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临床试验/NCT04275466
NCT04275466Unknown不适用

A Randomized Controlled Trials on the Effect of Necrotic Cavity Lavage After Laparoscope-assisted Debridement for Patients With Infected Pancreatic Necrosis

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年6月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
112
试验地点
1
主要终点
sum rate of mortality and major complications

研究概览

简要总结

The infected pancreatic necrosis (IPN) should be treated by debridement and drainage. In recent years, the results of clinical research show that minimally invasive debridement such as video-assisted (laparoscope, nephroscope, endoscopy, etc.) and total laparoscopic debridement can significantly improve the prognosis of IPN patients. After a long period of clinical practice, laparoscope-assisted debridement was selected as the main surgical method in our center. In many large-scale clinical studies, patients after surgery underwent necrotic cavity lavage (such as small omental sac lavage, retroperitoneal space lavage, peripancreatic lavage, etc.), but its necessity and clinical significance were not clearly stated in the guidelines. At present, the clinical research mainly focuses on the improvement of minimally invasive debridement, and less on the necessity of lavage. In the past, necrotic cavity lavage was performed in IPN patients, but long-term clinical observation showed that lavage may lead to spread of infection and increase the incidence of lower extremity venous thrombosis which is not accorded with ERAS(Enhanced Recovery After Surgery). Therefore, since 2012, our center has stopped necrotic cavity lavage for IPN patients after debridement. We retrospectively analyzed the therapeutic effect from February 2014 to August 2017 and found that even without necrotic cavity lavage, better therapeutic effect could be achieved. Meanwhile it can simplify the operation process and avoid infection spread. This treatment method provides a new idea. However, it is a retrospective study not a randomized controlled trials(RCT) which is low effectiveness of proof. Therefore, we design this RCT to verify the necessity of necrotic cavity lavage after laparoscope-assisted debridement for patients with infected pancreatic necrosis.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of IPN
  • onset time of >4 weeks
  • performance of LAD for IPN
  • provision of written informed consent

排除标准

  • the highest temperature in 24 hours of ≥38.5ºC
  • new organ failure occurring within 24 hours after the operation
  • digestive tract fistula, biliary tract or digestive tract obstruction, or bleeding occurring within 24 hours after the operation
  • abdominal pressure of ≥10 mmHg within 24 hours after the operation
  • traumatic pancreatitis or a pancreatic fistula-related infection after the pancreatic operation

结局指标

主要结局

sum rate of mortality and major complications

时间窗: 1 year

number of deaths and major complications (new organ failure or intraperitoneal hemorrhage/gastrointestinal fistula requiring surgical treatment)/total enrollment

次要结局

  • Acute Physiology and Chronic Health Evaluation (range:0-71)(through study completion, an average of 2 months)
  • incidence of peritonitis and lower extremity deep vein thrombosis(through study completion, an average of 2 months)
  • Total stay in hospital(through study completion, an average of 2 months)
  • Length of stay in Intensive Care Unit(through study completion, an average of 2 months)
  • physiological parameter(through study completion, an average of 2 months)
  • assay index(through study completion, an average of 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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