Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet TechniqueNCT06833619
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
A study testing Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique in people with Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique, run by Sohag University at 1 site in Egypt.
Trial summary
Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
- What is being tested?
- Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test
Who cannot join
- Using anti-platelets or anticoagulants within the last 5days
- Inability to provide informed consent
- Moderate-to-gross ascites
- Child C cirrhosis
- INR more than 2.01
- Platelet count less than 50,000/µL3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Sara Elbadry Elrabie, master, 01147045010
About this study
Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.
Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.
However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).
- Being tested
- Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet TechniqueDevice
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique | Other | Not described Receives: Device: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
Measurement the efficacy of liver biopsy specimens by European Association for the Study of Liver Disease (EASL) criteria .
- Total Specimen Length (TSL) of more than or equal to 15 mile-meters.
Measured: -Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Dec 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet TechniqueStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Elbadry Elrabie, Sohag University
- Investigators
- Sara Elbadry Eirabie, master, Study director, Sohag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833619
- Sponsor's protocol ID
- Soh-Med-24-12---6MD
- Status last verified
- Feb 2025
- First submitted
- 18 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
- ClinicalTrials.gov ID
- NCT06833619
- Acronym / sponsor ID
- Soh-Med-24-12---6MD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- 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.
Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.
Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.
However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique | Other | Device: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test
Key exclusion criteria (6 listed)
- Using anti-platelets or anticoagulants within the last 5days
- Inability to provide informed consent
- Moderate-to-gross ascites
- Child C cirrhosis
- INR more than 2.01
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 |
|---|---|---|
| Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet TechniqueEfficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique | Device | Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique |
Primary outcome
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique
Time frame: -Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.
Measurement the efficacy of liver biopsy specimens by European Association for the Study of Liver Disease (EASL) criteria . - Total Specimen Length (TSL) of more than or equal to 15 mile-meters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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.
Sara Elbadry Eirabie, master study director
Sohag
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique in people with Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Elbadry Elrabie, master (01023941334, elbadrysara615@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique (time frame: -Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.). 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 19 Feb 2025.