Device Development for a Diagnostic Procedure in Liver Diseases

Not Applicable

• Conditions: iver Cirrhosis; A03.620

• Registration Number: RBR-4n6rqyj
• Lead Sponsor: Instituto para O Desenvolvimento da Educação Ltda.

Brief Summary

Percutaneous liver biopsy is the gold standard technique for establishing the cause of cirrhosis and liver disease activity assessment. However, some cases of steatohepatitis or other chronic liver diseases show a high number of false negative results in samples obtained via the percutaneous route. This fact justifies performing a liver biopsy via the laparoscopic route. However, this is an expensive technique, with morbidities associated with pneumoperitoneum and anesthetic complications. The main objective of this study is to develop a video-assisted technique that uses only a minimally-invasive device for the liver biopsy and the optical trocar. Without additional trocars, this technique constitutes a less invasive procedure than the existing techniques in clinical practice. This is a device development and validation study and patients submitted to abdominal laparoscopic surgery and required liver biopsy for moderate to severe steatosis were recruited. The patients were randomized into two groups: laparoscopic liver biopsy technique (n = 10, control group) and mini-laparoscopic liver biopsy technique (n = 8, experimental group). The times associated with procedure performance in both groups were evaluated using the Mann-Whitney or Kruskal-Wallis tests according to data distribution. At baseline, there was no statistical difference regarding gender and type of surgery. The experimental group had a significantly shorter time compared to the mean procedure time (p = 0.003), biopsy time (p = 0.002) and hemostasis time (p = 0.003). The mini-laparoscopic biopsy device and technique showed to be capable of safely obtaining sufficient tissue sample, which was minimally invasive and in a shorter time than the classic technique.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-01
• Study Start: 2023-02-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with moderate to severe hepatic steatosis, submitted to abdominal laparoscopic surgery for another underlying disease; Patients who needed a liver biopsy for etiological confirmation or staging of disease activity

Exclusion Criteria

Refusal to participate in the study: Patients diagnosed with hepatocellular carcinoma (HCC) AND The following risk factors: Patients with INR > 1.8 and/or platelets < 70,000/mm3; Patients diagnosed with hepatocellular carcinoma (HCC); Patients with coagulopathy

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome: 44% reduction in painful symptoms and bleeding.;Outcome reached: 44% reduction in painful symptoms and bleeding.

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes planned.