Clinical trial NCT02041390: Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases
Official title: Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases: a Prospectively Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Message Service
Adherence
Stent Exchange
ERCP
Biliary Stricture
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 48
Sex: ALL
Minimum age (years): 80
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence rate of biliary stent removal/exchange
timeFrame: up to 1 year
Secondary outcomes:
measure: Stent-related adverse events
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
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