Liver Diseases
Conditions
Brief 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).
Detailed 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. .
Interventions
DIAGNOSTIC_TESTCore Liver Biopsy
Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
Sponsors
Parkview Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
prospective, randomized, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Yield Fragmentation | At day 7 post biopsy | 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. |
| Pathological Yield Length | At time of completion of pathology report | 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. |
| Pathological Yield Quantity | At time of completion of pathology report | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | Complications occurring at time of consent, at procedure time and at day 7 post procedure | Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 -Modified Wet Suction Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease. | 75 |
| Arm 2- Slow Pull Intervention: Procedure Core Liver Biopsy Technique: Slow Pull
Core Liver Biopsy: Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease. | 78 |
| Total | 153 |
Baseline characteristics
| Characteristic | Arm 1 -Modified Wet Suction | Arm 2- Slow Pull | Total |
|---|---|---|---|
| Age, Continuous | 55.1 years | 56.6 years | 55.85 years |
| Anticoagulants/Antiplatelet Therapy | 20 Participants | 17 Participants | 37 Participants |
| Diabetic | 27 Participants | 23 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 71 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Hypertension | 37 Participants | 39 Participants | 76 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 12 Participants |
| Race (NIH/OMB) White | 65 Participants | 66 Participants | 131 Participants |
| Region of Enrollment United States | 75 participants | 76 participants | 153 participants |
| Sex: Female, Male Female | 60 Participants | 44 Participants | 104 Participants |
| Sex: Female, Male Male | 15 Participants | 34 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 78 |
| other Total, other adverse events | 13 / 75 | 10 / 78 |
| serious Total, serious adverse events | 7 / 75 | 2 / 78 |
Outcome results
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.
Time frame: At day 7 post biopsy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1 -Modified Wet Suction | Pathological Yield Fragmentation | Length of Longest Fragment- Right Lobe | 13 mm |
| Arm 1 -Modified Wet Suction | Pathological Yield Fragmentation | Length of Longest Fragment- Left Lobe | 14 mm |
| Arm 2- Slow Pull | Pathological Yield Fragmentation | Length of Longest Fragment- Left Lobe | 11 mm |
| Arm 2- Slow Pull | Pathological Yield Fragmentation | Length of Longest Fragment- Right Lobe | 10 mm |
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.
Time frame: At time of completion of pathology report
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1 -Modified Wet Suction | Pathological Yield Length | Total Length of Fragments-Right Lobe | 38 mm |
| Arm 1 -Modified Wet Suction | Pathological Yield Length | Total Length of Fragments - Left Lobe | 46.5 mm |
| Arm 2- Slow Pull | Pathological Yield Length | Total Length of Fragments - Left Lobe | 34.5 mm |
| Arm 2- Slow Pull | Pathological Yield Length | Total Length of Fragments-Right Lobe | 28 mm |
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.
Time frame: At time of completion of pathology report
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1 -Modified Wet Suction | Pathological Yield Quantity | Total Number of Portal Tracts Left Lobe | 16 Number of portal tracts |
| Arm 1 -Modified Wet Suction | Pathological Yield Quantity | Total Number of Portal Tracts Right Lobe | 14 Number of portal tracts |
| Arm 2- Slow Pull | Pathological Yield Quantity | Total Number of Portal Tracts Left Lobe | 11.5 Number of portal tracts |
| Arm 2- Slow Pull | Pathological Yield Quantity | Total Number of Portal Tracts Right Lobe | 12 Number of portal tracts |
Secondary
Complications
Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
Time frame: Complications occurring at time of consent, at procedure time and at day 7 post procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 -Modified Wet Suction | Complications | Minor Adverse Events Grade 1 | 10 Number of Adverse Events |
| Arm 1 -Modified Wet Suction | Complications | Minor Adverse Events Grade 2 | 1 Number of Adverse Events |
| Arm 1 -Modified Wet Suction | Complications | Minor Adverse Events Grade 3 | 2 Number of Adverse Events |
| Arm 1 -Modified Wet Suction | Complications | Serious Adverse Events Grade 1 | 7 Number of Adverse Events |
| Arm 2- Slow Pull | Complications | Serious Adverse Events Grade 1 | 2 Number of Adverse Events |
| Arm 2- Slow Pull | Complications | Minor Adverse Events Grade 1 | 4 Number of Adverse Events |
| Arm 2- Slow Pull | Complications | Minor Adverse Events Grade 3 | 2 Number of Adverse Events |
| Arm 2- Slow Pull | Complications | Minor Adverse Events Grade 2 | 4 Number of Adverse Events |