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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).
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. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 -modified wet suction | Other | Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction |
|
| Arm 2- Slow Pull | Other | Intervention: Procedure Core Liver Biopsy Technique: Slow Pull |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Liver Biopsy | Diagnostic Test | Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Neil R Sharma, MD | parkview cancer institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University South Alabama | Mobile | Alabama | 36608 | United States | ||
| Santa CLara Valley Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Arm 2- Slow Pull |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | mm | At day 7 post biopsy | Total number liver biopsy specimens | Total number liver biopsy specimens |
|
Data collected for one week following procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Zelt RN | Parkview Mirro Research Center | 2602664153 | christina.zelt@parkview.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2020 | Dec 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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prospective, randomized, multicenter study
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| San Jose |
| California |
| 95128 |
| United States |
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Oschner Health System | New Orleans | Louisiana | 70121 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Baylor Medical Center | Houston | Texas | 77030 | United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetic | Count of Participants | Participants |
|
| Anticoagulants/Antiplatelet Therapy | Count of Participants | Participants |
|
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. |
|
|
| 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. | Posted | Mean | Full Range | mm | At time of completion of pathology report | Number of liver biopsy specimens | Number of liver biopsy specimens |
|
|
|
| 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. | Posted | Mean | Full Range | Number of portal tracts | At time of completion of pathology report | Number of liver biopsy specimens | Number of liver biopsy specimens |
|
|
|
| Secondary | Complications | Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4. | Posted | Number | Number of Adverse Events | Complications occurring at time of consent, at procedure time and at day 7 post procedure |
|
|
|
| 0 |
| 75 |
| 7 |
| 75 |
| 13 |
| 75 |
| EG001 | 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. | 0 | 78 | 2 | 78 | 10 | 78 |
| Pancreatitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Intraabdominal Hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fever | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Flank Pain | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment | Fall from bed |
|
| Bronchial Infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
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| Minor Adverse Events Grade 3 |
|
| Serious Adverse Events Grade 1 |
|