Applicability of sentinel lymph node oriented treatment strategy for gallbladder cancer

Koya Yasukawa; Akira Shimizu; Hiroaki Motoyama; Koji Kubota; Tsuyoshi Notake; Shinsuke Sugenoya; Kiyotaka Hosoda; Hikaru Hayashi; Ryoichiro Kobayashi; Yuji Soejima

doi:10.1371/journal.pone.0247079

Peer Review History

Original SubmissionOctober 19, 2020
31 Dec 2020 Decision Letter - Mitesh J Borad, Editor PONE-D-20-32884 Applicability of Sentinel Lymph Node Oriented Treatment Strategy for Gallbladder Cancer PLOS ONE Dear Dr. Yasukawa, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. A few minor revisions are noted, mostly in terms of clarifying language. These are noted clearly in the reviewer's comments provided to you. Please submit your revised manuscript by January 31, 2021. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. In ethics statement in the manuscript and in the online submission form, please provide additional information about the patient records/samples used in your retrospective study. Specifically, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data/samples from their medical records used in research, please include this information. 3. We note that you have indicated that data from this study are available upon request. 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Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. [Note: HTML markup is below. Please do not edit.] 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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 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 ****** 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: No ****** 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: I commend the authors for address a very important question in GBC surgery. The paper did a good job of putting these findings into clinical context. Please see my attachment for grammatical edits and a question about the definition of DFS. ****** 6. 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: Yes:** Kristen Spencer, DO, MPH [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Manuscript edits_KS.docx https://doi.org/10.1371/journal.pone.0247079.r001
Revision 1
12 Jan 2021 Author Response January, 4, 2021 Joerg Heber Editor-in-Chief PLoS ONE Dear Dr. Heber We are pleased to submit the first revised version of our manuscript “Applicability of a sentinel lymph node-oriented treatment strategy for gallbladder cancer” to PLoS ONE. . We have revised the original manuscript in accordance with the reviewers’ comments. Please find the following files attached: • Response letter including our point-by-point responses to the reviewers’ comments • Revised manuscript 1: changes are highlighted in yellow • Manuscript: before change This manuscript has not been submitted for publication in any other venue. All coauthors have reviewed and approved the re-submission of this manuscript to the Applicability of a sentinel lymph node-oriented treatment strategy for gallbladder cancer, and all coauthors declare no conflicts of interest. Please address all correspondence to: Koya Yasukawa, MD Department of Surgery, Shinshu University School of Medicine 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan Phone: +81 263 37 2654 Fax: +81 263 35 1282 E-mail: kouyayasu@shinshu-u.ac.jp We hope that our paper will now be considered suitable for publication in the Applicability of a sentinel lymph node-oriented treatment strategy for gallbladder cancer, and we look forward to hearing from you concerning your editorial decision. Yours sincerely, Koya Yasukawa, MD Associate Editor Comments to Author: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response: We thank the associate editor for this comment. We changed our manuscript, and please check. 2. In ethics statement in the manuscript and in the online submission form, please provide additional information about the patient records/samples used in your retrospective study. Specifically, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data/samples from their medical records used in research, please include this information. Response: We thank the associate editor for this comment. We added the level 2 heading for sub-sections or major sections, Ethics statements. In accordance with the reviewer’s comment, we modified the corresponding text in the revised manuscript, as follows: Pages 7-8, lines 140-146 (new): This study was approved by the ethics committee of Shinshu University School of Medicine (approval no. 2020-4558), and the investigation was conducted according to the principles expressed in the Declaration of Helsinki. All patients were provided with complete information about the study and provided their consent for participation, and written informed consent was obtained from all patients before enrolment. The data were analyzed retrospectively and anonymously on the basis of medical records, and the authors did not have access to identifying patient information or direct access to the study participants. 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Response: We are sorry for not describing the Data Availability statement. We added that information. In accordance with the reviewer’s comment, we modified the corresponding text in the revised manuscript, as follows: Page 18, lines 312-316 (new): Data Availability Data cannot be shared publicly because of the point of view of personal information protection. Data are available from the Shinshu Institutional Data Access / Ethics Committee (contact via shinhp@shinshu-u.ac.jp) for researchers who meet the criteria for access to confidential data. The data underlying the results presented in the study are available from (Shinshu University: shinhp@shinshu-u.ac.jp). Reviewer(s)' Comments to Author: Reviewer: Kristen Spencer, DO, MPH I commend the authors for address a very important question in GBC surgery. The paper did a good job of putting these findings into clinical context. Please see my attachment for grammatical edits and a question about the definition of DFS. Response: Thank you for your comments. We sincerely appreciate these insightful comments, in response to which we have revised and made extensive changes to our manuscript. We believe that our manuscript is greatly improved as a result. Our point-by-point responses to the comments are presented below. Abstract Line 39- change malignancy to malignancies We changed. Line 52-53 reads as incomplete. We changed as follows: Page 3, lines 53-54 (new): In T3, patients with skipped LN metastasis were significantly higher in T3h (n=11) than those in T3p (n=2) (P<0.001). Line 87- would say examination of “the” SLN; and change malignancy to malignancies We changed. Lines 90-92- major pathways to what? Assume means lymph drainage but would clarify We thank your advice. We changed as follows: Page 4, lines 75-77 (new): Some researchers[9-11] reported that there were two major pathways for lymph drainage (the left oblique pathway to the celiac nodes and the right descending pathway to the superior retropancreaticoduodenal node) and one minor pathway for lymph drainage (the superior mesenteric nodes). Line 96- Change according to accordingly We changed. Line 104- change to patients who did not have data on location or had missing data on location We changed. Line 129- would change to underwent laparotomy We changed. Line 131- would add “were done” in T2h We added. Line 144- add status (“performance status”) We added. Line 153- surgical mortality “was” defined We added. Line 164- typically DFS is length of time from randomization (not applicable here) to recurrence of tumor OR death. Does not including patients who recurred OR died impact the study? We are so sorry for not describing accurately regarding DFS in our previous manuscript. We included patients who recurred OR died in this study. We changed as follows: Page 8, lines 153-154 (new): DFS was defined as the time from surgery to recurrence, death from any cause, or the final follow-up. Line 174- were not significantly different We changed. Line 178- would take out “the incidence of LN metastasis” as you already reported this above. We changed as follows: Page 9, lines 166-167 (new): Furthermore, the incidence of postoperative complications differed significantly between T3p and T3h (0.011). Line 184- what was the difference for these other post-op complications between T3p & T3h? We thank the reviewer for this comment. Occurrence of posthepatectomy biliary leakage (T3p: n=2, T3h: n=7) and cholangitis (T3p: n=0, T3h: n=4) was significantly higher in T3h than that in T3p, however, no significant difference was observed in the Clavien–Dindo classification19 grade ≥ III complication between the groups. In accordance with the reviewer’s comment, we modified the corresponding text in the revised manuscript, as follows: Page 9, lines 167-170 (new): Occurrence of posthepatectomy biliary leakage (T3p: n=2, T3h: n=7, P=0.021) and cholangitis (T3p: n=0, T3h: n=4, P=0.038) was significantly higher in T3h than that in T3p, however, no significant difference was observed in the Clavien–Dindo classification19 grade ≥ III complication between the groups. Line 186- remove each We removed. Line 202- change “while” to “as compared to” We changed. Line 214- on the peritoneal side We added. Lines 215- would change “especially among them” to “specifically” as this sets up for the breakdown of liver recurrence vs nodal We changed. Line 216- change to “then that of” We changed. Line 219- change to significant We changed. Line 220- take out “the” We removed. Line 234- change the extent to “extensive LND” We changed. Line 238- did not mention We changed. Line 240- take out “that” We removed. Line 245- change “pf” to “of” We changed. Line 254- take out “all” We removed. Line 256- change to “few reports of a difference in” We changed. Line 261- add “an” before independent poor We added. Line 262-263- change to something like “research into how GBC metastases through lymph nodes and the extent of LND are important” We changed. Line 265- add conducted in or on; & remove “a” after relatively We added and removed. Line 274- change to “how skip LN metastasis occurred” We changed. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0247079.r002
1 Feb 2021 Decision Letter - Mitesh J Borad, Editor Applicability of Sentinel Lymph Node Oriented Treatment Strategy for Gallbladder Cancer PONE-D-20-32884R1 Dear Dr. Yasukawa, 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. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Mitesh J Borad Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0247079.r003
Formally Accepted
3 Feb 2021 Acceptance Letter - Mitesh J Borad, Editor PONE-D-20-32884R1 Applicability of Sentinel Lymph Node Oriented Treatment Strategy for Gallbladder Cancer Dear Dr. Yasukawa: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Mitesh J Borad Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0247079.r004

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