CirrhosisPhase 4NCT00596414
Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
A Phase 4 study testing transjugular liver biopsy, midazolam and midazolam + pethidine in people with Cirrhosis and Chronic Hepatitis, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Chronic Hepatitis, Anxiety
- What is being tested?
- transjugular liver biopsy, midazolam and midazolam + pethidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- May 2003to Oct 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected liver disease
- known liver disease
Who cannot join
- liver transplants
- hepatocellular carcinoma
- hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cirrhosis, Chronic Hepatitis, Anxiety
- Being tested
- transjugular liver biopsy, placebo, midazolam, midazolam + pethidine
- Keywords
- liver, biopsy
- Medical subject headings
- Fibrosis, Hepatitis, Chronic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transjugular liver biopsyProcedure or surgery
liver biopsy through the transjugular route with hepatic-venous pressure gradient measurement
placeboDrug
midazolamDrug
midazolam + pethidineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Procedure: transjugular liver biopsy; Drug: placebo |
| 2 | Experimental | midazolam Receives: Procedure: transjugular liver biopsy; Drug: midazolam |
| 3 | Experimental | midazolam + pethidine Receives: Procedure: transjugular liver biopsy; Drug: midazolam + pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient tolerance to the procedure
Measured: 1 hour after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startMay 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596414
- Sponsor's protocol ID
- BHTJ-1
- Other IDs
- BHTJ-1
- Status last verified
- Dec 2007
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00596414
- Acronym / sponsor ID
- BHTJ-1
- Conditions
- Cirrhosis, Chronic Hepatitis, Anxiety
- Keywords
- liver, biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: transjugular liver biopsy, Drug: placebo |
| 2 | Experimental | Procedure: transjugular liver biopsy, Drug: midazolammidazolam |
| 3 | Experimental | Procedure: transjugular liver biopsy, Drug: midazolam + pethidinemidazolam + pethidine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected liver disease
- known liver disease
Key exclusion criteria (3 listed)
- liver transplants
- hepatocellular carcinoma
- hypersensitivity or allergy to benzodiazepines or morphinic derivatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transjugular liver biopsyliver biopsy through the transjugular route with hepatic-venous pressure gradient measurement | Procedure or surgery | 1, 2, 3 |
| placebo | Drug | 1 |
| midazolam | Drug | 2 |
| midazolam + pethidine | Drug | 3 |
Primary outcome
Patient tolerance to the procedure
Time frame: 1 hour after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transjugular liver biopsy, midazolam and midazolam + pethidine in people with Cirrhosis and Chronic Hepatitis, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient tolerance to the procedure (time frame: 1 hour after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2008.