Outcomes of patients with malignant duodenal obstruction after receiving self-expandable metallic stents: A single center experience

Tien-Hsin Wei; Bing-Wei Ye; Pei-Shan Wu; Chung-Pin Li; Yee Chao; Pei-Chang Lee; Yi-Hsiang Huang; Kuei-Chuan Lee; Ming-Chih Hou

doi:10.1371/journal.pone.0268920

Peer Review History

Original SubmissionJanuary 24, 2022
15 Feb 2022 Decision Letter - Wenguo Cui, Editor PONE-D-22-02289Outcomes of Patients with Malignant Duodenal Obstruction After Receiving Self-Expandable Metallic Stents: A Single Center ExperiencePLOS ONE Dear Dr. Kuei-Chuan Lee, 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 February 28th, 2022. 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. 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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 [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: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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 manuscript mainly reported a kind of self-expandable metallic stent (SEMS) placement in 79 patients with MDO between September 2009 and March 2021, who were divided into three groups according to the obstruction levels. The author claims that implantation improve the survival for these patients and a longer length of stenosis predicts higher mortality. However, still has some major issue which impairs the conclusion raised by authors. 1.In this paper, the stenosis is divided into types 1, 2, and 3 (above-papilla group (type 1), papilla involved group (type 2), and below-papilla group (type 3). In many cases, the stenosis caused by the tumor is also combined, as 1 and 2 combined, or 2 and 3 combined. This article does not consider or mention this special case. 2.There is bias in case selection. Different tumor types have different growth rates. After stent placement, the factors that lead to restenosis and shedding are also different. This manuscript did not clarify this part. 3.The authors only mentions the length of the stenosis, while no the degree of stenosis. The degree of stenosis in the same part of the stenosis is different, and the effect after placement is also different. 4.The type of stent placed was not specified. The same type of stent bears the same support force and different stents bear different support forces. Reviewer #2: The work Outcomes of Patients with Malignant Duodenal Obstruction After Receiving Self-Expandable Metallic Stents: A Single Center Experience summarized data from 79 malignant duodenal obstruction patients treated with self-Expandable Metallic Stents. Study is properly designed and executed and I have few comments for the work. First of all, author used ECOG score to indicate patients health condition. Table 1 and 3 should follow Table S1 change ECOG to ECOG score. Or the abbreviation of the Oncology Group will not give any meaning for the numbers. Second, GOOSS score was summarized till day 30. Since patients did not receive chemotherapy after put in stent has a median survival around 60 days. Is there any GOOSS score data for patients till day 60, 90? Last but not the least, GOOSS score largely influenced patient recovery due to the nutrient acquired always determined by diet. To understand the recovery progress, is it possible to include a GOOSS score chart with detailed classification. ****** 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 Reviewer #2: 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.0268920.r001
Revision 1
18 Feb 2022 Author Response Reviewer #1: This manuscript mainly reported a kind of self-expandable metallic stent (SEMS) placement in 79 patients with MDO between September 2009 and March 2021, who were divided into three groups according to the obstruction levels. The author claims that implantation improve the survival for these patients and a longer length of stenosis predicts higher mortality. However, still has some major issue which impairs the conclusion raised by authors. 1.In this paper, the stenosis is divided into types 1, 2, and 3 (above-papilla group (type 1), papilla involved group (type 2), and below-papilla group (type 3). In many cases, the stenosis caused by the tumor is also combined, as 1 and 2 combined, or 2 and 3 combined. This article does not consider or mention this special case. Reply: Thank you for the comments. The above-papilla group (type 1) is defined as tumor obstruction at the level above the papilla and does not involve the papilla; the papilla involved group (type 2) is defined as tumors affecting the second portion of the duodenum and involve the papilla; the below-papilla group (type 3) has duodenal obstruction distal to the papilla and does not involve the papilla. Therefore, there is no combined case according to the definitions in our study. The detailed definitions of the three MDO types are added in the manuscript. Please page 9-10, line 155-159. 2.There is bias in case selection. Different tumor types have different growth rates. After stent placement, the factors that lead to restenosis and shedding are also different. This manuscript did not clarify this part. Reply: Thank you for the important opinions. In the present study, pancreatic cancer is the major etiology of MDO (62 patients, 78.5%), followed by duodenal cancer (6 patients, 7.6%), cholangiocarcinoma (4 patients,5.1%) and other tumors (7 patients, 8.9%). Owing to the retrospective nature and limited patient numbers in tumors other than pancreatic cancer, it is difficult to compare the differences among different cancers. However, we found that there is no statistic difference in survival time [121 (11-713) vs. 78 (10-887) days, p = 0.737] and stent patency time [116 (10-671) vs. 70 (7-564), p = 0.854] between pancreatic cancer and non-pancreatic cancers in our study. We have added the information in the manuscript. Please see page 14, line 235-238. 3.The authors only mentions the length of the stenosis, while no the degree of stenosis. The degree of stenosis in the same part of the stenosis is different, and the effect after placement is also different. Reply: Thank you for the comments. In our study, lesions that were considered total obstructed when a standard upper endoscope cannot pass through the obstruction site. Only patients with total obstruction of duodenum on endoscopic evaluation were enrolled for stent placement. Therefore, only the length of stenosis was measured under fluoroscopy in our study. 4.The type of stent placed was not specified. The same type of stent bears the same support force and different stents bear different support forces. Reply: Thank you for the comments. In our study cohort, the WallFlex Single-use Duodenal Stent (Boston Scientific Corporation, USA) or Bonastent (Standard SCI. Tech Inc, South Korea) were used (21 vs. 56 patients, respectively). There was no significant difference in terms of survival time [120.0 (11-541) vs. 118.5 (10-887), p = 0.455] and stent patency time [106.0 (11-541) vs. 106.0 (7-671), p = 0.544] between the two stent types. The information is added in the text. Please see page 15, line 238-242. Reviewer #2: The work Outcomes of Patients with Malignant Duodenal Obstruction After Receiving Self-Expandable Metallic Stents: A Single Center Experience summarized data from 79 malignant duodenal obstruction patients treated with self-Expandable Metallic Stents. Study is properly designed and executed, and I have few comments for the work. 1.First of all, author used ECOG score to indicate patients’ health condition. Table 1 and 3 should follow Table S1 change ECOG to ECOG score. Or the abbreviation of the Oncology Group will not give any meaning for the numbers. Reply: Thank you for your kindest suggestion. We have adjusted the term “ECOG” to “ECOG scores” in revised Table 1 and 3 accordingly. 2.Second, GOOSS score was summarized till day 30. Since patients did not receive chemotherapy after put in stent has a median survival around 60 days. Is there any GOOSS score data for patients till day 60, 90? Reply: Thank you for your comments. In our study, the GOOSS score was recorded only till day 30. After one month, we did not routinely follow up the condition of oral intakes and only patients who had symptoms of restenosis would receive re-evaluation. Therefore, most of the data at day 60 and 90 are missing. Thanks again for the useful suggestions. We will keep following up the GOOSS scores at day 60 and day 90 for patients who receive stent insertion and perform further analysis in future studies. 3.Last but not the least, GOOSS score largely influenced patient recovery due to the nutrient acquired always determined by diet. To understand the recovery progress, is it possible to include a GOOSS score chart with detailed classification. Reply: Thank you for the suggestion. The detailed classifications are added in the S1 Table in the supplementary data. Attachments Attachment Submitted filename: Response to reviewers 0217.docx https://doi.org/10.1371/journal.pone.0268920.r002
11 May 2022 Decision Letter - Wenguo Cui, Editor Outcomes of Patients with Malignant Duodenal Obstruction After Receiving Self-Expandable Metallic Stents: A Single Center Experience PONE-D-22-02289R1 Dear Dr. Kuei-Chuan Lee, 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, Wenguo Cui, Ph.D 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 ******** 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: 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 Reviewer #2: 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 Reviewer #2: 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: The revised manuscript is able to clearly answer the relevant questions. Moreover, please also explain the statistical method in the text clearly. Other than that, no other problem. Reviewer #2: Author addressed all the comments from both reviewers in current revision. This center summarized data from 79 Malignant Duodenal Obstruction patients across almost 12 years. This summary could provide insightful information for future MDO patient treatment. ****** 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 https://doi.org/10.1371/journal.pone.0268920.r003
Formally Accepted
17 May 2022 Acceptance Letter - Wenguo Cui, Editor PONE-D-22-02289R1 Outcomes of Patients with Malignant Duodenal Obstruction After Receiving Self-Expandable Metallic Stents: A Single Center Experience Dear Dr. Lee: 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 Professor Wenguo Cui Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0268920.r004

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