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临床试验/NCT04255095
NCT04255095Unknown不适用

Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Rehabilitation

研究概览

简要总结

The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.

详细描述

This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.

Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.
  • Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.

排除标准

  • Older than 75 or younger than
  • The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.

结局指标

主要结局

Rehabilitation

时间窗: 2 months

time from ERCP to ischarge

complication rate

时间窗: 1 months

Pancreatitis aggravation, hemorrhage,fistula

次要结局

  • death rate(postoperative period(1 month ))
  • LOS(length of stay)(postoperative period(1 month ))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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