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临床试验/NCT02790333
NCT02790333已完成不适用

A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy

Yi-Ping Mou1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification

研究概览

简要总结

The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

详细描述

Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.

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

入选标准

  • disease of pancreatic body and tail
  • Age: 18 years or older
  • distant metastases are not diagnosed preoperatively.
  • Patients who can provide written informed consent

排除标准

  • Patients with severe organ disease such as cardiac disease,respiratory illness
  • Patients with pancreaticojejunostomy,pancreatogastrostomy
  • Patients with conversion to laparotomy
  • Patients with pregnancy

结局指标

主要结局

Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification

时间窗: Thirty days after operation

Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase \> 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later

Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell

时间窗: intraoperative

次要结局

  • Time to oral intake(Duration of hospital stay)
  • Postoperative hospital stay(Duration of hospital stay)
  • Readmission rate(Thirty days after operation)
  • Morbidity(Thirty days after operation)
  • Mortality(Thirty days after operation)

研究者

发起方
Yi-Ping Mou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yi-Ping Mou

MD,Director

Zhejiang Provincial People's Hospital

研究点 (1)

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