NCT04915703

Brief Summary

Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. The onset of these symptoms results in hospital visits, opening of the external catheter of an internal external PTBD and re-interventions. The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset.

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3.1 years

First QC Date

June 1, 2021

Last Update Submit

August 1, 2022

Conditions

Bile Duct Obstruction

Keywords

bile ductobstruction

Outcome Measures

Primary Outcomes (1)

  • time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter

    time-to-symptom-onset

    12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

flushing of internal external PTBD catheter 3 times a day

Procedure: Flushing of PTBD catheter

Standard of Care

NO INTERVENTION

no flushing of PTBD catheter

Interventions

Flushing of PTBD catheterPROCEDURE

flushing of internal external PTBD catheter 3 times a day

Intervention

Eligibility Criteria

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

You may qualify if:

  • Patient with obstruction of the bile duct(s) planned for internal external PTBD;
  • Proficient in Dutch language;
  • Written informed consent.

You may not qualify if:

  • Age \< 18 years;
  • No informed consent;
  • Pregnancy;
  • Obstruction caused by gall stones;
  • External PTBD catheter (without internalization);
  • Patient has already a PTBD catheter;
  • More than 1 PTBD catheter is placed at intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

RECRUITING

MeSH Terms

Conditions

CholestasisBites and Stings

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • laurens Groenendijk

    Erasmus Medical Center

    STUDY DIRECTOR

Central Study Contacts

laurens Groenendijk

CONTACT

31 0 7033612l.groenendijk@erasmusmc.nl

Louise van Dijk

CONTACT

31 10 7033612imaging.trialbureau@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Non-blinded randomized controlled trial with 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 7, 2021

Study Start

June 1, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)