EUS-guided choledochoduodenostomy using a lumen apposing metal stent vs. ERCP in malignant distal biliary obstruction: an individual patient data meta-analysis of randomized controlled trials
Bibliographic record
Abstract
Aims EUS-guided choledochoduodenostomy (EUS-CDS) using a lumen apposing metal stent (LAMS) has been shown in RCTs to be effective in malignant distal biliary obstruction. Its safety when compared to endoscopic retrograde cholangiopancreatography (ERCP), however, has not been adequately assessed due to the limited sample size. This meta-analysis aims to ascertain the safety of EUS-CDS compared to ERCP. We hypothesize that EUS-CDS has comparable safety and clinical success as ERCP while have superior technical success. Methods This is a meta-analysis of RCTs using individual patient data (IPD) following the PRISMA-IPD statement. This study was registered in Prospero prior to analysis (481542). A comprehensive literature search was performed from Jan 2013 to Nov 2024 using OVID MEDLINE, EMBASE, Cochrane Library, and ISI Web of Science with MeSH and controlled vocabulary for terms specified for 1) endoscopic ultrasound guided biliary drainage, 2) endoscopic ultrasound guided choledochoduodenostomy, 3) endosonography guided biliary drainage, 4) endosonography guided choledochoduodenostomy. We additionally searched abstracts and the gray literature. RCTs comparing EUS-CDS with LAMS vs. ERCP in malignant distal biliary obstruction were included. Studies using other types of stents, retrospective studies, non-randomized prospective studies, and sole abstracts were excluded. The primary endpoint was the rate of procedure related severe or fatal adverse events as defined by the ASGE lexicon within 14 days. Secondary endpoints include overall 30-day adverse events (AE), stent dysfunction, technical success, clinical success, and procedure time. Deanonymized dataset of published RCTs were obtained following ethics approval. Data were interpreted using a homogenized definition for each endpoint. A one-stage approach was used for all analyses Logistic mixed effects model was used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI). Results A total of 2679 citations were screened with three RCTs included involving a total of 519 patients (263 EUS-CDS and 256 ERCP). There was no significant difference in the odds of<14 days severe or fatal AEs between EUS-CDS and ERCP (OR 0.64, 95% CI 0.22-1.83). The odds of technical success were higher with EUS-CDS (OR 4.22 (95%CI 2.35; 7.60)) and faster with a mean difference in procedure time of SMD=-10.50(95% CI-15.28, -5.73) when compared to ERCP. Lastly, no significant differences were noted in the odds of 30-day AEs (OR 0.72, 95% CI 0.44-1.16), stent dysfunction (OR 0.78, 95% CI 0.42-1.49), or clinical success (OR 1.03, 95% CI 0.64-1.65). Conclusions Our IPD meta-analysis provides high-quality evidence supporting the adoption of EUS-CDS as a safe, more efficient, and technically superior first-line alternative to ERCP in malignant distal biliary obstruction. Cost-effectiveness data are needed to optimally inform clinical implementation of EUS-CDS Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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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 | 0.009 | 0.020 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.030 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.003 | 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".