دورية أكاديمية

Association of Image-Guided Navigation With Complete Resection Rate in Patients With Locally Advanced Primary and Recurrent Rectal Cancer: A Nonrandomized Controlled Trial.

التفاصيل البيبلوغرافية
العنوان: Association of Image-Guided Navigation With Complete Resection Rate in Patients With Locally Advanced Primary and Recurrent Rectal Cancer: A Nonrandomized Controlled Trial.
المؤلفون: Kok END; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., van Veen R; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Groen HC; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Heerink WJ; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Hoetjes NJ; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., van Werkhoven E; Department of Biometrics, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Beets GL; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Aalbers AGJ; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Kuhlmann KFD; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Nijkamp J; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands., Ruers TJM; Department of Surgical Oncology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.; Faculty Applied Sciences, Group Nanobiophysics, Twente University, Enschede, the Netherlands.
المصدر: JAMA network open [JAMA Netw Open] 2020 Jul 01; Vol. 3 (7), pp. e208522. Date of Electronic Publication: 2020 Jul 01.
نوع المنشور: Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Chicago, IL : American Medical Association, [2018]-
مواضيع طبية MeSH: Dissection*/adverse effects , Dissection*/methods , Neoplasm Recurrence, Local*/pathology , Neoplasm Recurrence, Local*/surgery , Rectal Neoplasms*/epidemiology , Rectal Neoplasms*/pathology , Rectal Neoplasms*/surgery , Rectum*/diagnostic imaging , Rectum*/pathology , Rectum*/surgery , Surgery, Computer-Assisted*/adverse effects , Surgery, Computer-Assisted*/methods, Female ; Humans ; Male ; Margins of Excision ; Middle Aged ; Neoplasm Staging ; Netherlands/epidemiology ; Prospective Studies
مستخلص: Importance: The percentage of tumor-positive surgical resection margin rates in patients treated for locally advanced primary or recurrent rectal cancer is high. Image-guided navigation may improve complete resection rates.
Objective: To ascertain whether image-guided navigation during rectal cancer resection improves complete resection rates compared with surgical procedures without navigation.
Design, Setting, and Participants: This prospective single-center nonrandomized controlled trial was conducted at the Netherlands Cancer Institute-Antoni van Leeuwenhoek in Amsterdam, the Netherlands. The prospective or navigation cohort included adult patients with locally advanced primary or recurrent rectal cancer who underwent resection with image-guided navigation between February 1, 2016, and September 30, 2019, at the tertiary referral hospital. Clinical results of this cohort were compared with results of the historical cohort, which was composed of adult patients who received rectal cancer resection without image-guided navigation between January 1, 2009, and December 31, 2015.
Intervention: Rectal cancer resection with image-guided navigation.
Main Outcomes and Measures: The primary end point was the complete resection rate, measured by the amount of tumor-negative resection margin rates. Secondary outcomes were safety and usability of the system. Safety was evaluated by the number of navigation system-associated surgical adverse events. Usability was assessed from responses to a questionnaire completed by the participating surgeons after each procedure.
Results: In total, 33 patients with locally advanced or recurrent rectal cancer were included (23 men [69.7%]; median [interquartile range] age at start of treatment, 61 [55.0-69.0] years). With image-guided navigation, a radical resection (R0) was achieved in 13 of 14 patients (92.9%; 95% CI, 66.1%-99.8%) after primary resection of locally advanced tumors and in 15 of 19 patients (78.9%; 95% CI, 54.4%-94.0%) after resection of recurrent rectal cancer. No navigation system-associated complications occurred before or during surgical procedures. In the historical cohort, 142 patients who underwent resection without image-guided navigation were included (95 men [66.9%]; median [interquartile range] age at start of treatment, 64 [55.0-70.0] years). In these patients, an R0 resection was accomplished in 85 of 101 patients (84.2%) with locally advanced rectal cancer and in 20 of 41 patients (48.8%) with recurrent rectal cancer. A significant difference was found between the navigation and historical cohorts after recurrent rectal cancer resection (21.1% vs 51.2%; P = .047). For locally advanced primary tumor resection, the difference was not significant (7.1% vs 15.8%; P = .69). Surgeons stated in completed questionnaires that the navigation system improved decisiveness and helped with tumor localization.
Conclusions and Relevance: Findings of this study suggest that image-guided navigation used during rectal cancer resection is safe and intuitive and may improve tumor-free resection margin rates in recurrent rectal cancer.
Trial Registration: Netherlands Trial Register Identifier: NTR7184.
التعليقات: Comment in: JAMA Netw Open. 2020 Jul 1;3(7):e208810. (PMID: 32639563)
Erratum in: JAMA Netw Open. 2020 Aug 3;3(8):e2018477. (PMID: 32797171)
References: Minim Invasive Ther Allied Technol. 2016 Oct;25(5):271-7. (PMID: 27348417)
Surg Endosc. 2015 Jan;29(1):207-11. (PMID: 24972925)
Dis Colon Rectum. 2008 Mar;51(3):284-91. (PMID: 18204879)
Ann Surg. 2015 Dec;262(6):891-8. (PMID: 26473651)
J Surg Oncol. 2019 Mar;119(4):510-517. (PMID: 30582622)
Ann Surg. 2014 Feb;259(2):315-22. (PMID: 23478530)
Lancet Oncol. 2011 Oct;12(11):997-1003. (PMID: 21868284)
Colorectal Dis. 2006 Nov;8(9):733-47. (PMID: 17032318)
Dis Colon Rectum. 2013 Apr;56(4):519-31. (PMID: 23478621)
Colorectal Dis. 2012 Dec;14(12):1457-66. (PMID: 22356246)
Dis Colon Rectum. 2014 Aug;57(8):933-40. (PMID: 25003288)
Tech Coloproctol. 2015 Nov;19(11):679-84. (PMID: 26153411)
Colorectal Dis. 2012 Sep;14(9):1076-83. (PMID: 22107085)
J Clin Oncol. 2008 Jan 10;26(2):303-12. (PMID: 18182672)
Ann Surg. 2003 Apr;237(4):502-8. (PMID: 12677146)
Eur J Surg Oncol. 2007 May;33(4):452-8. (PMID: 17071043)
Dis Colon Rectum. 2019 Jan;62(1):123-129. (PMID: 30531268)
N Engl J Med. 2015 Apr 2;372(14):1324-32. (PMID: 25830422)
Ann Surg. 2016 Aug;264(2):323-9. (PMID: 26692078)
سلسلة جزيئية: NTR NTR7184
تواريخ الأحداث: Date Created: 20200709 Date Completed: 20201225 Latest Revision: 20210110
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC7344384
DOI: 10.1001/jamanetworkopen.2020.8522
PMID: 32639566
قاعدة البيانات: MEDLINE
الوصف
تدمد:2574-3805
DOI:10.1001/jamanetworkopen.2020.8522