Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04750031
Other study ID # KouGasLVBx01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 1, 2021

Study information

Verified date February 2021
Source Kocaeli University
Contact Hasan Yilmaz
Phone +905058774821
Email gyrusus@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Liver biopsy is still used as the gold standard in the diagnosis of many liver diseases. The health practice notification (SUT) makes the diagnosis with liver biopsy mandatory for the treatment of chronic viral hepatitis (Chronic Hepatitis B Inf. And Chronic Hepatitis C Inf.). In daily gastroenterology practice, clinicians frequently perform a liver biopsy for the diagnosis of non-alcoholic fatty liver (NASH), and to a lesser extent, for the diagnosis of Wilson Disease and Hemochromatosis. During the observation after liver biopsy, patients are hospitalized on their right side, which is the biopsy side, with the argument that there will be less bleeding or bile leakage complications. Patients who do not develop complications after 4-6 hours of observation are discharged to their homes. (1) In this study, researchers aimed to investigate the post-biopsy position of patients who were referred to the clinic for liver biopsy, the rate of complications after biopsy, and to what extent the patients found the procedure acceptable according to their post-biopsy position.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Cronic hepatitis B Infection 2. Chronic hepatitis C Infection 3. NASH 4. DILI 5. Acute or chronic liver damage caused unknown aetiology Exclusion Criteria: 1.Refuse to give written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Kocaeli University Medical Faculty Hospital Izmit Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Complications Complications such as liver lickage ,bleeding, infection at biopsy site will be recorded within 2 weeks after the procedure
See also
  Status Clinical Trial Phase
Completed NCT05396820 - Adaptation of the Motor System to Experimental Pain N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Recruiting NCT06350084 - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05458037 - RCT of Pain Perception With Fast and Slow Tenaculum Application N/A
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Completed NCT06005480 - Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers Phase 1
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Completed NCT04851353 - Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures N/A
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Not yet recruiting NCT04523623 - Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries N/A
Not yet recruiting NCT04491630 - COping With PAin Through Hypnosis, Mindfulness and Spirituality N/A
Not yet recruiting NCT04062513 - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response N/A
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Completed NCT04659395 - How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block N/A