聚乙二醇酸毡片加强在预防胰十二指肠切除术后胰肠吻合口瘘中的疗效：一项多中心、随机、III 期临床试验研究方案，入组胰管直径＜3mm 且胰腺质地软的患者
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.
机构信息
Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama, 930-0194, Japan.
Department of Surgery, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
出版信息
Trials. 2019 Aug 9;20(1):490. doi: 10.1186/s13063-019-3595-x.
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.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03331718 . University Hospital Medical Information Network Clinical Trials Registry, UMIN000029647. Registered on 30 November 2017. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874.
背景
胰头区域的良恶性疾病需要施行胰十二指肠部分切除术。该手术被认为难度高、创伤大。术后胰瘘（POPF）是一种重要的并发症，因为它会导致多种后续并发症，包括腹腔内出血，这通常会增加住院时间和手术死亡率。尽管迄今为止已经检查了许多种旨在降低 POPF 的胰肠吻合术，但该技术尚未标准化。我们在胰肠吻合术后使用双层聚乙二醇酸毡设计了一种新方法。PLANET-PJ 试验的目的是评估聚乙二醇酸毡强化在预防胰十二指肠部分切除术后胰肠吻合术 POPF 方面相对于既往吻合方法的优越性。
方法
患有胰腺或壶腹周围病变的患者，如果在门静脉左侧判断主胰管直径为 3mm 或更小且没有因阻塞性胰腺炎导致的胰腺实质萎缩，则认为符合纳入标准。这项研究在日本和韩国设计为一项多中心、随机、III 期试验。符合条件的患者将在中央随机分为 A 组（聚乙二醇酸毡强化）或 B 组（对照组）。共有 514 名患者将在日本和韩国的 31 个高容量中心进行随机分组。主要终点是 POPF（国际胰腺外科研究组分级 B/C）的发生率。
讨论
PLANET-PJ 试验评估了使用双层聚乙二醇酸毡强化预防胰肠吻合术后 POPF 的新方法的疗效。这种新方法可能会降低 POPF 的发生率。
试验注册
ClinicalTrials.gov，NCT03331718。大学医院医疗信息网络临床试验注册中心，UMIN000029647。于 2017 年 11 月 30 日注册。https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033874。
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