The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea
The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea
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DOI：
10.1186/s13063-019-3595-x
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发表时间：
2019-08-09
期刊：
影响因子：
2.5
通讯作者：
Fujii, Tsutomu
中科院分区：
文献类型：
--
作者：
Shibuya, Kazuto;Jang, Jin-Young;Fujii, Tsutomu
背景胰头部分切除术是治疗胰头区恶性和良性疾病的一种手术方式。该手术被认为是非常困难和高度侵入性的。术后胰瘘（POPF）是一种重要的并发症，因为它会导致腹腔内出血等并发症，通常会增加住院时间和手术死亡率。尽管迄今为止已经研究了多种旨在减少POPF的胰肠吻合术，但该技术尚未标准化。我们设计了一种新的方法，在胰肠吻合术后使用双层涂层聚乙醇酸毡。PLANET-PJ试验的目的是评价聚乙醇酸毡加固在预防部分胰管切除术患者胰肠吻合术后POPF方面优于既往吻合方法。方法诊断为胰腺或壶腹周围病变的患者，其中主胰管直径在门静脉左侧为3 mm或更小，没有由于梗阻性胰腺炎导致的胰腺实质萎缩，被认为有资格入选。本研究设计为在日本和韩国进行的多中心随机III期试验。合格患者将被集中随机分配至A组（聚乙醇酸毡加固）或B组（对照）。总共有514例患者将在日本和韩国的31个高容量中心接受随机化。主要终点是POPF（国际胰腺外科研究组B/C级）的发生率。讨论PLANET-PJ试验评价了使用双层涂层聚乙醇酸毡加固的新方法预防胰肠吻合术后POPF的有效性。这种新方法可以降低POPF。
Background Partial pancreatoduodenectomy is performed for malignant and benign diseases of the pancreatic head region. The procedure is considered highly difficult and highly invasive. Postoperative pancreatic fistula (POPF) is an important complication because of several consequent complications, including intraabdominal haemorrhage, often increasing hospital stays and surgical mortality. Although many kinds of pancreaticojejunostomy aimed at reducing POPF have been examined to date, the technique has not yet been standardized. We devised a new method using double-coated polyglycolic acid felt after pancreaticojejunostomy. The aim of the PLANET-PJ trial is to evaluate the superiority of polyglycolic acid felt reinforcement in preventing POPF after pancreaticojejunostomy in patients undergoing partial pancreatoduodenectomy to previous anastomosis methods. Methods Patients diagnosed with pancreatic or periampullary lesions in whom it is judged that the main pancreatic duct diameter was 3 mm or less on the left side of the portal vein without pancreatic parenchymal atrophy due to obstructive pancreatitis are considered eligible for inclusion. This study is designed as a multicentre randomized phase III trial in Japan and the Republic of Korea. Eligible patients will be centrally randomized to either group A (polyglycolic acid felt reinforcement) or group B (control). In total, 514 patients will be randomized in 31 high-volume centres in Japan and Republic of Korea. The primary endpoint is the incidence of POPF (International Study Group of Pancreatic Surgery grade B/C). Discussion The PLANET-PJ trial evaluates the efficacy of a new method using double-coated polyglycolic acid felt reinforcement for preventing POPF after pancreaticojejunostomy. This new method may reduce POPF.