Halloran Christopher M, Platt Kellie, Gerard Abbie, Polydoros Fotis, O'Reilly Derek A, Gomez Dhanwant, Smith Andrew, Neoptolemos John P, Soonwalla Zahir, Taylor Mark, Blazeby Jane M, Ghaneh Paula
National Institutes of Health Research Liverpool Pancreas Biomedical Research Unit and Clinical Directorate of General Surgery, Royal Liverpool and Broadgreen University Hospitals NHS Trust and the University of Liverpool, Liverpool, L69 3GA, UK.
Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, The Duncan Building, Daulby Street, Liverpool, L69 3GA, UK.
Trials. 2016 Jan 15;17:30. doi: 10.1186/s13063-015-1144-9.
Failure of the pancreatic remnant anastomosis to heal following pancreato-duodenectomy is a major cause of significant and life-threatening complications, notably a post-operative pancreatic fistula. Recently, non-randomized trials have shown superiority of a most intuitive anastomosis (Blumgart technique), which involves both a duct-to-mucosa and a full-thickness pancreatic "U" stitch, in effect a mattress stitch, over a standard duct-mucosa technique (Cattell-Warren). The aim of this study is to examine if these findings remain within a randomized setting.
METHODS/DESIGN: The PANasta trial is a randomized, double-blinded multi-center study, whose primary aim is to assess whether a Blumgart pancreatic anastomosis (trial intervention) is superior to a Cattell-Warren pancreatic anastomosis (control intervention), in terms of pancreatic fistula rates. Patients with suspected malignancy of the pancreatic head, in whom a pancreato-duodenectomy is recommended, would be recruited from several UK specialist regional centers. The hypothesis to be tested is that a Blumgart anastomosis will reduce fistula rate from 20 to 10 %. Subjects will be stratified by research site, pancreatic consistency and diameter of pancreatic duct; giving a sample size of 253 per group. The primary outcome measure is fistula rate at the pancreatico-jejunostomy. Secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay, cancer-specific quality of life and health economic assessments. Enrolled patients will undergo pancreatic resection and be randomized immediately prior to pancreatic reconstruction. The operation note will only record "anastomosis constructed as per PANasta trial randomization," thus the other members of the trial team and patient are blinded. An inbuilt internal pilot study will assess the ability to randomize patients, while the construction of an operative manual and review of operative photographs will maintain standardization of techniques.
The PANasta trial will be the first multi-center randomized controlled trial (RCT) comparing two types of duct-to-mucosa pancreatic anastomosis with surgical quality assurance.
ISRCTN52263879 . Date of registration 15 January 2015.
胰十二指肠切除术后胰残端吻合口愈合失败是导致严重且危及生命并发症的主要原因，尤其是术后胰瘘。最近，非随机试验表明，一种最直观的吻合术（布卢姆加特技术）在减少胰瘘方面优于标准的导管-黏膜技术（卡特尔-沃伦技术），前者涉及导管对黏膜和全层胰腺“U”形缝合，实际上是一种褥式缝合。本研究的目的是检验这些发现在随机对照试验中是否依然成立。
方法/设计：PANasta试验是一项随机、双盲、多中心研究，其主要目的是评估就胰瘘发生率而言，布卢姆加特胰肠吻合术（试验干预）是否优于卡特尔-沃伦胰肠吻合术（对照干预）。疑似胰头恶性肿瘤且建议行胰十二指肠切除术的患者将从英国几个专科区域中心招募。待检验的假设是，布卢姆加特吻合术将使胰瘘发生率从20%降至10%。受试者将按研究地点、胰腺质地和胰管直径进行分层；每组样本量为253例。主要结局指标是胰肠吻合口的胰瘘发生率。次要结局指标包括：接受辅助治疗情况、死亡率、手术并发症、非手术并发症以及住院时间、癌症特异性生活质量和卫生经济学评估。入组患者将接受胰腺切除术，并在胰腺重建前立即进行随机分组。手术记录仅记录“根据PANasta试验随机分组构建吻合口”，因此试验团队的其他成员和患者均处于盲态。一项内置的内部预试验将评估随机分组患者的能力，同时编写手术操作手册并审查手术照片将维持技术的标准化。
PANasta试验将是第一项比较两种导管对黏膜胰肠吻合术并确保手术质量的多中心随机对照试验（RCT）。
ISRCTN编号52263879。注册日期为2015年1月15日。
