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The study stopped as the used needle was difficult to maneuver in the corkscrew method being studied so no more participants were included.
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This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic mass | Experimental | Patients with pancreatic mass presenting for EUS-FNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-FNA with Corkscrew technique | Procedure |
| ||
| Expect 19 G Flex needle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Yield of the FNA Using Corkscrew Technique | Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouen A Khashab, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
A total of 4 participants were enrolled. However, 3 participants were excluded before being assigned to the study arm because the performing endoscopist didn't find it possible to do the procedure due to the unfavorable size of the mass or technical difficulty.
Patients were enrolled between 7/18/14 and 2/18/15 in an academic tertiary center
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| ID | Title | Description |
|---|---|---|
| FG000 | Pancreatic Mass | Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pancreatic Mass | Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events as a Measure of Safety | Posted | Number | participants | 30 days |
|
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| ||||||||||||||||||||||||||||
| Secondary | Diagnostic Yield of the FNA Using Corkscrew Technique | Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis. | Posted | Number | percentage of masses | 30 days |
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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 | Pancreatic Mass | Patients with pancreatic mass presenting for EUS-FNA EUS-FNA with Corkscrew technique Expect 19 G Flex needle | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mouen Khashab | Johns Hopkins Hospital | 443-287-1960 | mkhasha1@jhmi.edu |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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| Title | Denominators | Categories |
|---|
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