B T M Strijbos, J S Hopstaken, C Endo, M de Vries, F Atsma, E Adang, P van der Wees, M G H Besselink, H van Santvoort, M den Dulk, B Groot Koerkamp, J S D Mieog, S Zeverijn, C J H M van Laarhoven, M W J Stommel
{"title":"在标准儿童重建中加入Braun吻合以减少胰十二指肠切除术后胃排空延迟的有效性（REMBRANDT）：一项多中心随机对照试验的研究方案。","authors":"B T M Strijbos, J S Hopstaken, C Endo, M de Vries, F Atsma, E Adang, P van der Wees, M G H Besselink, H van Santvoort, M den Dulk, B Groot Koerkamp, J S D Mieog, S Zeverijn, C J H M van Laarhoven, M W J Stommel","doi":"10.1186/s13063-025-09051-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Pancreatoduodenectomy (PD) is associated with a high risk of complications, such as delayed gastric emptying (DGE) (19-45%). Patients with DGE experience symptoms of nausea, vomiting, inability to tolerate solid food and prolonged dependence on a nasogastric tube (> 7 days), leading to extended hospital stay. A potential mean to reduce DGE is reconstruction after PD with addition of Braun's enteroenterostomy (BE), an anastomosis between the afferent and efferent jejunal limbs distal to the gastrojejunostomy (GJ). Previous prospective-cohort studies and few small randomised controlled studies demonstrated a beneficial effect of BE in reducing DGE. Aim of this study is to obtain robust evidence for the effectiveness of BE in reducing DGE in patients undergoing PD.</p><p><strong>Methods: </strong>The REMBRANDT trial is a multicentre, patient-observer blinded, randomised controlled trial. Adult patients undergoing open PD are recruited in 12 participating centres. Primary outcome is the incidence of DGE. Secondary outcomes include postoperative complications, such as postoperative pancreatic fistula, anastomotic leakage and mortality. Additionally, the study will assess length of hospital stay, patient-reported outcomes, functional outcomes after 12 months and costs. Randomisation is performed intraoperatively (1:1) with stratification of groups by centre, with a sample size of 128 patients per arm.</p><p><strong>Discussion: </strong>This trial is designed to evaluate the effectiveness of Braun anastomosis in reducing delayed gastric emptying after open pancreatoduodenectomy. Throughout the trial, semi-structured interviews will be conducted with surgeons in order to perform a barrier-facilitator analysis, allowing for successful implementation of BE if proven effective.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05709197. Registered on January 24, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"387"},"PeriodicalIF":2.0000,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490083/pdf/","citationCount":"0","resultStr":"{\"title\":\"The effectiveness of adding Braun anastomosis to standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): study protocol for a multicentre randomised-controlled trial.\",\"authors\":\"B T M Strijbos, J S Hopstaken, C Endo, M de Vries, F Atsma, E Adang, P van der Wees, M G H Besselink, H van Santvoort, M den Dulk, B Groot Koerkamp, J S D Mieog, S Zeverijn, C J H M van Laarhoven, M W J Stommel\",\"doi\":\"10.1186/s13063-025-09051-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Pancreatoduodenectomy (PD) is associated with a high risk of complications, such as delayed gastric emptying (DGE) (19-45%). Patients with DGE experience symptoms of nausea, vomiting, inability to tolerate solid food and prolonged dependence on a nasogastric tube (> 7 days), leading to extended hospital stay. A potential mean to reduce DGE is reconstruction after PD with addition of Braun's enteroenterostomy (BE), an anastomosis between the afferent and efferent jejunal limbs distal to the gastrojejunostomy (GJ). Previous prospective-cohort studies and few small randomised controlled studies demonstrated a beneficial effect of BE in reducing DGE. Aim of this study is to obtain robust evidence for the effectiveness of BE in reducing DGE in patients undergoing PD.</p><p><strong>Methods: </strong>The REMBRANDT trial is a multicentre, patient-observer blinded, randomised controlled trial. Adult patients undergoing open PD are recruited in 12 participating centres. Primary outcome is the incidence of DGE. Secondary outcomes include postoperative complications, such as postoperative pancreatic fistula, anastomotic leakage and mortality. Additionally, the study will assess length of hospital stay, patient-reported outcomes, functional outcomes after 12 months and costs. Randomisation is performed intraoperatively (1:1) with stratification of groups by centre, with a sample size of 128 patients per arm.</p><p><strong>Discussion: </strong>This trial is designed to evaluate the effectiveness of Braun anastomosis in reducing delayed gastric emptying after open pancreatoduodenectomy. Throughout the trial, semi-structured interviews will be conducted with surgeons in order to perform a barrier-facilitator analysis, allowing for successful implementation of BE if proven effective.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05709197. Registered on January 24, 2023.</p>\",\"PeriodicalId\":23333,\"journal\":{\"name\":\"Trials\",\"volume\":\"26 1\",\"pages\":\"387\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-10-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490083/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13063-025-09051-x\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09051-x","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The effectiveness of adding Braun anastomosis to standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): study protocol for a multicentre randomised-controlled trial.
Background: Pancreatoduodenectomy (PD) is associated with a high risk of complications, such as delayed gastric emptying (DGE) (19-45%). Patients with DGE experience symptoms of nausea, vomiting, inability to tolerate solid food and prolonged dependence on a nasogastric tube (> 7 days), leading to extended hospital stay. A potential mean to reduce DGE is reconstruction after PD with addition of Braun's enteroenterostomy (BE), an anastomosis between the afferent and efferent jejunal limbs distal to the gastrojejunostomy (GJ). Previous prospective-cohort studies and few small randomised controlled studies demonstrated a beneficial effect of BE in reducing DGE. Aim of this study is to obtain robust evidence for the effectiveness of BE in reducing DGE in patients undergoing PD.
Methods: The REMBRANDT trial is a multicentre, patient-observer blinded, randomised controlled trial. Adult patients undergoing open PD are recruited in 12 participating centres. Primary outcome is the incidence of DGE. Secondary outcomes include postoperative complications, such as postoperative pancreatic fistula, anastomotic leakage and mortality. Additionally, the study will assess length of hospital stay, patient-reported outcomes, functional outcomes after 12 months and costs. Randomisation is performed intraoperatively (1:1) with stratification of groups by centre, with a sample size of 128 patients per arm.
Discussion: This trial is designed to evaluate the effectiveness of Braun anastomosis in reducing delayed gastric emptying after open pancreatoduodenectomy. Throughout the trial, semi-structured interviews will be conducted with surgeons in order to perform a barrier-facilitator analysis, allowing for successful implementation of BE if proven effective.
Trial registration: ClinicalTrials.gov NCT05709197. Registered on January 24, 2023.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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