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

Primary Purpose

Short Message Service, Adherence, Stent Exchange

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SMS reminder
Conventional reminder
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Short Message Service

Eligibility Criteria

80 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMS group

Conventional reminder group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Stent-related adverse events
Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain, during follow.

Full Information

First Posted
January 18, 2014
Last Updated
January 18, 2014
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02041390
Brief Title
Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Message Service, Adherence, Stent Exchange, ERCP, Biliary Stricture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS group
Arm Type
Experimental
Arm Description
Patients in SMS group will receive reminding by additional SMS messages monthly after stent implantation.
Arm Title
Conventional reminder group
Arm Type
Active Comparator
Arm Description
Patients in control group will not receive additional SMS reminder monthly after stent implantation.
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional reminder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence rate of biliary stent removal/exchange
Description
Percentage of patients adherence to stent removal/exchange within appropriate time (4 months for plastic stent or 7 months for covered stent).
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Stent-related adverse events
Description
Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain, during follow.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21365514
Citation
Tuvignon N, Liguory C, Ponchon T, Meduri B, Fritsch J, Sahel J, Boyer J, Legoux JL, Escourrou J, Boustiere C, Arpurt JP, Barthet M, Tuvignon P, Bommelaer G, Ducot B, Prat F. Long-term follow-up after biliary stent placement for postcholecystectomy bile duct strictures: a multicenter study. Endoscopy. 2011 Mar;43(3):208-16. doi: 10.1055/s-0030-1256106. Epub 2011 Mar 1.
Results Reference
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PubMed Identifier
23410693
Citation
ASGE Technology Assessment Committee; Pfau PR, Pleskow DK, Banerjee S, Barth BA, Bhat YM, Desilets DJ, Gottlieb KT, Maple JT, Siddiqui UD, Tokar JL, Wang A, Song LM, Rodriguez SA. Pancreatic and biliary stents. Gastrointest Endosc. 2013 Mar;77(3):319-27. doi: 10.1016/j.gie.2012.09.026. Erratum In: Gastrointest Endosc. 2013 Jul;78(1):193-5.
Results Reference
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PubMed Identifier
21470603
Citation
Kasher JA, Corasanti JG, Tarnasky PR, McHenry L, Fogel E, Cunningham J. A multicenter analysis of safety and outcome of removal of a fully covered self-expandable metal stent during ERCP. Gastrointest Endosc. 2011 Jun;73(6):1292-7. doi: 10.1016/j.gie.2011.01.043. Epub 2011 Apr 5.
Results Reference
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PubMed Identifier
21071074
Citation
Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
Results Reference
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PubMed Identifier
23503044
Citation
Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.
Results Reference
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Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases

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