Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.

Name: Αlpha¹ Rigor Record — Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.
Item: Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.
Rating: 59
Author: Αlpha¹

Elmunzer BJ, Foster LD, Serrano J, Coté GA, Edmundowicz SA, Wani S, Shah R, Bang JY, Varadarajulu S, Singh VK, Khashab M, Kwon RS, Scheiman JM, Willingham FF, Keilin SA, Papachristou GI, Chak A, Slivka A, Mullady D, Kushnir V, Buxbaum J, Keswani R, Gardner TB, Forbes N, Rastogi A, Ross A, Law J, Yachimski P, Chen YI, Barkun A, Smith ZL, Petersen B, Wang AY, Saltzman JR, Spitzer RL, Ordiah C, Spino C, Durkalski-Mauldin V, SVI Study Group

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Αlpha¹ Rigor Review — 3★ (Adequate), 0 critical, 4 high issues for “Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 16, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce ×3−1.5★
IntegrityIntegrity concern−0.5★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 reported means were read, and their group size is not stated where the values are printed. These checks need the count the mean was averaged over, so none was performed.

Problems surfaced3 types

Numerical inconsistencies2

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions1

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Significance claim flips when recomputedRecomputed

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted multicenter randomized non-inferiority trial with strong design, clear reporting, and a concrete data sharing plan. The main weaknesses are minor reporting gaps (randomization method, informed consent, statistical software, CONSORT mention) and a potentially serious inconsistency in the primary non-inferiority p-value that warrants verification.

Both reviewers agreed on study type (interventional) and on most dimensions. The only substantive divergence was in statistical analysis, where the deterministic verification component found an inconsistency that overrides the reviewers' pass. The statistics verification covered only a subset of tests (those with test statistics/CI); other reported statistics were not independently verified.

6 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Recomputed 3 tests: 2 consistent, 1 inconsistent (1 change significance at p<.05); 3 via agent-written checks. 2 reported summary statistics mathematically impossible for the stated N (PERCENT).

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions8 pass

The introduction cites prior trials on NSAIDs and stents, acknowledges limitations of prior studies (open-label, expert centers), and provides a rationale for testing indomethacin alone. The hypothesis follows logically from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

direct quote[Introduction, paragraph 3]

“the perceived benefit of prophylactic stent placement may be exaggerated as prior trials were un-blinded in design and conducted by a small number of expert centers, limiting generalizability to broader practice settings”