NCT00596414

Brief Summary

Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown. The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or without conscious sedation/analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2003

Typical duration for phase_4

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

May 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
Last Updated

January 17, 2008

Status Verified

December 1, 2007

Enrollment Period

2.4 years

First QC Date

January 8, 2008

Last Update Submit

January 16, 2008

Conditions

CirrhosisChronic HepatitisAnxiety

Keywords

liverbiopsy

Outcome Measures

Primary Outcomes (1)

  • Patient tolerance to the procedure

    1 hour after the procedure

Study Arms (3)

1

PLACEBO COMPARATOR
Procedure: transjugular liver biopsyDrug: placebo

2

EXPERIMENTAL

midazolam

Procedure: transjugular liver biopsyDrug: midazolam

3

EXPERIMENTAL

midazolam + pethidine

Procedure: transjugular liver biopsyDrug: midazolam + pethidine

Interventions

transjugular liver biopsyPROCEDURE

liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement

123
placeboDRUG
1
midazolamDRUG
2
midazolam + pethidineDRUG
3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suspected liver disease
  • known liver disease

You may not qualify if:

  • liver transplants
  • hepatocellular carcinoma
  • hypersensitivity or allergy to benzodiazepines or morphinic derivatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme - Dpt of Gastroenterology

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

FibrosisHepatitis, ChronicAnxiety Disorders

Interventions

MidazolamMeperidine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

May 1, 2003

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

January 17, 2008

Record last verified: 2007-12

Locations

BE(1)