Efficacy and safety of a single-use cholangioscope for percutaneous transhepatic cholangioscopy
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Bibliographic record
Abstract
Abstract Background and study aims Percutaneous transhepatic cholangioscopy (PTCS) is a management option for patients in whom peroral cholangioscopy or endoscopic retrograde cholangiopancreatography (ERCP) fail. We conducted a case series on the efficacy and safety of PTCS using a cholangiopancreatoscope cleared by the US Food and Drug Administration in 2020. Patients and methods Fifty adult patients scheduled for PTCS or other cholangioscopic procedure were enrolled at seven academic medical centers and followed for 30 days after the index procedure. The primary efficacy endpoint was achievement of clinical intent by 30 days after the index PTCS procedure. Secondary endpoints included technical success, procedure time, endoscopist ratings of device attributes on a scale of 1 to 10 (best), and serious adverse events (SAEs) related to the device or procedure. Results Patients had a mean age of 64.7±15.9 years, and 60.0% (30/50) were male. Forty-four patients (88.0%) achieved clinical intent by 30 days post-procedure. The most common reasons for the percutaneous approach were past (38.0%) or anticipated (30.0%) failed ERCP. The technical success rate was 96.0% (48/50), with a mean procedure time of 37.6 minutes (SD, 25.1; range 5.0–125.0). The endoscopist rated the overall ability of the cholangioscope to complete the procedure as a mean 9.2 (SD, 1.6; range 1.0–10.0). Two patients (4.0%) experienced related SAEs, one of whom had a fatal periprocedure aspiration. Conclusions PTCS is an important endoscopic option for selected patients with impossible retrograde access or in whom ERCP fails. Because of the associated risk, this technique should be practiced by highly trained endoscopists at high-volume centers. (ClinicalTrials.gov number, NCT04580940)
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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 it