1 line
No EOL
21 KiB
Text
1 line
No EOL
21 KiB
Text
{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,3,27]],"date-time":"2023-03-27T04:25:52Z","timestamp":1679891152831},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,3,10]],"date-time":"2023-03-10T00:00:00Z","timestamp":1678406400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,3,10]],"date-time":"2023-03-10T00:00:00Z","timestamp":1678406400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","award":["01KG2028"]},{"DOI":"10.13039\/501100008977","name":"Universit\u00e4t Ulm","doi-asserted-by":"crossref"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n <jats:title>Background<\/jats:title>\n <jats:p>Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications. To reduce postoperative morbidity, several minimally invasive techniques have been developed that can be broadly classified into either hybrid oesophagectomy (HYBRID-E) via laparoscopic\/robotic abdominal and open thoracic surgery or total minimally invasive oesophagectomy (MIN-E). Both, HYBIRD-E and MIN-E, compare favourable to open oesophagectomy. However, there is still an evidence gap comparing HYBRID-E with MIN-E with regard to postoperative morbidity.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Methods<\/jats:title>\n <jats:p>The MICkey trial is a multicentre randomized controlled superiority trial with two parallel study groups. A total of 152 patients with oesophageal cancer scheduled for elective oesophagectomy will be randomly assigned 1:1 to the control group (HYBRID-E) or to the intervention group (MIN-E). The primary endpoint will be overall postoperative morbidity assessed via the comprehensive complication index (CCI) within 30 days after surgery. Specific perioperative parameters, as well as patient-reported and oncological outcomes, will be analysed as secondary outcomes.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Discussion<\/jats:title>\n <jats:p>The MICkey trial will address the yet unanswered question whether the total minimally invasive oesophagectomy (MIN-E) is superior to the HYBRID-E procedure regarding overall postoperative morbidity.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Trial registration<\/jats:title>\n <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/drks.de\/search\/de\/trial\/DRKS00027927\">DRKS00027927<\/jats:ext-link> U1111-1277-0214. Registered on 4th July 2022<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-023-07134-1","type":"journal-article","created":{"date-parts":[[2023,3,26]],"date-time":"2023-03-26T20:19:02Z","timestamp":1679861942000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial"],"prefix":"10.1186","volume":"24","author":[{"given":"Rosa","family":"Klotz","sequence":"first","affiliation":[]},{"given":"Markus K.","family":"Diener","sequence":"additional","affiliation":[]},{"given":"Thomas","family":"Schmidt","sequence":"additional","affiliation":[]},{"given":"Thilo","family":"Hackert","sequence":"additional","affiliation":[]},{"given":"Sandra","family":"Graf","sequence":"additional","affiliation":[]},{"given":"Hans F.","family":"Fuchs","sequence":"additional","affiliation":[]},{"given":"Peter","family":"Grimminger","sequence":"additional","affiliation":[]},{"given":"Jan-Hendrick","family":"Egberts","sequence":"additional","affiliation":[]},{"given":"Ines","family":"Gockel","sequence":"additional","affiliation":[]},{"given":"Pieter C.","family":"van der Sluis","sequence":"additional","affiliation":[]},{"given":"Colette","family":"Doerr-Harim","sequence":"additional","affiliation":[]},{"given":"Christina","family":"Klose","sequence":"additional","affiliation":[]},{"given":"Manuel","family":"Fei\u00dft","sequence":"additional","affiliation":[]},{"ORCID":"http:\/\/orcid.org\/0000-0003-1902-657X","authenticated-orcid":false,"given":"Andre L.","family":"Mihaljevic","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,3,10]]},"reference":[{"issue":"1","key":"7134_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1097\/SLA.0b013e318296c732","volume":"258","author":"K Slankamenac","year":"2013","unstructured":"Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien P-A. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013;258(1):1\u20137.","journal-title":"Ann Surg"},{"issue":"1","key":"7134_CR2","doi-asserted-by":"publisher","first-page":"48","DOI":"10.1186\/1749-8090-3-48","volume":"3","author":"JC Reeve","year":"2008","unstructured":"Reeve JC, Nicol K, Stiller K, McPherson KM, Denehy L. Does physiotherapy reduce the incidence of postoperative complications in patients following pulmonary resection via thoracotomy? A protocol for a randomised controlled trial. J Cardiothorac Surg. 2008;3(1):48.","journal-title":"J Cardiothorac Surg"},{"issue":"23","key":"7134_CR3","doi-asserted-by":"publisher","first-page":"2416","DOI":"10.1200\/JCO.2013.53.6532","volume":"32","author":"C Mariette","year":"2014","unstructured":"Mariette C, Dahan L, Mornex F, Maillard E, Thomas P-A, Meunier B, et al. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014;32(23):2416\u201322.","journal-title":"J Clin Oncol"},{"issue":"6","key":"7134_CR4","doi-asserted-by":"publisher","first-page":"1332","DOI":"10.1097\/ALN.0b013e318289b84b","volume":"118","author":"PA Stark","year":"2013","unstructured":"Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. J Am Soc Anesthesiol. 2013;118(6):1332\u201340.","journal-title":"J Am Soc Anesthesiol"},{"issue":"10","key":"7134_CR5","doi-asserted-by":"publisher","first-page":"1384","DOI":"10.1016\/S0959-8049(03)00270-3","volume":"39","author":"J Blazeby","year":"2003","unstructured":"Blazeby J, Conroy T, Hammerlid E, Fayers P, Sezer O, Koller M, et al. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer. 2003;39(10):1384\u201394.","journal-title":"Eur J Cancer"},{"issue":"4","key":"7134_CR6","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1097\/SLA.0000000000001490","volume":"263","author":"R Mamidanna","year":"2016","unstructured":"Mamidanna R, Ni Z, Anderson O, Spiegelhalter SD, Bottle A, Aylin P, et al. Surgeon volume and cancer esophagectomy, gastrectomy, and pancreatectomy. Ann Surg. 2016;263(4):727\u201332.","journal-title":"Ann Surg"},{"issue":"3","key":"7134_CR7","doi-asserted-by":"publisher","first-page":"916","DOI":"10.1016\/j.athoracsur.2018.04.004","volume":"106","author":"AC Chang","year":"2018","unstructured":"Chang AC. Centralizing esophagectomy to improve outcomes and enhance clinical research: invited expert review. Ann Thorac Surg. 2018;106(3):916\u201323.","journal-title":"Ann Thorac Surg"},{"issue":"3","key":"7134_CR8","doi-asserted-by":"publisher","first-page":"865","DOI":"10.1016\/j.athoracsur.2019.09.044","volume":"109","author":"ZM Abdelsattar","year":"2020","unstructured":"Abdelsattar ZM, Habermann E, Borah BJ, Moriarty JP, Rojas RL, Blackmon SH. Understanding failure to rescue after esophagectomy in the United States. Ann Thorac Surg. 2020;109(3):865\u201371. https:\/\/doi.org\/10.1016\/j.athoracsur.2019.09.044 Epub 2019 Nov 9. PMID: 31706867.","journal-title":"Ann Thorac Surg"},{"issue":"5","key":"7134_CR9","doi-asserted-by":"publisher","first-page":"1055","DOI":"10.1007\/s11605-011-1731-3","volume":"16","author":"SR Markar","year":"2012","unstructured":"Markar SR, Karthikesalingam A, Thrumurthy S, Low DE. Volume-outcome relationship in surgery for esophageal malignancy: systematic review and meta-analysis 2000-2011. J Gastrointest Surg. 2012;16(5):1055\u201363.","journal-title":"J Gastrointest Surg"},{"issue":"2","key":"7134_CR10","doi-asserted-by":"publisher","first-page":"152","DOI":"10.1056\/NEJMoa1805101","volume":"380","author":"C Mariette","year":"2019","unstructured":"Mariette C, Markar SR, Dabakuyo-Yonli TS, Meunier B, Pezet D, Collet D, et al. Hybrid minimally invasive esophagectomy for esophageal cancer. N Engl J Med. 2019;380(2):152\u201362.","journal-title":"N Engl J Med"},{"issue":"2","key":"7134_CR11","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1097\/SLA.0000000000002171","volume":"266","author":"J Straatman","year":"2017","unstructured":"Straatman J, Van Der Wielen N, Cuesta MA, Daams F, Garcia JR, Bonavina L, et al. Minimally invasive versus open esophageal resection: three-year follow-up of the previously reported randomized controlled trial the TIME Trial. Ann Surg. 2017;266(2):232\u20136.","journal-title":"Ann Surg"},{"issue":"6","key":"7134_CR12","doi-asserted-by":"publisher","first-page":"1130","DOI":"10.1016\/j.jamcollsurg.2014.02.014","volume":"218","author":"LF Tapias","year":"2014","unstructured":"Tapias LF, Morse CR. Minimally invasive Ivor Lewis esophagectomy: description of a learning curve. J Am Coll Surg. 2014;218(6):1130\u201340.","journal-title":"J Am Coll Surg"},{"issue":"4","key":"7134_CR13","doi-asserted-by":"publisher","first-page":"1346","DOI":"10.1007\/s00464-012-2614-8","volume":"27","author":"W Guo","year":"2013","unstructured":"Guo W, Zou Y-B, Ma Z, Niu H-J, Jiang Y-G, Zhao Y-P, et al. One surgeon\u2019s learning curve for video-assisted thoracoscopic esophagectomy for esophageal cancer with the patient in lateral position: how many cases are needed to reach competence? Surg Endosc. 2013;27(4):1346\u201352.","journal-title":"Surg Endosc"},{"issue":"8","key":"7134_CR14","doi-asserted-by":"publisher","first-page":"1346","DOI":"10.1007\/s11605-013-2225-2","volume":"17","author":"JM Hernandez","year":"2013","unstructured":"Hernandez JM, Dimou F, Weber J, Almhanna K, Hoffe S, Shridhar R, et al. Defining the learning curve for robotic-assisted esophagogastrectomy. J Gastrointest Surg. 2013;17(8):1346\u201351.","journal-title":"J Gastrointest Surg"},{"issue":"3","key":"7134_CR15","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1093\/bjs\/znab432","volume":"109","author":"BJ van der Wilk","year":"2022","unstructured":"van der Wilk BJ, Hagens ERC, Eyck BM, Gisbertz SS, van Hillegersberg R, Nafteux P, et al. International Esodata Study Group Collaborators. Outcomes after totally minimally invasive versus hybrid and open Ivor Lewis oesophagectomy: results from the International Esodata Study Group. Br J Surg. 2022;109(3):283\u201390. https:\/\/doi.org\/10.1093\/bjs\/znab432 PMID: 35024794.","journal-title":"Br J Surg"},{"issue":"12","key":"7134_CR16","doi-asserted-by":"publisher","first-page":"1049","DOI":"10.1080\/10629360600810434","volume":"76","author":"S Van Buuren","year":"2006","unstructured":"Van Buuren S, Brand JP, Groothuis-Oudshoorn CG, Rubin DB. Fully conditional specification in multivariate imputation. J Stat Comput Simul. 2006;76(12):1049\u201364.","journal-title":"J Stat Comput Simul"},{"issue":"5","key":"7134_CR17","doi-asserted-by":"publisher","first-page":"1484","DOI":"10.1016\/j.athoracsur.2018.05.062","volume":"106","author":"R Jiang","year":"2018","unstructured":"Jiang R, Liu Y, Ward KC, Force SD, Pickens A, Sancheti MS, et al. Excess cost and predictive factors of esophagectomy complications in the SEER-Medicare database. Ann Thorac Surg. 2018;106(5):1484\u201391.","journal-title":"Ann Thorac Surg"},{"issue":"11","key":"7134_CR18","doi-asserted-by":"publisher","first-page":"1757","DOI":"10.1007\/s11605-017-3572-1","volume":"21","author":"F Schlottmann","year":"2017","unstructured":"Schlottmann F, Strassle PD, Patti MG. Transhiatal vs. transthoracic esophagectomy: a NSQIP analysis of postoperative outcomes and risk factors for morbidity. J Gastrointest Surg. 2017;21(11):1757\u201363.","journal-title":"J Gastrointest Surg"},{"issue":"6","key":"7134_CR19","doi-asserted-by":"publisher","first-page":"249","DOI":"10.1007\/s10353-018-0552-y","volume":"50","author":"M Paireder","year":"2018","unstructured":"Paireder M, Asari R, Kristo I, Rieder E, Zacherl J, Kabon B, et al. Morbidity in open versus minimally invasive hybrid esophagectomy (MIOMIE). Eur Surg. 2018;50(6):249\u201355.","journal-title":"Eur Surg"},{"issue":"4","key":"7134_CR20","doi-asserted-by":"publisher","first-page":"621","DOI":"10.1097\/SLA.0000000000003031","volume":"269","author":"PC van der Sluis","year":"2019","unstructured":"van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LA, Joore HC, et al. Robot-assisted minimally invasive thoracolaparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer: a randomized controlled trial. Ann Surg. 2019;269(4):621\u201330.","journal-title":"Ann Surg"},{"issue":"6","key":"7134_CR21","doi-asserted-by":"publisher","first-page":"1021","DOI":"10.1097\/SLA.0000000000002480","volume":"267","author":"T Hackert","year":"2018","unstructured":"Hackert T, Probst P, Knebel P, Doerr-Harim C, Bruckner T, Klaiber U, et al. Pylorus resection does not reduce delayed gastric emptying after partial pancreatoduodenectomy: a blinded randomized controlled trial (PROPP Study, DRKS00004191). Ann Surg. 2018;267(6):1021\u20137.","journal-title":"Ann Surg"},{"issue":"9776","key":"7134_CR22","doi-asserted-by":"publisher","first-page":"1514","DOI":"10.1016\/S0140-6736(11)60237-7","volume":"377","author":"MK Diener","year":"2011","unstructured":"Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377(9776):1514\u201322.","journal-title":"Lancet."},{"key":"7134_CR23","unstructured":"S3-Leitlinie \u00d6sophaguskarzinom - Version 3.1, 2022, AWMF-Registernummer: 021\/023OL. Available at: https:\/\/www.leitlinienprogramm-onkologie.de\/fileadmin\/user_upload\/Downloads\/Leitlinien\/Oesophaguskarzinom\/Version_3\/LL_%C3%96sophaguskarzinom_Langversion_3.1.pdf"},{"issue":"12","key":"7134_CR24","doi-asserted-by":"publisher","first-page":"1504","DOI":"10.1016\/j.jclinepi.2015.03.016","volume":"68","author":"BC Kahan","year":"2015","unstructured":"Kahan BC, Harhay MO. Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs. J Clin Epidemiol. 2015;68(12):1504\u201311.","journal-title":"J Clin Epidemiol"},{"issue":"4","key":"7134_CR25","doi-asserted-by":"publisher","first-page":"524","DOI":"10.1001\/jamaoncol.2016.5688","volume":"3","author":"C Fitzmaurice","year":"2017","unstructured":"Fitzmaurice C, Allen C, Barber RM, Barregard L, Bhutta ZA, Brenner H, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: a systematic analysis for the global burden of disease study. JAMA Oncol. 2017;3(4):524\u201348.","journal-title":"JAMA Oncol"},{"issue":"6","key":"7134_CR26","doi-asserted-by":"publisher","first-page":"907","DOI":"10.1097\/SLA.0b013e31821d4a43","volume":"254","author":"R Vonlanthen","year":"2011","unstructured":"Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, et al. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011;254(6):907\u201313.","journal-title":"Ann Surg"},{"issue":"4","key":"7134_CR27","doi-asserted-by":"publisher","first-page":"789","DOI":"10.4103\/jcrt.JCRT_48_18","volume":"14","author":"G Ma","year":"2018","unstructured":"Ma G, Cao H, Wei R, Qu X, Wang L, Zhu L, et al. Comparison of the short-term clinical outcome between open and minimally invasive esophagectomy by comprehensive complication index. J Cancer Res Ther. 2018;14(4):789\u201394.","journal-title":"J Cancer Res Ther"},{"issue":"1","key":"7134_CR28","doi-asserted-by":"publisher","first-page":"7","DOI":"10.3322\/caac.21387","volume":"67","author":"RL Siegel","year":"2017","unstructured":"Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67(1):7\u201330.","journal-title":"CA Cancer J Clin"},{"key":"7134_CR29","unstructured":"Statistisches Bundesamt OuPdvPuPiK, ausf\u00fchrliche Darstellung. 2017."},{"issue":"6","key":"7134_CR30","doi-asserted-by":"publisher","first-page":"545","DOI":"10.1016\/S1470-2045(07)70172-9","volume":"8","author":"C Mariette","year":"2007","unstructured":"Mariette C, Piessen G, Triboulet J-P. Therapeutic strategies in oesophageal carcinoma: role of surgery and other modalities. Lancet Oncol. 2007;8(6):545\u201353.","journal-title":"Lancet Oncol"},{"issue":"1","key":"7134_CR31","first-page":"7","volume":"37","author":"A Cuschieri","year":"1992","unstructured":"Cuschieri A, Shimi S, Banting S. Endoscopic oesophagectomy through a right thoracoscopic approach. J R Coll Surg Edinb. 1992;37(1):7\u201311 PMID: 1573620.","journal-title":"J R Coll Surg Edinb"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-023-07134-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-023-07134-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-023-07134-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,26]],"date-time":"2023-03-26T20:22:39Z","timestamp":1679862159000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-023-07134-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,10]]},"references-count":31,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["7134"],"URL":"http:\/\/dx.doi.org\/10.1186\/s13063-023-07134-1","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":["Pharmacology (medical)","Medicine (miscellaneous)"],"published":{"date-parts":[[2023,3,10]]},"assertion":[{"value":"30 November 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 February 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 March 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The MICkey trial is conducted according to the Medical Association\u2019s professional code (Berufsordnung der Bundes\u00e4rztekammer) \u00a715. To ensure patient\u2019s rights and safety, the responsible investigator will ensure that the trial will be conducted according to the ethical principles laid out in the Declaration of Helsinki. Before participation in the MICkey trial, written informed consent will be obtained from all study participants. This protocol is designed to ensure that the trial will be conducted and analysed in accordance with ICH-GCP E6. The protocol has already been approved by the independent ethics committee (IEC) of the medical faculty of the University of Ulm (157\/22, 05\/23\/22), and secondary approval of the corresponding ethical bodies of all other participating centres has been or will be obtained. The trial protocol has been formulated in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT guidelines.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"A model consent form is provided on request. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"175"}} |