A comparison of two types of contrast media used in endoscopic retrograde cholangiopancreatography: A retrospective study

Tomoharu Matsuura; Yasushi Hamaya; Shunya Onoue; Satoshi Tamura; Natsuki Ishida; Mihoko Yamade; Shinya Tani; Moriya Iwaizumi; Satoshi Osawa; Takahisa Furuta; Ken Sugimoto

doi:10.1371/journal.pone.0280279

Peer Review History

Original SubmissionJuly 19, 2022
1 Sep 2022 Decision Letter - Jamie Males, Editor PONE-D-22-20342Comparison of two types of contrast media on endoscopic retrograde cholangiopancreatography: a retrospective studyPLOS ONE Dear Dr. Hamaya, 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. Please note that we have only been able to secure a single reviewer to assess your manuscript. We are issuing a decision on your manuscript at this point to prevent further delays in the evaluation of your manuscript. Please be aware that the editor who handles your revised manuscript might find it necessary to invite additional reviewers to assess this work once the revised manuscript is submitted. 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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: Yes ****** 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 is a retrospective study of contrast medium for ERCP. 1. As the authors admitted, the study results were highly biased due to its retrospective nature. The authors may want to perform multivariable analysis or propensity score matching to reduce biases. 2. A substantial portion of patients had more than one ERCP in the study cohort. The risk of PEP was low once EST was performed. Please consider a subgroup analysis in cases with native papilla. 3. What is the primary cannulation technique, WGC or contrast injection? 4. Guidewire insertion into the pancreatic duct was a risk factor for PEP (PMID: 34963021, 25442080). Please add this factor in the results and discuss in the context of effect of pancreatic stent for PEP. 5. The cost is high in iodixanol. Please consider cost analysis. 6. Table 3. Prophylactic pancreatic duct stent placement (%) was repeated. ****** 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: No ******** [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. https://doi.org/10.1371/journal.pone.0280279.r001
Revision 1
21 Oct 2022 Author Response Reviewer #1: This is a retrospective study of contrast medium for ERCP. 1. As the authors admitted, the study results were highly biased due to its retrospective nature. The authors may want to perform multivariable analysis or propensity score matching to reduce biases. Response: Thank you kindly for your comment and for this valuable advice. Further to your suggestion, we undertook to perform propensity score matching in this study. The manuscript has subsequently been revised as there were no longer differences found in terms of the amylase level and the length of hospital stay. Figure 2 and Table 2 have been revised accordingly. 2. A substantial portion of patients had more than one ERCP in the study cohort. The risk of PEP was low once EST was performed. Please consider a subgroup analysis in cases with native papilla. Response: Thank you for your kind comment. After propensity matching study, there were 107 of 162 cases with naïve papilla in the amidotrizoic acid group and 112 of 162 cases with naïve papilla in the iodixanol group. In the naïve papilla group, the incidence of PEP was 16 of 107 (15.0%) in the amidotrizoic acid, and 12 of 112 (10.7%) in the iodixanol group (P=0.420). In others, the incidence of PEP was 1 of 55 (1.82%) in the amidotrizoic acid, and 3 of 50 (6.00%) in the iodixanol group (P=0.345). Contrast media did not affect the incidence of PEP. 3. What is the primary cannulation technique, WGC or contrast injection? Response: Thank you for this important question. Our primary cannulation technique was contrast injection. I have included details concerning this primary cannulation technique in the METHODS section of the manuscript. 4. Guidewire insertion into the pancreatic duct was a risk factor for PEP (PMID: 34963021, 25442080). Please add this factor in the results and discuss in the context of effect of pancreatic stent for PEP. Response: Thank you for your meaningful comment. After propensity matching study, there were 43 cases in the amidotrizoic acid group with guidewire insertion into the pancreatic duct and 47 cases in the iodixanol group. In the cases with pancreatic stent, the incidence of PEP was 2 of 15 (13.3%) in the amidotrizoic acid, and 7 of 24 (29.2%) in the iodixanol group (P=0.254). In the cases without pancreatic stent, the incidence of PEP was 8 of 28 (28.6%) in the amidotrizoic acid, and 7 of 23 (30.4%) in the iodixanol group (P=1.00). Contrast media was not shown to have affected the incidence of PEP. As you have pointed out, guidewire insertion into the pancreatic duct and the placement of a pancreatic stent are related to the onset of PEP. However, these results have not been described in this manuscript because we investigated the effect of differences in contrast media on the onset of PEP, and because we adjusted for risk factors using propensity score matching. 5. The cost is high in iodixanol. Please consider cost analysis. Response: Thank you for your important comment and suggestion. After propensity score matching studies had been undertaken, there was no longer a difference in the length of hospital stay. The average duration of hospital stay was 13.8 days in the iodixanol/IOCM group and 17.5 days in amidotrizoic acid/HOCM group. Iodixanol (Visipaque 100 ml) is 6,000 yen more expensive than amidotrizoic acid (Urografin 100 ml). In Japan, hospitalization costs approximately 8,000 yen per day, but there was no difference in cost because there was no difference in hospital stay (P = 0.44). 6. Table 3. Prophylactic pancreatic duct stent placement (%) was repeated. Response: Thank you for pointing this out. The duplicate information has been deleted, as has our original Table 3, with the information contained now added to Table 2. Attachments Attachment Submitted filename: PONE20220901_response_20221016.docx https://doi.org/10.1371/journal.pone.0280279.r002
8 Nov 2022 Decision Letter - Kenji Fujiwara, Editor PONE-D-22-20342R1A comparison of two types of contrast media used in endoscopic retrograde cholangiopancreatography: a retrospective studyPLOS ONE Dear Dr. Hamaya, 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. Please submit your revised manuscript by Dec 23 2022 11:59PM. 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Kenji Fujiwara, Ph.D., M.D. Academic Editor PLOS ONE Additional Editor Comments Dear Dr. Hamaya. The article is a study about contrast media of ERCP in order to reduce common and severe complication, ERCP pancreatitis (PEP). The authors compared two types of contrast media as a retrospective study. The article is well-written and the authors responded appropriately to the questions from one reviewer. I reviewed the article as the editor and also one reviewer. I have some questions and I think the manuscript needs some revision. I summarized my opinions. 1. The article did not include the details of the criteria for diagnosis of PEP. The information of the reference was shown, but I recommend the authors should show an easy summary of the criteria. Especially, the level of serum amylase is not always necessary for the diagnosis of PEP. For easy understanding of readers, the authors should make clear the difference between PEP and high serum amylase levels in the manuscript. In addition, the authors should compare the other factors of diagnosis of PEP when the authors compared the serum factor which is just one factor of the diagnosis. 2. 13.8-17.5 days of hospital stays sound long. I guess the hospital stays may include other treatments like cholecystectomy or rehabilitation. If so, I am not sure the comparison of hospital stays between the two groups has meaning. If the authors wanted to compare the complications of ERCP by focusing on two contrast media, they may use other factors, like the period of high serum amylase level. [Note: HTML markup is below. Please do not edit.] 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 ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 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 ****** 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 ****** 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: 1. The authors provided a table for patient charcateristics in all cohort alone but please add a table for patient characteristics after propensity matching. ****** 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 ******** [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. https://doi.org/10.1371/journal.pone.0280279.r003
Revision 2
21 Dec 2022 Author Response Reviewer #1The article is a study about contrast media of ERCP in order to reduce common and severe complication, ERCP pancreatitis (PEP). The authors compared two types of contrast media as a retrospective study. The article is well-written and the authors responded appropriately to the questions from one reviewer. I reviewed the article as the editor and also one reviewer. I have some questions and I think the manuscript needs some revision. I summarized my opinions. 1. The article did not include the details of the criteria for diagnosis of PEP. The information of the reference was shown, but I recommend the authors should show an easy summary of the criteria. Especially, the level of serum amylase is not always necessary for the diagnosis of PEP. For easy understanding of readers, the authors should make clear the difference between PEP and high serum amylase levels in the manuscript. In addition, the authors should compare the other factors of diagnosis of PEP when the authors compared the serum factor which is just one factor of the diagnosis. Response: Thank you for your comment and the valuable advice. Further to your suggestion, we have added details of the diagnostic criteria for PEP to the “Materials and Methods” section. PEP was diagnosed in patients with all three of the following criteria: abdominal pain, hyperamylasemia (≥3 times the upper limit of normal), and prolonged hospital stay (required fasting for eight or more meals), according to the cited literature criteria. In the amidotrizoic acid group, 10.5% of the patients (17 of 162) had abdominal pain, and in the iodixanol group, 10.5% of the patients (17 of 162) had abdominal pain (P = 1.00). Further, 27.1% of the patients (44 of 162) required fasting for eight or more meals in the amidotrizoic acid group, and 17.9% of the patients (29 of 162) required fasting for 8 or more meals in iodixanol group (P = 0.062). 2. 13.8-17.5 days of hospital stays sound long. I guess the hospital stays may include other treatments like cholecystectomy or rehabilitation. If so, I am not sure the comparison of hospital stays between the two groups has meaning. If the authors wanted to compare the complications of ERCP by focusing on two contrast media, they may use other factors, like the period of high serum amylase level. Response: Thank you for your critical comment and suggestion. As noted by the reviewers, the length of hospital stay is strongly influenced by treatment of comorbidities and other diseases. We could not compare the duration of high amylase levels because the timing of blood tests after endoscopy was different in each case. However, we examined the period during which the subjects were able to start eating after ERCP (number of times of fasting after ERCP). The type of contrast media did not affect the duration of fasting (P = 0.499). We have added the result to the “Results.” sections. 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: 1. The authors provided a table for patient charcateristics in all cohort alone but please add a table for patient characteristics after propensity matching. Response: Thank you for your comment. We have added new tables about patient characteristics after propensity matching (Table 3). Attachments Attachment Submitted filename: PONE_response_20221221.docx https://doi.org/10.1371/journal.pone.0280279.r004
26 Dec 2022 Decision Letter - Kenji Fujiwara, Editor A comparison of two types of contrast media used in endoscopic retrograde cholangiopancreatography: a retrospective study PONE-D-22-20342R2 Dear Dr. Hamaya, 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, Kenji Fujiwara, Ph.D., M.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Dear Dr. Yousuke Nakai. Thank you for your prompt re-submission. I think the manuscript is appropriately revised and updated and is eligible for acceptance. Yours sincerely, Kenji Fujiwara Academic editor Reviewers' comments: https://doi.org/10.1371/journal.pone.0280279.r005
Formally Accepted
29 Dec 2022 Acceptance Letter - Kenji Fujiwara, Editor PONE-D-22-20342R2 A comparison of two types of contrast media used in endoscopic retrograde cholangiopancreatography: a retrospective study Dear Dr. Hamaya: 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. Kenji Fujiwara Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0280279.r006

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