Biliary Stricture Clinical Trial
Official title:
Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases: a Prospectively Randomized, Controlled Study
Verified date | January 2014 |
Source | Fourth Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | January 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 80 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
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. Review. Erratum in: Gastrointest Endosc. 2013 Jul;78(1):193-5. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | Yes |
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