{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T11:05:22Z","timestamp":1782903922002,"version":"3.54.5"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T00:00:00Z","timestamp":1643846400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T00:00:00Z","timestamp":1643846400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Capital Health Research and Development of Special","award":["2020-1-2012"],"award-info":[{"award-number":["2020-1-2012"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Currently, the minimally invasive \u201cStep-up\u201d surgical strategy is still the main treatment for infected pancreatic necrosis (IPN). However, indiscriminate implementation of the \u201cStep-up\u201d strategy can lead to increased numbers of operations and prolonged hospital stay. The \u201cStep-up\u201d approach is not appropriate for some patients due to unavailabilty of a safe puncture path. Therefore, we developed the \u201cOne-step\u201d surgical approach to treat IPN, which is safety. However, there is still a lack of comparison of the short and long-term efficacy between the \u201cOne-step\u201d and \u201cStep-up\u201d approach. Consequently, we are conducting this clinical trial to provide a reference for IPN treatment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is an ongoing, single-center, randomized controlled trial of patients with IPN. The total sample size required for the trial (May 2021\u2013December 2023) is approximately 128 patients. Patients will be randomly assigned to either an experimental group (One-step) or a control group (Step-up) at a ratio of 1:1 using the block randomization method. We used the case report forms and electronic data capture systems to obtain demographic information, preoperative laboratory examination, auxiliary examination results, surgery data, postoperative recovery outcomes, and follow-up outcomes. The patients will be followed up for 2\u00a0years after surgery. The primary endpoint is a composite endpoint, consisting of mortality and severe complications. The secondary endpoints include the incidence of organ dysfunction, the number of surgical procedures, mortality (the incidence of death in hospital and deaths within 30\u00a0days of discharge), hospital stay, intensive care unit stay, hospitalization costs, perioperative inflammatory marker changes, and short-and long-term complications.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Compared with the \u201cStep-up,\u201d the \u201cOne-step\u201d minimally invasive surgery can significantly reduce the number of operations, reduce the length of hospital stay and hospitalization costs without increasing the incidence of composite endpoint events, and has better short- and long-term efficacy and safety. Additionally, there was no statistically significant difference in perioperative complications and mortality between \u201cStep-up\u201d and \u201cOne-step\u201d. This study will assist with the formulation of an effective and scientific \u201cOne-step\u201d minimally invasive treatment strategy for IPN, and an understanding of this technique will facilitate clinical decision-making for IPN.<\/jats:p>\n                <jats:p><jats:italic>Trial Registration<\/jats:italic> ChiCTR2100044348. Trial status: Ongoing.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12876-022-02116-0","type":"journal-article","created":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T11:06:34Z","timestamp":1643886394000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["\u201cOne-step\u201d approach versus \u201cStep-up\u201d approach minimally invasive treatment for infected pancreatic necrosis: a study protocol for a single-center, prospective, randomized controlled trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Zhi","family":"Zheng","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiongdi","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Cao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yixuan","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulin","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wentong","family":"Mei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanxu","family":"Qu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haichen","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yeqing","family":"Cui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ang","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,2,3]]},"reference":[{"issue":"4","key":"2116_CR1","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1001\/jama.2020.20317","volume":"325","author":"MA Mederos","year":"2021","unstructured":"Mederos MA, Reber HA, Girgis MD. Acute pancreatitis: a review. JAMA. 2021;325(4):382\u201390.","journal-title":"JAMA"},{"issue":"8","key":"2116_CR2","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1038\/s41575-019-0158-2","volume":"16","author":"PJ Lee","year":"2019","unstructured":"Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019;16(8):479\u201396.","journal-title":"Nat Rev Gastroenterol Hepatol"},{"issue":"5","key":"2116_CR3","doi-asserted-by":"publisher","first-page":"992","DOI":"10.1097\/SLA.0000000000001407","volume":"263","author":"IP Gomatos","year":"2016","unstructured":"Gomatos IP, Halloran CM, Ghaneh P, Raraty MG, Polydoros F, Evans JC, Smart HL, Yagati-Satchidanand R, Garry JM, Whelan PA, et al. Outcomes from minimal access retroperitoneal and open pancreatic necrosectomy in 394 patients with necrotizing pancreatitis. Ann Surg. 2016;263(5):992\u20131001.","journal-title":"Ann Surg"},{"issue":"4","key":"2116_CR4","doi-asserted-by":"publisher","first-page":"1016","DOI":"10.1053\/j.gastro.2018.10.045","volume":"156","author":"RA Hollemans","year":"2019","unstructured":"Hollemans RA, Bakker OJ, Boermeester MA, Bollen TL, Bosscha K, Bruno MJ, Buskens E, Dejong CH, van Duijvendijk P, van Eijck CH, et al. Superiority of step-up approach vs open necrosectomy in long-term follow-up of patients with necrotizing pancreatitis. Gastroenterology. 2019;156(4):1016\u201326.","journal-title":"Gastroenterology"},{"issue":"16","key":"2116_CR5","doi-asserted-by":"publisher","first-page":"1491","DOI":"10.1056\/NEJMoa0908821","volume":"362","author":"HC van Santvoort","year":"2010","unstructured":"van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, et al. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010;362(16):1491\u2013502.","journal-title":"N Engl J Med"},{"issue":"4","key":"2116_CR6","doi-asserted-by":"publisher","first-page":"508","DOI":"10.1016\/j.pan.2016.03.014","volume":"16","author":"A Li","year":"2016","unstructured":"Li A, Cao F, Li J, Fang Y, Wang X, Liu DG, Li F. Step-up mini-invasive surgery for infected pancreatic necrosis: results from prospective cohort study. Pancreatology. 2016;16(4):508\u201314.","journal-title":"Pancreatology"},{"issue":"1","key":"2116_CR7","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1053\/j.gastro.2019.07.064","volume":"158","author":"TH Baron","year":"2020","unstructured":"Baron TH, DiMaio CJ, Wang AY, Morgan KA. American gastroenterological association clinical practice update: management of pancreatic necrosis. Gastroenterology. 2020;158(1):67\u201375.","journal-title":"Gastroenterology"},{"issue":"3","key":"2116_CR8","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1159\/000501076","volume":"37","author":"F Cao","year":"2020","unstructured":"Cao F, Duan N, Gao C, Li A, Li F. One-step verse step-up laparoscopic-assisted necrosectomy for infected pancreatic necrosis. Dig Surg. 2020;37(3):211\u20139.","journal-title":"Dig Surg"},{"issue":"2","key":"2116_CR9","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1097\/01.sla.0000133083.54934.ae","volume":"240","author":"D Dindo","year":"2004","unstructured":"Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205\u201313.","journal-title":"Ann Surg"},{"issue":"3","key":"2116_CR10","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1038\/s41575-018-0087-5","volume":"16","author":"MS Petrov","year":"2019","unstructured":"Petrov MS, Yadav D. Global epidemiology and holistic prevention of pancreatitis. Nat Rev Gastroenterol Hepatol. 2019;16(3):175\u201384.","journal-title":"Nat Rev Gastroenterol Hepatol"},{"issue":"10249","key":"2116_CR11","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1016\/S0140-6736(20)31318-0","volume":"396","author":"G Beyer","year":"2020","unstructured":"Beyer G, Habtezion A, Werner J, Lerch MM, Mayerle J. Chronic pancreatitis. Lancet. 2020;396(10249):499\u2013512.","journal-title":"Lancet"},{"issue":"10","key":"2116_CR12","doi-asserted-by":"publisher","first-page":"1550","DOI":"10.1038\/s41395-018-0232-3","volume":"113","author":"G Trikudanathan","year":"2018","unstructured":"Trikudanathan G, Tawfik P, Amateau SK, Munigala S, Arain M, Attam R, Beilman G, Flanagan S, Freeman ML, Mallery S, et al. Early (<4 Weeks) versus standard (>\/= 4 Weeks) endoscopically centered step-up interventions for necrotizing pancreatitis. Am J Gastroenterol. 2018;113(10):1550\u20138.","journal-title":"Am J Gastroenterol"},{"issue":"1","key":"2116_CR13","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1016\/j.surg.2005.03.010","volume":"138","author":"B Rau","year":"2005","unstructured":"Rau B, Bothe A, Beger HG. Surgical treatment of necrotizing pancreatitis by necrosectomy and closed lavage: changing patient characteristics and outcome in a 19-year, single-center series. Surgery. 2005;138(1):28\u201339.","journal-title":"Surgery"},{"issue":"10115","key":"2116_CR14","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1016\/S0140-6736(17)32404-2","volume":"391","author":"S van Brunschot","year":"2018","unstructured":"van Brunschot S, van Grinsven J, van Santvoort HC, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, et al. Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial. Lancet. 2018;391(10115):51\u20138.","journal-title":"Lancet"},{"key":"2116_CR15","doi-asserted-by":"crossref","unstructured":"Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN, American Gastroenterological Association Institute Clinical Guidelines C. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018; 154(4):1096\u20131101.","DOI":"10.1053\/j.gastro.2018.01.032"},{"issue":"6","key":"2116_CR16","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1002\/jhbp.259","volume":"22","author":"M Yokoe","year":"2015","unstructured":"Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, et al. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015;22(6):405\u201332.","journal-title":"J Hepatobiliary Pancreat Sci"},{"issue":"4","key":"2116_CR17","doi-asserted-by":"publisher","first-page":"787","DOI":"10.1097\/SLA.0000000000001203","volume":"263","author":"RA Hollemans","year":"2016","unstructured":"Hollemans RA, Bollen TL, van Brunschot S, Bakker OJ, Ahmed Ali U, van Goor H, Boermeester MA, Gooszen HG, Besselink MG, van Santvoort HC, et al. Predicting success of catheter drainage in infected necrotizing pancreatitis. Ann Surg. 2016;263(4):787\u201392.","journal-title":"Ann Surg"},{"issue":"4","key":"2116_CR18","doi-asserted-by":"publisher","first-page":"737","DOI":"10.1097\/SLA.0b013e318269d25d","volume":"257","author":"RY Babu","year":"2013","unstructured":"Babu RY, Gupta R, Kang M, Bhasin DK, Rana SS, Singh R. Predictors of surgery in patients with severe acute pancreatitis managed by the step-up approach. Ann Surg. 2013;257(4):737\u201350.","journal-title":"Ann Surg"},{"key":"2116_CR19","doi-asserted-by":"crossref","unstructured":"Italian Association for the Study of the P, Pezzilli R, Zerbi A, Campra D, Capurso G, Golfieri R, Arcidiacono PG, Billi P, Butturini G, Calculli L et al. Consensus guidelines on severe acute pancreatitis. Dig Liver Dis. 2015; 47(7):532\u201343.","DOI":"10.1016\/j.dld.2015.03.022"},{"issue":"2","key":"2116_CR20","doi-asserted-by":"publisher","first-page":"65","DOI":"10.14712\/23362936.2020.6","volume":"121","author":"J Paul","year":"2020","unstructured":"Paul J. Recent advances in diagnosis and severity assessment of acute pancreatitis. Prague Med Rep. 2020;121(2):65\u201386.","journal-title":"Prague Med Rep"}],"container-title":["BMC Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02116-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12876-022-02116-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12876-022-02116-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T11:09:48Z","timestamp":1643886588000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcgastroenterol.biomedcentral.com\/articles\/10.1186\/s12876-022-02116-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,3]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["2116"],"URL":"https:\/\/doi.org\/10.1186\/s12876-022-02116-0","relation":{},"ISSN":["1471-230X"],"issn-type":[{"value":"1471-230X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,3]]},"assertion":[{"value":"16 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 January 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 February 2022","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 authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study protocol was approved by the Ethics Committee of Xuan Wu Hospital, Capital Medical University (2020\u2013052). Written informed consent was obtained from all participants. The results will be disseminated to the public through paper in open-access journals.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"41"}}