PONE-D-22-13247Effectiveness of Ultrasound-guided Percutaneous Transhepatic Biliary Drainage to Reduce Radiation Exposure: A Single-Center ExperiencePLOS ONE

Dear Dr. Nam,

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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

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: No

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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

Reviewer #3: Yes

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

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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: This study evaluated the usefulness of US-guided PTBD in terms of reducing fluoroscopy time and radiation doses. Although the retrospective design without a comparison group is a major limitation of this study, the findings of this study is clinically significant to reduce radiation exposures.

1. Please add the exclusion criteria for PTBD in the Methods section.

2. This study included many cases of common bile duct stone cases. In cases with benign biliary stricture, the intrahepatic biliary tract is not markedly dilated compared with malignant biliary stenosis. I suggest the authors to compare fluoroscopy times between benign and malignant biliary strictures.

3. Is there a correlation between the number of punctures the punctured bile duct diameter?

Reviewer #2: The authors submitted a manuscript of a small retrospective, single-center study comparing the effectiveness of ultrasound-guided PTBD by radiologists in a small series of 47 patients. While I congratulate the authors for their hard work collating the data and the excellent success rate of 100% of their PTBDs I am not convinced of the novelty and impact of this investigation. In my eyes, the manuscript represents a case series with a detailed description. However, the descriptions are helpful for clinical routine and the manuscript is clear and well written. I made a few suggestions and I am happy to review the manuscript again should the authors decide to resubmit it.

Major

- In contrast to the presentation in the introduction, PTBD is not considered the gold standard for bile duct stenosis or obstructions. The authors should clarify why ERCP was not feasible in the series of 47 patients and why the alternative of EUS-guided bile duct drainage was not sought.

- The authors describe clearly their best practice how they perform PTBD with the excellent success rate of 100% even in non-dilated ducts. A few more details would be desirable: (i) Were antiplatet agents such as clopidogrel and aspirin also paused in patients with a clear indication (e.g. recent coronary stent)? (ii) was the puncture performed in a guided manner (e.g., ultrasound probe with preformed holes) or “free hand”)? (iii) what was the pulse rate for fluoroscopy

- How was “clinical success” exactly defined – i.e., in which interval should the total bilirubin level decrease and to which extent of the level pre-PTBD?

- The timepoint of laboratory controls should be clearly stated (e.g., 2 days after the procedure)

- Please show exact p values

Minor

- The abstract should clarify why ERCP was not initially feasible and that all PTBDs were performed by radiologists

- Please state the amount of punctures until successful bile duct cannulation was achieved. Was it higher in non-dilated bile ducts?

- Please clarify why PTBD should be better than ERCP for bile leak.

Reviewer #3: This study aimed to evaluate the effectiveness of US-guided PTBD (Percutaneous transhepatic biliary drainage), focusing on fluoroscopy time and radiation dose according to intrahepatic duct dilatation (IHD) degree, and differences between right- and left-sided approaches. The authors evaluated technical success, clinical success, procedural data (fluoroscopy time and radiation dose), and procedure-related complications. US-guided PTBD was found to be a safe and effective technique significantly reducing fluoroscopy time and radiation dose.

This study has some limitations:

1. it was retrospectively designed, which suggests selection bias.

2. the sample size was small.

3. there was no direct comparison in terms of fluoroscopy time and radiation dose between fluoroscopy-guided PTBD and US-guided PTBD, because all biliary punctures were routinely performed under US guidance initially.

Please focus more in the discussion section on the original elements of the study and on what you think this study brings in addition to what is already known.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Effectiveness of Ultrasound-guided Percutaneous Transhepatic Biliary Drainage to Reduce Radiation Exposure: A Single-Center Experience

PONE-D-22-13247R1

Dear Dr. Nam,

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, M.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear authors,

Thank you for re-submitting your manuscript after revision. The reviewers have evaluated your work and have no further comments.

I congratulate you to the successful review process.

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: (No Response)

Reviewer #3: 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: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #3: Yes

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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: The authors completely responded all my concerns. I have no further comments. Thank you for your efforts.

Reviewer #2: The authors answered my questions quite adequately. However, this descriptive "case series" is still not inducing a high level of enthusiasm. If you decide to accept the MS I would only request to tune down the statement that PTBD should be better than ERCP for treating bile leaks in the MS.

Reviewer #3: (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.

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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

Reviewer #3: No

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