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OpenTrials
Completed

NCT Number: NCT02831127

Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients does not follow the recommendation for further stent management after ERCP. we hopothesized that short message service (SMS) intervention monthly could improve the adherence in patients with benign pancreaticobiliary after ERCP.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be able to communicate via SMS by mobile phones of themselves or relatives living together

Exclusion criteria

  • primary or secondary sclerosing cholangitis (PSC)
  • malignant or suspected malignant stricture of biliary or pancreatic duct
  • implantation of pancreatic duct (PD) 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.

Treatment and study plan

short message service group

Other

Each month after stent implantation, the investigator sent a text message 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 to come back to the hospital for stent management. Patients were requested to respond by SMS and were encouraged to contact the investigator if they had any questions about stent management. Besides, patients received conventional reminder:After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.

Conventional Group

Other

After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.

Primary outcomes

  1. Adherence rate of biliary stent removal/exchange

    Time frame: up to 1 year

    Percentage of patients adherence to stent removal/exchange within appropriate time

Secondary outcomes

  1. Stent-associated adverse event

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2016
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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