TC-325 Superiority in Malignant Gastrointestinal Bleeding: An Individual Patient Data Meta-Analysis of Randomized Trials
Bibliographic record
Abstract
INTRODUCTION: The efficacy of topical hemostatic agents, recommended for peptic ulcer bleeding, remains poorly characterized in malignant gastrointestinal bleeding (GIB). METHODS: We performed an individual patient data meta-analysis assessing the efficacy of topical hemostatic agents in malignant GIB. The literature was searched using OVID MEDLINE, EMBASE, and ISI Web of Science databases (database inception to November 2023). Only randomized controlled trials (RCTs) comparing topical hemostatic agents with conventional endoscopic modalities in malignant GIB were included. Original RCT patient-level data were obtained. Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines were followed. Quality of the evidence was evaluated using the revised Cochrane risk-of-bias tool and certainty of evidence with the Grading of Recommendations Assessment, Development, and Evaluation approach. The primary outcome was immediate hemostasis; secondary outcomes were 30-day rebleeding and the composite measure of further bleeding (persistent bleeding or 30-day rebleeding). Other outcomes were all-cause mortality, adverse events, and need for additional nonendoscopic treatment. Odds ratios (ORs) from endpoint comparisons were pooled using logistic regression models. RESULTS: Overall, 985 citations were identified; 3 RCTs (n = 160 patients) were included with all assessing TC-325 (Hemospray). TC-325 achieved immediate hemostasis more often than conventional endoscopic modalities (OR 46.6, 95% confidence interval [CI] 5.89-369.1) (low-level certainty). Thirty-day rebleeding (OR 0.28, 95% CI 0.11-0.70) and further bleeding (OR 0.11, 95% CI 0.05-0.26) were both significantly lower with TC-325 (very-low-level certainty). All-cause mortality and need for additional nonendoscopic treatment did not differ between groups. No adverse events were reported. Subgroup analysis confirmed TC-325 superiority in patients with upper GIB. DISCUSSION: TC-325 seems superior to conventional endoscopic therapy in managing patients with malignant GIB. TC-325 results in improvements in immediate hemostasis, 30-day rebleeding, and further bleeding, based on very low-to-low certainties of evidence.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.033 | 0.050 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.021 | 0.058 |
| Bibliometrics | 0.005 | 0.005 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".