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

Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases: a Prospectively Randomized, Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture; ERCP; Adherence; Short Message Service; Stent Exchange
• Intervention / Treatment: Other: SMS reminder; Other: Conventional reminder

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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 (4 months for plastic stent or 7 months for covered stent).	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent-related adverse events	Percentage of patients with stent-related adverse events, including cholangitis, stent migration and abdominal pain, during follow.	up to 1 year

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: January 18, 2014
• First Submitted That Met QC Criteria: January 18, 2014
• First Posted (ESTIMATE): January 22, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 18, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 20120920-5 (OTHER: Institutional Review Board of Xijing Hospital)