Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.
The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19G FNA needle | Active Comparator | Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy. |
|
| 25G FNA needle | Active Comparator | Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic Biopsy | Procedure | A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Passes to Establish Diagnosis | To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procurement of Histological Samples | The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined. | 30 days |
| Needle Dysfunction |
Not provided
INCLUSION CRITERIA:
(1) Patients with solid pancreatic mass lesions.
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| shyam varadarajulu, MD | Florida Hospital Center for Interventional Endoscopy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Florida Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 19G FNA Needle | 19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures |
| FG001 | 25G FNA Needle | 25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 19G FNA Needle | Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy. Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes. Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Median Number of Passes to Establish Diagnosis | To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types. | Posted | Median | Inter-Quartile Range | No. of passes | 5 months |
|
10 days
Telephone follow up conducted at 24 hours and 10 days post-procedure
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 19G FNA Needle | 19G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding and fever | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shyam Varadarajulu, MD | Center for Interventional Endoscopy, Florida Hospital | 407-303-2570 | svaradarajulu@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Histological Samples | Procedure | The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed. |
|
The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.
| 2 hours |
| Complications | The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation. | 30 days |
| Orlando |
| Florida |
| 32814 |
| United States |
| BG001 | 25G FNA Needle | Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy. Pancreatic Biopsy: A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes. Histological Samples: The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Procurement of Histological Samples | The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined. | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Needle Dysfunction | The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient. | Posted | Number | percentage of participants | 2 hours |
|
|
|
| Secondary | Complications | The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation. | Posted | Number | percentage of participants | 30 days |
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| EG001 | 25G FNA Needle | 25G needle was used for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures | 0 | 36 | 0 | 36 |
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |