Trial reportBMJ open2025
Systemic indocyanine green administration to detect bile leakage after liver surgery: a prospective clinical trial, using historical controls.
Trial report in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe 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.
designThis 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.
settingTottori University Hospital, Japan.
participantsThis 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.
interventionIn 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. PRIMARY OUTCOME MEASURE: The primary outcome measure was the total bilirubin concentration in the drainage fluid on postoperative day 3 (POD 3).
resultsAccording 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<0.001). No adverse events or side effects related to ICG administration were reported in the intervention group, indicating both the efficacy and safety of this approach in reducing postoperative bilirubin levels.
conclusionsIntraoperative ICG administration and assessment effectively lower bilirubin levels in drainage fluid during hepatectomy, potentially reducing the incidence of BL. TRIAL REGISTRATION NUMBER: jRCTs061210043.
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