Sedation and Analgesia for Transjugular Liver Biopsy: A R... | NCT00596414

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

NCT00596414

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Jan 17, 2008Estimated

Enrollment

180Actual

Phase

Phase 4

Conditions

Cirrhosis
Chronic Hepatitis
Anxiety

Interventions

transjugular liver biopsy
placebo
midazolam
midazolam + pethidine

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BHTJ-1

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Jan 8, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2008

Last Update Posted Date

Jan 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Procedure: transjugular liver biopsy Drug: placebo
2	Experimental	midazolam	Procedure: transjugular liver biopsy Drug: midazolam
3	Experimental	midazolam + pethidine	Procedure: transjugular liver biopsy Drug: midazolam + pethidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transjugular liver biopsy	Procedure	liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient tolerance to the procedure		1 hour after the procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected liver disease
known liver disease

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Erasme - Dpt of Gastroenterology		Brussels		1070	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006521	Hepatitis, Chronic
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006505	Hepatitis
D008107	Liver Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam
D008614	Meperidine

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided