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临床试验/NCT01550406
NCT01550406已完成4 期

Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study

Seoul National University Hospital10 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
10
主要终点
The rate of pancreatic fistula between groups

研究概览

简要总结

To date, there has been many methods suggested to reduce pancreatic fistula. But there are no evidence of superiority to the other methods. This study is a multicenter prospective randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent of pancreatic fistula after distal pancreatectomy.

详细描述

Distal pancreatectomy has been called to by various names such as, left-sided pancreatectomy, distal partial pancreatectomy. It is difficult to define which part of the pancreas as distal in exactly, but typically the superior mesenteric vein (SMV) and splenic vein, come to meet portal vein to form the area that covers the pancreas, neck actually based on a relatively thin pancreatic resection area, if left to its distal pancreatic resection is generally defined as that.

Indication of distal pancreatectomy in Western countries have been trauma (16%), pancreas cancer (18%), neuroendocrine tumors (14%), chronic pancreatitis (24%), other benign disease (22%) and in Korea, in contrast, disease caused by inflammatory process such as chronic pancreatitis has had relatively low incidence. But the rate of combined resection of distal pancreas at the time of gastric surgery was relatively high.

Definitions and names of pancreatic fistula have been reported differently in each center. Heidelberg and Johns Hopkins groups defined pancreatic fistula as drain amylase levels more than three times of normal serum value , and with more than 50mL during 24 hours after postoperative 10 days. German and Italian groups defined that as drain amylase levels more than three times of normal serum value, and with more than 10mL during 24 hours after postoperative 3-4 days. Japanese group defined pancreatic fistula as drain amylase levels more than three times of normal serum value, and with persistent drainage after postoperative 7 days. Lowy et al defined clinically significant pancreatic fistula as 38℃ or more of fever and leukocytosis (> 10,000 cells/mm3), and sepsis associated or necessity of drainage of abdominal fluid.

To adjust this various criteria, International Study Group Pancreatic Fistula (ISGPF) 2005 defined pancreatic fistula as drain amylase levels more than three times of normal serum value at the time of postoperative 3 days, and divided severity by 3 category with A to C in accordance with clinical course.

As followed previous studies, pancreatic fistula has been one of major postoperative complications (13-64%), which is leading cause of intra-abdominal infections, abscesses, septicemia, wound infection, postoperative bleeding, and malnutrition Risk factors related pancreas fistula have been presented as a disease- associated factors (pancreatic hardness, pathological findings, diameter of main p- duct, and the thickness of pancreas resection area), surgery-related factors (method of pancreas resection, intraoperative blood loss, operative time, blood transfusion during surgery), patient-related factors (age, sex, race, comorbidity) and the experience of surgeon, etc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Expected survival time more than 12 months
  • Patients with at least one of the following pathologic diseases scheduled for elective resection
  • Resectable malignancies of the pancreatic body/ tail
  • Resectable pre-malignant lesions of the pancreatic body/ tail
  • Resectable benign lesion of the pancreatic body/ tail

排除标准

  • Current immunosuppressive therapy
  • Pancreatic atrophy or calcification due to severe pancreatitis
  • Chemotherapy or radiotherapy before operation
  • Severe psychiatric or neurologic diseases
  • Drug- and/or alcohol-abuse according to local standards
  • Participation in another intervention trial with interference of a primary or secondary endpoint of this study
  • Inability to follow the instructions given by the investigator
  • Lack of compliance

结局指标

主要结局

The rate of pancreatic fistula between groups

时间窗: postoperative 3rd day

Pancreatic fistula was defined by criterion of ISGPF, Output through an operatively placed drain or a subsequently placed percutaneous drain, of any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than three times the upper normal serum value

次要结局

  • Surgery-related risk factor(intraoperative time)
  • disease- associated factors(intraoperative time, within 1 day after operation)
  • patient-related risk factors analysis(1 week before the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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