Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases

Study Overview
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Brief Summary
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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.

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

Conditions
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Short Message Service, Adherence, Stent Exchange, ERCP, Biliary Stricture

Intervention / Treatment
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* Other: SMS reminder
* Other: Conventional reminder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 80 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS group<br>Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation. | Other: SMS reminder<br>* Each month after stent implantation, one investigator sent a text massage by SMS to inform patients the necessity of regular stent removal/exchange and the disadvantage of delayed management, and to remind them the appropriate date back to the hospital for stent management. Patients were requested to response by SMS and were encouraged to contact with the investigator if they had any questions about stent management.<br>Other: Conventional reminder<br>* After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.<br>|
| Active Comparator: Conventional reminder group<br>Patients in control group will not receive additional SMS reminder monthly after stent implantation. | Other: Conventional reminder<br>* After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate of biliary stent removal/exchange | Percentage of patients adherence to stent removal/exchange within appropriate time (4 months for plastic stent or 7 months for covered stent). | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent-related adverse events | Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain, during follow. | up to 1 year |