NCT05038917

Brief Summary

Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

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

March 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

May 26, 2021

Last Update Submit

September 8, 2021

Conditions

Endoscopic Surgical Procedure

Keywords

Quality of recoveryHealth LiteracyModerate sedationDeep sedationAnesthesia

Outcome Measures

Primary Outcomes (3)

  • Dimensions of recovery recorded by Quality of Recovery 15 swedish version

    Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better

    Baseline (Day 0)

  • Dimensions of recovery recorded by Quality of Recovery 15 swedish version

    Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better

    Day 1

  • Dimensions of recovery recorded by Quality of Recovery 15 swedish version

    Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better

    Day 5

Secondary Outcomes (2)

  • Health literacy measured by the use of FHL (swedish version)

    Before procedure (Day 0)

  • Aborted or increased difficulty to performed the planned procedure

    From start of procedure to the end of it (Day 0)

Eligibility Criteria

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

Adult patients (≥18 years) scheduled for ERCP or/and EUS

You may qualify if:

  • Adult patients (≥18 years)
  • Patients cheduled for ERCP or/and EUS
  • Patients who have given their informed and written concent to participate

You may not qualify if:

  • Patients with
  • confusion
  • dementia
  • communication problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Linköping

Linköping, Östergötland County, 58183, Sweden

RECRUITING

Study Officials

  • Andreas o Nilsson, PhD

    Ljungsborg Haga 1

    STUDY CHAIR

Central Study Contacts

Andreas Nilsson, PhD

CONTACT

+46(0)704417975andreas.nilsson@regionostergotland.se

Sara Lyckner, PhD-stud

CONTACT

sara.lyckner@regionsormland.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior nurse anesthetist, Researcher, Principal Investigator

Study Record Dates

First Submitted

May 26, 2021

First Posted

September 9, 2021

Study Start

March 30, 2020

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

No sharing plans

Locations

SE(1)