PoLyglycolic Acid felt reiNforcEmenT of the PancreaticoJejunostomy;Japan-Korea Multicenter prospective randomized phase III trial - PLANET-PJ trial

Fujii Tsutomu0 个研究点目标入组 514 人开始时间: 2019年3月13日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1)Disease of pancreatic or periampullary lesions to require pancreatoduodenectomy
•2)Planned pancreaticojejunostomy including duct-to-mucosa anastomosis
•3)MPD diameter less than 3mm on the left side of the portal vein in preoperative imaging (CT or MRI)
•4)Performance status (ECOG scale): 0-1 at the time of enrollment
•5)Age: 20 years or older
•6)Adequate organ function
•A)Leukocyte count: over 2500 mm3, 14000 mm3 or less
•B)Hemoglobin: over 9.0 g/dL
•C)Platelet count: 100,000 mm3 or less
•D)Total Bilirubin: 2.0 mg/dL or less
•E)Creatinine: 2.0 mg/dL or less
•7)Ability to understand and the willingness to sign a written informed consent

•1)Planned pancreatogastrostomy
•2)Laparoscopic
•or laparoscope-assisted pancreatoduodenectomy
•3)Pancreatic parenchymal atrophy
•or calcification due to chronic pancreatitis
•4)Neoadjuvant treatment including chemotherapy
•or radiotherapy
•5)History of upper abdominal surgery
•(both of open and laparoscopic) except cholecystectomy
•6)Emergency operation
•7)Arterial reconstruction such as superior mesenteric artery, common hepatic artery, or celiac artery
•8)Severe ischemic heart disease
•9)Severe liver dysfunction
•due to liver cirrhosis or active hepatitis
•10)Severe respiratory disorder
•required oxygen inhalation
•11)Chronic renal failure with dialysis
•12)Requiring resection of other organs (liver or colon)
•during pancreatoduodenectomy
•13)Immunosuppressive treatment
•14)History of severe hypersensitivity
•to PGA felt and fibrin glue
•15)Other severe drug allergies
•16)Contrast media allergy of both iodine and gadolinium
•17)Active duplicate cancer thought
•to affect adverse events
•18)Severe psychological or neurological disease
•19)Drug abuse or alcoholics
•20)Planned use of octreotide

发起方

Fujii Tsutomu