NCT02831127

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

July 10, 2016

Last Update Submit

July 10, 2016

Conditions

Healthy

Keywords

short message service; adherence; stent exchange; ERCP

Outcome Measures

Primary Outcomes (1)

  • Adherence rate of biliary stent removal/exchange

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

    up to 1 year

Secondary Outcomes (1)

  • Stent-associated adverse event

    1 year

Study Arms (2)

short message service group

EXPERIMENTAL

Patients in this arm received conventional instructions plus short message reminder.

Other: short message service group

conventional group

ACTIVE COMPARATOR

Patients in this arm just received conventional instructions.

Other: conventional group

Interventions

short message service groupOTHER

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.

short message service group
conventional groupOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

Related Publications (1)

  • Gu Y, Wang L, Zhao L, Liu Z, Luo H, Tao Q, Zhang R, He S, Wang X, Huang R, Zhang L, Pan Y, Guo X. Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study. BMC Gastroenterol. 2016 Aug 26;16(1):105. doi: 10.1186/s12876-016-0522-4.

    PMID: 27565717DERIVED

Study Officials

  • Yanglin Pan, MD

    Xijing Hospital of Disgestive Diseases.The Fourth Military University

    PRINCIPAL INVESTIGATOR

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

July 10, 2016

First Posted

July 13, 2016

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 13, 2016

Record last verified: 2016-07

Locations

CN(1)