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临床试验/NCT01898780
NCT01898780Unknown3 期

Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

Wakayama Medical University2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
190
试验地点
2
主要终点
The frequency of pancreatic fistula including ISGPF grade B and C

研究概览

简要总结

The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients from whom we obtained written informed consent of this study

排除标准

  • Patients with severe ischemic cardiac disease
  • Patients with severe liver damage
  • Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
  • Patients requiring dialysis treatment due to chronic renal failure
  • Patients who are considered as inappropriate by attending physician

研究组 & 干预措施

horizontal mattress

Experimental

pancreaticojejunostomy with horizontal mattress suture

干预措施: pancreaticojejunostomy with horizontal mattress suture (Procedure)

interrupted suture

Experimental

pancreaticojejunostomy with interrupted suture

干预措施: pancreaticojejunostomy with interrupted suture (Procedure)

结局指标

主要结局

The frequency of pancreatic fistula including ISGPF grade B and C

时间窗: Ninety days after operation

次要结局

  • The rates of postoperative complications(Ninety days after operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hiroki Yamaue

Second Department of Surgery

Wakayama Medical University

研究点 (2)

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