NCT04750031

Brief Summary

Liver biopsy is still used as the gold standard in the diagnosis of many liver diseases. During the observation after liver biopsy, patients are hospitalized on their right side, which is the biopsy side, with the thought that adverse events (complications) such as bleeding or bile leakage will be less. Patients who do not develop complications after 4-6 hours of observation are discharged home. Some of the patients state that the right side-lying position for 4-6 hours is uncomfortable than the biopsy itself, and they prefer to lie on their back. In our study, researchers aim to investigate the rate of complications after biopsy, what recovery position found more acceptable by the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

February 6, 2021

Last Update Submit

February 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Patient reported pain scores will be assesed by visual analog scale, minimum score "0" refers no pain and "10" refers worst pain

    Immediately after the procedure

Secondary Outcomes (1)

  • Complications

    within 2 weeks after the procedure

Interventions

Liver BiopsyPROCEDURE

Liver biopsy is a procedure to obtain small amount of liver by a needle.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute and chronic liver damaged patients

You may qualify if:

  • Cronic hepatitis B İnfection
  • Chronic hepatitis C İnfection
  • NASH
  • DILI
  • Acute or chronic liver damage caused unknown aetiology

You may not qualify if:

  • Refuse to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty Hospital

İzmit, Kocaeli, 41001, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Costa RS, Cardoso AF, Ferreira A, Costa J, Costa D, Fernandes D, Caetano AC. What recovery position should patients adopt after percutaneous liver biopsy? Eur J Gastroenterol Hepatol. 2019 Feb;31(2):253-259. doi: 10.1097/MEG.0000000000001290.

MeSH Terms

Conditions

Acute PainLiver Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 11, 2021

Study Start

January 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Anonymised pain scores and descriptive data

Shared Documents
CSR, ANALYTIC CODE
Time Frame
Data will be shared 3 months after the last patient recruited and it will be available 1 year.
Access Criteria
publicly aviable

Locations