-->PONE-D-26-05028-->-->Spontaneous passage of common bile duct stones: predictive factors and impact on post-ERCP complications-->-->PLOS One

Dear Dr. Thinrungroj,

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Additional Editor Comments :

Dear authors, thank you for your submission.

Your manuscript addresses a relevant clinical question. The manuscript was assessed by two external reviewers and myself. Although your findings are of interest, the main conclusion requires substantial revision before it can be considered further. In particular, the analysis of post-ERCP pancreatitis needs more adjustment for procedural confounders and key sensitivity analyses should be added. Please pay attention on predictive and causal interpretations which should be more clearly separated. The recommendation of an “EUS-first” strategy should be discussed more conservativelly and aligned with current guideline-based risk stratification.

We therefore invite a thoroughly revised version that addresses these points and further issues raised by the two reviewers in depth.

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Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: Yes

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-->2. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #1: Yes

Reviewer #2: Yes

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-->3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #1: Yes

Reviewer #2: Yes

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-->4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #1: Yes

Reviewer #2: Yes

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-->5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: The manuscript entitled “ Spontaneous passage of common bile duct stones: predictive factors and impact on post-ERCP complications” aimed to identify clinical predictors of spontaneous passage and evaluate its association with post-ERCP complications. The authors concluded that spontaneous passage of CBDSs is an independent risk factor for PEP and younger age, smaller stone size, and a single stone are significant predictors of spontaneous passage.

The manuscript is well written, novel and the results may be of clinical relevance. However, there are some comments that need to be addressed.

- The diagnosis of CBDS was made using various imaging techniques. False-positive results are also possible. Please discuss the ‘false-positive rate’ for each technique and mention this in the text.

- The risk of PEP is influenced not only by patient-related factors but also, to a significant extent, by factors related to the examination. Factors such as cannulation of the pancreatic duct, contrast injection into the pancreatic duct and placement of a protective stent in the pancreatic duct were not mentioned. Nor was it mentioned whether rectal NSAIDs are administered for PEP prophylaxis. Please mention and discuss.

-What was the technical success rate of the ERCPs? How often was a pre-cut papillotomy necessary?

-Even a spontaneous stone passage can lead to pancreatitis. How was the distinction made between PEP and biliary pancreatitis caused by a spontaneous stone passage if this occurred shortly before the ERCP? If a clear distinction cannot be made, this should be noted under ‘possible limitations’.

- The mean duration from diagnosis of CBDS to procedure (ERCP/EUS) was 29 days. That is a quiet long time. This is surprising, given that a large proportion of patients presented with acute cholangitis (Table 1). National and international guidelines recommend early ERCP for acute cholangitis. This should be discussed, as should the limited applicability of these data to other patient groups who have easier access to prompt ERCP.

- Why was an EUS performed on some patients prior to a potential ERCP, despite their previously confirmed CBDS? Please explain.

Reviewer #2: In this manuscript Wanchaitanawong et al. report on the frequency and predictors of spontaneous passage of common bile duct stones in a retrospective cohort of 113 patients. The observed spontaneous passage in 28% of the patients and identify several factors associated with this outcome. Most importantly, they also observe a higher number of complications in patients with spontaneous passage underscoring the need to identify these before the procedure.

The study is technically sound and the manuscript is well written. The data are interesting.

However, a few points need to be considered:

- While the various predictors of spontaneous passage are certainly interesting, one very important aspect is inadequately covered: The predictive value of confirmation or exclusion of CBDS by appropriate imaging DIRECTLY before the ERCP. To this end, it is important to include this into the list of predictors. Roughly estimated, the p-value for positive EUS to exclude spontaneous CBDS passage should be 0.005 in this cohort and is therefore certainly relevant.

- This is also the most important and clinically relevant conclusion of the manuscript and should be made clearer in the discussion: In particular in cases with a substantial delay between diagnosis and intervention, EUS should be performed directly prior to ERCP to confirm or rule out CBDS.

- To identify cases, where the cumulative evidence from clinical predictors for spontaneous stone passage is so high that re-EUS might be omitted, I suggest the authors build a predictive model from these factors and indicate its sensitivity, specificity, NPV and PPV.

- The study design comes with the weakness that a subgroup of patients has previously undergone EUS. Thus, the passage group includes a subgroup that has not undergone ERCP and the non-passage group includes a subgroup, where non-passage has already been confirmed before ERCP. This introduces some - probably minor - inconsistencies. However, I suggest to provide (e.g. as Supplementary Data) a separate analysis only focussing on the ERCP cases without previous EUS.

- Please analyze whether the type of diagnostic mortality is associated with stone passage. Given the high number of diagnoses made with CT scan, I suspect that a high number of CBDS in this group were incidental findings on imaging performed for another indication.

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Reviewer #1: No

Reviewer #2: No

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Spontaneous passage of common bile duct stones: predictive factors and impact on post-ERCP complications

PONE-D-26-05028R1

Dear Dr. Thinrungroj,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Thomas Karlas

Academic Editor

PLOS One

Additional Editor Comments (optional):

-

Reviewers' comments:

Reviewer's Responses to Questions

-->Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.-->

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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-->2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. -->

Reviewer #1: Yes

Reviewer #2: (No Response)

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-->3. Has the statistical analysis been performed appropriately and rigorously? -->

Reviewer #1: Yes

Reviewer #2: (No Response)

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-->4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.-->

Reviewer #1: Yes

Reviewer #2: (No Response)

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-->5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.-->

Reviewer #1: Yes

Reviewer #2: (No Response)

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-->6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)-->

Reviewer #1: (No Response)

Reviewer #2: (No Response)

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-->7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review?  For information about this choice, including consent withdrawal, please see our Privacy Policy.-->

Reviewer #1: No

Reviewer #2: No

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