary analysis of a cluster-randomised trial (the Japan Diabetes Outcome Intervention Trial 2 Large-Scale Trial), focusing on the non-intervention group over the study period.

Data were obtained from a multisite trial conducted in Japan, encompassing patients with type 2 diabetes who received routine clinical care at participating clinics.

A total of 996 patients with type 2 diabetes from the non-intervention group were included in the analysis. Baseline characteristics (eg, age, sex, smoking status, occupational status and diabetes medication use) were recorded at study entry.

The primary outcome measure was subsequent treatment dropout. The Cox proportional hazards model with the Huber/White method was used to estimate HRs and 95% CIs, with adjustment for age, sex, smoking status, occupational status and diabetes medication use at baseline.

Participants with treatment dropout history had a higher dropout rate than those without dropout history (multivariable-adjusted HR=3.59; 95% CI=2.25 to 5.71). Overall, HbA1c levels were not significantly associated with dropout risk. However, among the 855 participants without dropout history, the dropout risk was higher in the group with HbA1c level ≥10.0% (HR=3.76; CI=1.29 to 10.9) than in the group with HbA1c level of 6.0–6.9%.

This prospective cohort study of Japanese patients with type 2 diabetes suggests that dropout history is strongly associated with a higher subsequent dropout risk. High HbA1c levels (≥10%) may be related to a higher dropout risk in patients without a dropout history. These findings may provide actionable indicators for tailored interventions, enhancing targeted healthcare strategies and improving continuity of care.

UMIN000002186.

The aim of this study was to evaluate the clinical impact of intraoperative indocyanine green (ICG) assessment and subsequent interventions on the total bilirubin concentration in postoperative drainage fluid after hepatectomy. Specifically, this study was conducted to determine whether systemic ICG administration and near-infrared (NIR) imaging to detect and address bile leakage (BL) during liver surgery could improve postoperative outcomes in an intervention group compared with a historical control group.

This was a prospective clinical trial with historical controls that involved inverse probability of treatment weighting (IPTW) analysis to adjust for potential confounding biases resulting from nonrandomised treatment assignments.

Tottori University Hospital, Japan.

This study included 84 participants who were undergoing hepatectomy. Among these participants, 40 were prospectively enrolled in the intervention group. The remaining 44 participants underwent hepatectomy without ICG-based assessment or interventions and served as historical controls.

In the intervention group, 10 mg of ICG was intravenously administered before liver parenchymal dissection. After hepatic dissection, the resection plane was evaluated and treated as necessary via NIR imaging to detect and address BL.

The primary outcome measure was the total bilirubin concentration in the drainage fluid on postoperative day 3 (POD 3).

According to the IPTW analysis, the total bilirubin concentration in the drainage fluid on POD 3 was significantly lower in the intervention group than in the historical control group. The adjusted mean difference was –1.11 mg/dL (95% CI: –1.49 to –0.72; p

Intraoperative ICG administration and assessment effectively lower bilirubin levels in drainage fluid during hepatectomy, potentially reducing the incidence of BL.

jRCTs061210043.

We aimed to evaluate the effect of projection mapping (PM) on the quality and safety of central venous catheter (CVC) insertion under real-time ultrasound guidance.

Prospective, observational, simulation study.

This study was conducted at the Yokohama City University Medical Center (Yokohama, Japan). Volunteer residents were enrolled over 12 months from January to December 2023.

12 rotating residents (postgraduation year (PGY) 1 and 2) and eight anaesthesia residents (PGY 3–5) placed the CVC in the internal jugular vein in a simulator under the real-time ultrasound guidance using the short-axis out-of-plane approach. The ultrasound image was provided either just caudad to the puncture site using the PM method or on the monitor of the ultrasound machine (conventional method) placed next to the simulator’s right shoulder. Each resident performed four punctures alternating between the PM and conventional methods, and the first method for each resident was chosen randomly. Eye-tracking analysis was also used to evaluate differences in gaze behaviour.

The primary outcome was the procedure time defined as the time from the application of the ultrasound probe on the puncture field until successful puncture of the vein. The secondary outcomes were incidence of complications and eye-tracking analysis data.

The time to complete the line placement was significantly shorter for the PM than for the conventional method (median (IQR) 22.5 (15.5–30.6) s vs 30.0 (20.4–95.4) s; p=0.02, Wilcoxon’s signed-rank test). The incidence of posterior vessel wall puncture was significantly lower in the PM method (0% vs 25%; p=0.02, McNemar’s test). Eye-tracking analysis revealed that the percentage of time spent gazing at the ultrasound image was higher in the PM than in the conventional method (61.6% (55.0–69.2) vs 45.7% (34.1–54.5); p

The PM method facilitates ultrasound-guided CVC placement while preventing excessive needle advancement in the inexperienced operators. This was accompanied by enhanced fixation of the participants’ line-of-sight on the ultrasound image.