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Clinical Trials/NCT02041390
NCT02041390CompletedNot Applicable

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 site in 1 country48 target enrollmentStarted: September 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
Adherence rate of biliary stent removal/exchange

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
80 Years to 90 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Adherence rate of biliary stent removal/exchange

Time Frame: 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).

Secondary Outcomes

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

Investigators

Sponsor
Air Force Military Medical University, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yanglin Pan

Associated professor

Air Force Military Medical University, China

Study Sites (1)

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