Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: A protocol for a single centre randomized controlled trial
Bibliographic record
Abstract
Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable procedure for the management of pancreaticobiliary diseases. Post-ERCP pancreatitis (PEP) is the most common serious adverse event. One risk factor of PEP is difficulty achieving biliary access. The conventional ERCP technique involves the cannulation of the bile duct via the ampulla of Vater, followed by sphincter incision using electrocautery. Conventionally if the standard method fails then precut techniques have been utilized as an alternative means of gaining biliary access. The needle-knife fistulotomy (NKF) technique involves identifying the intra-duodenal segment of the bile duct and uses a needle knife to incise directly into the bile duct. This is done above and away from the natural office, thus minimizing thermal damage which may result in PEP. Our recent prospective study of 50 patients demonstrated the safety and feasibility of the NKF precut technique as a primary means of gaining biliary access. The next step is to conduct a randomized-controlled trial to compare the efficacy and safety of initial NKF to the standard cannulation in a non-selective patient population undergoing ERCP.Methods A randomized control trial of 538 consecutive, non-selective patients with pancreatoticobiliary disease undergoing ERCP at a tertiary care centre in Kingston, Ontario, Canada will be conducted. Patients will be randomized to one of two treatment groups, standard cannulation or NKF. The primary outcome of the study will be the incidence of PEP. Secondary outcomes will include rate of successful cannulation of the CBD, time to successful cannulation, total procedure time, difficulty of cannulation and incidence of complications. Discussion This RCT will yield important answers regarding the efficacy and safety of initial NKF to the standard cannulaton in a non-selective patient population undergoing ERCP. The results of our study could alter ERCP practices and outcomes if NKF is shown to reduce PEP risk.Trial Registration This trial was registered on clinicaltrials.gov (NCT04559867) on September 23, 2020. https://clinicaltrials.gov/ct2/show/NCT04559867?term=bechara&draw=2&rank=2
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | low |
| gpt | no category Domain: not available · Genre: Protocol About the Canadian research system: no · About a Canadian topic: no | Randomized trial | high |
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 | 0.021 | 0.021 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.026 | 0.003 |
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, unvalidatedLabeled directly by 2 models reading the full record.
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".