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临床试验/NCT02041390
NCT02041390已完成不适用

Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases: a Prospectively Randomized, Controlled Study

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Adherence rate of biliary stent removal/exchange

研究概览

简要总结

Endoscopic implantation of plastic or covered metal stents is widely used in a variety of benign pancreaticobiliary diseases, including duct stricture, large or difficult stones, bile or pancreatic juice leak, etc. There are some late-stage adverse events after stent insertion, such as stent occlusion, proximal or distal migration, secondary duct injury and failure of stent removal, etc. The longer the stents were inserted, more likely the adverse events would happen.

Although the optimal time of stent placement has not been well established, it has been recommended that plastic stent should be removed/exchanged within 3-4 months and covered metal stent be removed within 6 months. However, it was not uncommon that patients with stent implantation did not follow the recommendation of further stent management by endoscopists.

Many methods have been used to improve the adherence of patients in medical service. With the advance of mobile technology and popular use of mobile phones, it was believed that the patient-centered outcome could be improved by mobile telecommunication with the timely support of a patient by a health professional. Thus we hypothesize that mobile technology, reminding the patients the necessity of stent management in time by short message service (SMS), might increase the patient adherence in patients with benign pancreaticobiliary diseases after ERCP.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
80 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients more than 18 years old with plastic or covered stent implantation for the drainage of bile or pancreatic juice.

排除标准

  • primary or secondary sclerosing cholangitis;
  • malignant or suspected malignant stricture of biliary or pancreatic duct;
  • implantation of pancreatic duct stent for prevention of post-ERCP pancreatitis;
  • expected survival time less than 6 months;
  • plan of surgery within 6 months;
  • pregnant or lactating women;
  • patients who could not give informed consent.

结局指标

主要结局

Adherence rate of biliary stent removal/exchange

时间窗: up to 1 year

Percentage of patients adherence to stent removal/exchange within appropriate time (4 months for plastic stent or 7 months for covered stent).

次要结局

  • Stent-related adverse events(up to 1 year)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (1)

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