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Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

Primary Purpose

Cirrhosis, Chronic Hepatitis, Anxiety

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
transjugular liver biopsy
placebo
midazolam
midazolam + pethidine
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring liver, biopsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected liver disease
  • known liver disease

Exclusion Criteria:

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

Sites / Locations

  • Hopital Erasme - Dpt of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

midazolam

midazolam + pethidine

Outcomes

Primary Outcome Measures

Patient tolerance to the procedure

Secondary Outcome Measures

Full Information

First Posted
January 8, 2008
Last Updated
January 16, 2008
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00596414
Brief Title
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Official Title
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Erasme University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to receive either placebo or midazolam (0.02 mg/kg) or 0.02 mg/kg midazolam combined with 1 mg/kg pethidine before the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Chronic Hepatitis, Anxiety
Keywords
liver, biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
midazolam
Arm Title
3
Arm Type
Experimental
Arm Description
midazolam + pethidine
Intervention Type
Procedure
Intervention Name(s)
transjugular liver biopsy
Intervention Description
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Type
Drug
Intervention Name(s)
midazolam + pethidine
Primary Outcome Measure Information:
Title
Patient tolerance to the procedure
Time Frame
1 hour after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected liver disease known liver disease Exclusion Criteria: liver transplants hepatocellular carcinoma hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Facility Information:
Facility Name
Hopital Erasme - Dpt of Gastroenterology
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

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Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial

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