Short Message Service, Adherence, Stent Exchange, ERCP, Biliary Stricture
Conditions
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.
Interventions
OTHERSMS reminder
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.
OTHERConventional reminder
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
80 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate of biliary stent removal/exchange | 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
| Measure | Time frame | Description |
|---|---|---|
| Stent-related adverse events | up to 1 year | Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain, during follow. |
Countries
China
Outcome results
None listed