NCT02810379

Brief Summary

To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

April 25, 2016

Last Update Submit

June 19, 2016

Conditions

Consent Forms of ERCP

Keywords

informed consentERCPvideo

Outcome Measures

Primary Outcomes (2)

  • time for informed consent practices before ERCP

    2 days

  • time for extra explanation about ERCP

    2 days

Secondary Outcomes (1)

  • satisfaction degree about the informed consent practices

    2 days

Other Outcomes (1)

  • anxiety level after the informed consent practices

    2 days

Study Arms (2)

written informed consent

PLACEBO COMPARATOR

participants read the written informed consent documents befor ERCP

Procedure: written informed consent

video+written informed consent

EXPERIMENTAL

participants watch a video about the ERCP and read the written informed consent documents before ERCP

Procedure: video+written informed consent

Interventions

written informed consentPROCEDURE
written informed consent
video+written informed consentPROCEDURE
video+written informed consent

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All inpatients who will receive ERCP

You may not qualify if:

  • under 18 years or more than 70 years
  • pregnancy or breast-feeding women
  • circulatory and respiratory disorders
  • mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (1)

  • Xia T, Zhu YB, Zeng YB, Chen C, Wang SL, Zhao SB, Su XJ, Wang D, Yao J, Li ZS, Bai Y. Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial. J Dig Dis. 2019 Dec;20(12):656-662. doi: 10.1111/1751-2980.12824. Epub 2019 Nov 21.

    PMID: 31618520DERIVED

Study Officials

  • Zhaoshen Li, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

+86-21-25070552zhaoshenlismmu@gmail.com

Yu Bai, MD

CONTACT

+86-13564665324baiyu1998@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept.

Study Record Dates

First Submitted

April 25, 2016

First Posted

June 23, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

CN(1)