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

NCT02041390 | Completed DMC

• 1 other identifier: 20120920-5
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Message Service; Adherence; Stent Exchange; ERCP; Biliary Stricture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stent-related adverse events

  up to 1 year

Study Arms (2)

SMS group

EXPERIMENTAL

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

Other: SMS reminder; Other: Conventional reminder

Conventional reminder group

ACTIVE COMPARATOR

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

Other: Conventional reminder

Interventions

SMS reminder OTHER

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.

SMS group

Conventional reminder OTHER

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.

Conventional reminder group; SMS group

Eligibility Criteria

• Age: 80 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients more than 18 years old with plastic or covered stent implantation for the drainage of bile or pancreatic juice.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

• 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.

  PMID: 21365514 BACKGROUND

• 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.

  PMID: 23410693 BACKGROUND

• 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.

  PMID: 21470603 BACKGROUND

• 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.

  PMID: 21071074 BACKGROUND

• 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.

  PMID: 23503044 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: January 18, 2014
• First Posted: January 22, 2014
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

CN (1)