Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

Liver Diseases Clinical Trial

— BLOCS  

Official title:

Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245580
• Other study ID #: PRC17-0714
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: March 2022
• Source: Parkview Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).

Description:

Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver.

Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.

• History of abnormal LFTs

• Documented history of chronic liver disease

• Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder

• Fatty liver disease

• Subjects 18 years of age or older

• Subject must be able to hold anticoagulants as per institutional standard of care

• Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia.

• Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent

• Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included.

Exclusion Criteria

• Subjects that are unable to tolerate anesthesia for the procedure

• Subjects 17 or under

• Subjects whose anticoagulants cannot be held

• Subjects who cannot have or refuse EUS guided procedure

• Subjects who are pregnant

• INR >1.5

• Platelets 50,000 or less

• Subjects requiring control of bleeding on initial upper endoscopy

• Subjects requiring endoscopic mucosal resection

• Subjects with large volume ascites

• Subjects requiring pancreatic biopsies

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Diagnostic Test:
• Core Liver Biopsy
Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Parkview Regional Medical Center	Fort Wayne	Indiana
United States	Baylor Medical Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University South Alabama	Mobile	Alabama
United States	Oschner Health System	New Orleans	Louisiana
United States	Santa CLara Valley Medical Center	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Parkview Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Yield Fragmentation	To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.	At day 7 post biopsy
Primary	Pathological Yield Length	To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.	At time of completion of pathology report
Primary	Pathological Yield Quantity	To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.	At time of completion of pathology report
Secondary	Complications	Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.	Complications occurring at time of consent, at procedure time and at day 7 post procedure