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

Not Applicable

Completed

• Conditions: Adherence; ERCP; Biliary Stricture; Stent Exchange; Short Message Service
• Interventions: Other: SMS reminder; Other: Conventional reminder

• Registration Number: NCT02041390
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-10
• Status Verified: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-18
• Study First Submitted QC: 2014-01-18
• Last Update Submitted: 2014-01-18
• Study First Posted: 2014-01-22
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS group	SMS reminder	Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation.
Conventional reminder group	Conventional reminder	Patients in control group will not receive additional SMS reminder monthly after stent implantation.
SMS group	Conventional reminder	Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China