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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Completed
CT.gov ID
NCT02041390
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
16
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SMS reminder
  • Other: Conventional reminder
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: SMS group

Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation.

Other: SMS 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.

Other: Conventional 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.
Active Comparator: Conventional reminder group

Patients in control group will not receive additional SMS reminder monthly after stent implantation.

Other: Conventional 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
80 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital of Digestive Diseases Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT02041390
Other Study ID Numbers:
  • 20120920-5
  • 20120920-5
First Posted:
Jan 22, 2014
Last Update Posted:
Jan 22, 2014
Last Verified:
Jan 1, 2014
Additional relevant MeSH terms:
Constriction, Pathologic

Study Results

No Results Posted as of Jan 22, 2014