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临床试验/NCT02220010
NCT02220010Unknown不适用

Does a Pancreatic Stent Reduce the Healing Time of Post Operative Pancreatic Fistula (POPF) After Distal Pancreatic Resection - an Open Randomized Clinical Multicenter Trial

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
POPF healing time (days)

研究概览

简要总结

Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further.

Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation.

In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Signed informed consent
  • Left sided or distal pancreatic resection
  • Grade B or C fistula on postoperative day 3 or later

排除标准

  • Do not want to participate in study
  • Can not read patient information in swedish
  • The papilla can not be endoscopically reached

研究组 & 干预措施

Pancreatic stent

Experimental

If POPF grade B or C is detected on post operative day 3 or more, a pancreatic stent is endoscopically positioned in the pancreatic duct.

干预措施: Pancreatic stent (Device)

Drain only

No Intervention

If POPF grade B or C is detected on post operative day 3 or more, only the per-operatively placed drain is used as treatment

结局指标

主要结局

POPF healing time (days)

时间窗: 12 days (median hospital stay)

Post operative pancreatic fistula(POPF) and grade (A,B,C) is diagnosed according to ISGPF on post operative day 3 or later if the pancrease-amylase concentration is more than three times the upper limit of the normal plasma concentration of pancreas-amylase. When the drain fluid concentration is below this value the fistula is defined as healed.

次要结局

  • POPF grade (A,B,C)(12 days (median hospital stay))

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

John Blomberg

M.D., PhD

Karolinska University Hospital

研究点 (2)

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