Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

Study Overview
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Brief Summary
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Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients does not follow the recommendation for further stent management after ERCP. we hopothesized that short message service (SMS) intervention monthly could improve the adherence in patients with benign pancreaticobiliary after ERCP.

Official Title
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Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

Conditions
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Healthy

Intervention / Treatment
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* Other: short message service group
* Other: conventional group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be able to communicate via SMS by mobile phones of themselves or relatives living together Exclusion Criteria: primary or secondary sclerosing cholangitis (PSC) malignant or suspected malignant stricture of biliary or pancreatic duct implantation of pancreatic duct (PD) 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: 18 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: short message service group<br>Patients in this arm received conventional instructions plus short message reminder. | Other: short message service group<br>* Each month after stent implantation, the investigator sent a text message 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 to come back to the hospital for stent management. Patients were requested to respond by SMS and were encouraged to contact the investigator if they had any questions about stent management. Besides, patients received conventional reminder:After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.<br>|
| Active Comparator: conventional group<br>Patients in this arm just received conventional instructions. | Other: conventional group<br>* After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.<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 | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent-associated adverse event | Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short message service; adherence; stent exchange; ERCP