NCT05220774

Brief Summary

Studies directly comparing EDCS with AAS during ERCP are scarce, varying widely in their designs and reaching conflicting conclusions regarding safety and effectiveness. The investigators will assess, via a multi-center prospective study, the success, adverse event rates, and patient tolerability of ERCP when performed under AAS versus EDCS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,174

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

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

October 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

4.9 years

First QC Date

November 30, 2021

Last Update Submit

January 5, 2024

Conditions

ERCP

Outcome Measures

Primary Outcomes (1)

  • procedural success of ERCP

    Defined using a previously published set of a priori criteria by indication (Forbes et al. BMC Gastroenterology 2020; 20:64).

    1 day

Secondary Outcomes (4)

  • post-ERCP pancreatitis

    30 days

  • post-ERCP bleeding

    30 days

  • post-ERCP cholangitis

    30 days

  • patient tolerability

    1 day

Study Arms (2)

anesthetist-administered sedation (AAS)

Patients undergoing ERCP and receiving AAS

endoscopist-directed conscious sedation (EDCS)

Patients undergoing ERCP and receiving EDCS

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to a hospital-based endoscopy unit for consideration of ERCP.

You may qualify if:

  • Subject referred for ERCP for biliary indication;
  • Subject has not undergone prior ERCP, sphincterotomy, and/or sphincteroplasty;
  • Subject age 18 years or older;
  • Subject able to give informed consent to involvement be included.

You may not qualify if:

  • Subject has a standard contraindication to ERCP;
  • Subject or surrogate unable or unwilling to provide informed consent;
  • Subject age \< 18 years;
  • Pancreatic indication for ERCP;
  • Morbid obesity;
  • Known history of difficult sedation and/or failed medical procedure(s), endoscopy or other, using EDCS;
  • Planned cholangioscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter Lougheed Hospital

Calgary, Alberta, Canada

Location

Study Officials

  • Nauzer Forbes, MD, MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

February 2, 2022

Study Start

October 1, 2018

Primary Completion

August 30, 2023

Study Completion

November 30, 2023

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Deidentified aggregate-level data may be available upon reasonable request.

Locations

CA(1)